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All Menopause (HRT) treatment

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Climagest Tablets 2mg
Pack Size: 84 tablets
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  1. ) How to take Climagest

    Always use this medicine exactly as your doctor has told you. Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough. During the treatment your doctor may adjust the dose according to your individual needs.

    When to start treatment

    Climagest is a continuous sequential HRT. This means that oestrogen is given continuously, and progestogen is added for 12 days of the cycle.
    ? If you are not currently taking HRT and still having periods, it is

    advisable to take the first tablet on the first day of your period (first day of the bleed) unless your doctor tells you otherwise. If your periods are infrequent, or have stopped, your doctor may suggest that you start immediately.

    ? If you are changing from a sequential HRT or cyclic HRT, you should complete your treatment cycle and then start taking Climagest immediately.

    ? If you are changing from a continuous combined HRT and your periods have stopped, you can start taking Climagest at any time. If you still have periods, start taking Climagest on the first day of your period.

    How to take Climagest
    Take one tablet each day by following the sequence of numbers and arrows on the calendar pack.
    Swallow your tablets whole with a glass of water.
    The pack has been designed specifically to help you take the tablets correctly.
    Write the name of the day you take your first tablet in the box below. For example, if you start your tablets on a Wednesday, then write “Wednesday” in the box. This day will also be the day on which you will take tablets 8, 15 and 22. This will help you check that you have taken each tablet on the right day. 

    1. When you finish one blister pack, start the new one the next day whether or not you experience bleeding. This will normally be the same day of the week as you started the previous blister pack. Do not take a break between blister packs unless your doctor tells you.

      The tablets are best taken at the same time every day; try to get into a routine.
      Follow your doctor’s instructions as to how and when you should take Climagest tablets and never change the dose yourself, however well you feel.

      If you are unsure about how much medicine to take or when to take it, ask your doctor or pharmacist.

      How long to take Climagest

      From time to time, you will need to discuss with your doctor the possible risks and benefits associated with Climagest and whether you still need the treatment. It is important that you take the lowest possible effective dose and only for as long as needed.

      If you have taken more Climagest than you should

      Contact your doctor or pharmacist immediately if you have taken too much Climagest.

      If you forget to take Climagest

      If you forget to take a tablet at your usual time, try to take it within 12 hours. If this is not possible, leave the forgotten tablet and continue to take the remaining tablets at the usual time.

      If you need to have surgery

      If you are going to have surgery, tell the surgeon that you are taking Climagest. You may need to stop taking Climagest about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Climagest again.

      If you stop taking Climagest

      Stopping Climagest may increase the risk of breakthrough bleeding or spotting. If this occurs after you stop treatment, contact your doctor immediately. Your doctor will need to work out the reasons for this.
      After a long treatment break, consult your doctor before starting to take Climagest again.

      If you have any further questions on the use of this product, ask your doctor or pharmacist. 

Climagest is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. Climagest is used in postmenopausal women with at least 6 months since their last natural period.

Oestradiol valerate is identical to the natural female hormone oestrogen. This hormone is produced by the ovaries before the menopause. Norethisterone belongs to the group of hormones known as progestogens. It has effects similar to the natural female hormone progesterone, also produced by the ovaries before the menopause.

Climagest is used for:

Relief of symptoms occurring after menopause

Menopause occurs naturally in all women, usually between the ages of 45 and 55 years. It occurs also in younger women who have their ovaries removed by surgery.
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause unpleasant symptoms such as hot face, neck and chest (“hot flushes”), sleep problems, irritability and depression. Some women also have problems with urine control or dryness of the vagina, which may cause discomfort during or after sexual intercourse.

Climagest alleviates these symptoms after menopause. You will only be prescribed Climagest if your symptoms seriously hinder your daily life.
If oestrogen is taken on its own, there is a greater risk of abnormal growth of the womb lining (endometrial hyperplasia) and endometrial cancer. The norethisterone in the white Climagest tablet reduces these risks in women who still have their womb. 

  1. The following diseases are reported more often in women using HRT compared to women not using HRT:

    • ?  breast cancer

    • ?  abnormal growth or cancer of the lining of the womb (endometrial

      hyperplasia or cancer)

    • ?  ovarian cancer

    • ?  blood clots in the veins of the legs or lungs (venous thromboembolism)

    • ?  heart disease

    • ?  stroke

    • ?  probable memory loss if HRT is started over the age of 65 

Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) Climagest, your doctor will ask you about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary. He/she should tell you what kind of changes in the breast you should look out for and may advise you to have a breast X-ray (a mammogram).
Once you have started on Climagest you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Climagest.
Go for regular breast screening, as recommended by your doctor.

Do not take Climagest

If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Climagest,

  • ?  if you have or have ever had breast cancer, or if you are suspected of

    having it;

  • ?  if you have cancer which is sensitive to oestrogens, such as cancer of

    the womb lining (endometrium), or if you are suspected of having it;

  • ?  if you have any unexplained vaginal bleeding;

  • ?  if you have excessive thickening of the womb lining (endometrial

    hyperplasia) that is not being treated;

  • ?  if you have severe kidney disease;

  • ?  if you have or have ever had a blood clot in a vein (thrombosis), such as

    in the legs (deep venous thrombosis) or the lungs (pulmonary embolism);

  • ?  if you have a blood clotting disorder (such as protein C, protein S, or

    antithrombin deficiency);

  • ?  if you have or recently have had a disease caused by blood clots in the

    arteries, such as a heart attack, stroke or angina;

  • ?  if you have or have ever had a liver disease and your liver function tests

    have not returned to normal;

  • ?  if you have a rare blood problem called “porphyria” which is passed down

    in families (inherited);

  • ?  if you are allergic (hypersensitive) to oestradiol valerate or norethisterone

    or any of the other ingredients of Climagest (listed in section 6);

  • ?  if you are pregnant, or think you might be.

If any of the above conditions appear for the first time while taking Climagest, stop taking it at once and consult your doctor immediately. 

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Climaval Tablets 1mg
Pack Size: 84 tablets
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Take one tablet each day by following the numbers and arrows on the calendar pack. Swallow your tablets whole with a glass of water. Note the day you first took your tablet. The tablets are best taken at the same time every day.

Climaval (Estradiol Valerate) tablets is used for a hormone replacement therapy (commonly known as HRT). It contains the female hormone Oestrogen. Oestradiol valerate is identical to the natural female hormone Oestrogen. This hormone is produced by the ovaries before the menopause. Climaval is used for the relief of symptoms occurring after menopause.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Breakthrough bleeding and spotting.
  • Breast pain, tenderness or enlargement.
  • Headache/migraine.
  • Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion.
  • Leg cramps.
  • Fatigue.
  • Weight gain.
  • Vaginal discharge.
  • Depression.
  • Anxiety.
  • Dizziness.
  • Changes in sex drive.
  • Rise in blood pressure.
  • Gall bladder disease.
  • Swelling of the ankles due to to fluid retention (peripheral oedema).
  • Skin reactions such as rash and itch.
  • Steepening of corneal curvature, which may make contact lenses uncomfortable.
  • Premenstrual-like symptoms.
  • Disturbance in liver function.
  • Irregular brown patches on the skin, usually of the face (chloasma).
  • Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above).

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.



Keep out of the reach and sight of children. Take as directed by your doctor. Do not take if you have ever had breast cancer, vaginal bleeding, thickening of the womb lining, kidney disease, blood clots, heart attack, angina, stroke or ever had liver disease. 

Tell your doctor before taking the treatment if you suffer from fibroids, high blood pressure, liver disorder, diabetes gallstones, epilepsy, asthma, fluid retention or hereditary angioedema (swelling of hands, feet, lips). Climaval contains Lactose.

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Climaval Tablets 2mg
Pack Size: 84 tablets
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Take one tablet each day by following the numbers and arrows on the calendar pack. Swallow your tablets whole with a glass of water. Note the day you first took your tablet. The tablets are best taken at the same time every day.

Climaval (Estradiol Valerate) tablets is used for a hormone replacement therapy (commonly known as HRT). It contains the female hormone Oestrogen. Oestradiol valerate is identical to the natural female hormone Oestrogen. This hormone is produced by the ovaries before the menopause. Climaval is used for the relief of symptoms occurring after menopause.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Breakthrough bleeding and spotting.
  • Breast pain, tenderness or enlargement.
  • Headache/migraine.
  • Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion.
  • Leg cramps.
  • Fatigue.
  • Weight gain.
  • Vaginal discharge.
  • Depression.
  • Anxiety.
  • Dizziness.
  • Changes in sex drive.
  • Rise in blood pressure.
  • Gall bladder disease.
  • Swelling of the ankles due to to fluid retention (peripheral oedema).
  • Skin reactions such as rash and itch.
  • Steepening of corneal curvature, which may make contact lenses uncomfortable.
  • Premenstrual-like symptoms.
  • Disturbance in liver function.
  • Irregular brown patches on the skin, usually of the face (chloasma).
  • Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above).

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Keep out of the reach and sight of children. Take as directed by your doctor. Do not take if you have ever had breast cancer, vaginal bleeding, thickening of the womb lining, kidney disease, blood clots, heart attack, angina, stroke or ever had liver disease. 

Tell your doctor before taking the treatment if you suffer from fibroids, high blood pressure, liver disorder, diabetes gallstones, epilepsy, asthma, fluid retention or hereditary angioedema (swelling of hands, feet, lips). Climaval contains Lactose.

Elleste Duet Conti Tablets
Pack Size: 84 tablets (3 months supply)
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RRP*: £41.99
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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think the dose is too strong or not strong enough.

If you are not taking any HRT

If you are not taking any HRT, you can start taking Elleste Duet Conti Tablets straightaway.

  • Take one tablet each day. You can take the tablets at a time of the day that suits you, but it is best to take them at about the same time each day.
  • Swallow the tablets whole, with some water. All the tablets are the same.
  • The days are marked on the strip to help you to remember to take one each day.
  • Follow the direction of the arrows on the pack and take a tablet every day until the pack is empty.
  • When you finish a foil strip, start a new strip the next day.

Changing from another type of HRT

If you are changing from another type of HRT, and you usually have a monthly bleed, start taking Elleste Duet Conti Tablets on the first day of bleeding.

If you do not have a monthly bleed, start taking Elleste Duet Conti Tablets on any convenient day.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Duet Conti Tablets. You may need to stop taking Elleste Duet Conti Tablets about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Elleste Duet Conti Tablets again.

If you forget to take Elleste Duet Conti

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. You may experience some breakthrough bleeding or spotting.

If you take more Elleste Duet Conti than you should

There should be no problems, but you may experience breast tenderness, feel sick or actually be sick, have irregular periods, feel down, feel tired, develop acne or experience an increase in body and facial hair. If you are worried, contact your doctor. Take the usual tablet the following day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Elleste Duet Conti Tablets are a Hormone Replacement Therapy (HRT). They contain two types of female hormones, an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate).

Elleste Duet Conti Tablets are used in postmenopausal women with at least one year since their last natural period.

Elleste Duet Conti Tablets are used for:

Relief of symptoms occuring after menopause

During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Elleste Duet Conti Tablets alleviate these symptoms after menopause. You will only be prescribed Elleste Duet Conti Tablets if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Elleste Duet Conti Tablets to prevent osteoporosis after menopause.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think the dose is too strong or not strong enough.

If you are not taking any HRT

If you are not taking any HRT, you can start taking Elleste Duet Conti Tablets straightaway.

  • Take one tablet each day. You can take the tablets at a time of the day that suits you, but it is best to take them at about the same time each day.
  • Swallow the tablets whole, with some water. All the tablets are the same.
  • The days are marked on the strip to help you to remember to take one each day.
  • Follow the direction of the arrows on the pack and take a tablet every day until the pack is empty.
  • When you finish a foil strip, start a new strip the next day.

Changing from another type of HRT

If you are changing from another type of HRT, and you usually have a monthly bleed, start taking Elleste Duet Conti Tablets on the first day of bleeding.

If you do not have a monthly bleed, start taking Elleste Duet Conti Tablets on any convenient day.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Duet Conti Tablets. You may need to stop taking Elleste Duet Conti Tablets about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Elleste Duet Conti Tablets again.

If you forget to take Elleste Duet Conti

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. You may experience some breakthrough bleeding or spotting.

If you take more Elleste Duet Conti than you should

There should be no problems, but you may experience breast tenderness, feel sick or actually be sick, have irregular periods, feel down, feel tired, develop acne or experience an increase in body and facial hair. If you are worried, contact your doctor. Take the usual tablet the following day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited.

If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history.

Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Elleste Duet Conti Tablets you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Elleste Duet Conti Tablets.

Go for regular breast screening, as recommended by your doctor.

Do not take Elleste Duet Conti Tablets

if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Elleste Duet Conti Tablets,

Do not take Elleste Duet Conti Tablets

  • If you have or have ever had breast cancer, or if you are suspected of having it
  • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
  • If you have any unexplained vaginal bleeding
  • If you have excessive thickening of the womb lining(endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein(thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attackstroke or angina
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal
  • If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
  • If you are allergic (hypersensitive) to estradiol hemihydrate or norethisterone acetate or any of the other ingredients of Elleste Duet Conti Tablets (listed in section 6 Contents of the pack and other information).

If any of the above conditions appear for the first time while taking Elleste Duet Conti Tablets, stop taking them at once and consult your doctor immediately.

When to take special care with Elleste Duet Conti Tablets

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Elleste Duet Conti Tablets. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
  • increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems

Stop taking Elleste Duet Conti Tablets and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the ‘DO NOT take Elleste Duet Conti Tablets’ section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
  • migraine-like headaches which happen for the first time
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)‘

Note: Elleste Duet Conti Tablets are not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

The progestogen in Elleste Duet Conti Tablets protects you from this extra risk.

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Elleste Duet Conti Tablets. However, if the irregular bleeding:

  • carries on for more than the first 6 months
  • starts after you have been taking Elleste Duet Conti Tablets for more than 6 months
  • carries on after you have stopped taking Elleste Duet Conti Tablets

see your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

  • Regularly check your breasts. See your doctor if you notice any changes such as:
    • dimpling of the skin
    • changes in the nipple
    • any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer

For signs of a blood clot, see “Stop taking Elleste Duet Conti Tablets and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

Underactive thyroid gland

If you are having medicine for treatment of an underactive thyroid gland, your doctor will carry out tests while you are taking HRT, to ensure that your thyroid hormone levels remain acceptable.

Angioedema

If you have angioedema (a serious allergic reaction often involving swelling of the face, mouth and throat), oestrogens may make this worse.

Other conditions

  • HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Duet Conti Tablets

Some medicines may interfere with the effect of Elleste Duet Conti Tablets. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
  • Medicines for tuberculosis (such as rifampicin, rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, telaprevir and nelfinavir)
  • Herbal remedies containing St John’s Wort (Hypericum perforatum)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Elleste Duet Conti Tablets, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Elleste Duet Conti Tablets are for use in postmenopausal women only. If you become pregnant, stop taking Elleste Duet Conti Tablets and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been observed for Elleste Duet Conti Tablets.

Elleste Duet Conti Tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Enlarge
Elleste Duet Tablets 1mg
Pack Size: 84 tablets (3 months supply)
Order in for Next Day Delivery
RRP*: £32.99
Saving: £2.00
Our Price: £30.99
Qty: In Stock 
It’s easy and takes less than 3 minutes
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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think the dose is too strong or not strong enough.

The Elleste Duet 1mg pack contains 16 white tablets and 12 pale green tablets.

  • You must start with the white tablets.

The Elleste Duet 2mg pack contains 16 orange tablets and 12 grey tablets.

  • You must start with the orange tablets.

If you are still having regular periods, start on the first day of bleeding.

If you are not having regular periods you can start straight away.

  • Take one tablet each day. You can take the tablet at a time of the day that suits you but it is best to take it at about the same time each day.
  • Swallow the tablets whole, with some water.
  • Follow the direction of the arrows on the pack and take a tablet each day until the pack is empty.
  • When you finish your first foil strip, start a new strip on the next day. Remember to put a fresh sticker on your new foil strip.

To help you remember to take your tablets, we have included stickers in the pack with the days of the week marked on them. For example, if you are starting the tablets on a Friday, use the sticker which starts with 'Fri'. Stick this at the top of the foil strip on the side where you can see the tablets.

If you are taking

  • Elleste Duet 1 mg, the first day should be above the white tablet which has the start arrow next to it.
  • Elleste Duet 2 mg, the first day should be above the orange tablet which has the start arrow next to it.

Changing from another type of HRT

If you are changing from another type of HRT, start taking Elleste Duet when you finish the pack of HRT you are taking at the moment.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

Will I have periods?

You will probably have a monthly bleed. This may start any time between day 21 of the pack to day 5 of the next pack. This pattern will usually be the same from month to month. Some women may have no bleeds.

In the first few months you may get irregular bleeding. However, if this carries on you should tell your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Duet. You may need to stop taking Elleste Duet about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Elleste Duet again.

If you forget to take Elleste Duet

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. You may experience some breakthrough bleeding or spotting.

If you take more Elleste Duet than you should

There should be no problems, but you may experience breast tenderness, feel sick or actually be sick, have irregular periods, feel down, feel tired, develop acne or experience an increase in body and facial hair. If you are worried, contact your doctor. Take the usual tablet the following day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Elleste Duet is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate).

Elleste Duet is used for:

Relief of symptoms occuring after menopause

During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Elleste Duet alleviates these symptoms after menopause. You will only be prescribed Elleste Duet if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Elleste Duet 2 mg to prevent osteoporosis after menopause.

Like all medicines, Elleste Duet can cause side effects, although not everybody gets them.

The following diseases are reported more often in women using HRT compared to women not using HRT:

  • breast cancer
  • abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
  • ovarian cancer
  • blood clots in the veins of the legs or lungs (venous thromboembolism)
  • heart disease
  • stroke
  • probable memory loss if HRT is started over the age of 65

For more information about these side effects, see Section 2.

The following side effects have been associated with Elleste Duet:

Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Very common: headache, breast pain, breast tenderness, painful periods, problems with your menstrual cycle.

Common: feeling down, feeling anxious, mood changes, changes in sex drive, feeling dizzy, difficulty sleeping, feeling sick, bloating, diarrhoea, indigestion, stomach cramps, acne, rashes, itchiness, dry skin, back pain, pain in the extremities, breast enlargement, heavy periods, vaginal discharge, break-through bleeding, spasms (contractions) of the womb, vaginal infection, excessive thickening of the lining of the womb, pain, feeling of weakness, swelling of the ankles, feet or fingers, increase in weight.

Uncommon: migraine, a feeling of dizziness or “spinning”, high blood pressure, varicose veins, being sick, gallstones and gallbladder disease, change in colour of the skin, breast cancer, muscle cramps, increased levels of chemicals in the blood which may indicate disease.

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Elleste Duet you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Elleste Duet.

Go for regular breast screening, as recommended by your doctor.

Do not take Elleste Duet

if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Elleste Duet,

Do not take Elleste Duet

  • If you have or have ever had breast cancer, or if you are suspected of having it
  • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
  • If you have any unexplained vaginal bleeding
  • If you have excessive thickening of the womb lining(endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein(thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal
  • If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
  • If you are allergic (hypersensitive) to estradiol hemihydrate or norethisterone acetate or any of the other ingredients of Elleste Duet (listed in section 6 Contents of the pack and other information).

If any of the above conditions appear for the first time while taking Elleste Duet, stop taking it at once and consult your doctor immediately.

When to take special care with Elleste Duet

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Elleste Duet. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
  • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure.
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches.
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems

Stop taking Elleste Duet and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the ‘DO NOT take Elleste Duet’ section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness).
  • migraine-like headaches which happen for the first time.
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’

Note: Elleste Duet is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

The progestogen in Elleste Duet protects you from this extra risk.

Unexpected bleeding

You will have a bleed once a month (so-called withdrawal bleed) while taking Elleste Duet. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:

  • carries on for more than the first 6 months
  • starts after you have been taking Elleste Duet more than 6 months
  • carries on after you have stopped taking Elleste Duet

see your doctor as soon as possible

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

  • Regularly check your breasts. See your doctor if you notice any changes such as:
    • dimpling of the skin
    • changes in the nipple
    • any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer

For signs of a blood clot, see “Stop taking Elleste Duet and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

Underactive thyroid gland

If you are having medicine for treatment of an underactive thyroid gland, your doctor will carry out tests while you are taking HRT, to ensure that your thyroid hormone levels remain acceptable.

Angioedema

If you have angioedema (a serious allergic reaction often involving swelling of the face, mouth and throat), oestrogens may make this worse.

Other conditions

  • HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Duet

Some medicines may interfere with the effect of Elleste Duet. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
  • Medicines for tuberculosis (such as rifampicin, rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, telaprevir and nelfinavir)
  • Herbal remedies containing St John’s Wort (Hypericum perforatum).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Elleste Duet, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Elleste Duet is for use in postmenopausal women only. If you become pregnant, stop taking Elleste Duet and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been observed for Elleste Duet.

Elleste Duet 2 mg contains Sunset yellow colouring which can cause allergic-type reactions, including asthma. This allergy is more common in people who are allergic to aspirin.

Elleste Duet contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Enlarge
Elleste Duet Tablets 2mg
Pack Size: 84 tablets (3 months supply)
Order in for Next Day Delivery
RRP*: £33.99
Saving: £2.00
Our Price: £31.99
Qty: In Stock 
It’s easy and takes less than 3 minutes
  • Reasons to Shop
  • Similar Products
  • Directions
  • Description
  • Side Effects
  • Warnings

Easy Online Consultations

Takes less than 3 minutes to complete

Price
Guarantee

If you find it cheaper we will refund the difference

Fast, Discreet Delivery

Same day dispatch on orders before 4pm

Safe &
Secure

All data is safe & encrypted

UK Doctors & Pharmacists

Run by experienced, registered healthcare professionals

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think the dose is too strong or not strong enough.

The Elleste Duet 1mg pack contains 16 white tablets and 12 pale green tablets.

  • You must start with the white tablets.

The Elleste Duet 2mg pack contains 16 orange tablets and 12 grey tablets.

  • You must start with the orange tablets.

If you are still having regular periods, start on the first day of bleeding.

If you are not having regular periods you can start straight away.

  • Take one tablet each day. You can take the tablet at a time of the day that suits you but it is best to take it at about the same time each day.
  • Swallow the tablets whole, with some water.
  • Follow the direction of the arrows on the pack and take a tablet each day until the pack is empty.
  • When you finish your first foil strip, start a new strip on the next day. Remember to put a fresh sticker on your new foil strip.

To help you remember to take your tablets, we have included stickers in the pack with the days of the week marked on them. For example, if you are starting the tablets on a Friday, use the sticker which starts with 'Fri'. Stick this at the top of the foil strip on the side where you can see the tablets.

If you are taking

  • Elleste Duet 1 mg, the first day should be above the white tablet which has the start arrow next to it.
  • Elleste Duet 2 mg, the first day should be above the orange tablet which has the start arrow next to it.

Changing from another type of HRT

If you are changing from another type of HRT, start taking Elleste Duet when you finish the pack of HRT you are taking at the moment.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

Will I have periods?

You will probably have a monthly bleed. This may start any time between day 21 of the pack to day 5 of the next pack. This pattern will usually be the same from month to month. Some women may have no bleeds.

In the first few months you may get irregular bleeding. However, if this carries on you should tell your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Duet. You may need to stop taking Elleste Duet about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Elleste Duet again.

If you forget to take Elleste Duet

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. You may experience some breakthrough bleeding or spotting.

If you take more Elleste Duet than you should

There should be no problems, but you may experience breast tenderness, feel sick or actually be sick, have irregular periods, feel down, feel tired, develop acne or experience an increase in body and facial hair. If you are worried, contact your doctor. Take the usual tablet the following day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Elleste Duet is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate).

Elleste Duet is used for:

Relief of symptoms occuring after menopause

During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Elleste Duet alleviates these symptoms after menopause. You will only be prescribed Elleste Duet if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Elleste Duet 2 mg to prevent osteoporosis after menopause.

Like all medicines, Elleste Duet can cause side effects, although not everybody gets them.

The following diseases are reported more often in women using HRT compared to women not using HRT:

  • breast cancer
  • abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
  • ovarian cancer
  • blood clots in the veins of the legs or lungs (venous thromboembolism)
  • heart disease
  • stroke
  • probable memory loss if HRT is started over the age of 65

For more information about these side effects, see Section 2.

The following side effects have been associated with Elleste Duet:

Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Very common: headache, breast pain, breast tenderness, painful periods, problems with your menstrual cycle.

Common: feeling down, feeling anxious, mood changes, changes in sex drive, feeling dizzy, difficulty sleeping, feeling sick, bloating, diarrhoea, indigestion, stomach cramps, acne, rashes, itchiness, dry skin, back pain, pain in the extremities, breast enlargement, heavy periods, vaginal discharge, break-through bleeding, spasms (contractions) of the womb, vaginal infection, excessive thickening of the lining of the womb, pain, feeling of weakness, swelling of the ankles, feet or fingers, increase in weight.

Uncommon: migraine, a feeling of dizziness or “spinning”, high blood pressure, varicose veins, being sick, gallstones and gallbladder disease, change in colour of the skin, breast cancer, muscle cramps, increased levels of chemicals in the blood which may indicate disease.

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Elleste Duet you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Elleste Duet.

Go for regular breast screening, as recommended by your doctor.

Do not take Elleste Duet

if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Elleste Duet,

Do not take Elleste Duet

  • If you have or have ever had breast cancer, or if you are suspected of having it
  • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
  • If you have any unexplained vaginal bleeding
  • If you have excessive thickening of the womb lining(endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein(thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal
  • If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
  • If you are allergic (hypersensitive) to estradiol hemihydrate or norethisterone acetate or any of the other ingredients of Elleste Duet (listed in section 6 Contents of the pack and other information).

If any of the above conditions appear for the first time while taking Elleste Duet, stop taking it at once and consult your doctor immediately.

When to take special care with Elleste Duet

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Elleste Duet. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
  • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure.
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches.
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems

Stop taking Elleste Duet and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the ‘DO NOT take Elleste Duet’ section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness).
  • migraine-like headaches which happen for the first time.
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’

Note: Elleste Duet is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

The progestogen in Elleste Duet protects you from this extra risk.

Unexpected bleeding

You will have a bleed once a month (so-called withdrawal bleed) while taking Elleste Duet. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:

  • carries on for more than the first 6 months
  • starts after you have been taking Elleste Duet more than 6 months
  • carries on after you have stopped taking Elleste Duet

see your doctor as soon as possible

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

  • Regularly check your breasts. See your doctor if you notice any changes such as:
    • dimpling of the skin
    • changes in the nipple
    • any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer

For signs of a blood clot, see “Stop taking Elleste Duet and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

Underactive thyroid gland

If you are having medicine for treatment of an underactive thyroid gland, your doctor will carry out tests while you are taking HRT, to ensure that your thyroid hormone levels remain acceptable.

Angioedema

If you have angioedema (a serious allergic reaction often involving swelling of the face, mouth and throat), oestrogens may make this worse.

Other conditions

  • HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Duet

Some medicines may interfere with the effect of Elleste Duet. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
  • Medicines for tuberculosis (such as rifampicin, rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, telaprevir and nelfinavir)
  • Herbal remedies containing St John’s Wort (Hypericum perforatum).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Elleste Duet, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Elleste Duet is for use in postmenopausal women only. If you become pregnant, stop taking Elleste Duet and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been observed for Elleste Duet.

Elleste Duet 2 mg contains Sunset yellow colouring which can cause allergic-type reactions, including asthma. This allergy is more common in people who are allergic to aspirin.

Elleste Duet contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Elleste Solo Tablets 1mg
Pack Size: 84 tablets (3 months supply)
Order in for Next Day Delivery
RRP*: £29.99
Saving: £2.00
Our Price: £27.99
Qty: In Stock 
It’s easy and takes less than 3 minutes
  • Reasons to Shop
  • Similar Products
  • Directions
  • Description
  • Side Effects
  • Warnings

Easy Online Consultations

Takes less than 3 minutes to complete

Price
Guarantee

If you find it cheaper we will refund the difference

Fast, Discreet Delivery

Same day dispatch on orders before 4pm

Safe &
Secure

All data is safe & encrypted

UK Doctors & Pharmacists

Run by experienced, registered healthcare professionals

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

If you are still having regular periods, take your first tablet on the first day of bleeding.

If you are not having regular periods, you can start straight away.

  • Take one tablet each day. You can take the tablet at a time of the day that suits you. But it is best to take it about the same time each day.
  • Swallow the tablets whole, with some water.
  • Follow the direction of the arrows on the pack and take a tablet each day until the pack is empty. All the tablets are the same.
  • The days of the week are marked on the strip to help you to remember to take one each day.
  • When you finish a foil strip, start a new strip on the next day.

Changing from another type of HRT

If you are changing from another type of HRT, start taking Elleste Solo when you finish the pack of HRT you are taking at the moment.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

Will I have periods?

If you have not had a hysterectomy, and you are also taking a progestogen, you will probably have a monthly bleed. In the first few months you may get irregular bleeding. However, if this carries on you should tell your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Solo. You may need to stop taking Elleste Solo about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Elleste Solo again.

If you forget to take Elleste Solo

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. If you have not had a hysterectomy you may experience breakthrough bleeding or spotting.

If you take more Elleste Solo than you should

There should be no problems, but you may feel sick or actually be sick. If you are worried contact your doctor. Take the usual tablet the following day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Elleste Solo is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen (estradiol hemihydrate).

Elleste Solo is used for:

Relief of symptoms occuring after menopause

During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Elleste Solo alleviates these symptoms after menopause. You will only be prescribed Elleste Solo if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Elleste Solo 2 mg to prevent osteoporosis after menopause.

Like all medicines, Elleste Solo can cause side effects, although not everybody gets them. The following diseases are reported more often in women using HRT compared to women not using HRT:

  • breast cancer
  • abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
  • ovarian cancer
  • blood clots in the veins of the legs or lungs (venous thromboembolism)
  • heart disease
  • stroke
  • probable memory loss if HRT is started over the age of 65

For more information about these side effects, see section 2.

The following side effects have been associated with Elleste Solo. Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Common: feeling sick, stomach cramps, headache, an increase in size of fibroids in the womb, breakthrough bleeding, changes in weight, oedema (swelling) of legs, breast tenderness and enlargement, mood changes, changes in sex drive.

Uncommon: indigestion, being sick, flatulence, gallstones and gallbladder disease, feeling dizzy, migraine, vaginal thrush, increase in blood pressure, leg cramps.

Rare: loss of hair from the scalp, increase in body and facial hair, itchiness, rashes.

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Elleste Solo you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Elleste Solo.

Go for regular breast screening, as recommended by your doctor.

Do not take Elleste Solo

if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Elleste Solo,

Do not take Elleste Solo

  • If you have or have ever had breast cancer, or if you are suspected of having it
  • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
  • If you have any unexplained vaginal bleeding
  • If you have excessive thickening of the womb lining(endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein(thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal
  • If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
  • If you are allergic (hypersensitive) to estradiol hemihydrate or any of the other ingredients of Elleste Solo (listed in section 6 Contents of the pack and other information).

If any of the above conditions appear for the first time while taking Elleste Solo, stop taking it at once and consult your doctor immediately.

When to take special care with Elleste Solo

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Elleste Solo. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
  • increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems

Stop taking Elleste Solo and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the ‘DO NOT take Elleste Solo’ section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
  • migraine-like headaches which happen for the first time
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’

Note: Elleste Solo is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

Taking a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

  • Regularly check your breasts. See your doctor if you notice any changes such as:
    • dimpling of the skin
    • changes in the nipple
    • any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer

For signs of a blood clot, see “Stop taking Elleste Solo and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

Other conditions

  • HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Solo

Some medicines may interfere with the effect of Elleste Solo. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
  • Medicines for tuberculosis (such as rifampicin, rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
  • Herbal remedies containing St John’s Wort (Hypericum perforatum)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Pregnancy and breast-feeding

Elleste Solo is for use in postmenopausal women only. If you become pregnant, stop taking Elleste Solo and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been observed for Elleste Solo.

Elleste Solo 2 mg contains Sunset yellow colouring which can cause allergic-type reactions, including asthma. This allergy is more common in people who are allergic to aspirin.

Elleste Solo contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Enlarge
Elleste Solo Tablets 2mg
Pack Size: 84 tablets (3 months supply)
Order in for Next Day Delivery
RRP*: £30.99
Saving: £2.00
Our Price: £28.99
Qty: In Stock 
It’s easy and takes less than 3 minutes
  • Reasons to Shop
  • Similar Products
  • Directions
  • Description
  • Side Effects
  • Warnings

Easy Online Consultations

Takes less than 3 minutes to complete

Price
Guarantee

If you find it cheaper we will refund the difference

Fast, Discreet Delivery

Same day dispatch on orders before 4pm

Safe &
Secure

All data is safe & encrypted

UK Doctors & Pharmacists

Run by experienced, registered healthcare professionals

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

If you are still having regular periods, take your first tablet on the first day of bleeding.

If you are not having regular periods, you can start straight away.

  • Take one tablet each day. You can take the tablet at a time of the day that suits you. But it is best to take it about the same time each day.
  • Swallow the tablets whole, with some water.
  • Follow the direction of the arrows on the pack and take a tablet each day until the pack is empty. All the tablets are the same.
  • The days of the week are marked on the strip to help you to remember to take one each day.
  • When you finish a foil strip, start a new strip on the next day.

Changing from another type of HRT

If you are changing from another type of HRT, start taking Elleste Solo when you finish the pack of HRT you are taking at the moment.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

Will I have periods?

If you have not had a hysterectomy, and you are also taking a progestogen, you will probably have a monthly bleed. In the first few months you may get irregular bleeding. However, if this carries on you should tell your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Solo. You may need to stop taking Elleste Solo about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Elleste Solo again.

If you forget to take Elleste Solo

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. If you have not had a hysterectomy you may experience breakthrough bleeding or spotting.

If you take more Elleste Solo than you should

There should be no problems, but you may feel sick or actually be sick. If you are worried contact your doctor. Take the usual tablet the following day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Elleste Solo is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen (estradiol hemihydrate).

Elleste Solo is used for:

Relief of symptoms occuring after menopause

During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Elleste Solo alleviates these symptoms after menopause. You will only be prescribed Elleste Solo if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Elleste Solo 2 mg to prevent osteoporosis after menopause.

Like all medicines, Elleste Solo can cause side effects, although not everybody gets them. The following diseases are reported more often in women using HRT compared to women not using HRT:

  • breast cancer
  • abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
  • ovarian cancer
  • blood clots in the veins of the legs or lungs (venous thromboembolism)
  • heart disease
  • stroke
  • probable memory loss if HRT is started over the age of 65

For more information about these side effects, see section 2.

The following side effects have been associated with Elleste Solo. Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Common: feeling sick, stomach cramps, headache, an increase in size of fibroids in the womb, breakthrough bleeding, changes in weight, oedema (swelling) of legs, breast tenderness and enlargement, mood changes, changes in sex drive.

Uncommon: indigestion, being sick, flatulence, gallstones and gallbladder disease, feeling dizzy, migraine, vaginal thrush, increase in blood pressure, leg cramps.

Rare: loss of hair from the scalp, increase in body and facial hair, itchiness, rashes.

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Elleste Solo you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Elleste Solo.

Go for regular breast screening, as recommended by your doctor.

Do not take Elleste Solo

if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Elleste Solo,

Do not take Elleste Solo

  • If you have or have ever had breast cancer, or if you are suspected of having it
  • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
  • If you have any unexplained vaginal bleeding
  • If you have excessive thickening of the womb lining(endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein(thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal
  • If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
  • If you are allergic (hypersensitive) to estradiol hemihydrate or any of the other ingredients of Elleste Solo (listed in section 6 Contents of the pack and other information).

If any of the above conditions appear for the first time while taking Elleste Solo, stop taking it at once and consult your doctor immediately.

When to take special care with Elleste Solo

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Elleste Solo. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
  • increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems

Stop taking Elleste Solo and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the ‘DO NOT take Elleste Solo’ section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
  • migraine-like headaches which happen for the first time
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’

Note: Elleste Solo is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

Taking a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

  • Regularly check your breasts. See your doctor if you notice any changes such as:
    • dimpling of the skin
    • changes in the nipple
    • any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer

For signs of a blood clot, see “Stop taking Elleste Solo and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

Other conditions

  • HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Children

Do not give this medicine to children.

Other medicines and Elleste Solo

Some medicines may interfere with the effect of Elleste Solo. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
  • Medicines for tuberculosis (such as rifampicin, rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
  • Herbal remedies containing St John’s Wort (Hypericum perforatum)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Pregnancy and breast-feeding

Elleste Solo is for use in postmenopausal women only. If you become pregnant, stop taking Elleste Solo and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been observed for Elleste Solo.

Elleste Solo 2 mg contains Sunset yellow colouring which can cause allergic-type reactions, including asthma. This allergy is more common in people who are allergic to aspirin.

Elleste Solo contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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Evorel Conti Patches
Pack Size: 8 patches
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Use Evorel as advised by your doctor. If you are unsure seek medical advice. You can apply an Evorel patch anytime if you have not been using another form of HRT treatment. Put on the Evorel patch on at the end of a treatment cycle or one week after you finish using another HRT product.. 

The patch should be changed twice a week. Do not leave a break between each patch to ensure a regular supply of hormones is delivered. Change your patch the same two days every week. Most women prefer to wear the patch on the thigh or bottom. Do not apply on or near the breasts. Do not apply the patch on the same area of skin twice in a row. Do not wear the patch under elasticated areas or a tight waistband. Apply the patch to clean, dry cool skin as soon as you open the protective pouch. 

Open and peel- using the notches as a guide, tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and feel off half the backing. Do not touch the sticky side, it may not stick properly. Apply and press- apply the open half of the patch to your skin. Remove the remaining backing and press down the rest of the path. Press the patch with the palm of your hand to make sure it is firmly stuck down.

Evorel conti belongs to a group of medicines called hormone replacement therapy ( more commonly known as HRT). Evorel conti contains two different medicines: Oestrogen (Estradiol) and Progestogen (Norethisterone). Evorel comes in a memory pack which can be used to help you remember when you change your patches. The hormones are spread evenly in each patch. 

Evorel conti is used for the symptoms of the menopause. It is suitable for women who have not had a period for at least 18 months. To prevent Osteoporosis (weaking of the bones) in women who have had the menopause and are most likely to have bone problems. Evorel conti is only used if other medicines for Oesteoporosis have been tried first and they have not worked. 

Evorel conti is known as a continuous combined HRT because both hormones in the patch are released at the same time. Evorel conti patches replace the oestrogen that is normally released by the ovaries. However in women who still have a womb, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker. This means it is necessary to add a progestogen hormone to the oestrogen which will help shed the lining of the womb and stop any problems happening.

Keep out of the reach and sight of children. Use as directed by your doctor. Do not use Evorel if you are allergic to any of the ingredients, ever had breast cancer, if you have a thickening of the lining of the womb, vaginal bleeding which you cannot explain, ever had blood clots, if you have liver disease, blocked arteries. Tell your doctor if you are taking any other medication. Do not use if you are pregnant or you might become pregnant and do not use if you are breast feeding.

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Evorel Patches 100
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Use Evorel as advised by your doctor. If you are unsure seek medical advice. The highest dose you should have is 100 mg of Estradiol in a day. Put an Evorel patch on within 5 days of the start of your bleed or put a patch on at the end of your cycle or one week after you finish using another HRT product. 

The patch should be changed twice a week. Do not leave a break between each patch to ensure a regular supply of hormones is delivered. Change your patch the same two days every week. Most women prefer to wear the patch on the thigh or bottom. Do not apply on or near the breasts. Do not apply the patch on the same area of skin twice in a row. Do not wear the patch under elasticated areas or a tight waistband. Apply the patch to clean, dry cool skin as soon as you open the protective pouch. 

Open and peel- using the notches as a guide, tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and feel off half the backing. Do not touch the sticky side, it may not stick properly. Apply and press- apply the open half of the patch to your skin. Remove the remaining backing and press down the rest of the path. Press the patch with the palm of your hand to make sure it is firmly stuck down.

Evorel belongs to a group of medicines called HRT (hormone replacement therapy). Evorel contains the active ingredient Oestrogen (Estradiol) which is a female hormone. It comes in 4 different sizes Evorel 25, Evorel 50, Evorel 75 and Evorel 100. The hormone is spread evenly in each patch and slowly passes into your body through your skin. 

Evorel is used for the symptoms of the menopause and can also be used to prevent Osteoporosis (Fragile Bones) in women who have had the menopause and are most likely to have bone problems. Evorel, 50, 75 and 100 are only used if other medicines for Osteoporosis have been tried first and they have not worked. 

Evorel works by replacing the Oestrogen which is normally released by the ovaries. However in women who still have a womb, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker. This means it is necessary to add a progestogen hormone to the oestrogen. This helps shed the lining of the womb and stop any problems happening.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who use Evorel

  • application site problems such as redness, itching, rashes or oedema

Common: More than 1 in 100 people who use Evorel

  • breast pain
  • depression
  • diarrhoea
  • feeling dizzy
  • headaches– seek immediate medical advice if you have an unusually bad headache
  • itching
  • jointpain
  • menstrual problems including painful, heavy or long menstrual periods, bleeding or spotting between menstrual periods - some of these problems may happen within the first few months of starting treatment with Evorel or if you forget to apply your patch. If this continues to happen once Evorel has been used for some time or after you have stopped using Evorel you must contact your prescriber
  • migraine– seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • pain
  • skin rash or rashes
  • stomachpain
  • weight gain

Keep out of the reach and sight of children. Use as directed by your doctor. Do not use Evorel if you are allergic to any of the ingredients, ever had breast cancer, if you have a thickening of the lining of the womb, vaginal bleeding which you cannot explain, ever had blood clots, if you have liver disease, blocked arteries. Tell your doctor if you are taking any other medication. Do not use if you are pregnant or you might become pregnant and do not use if you are breast feeding.

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Evorel Patches 25
Pack Size: 8 patches
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Use Evorel as advised by your doctor. If you are unsure seek medical advice. The highest dose you should have is 100 mg of Estradiol in a day. Put an Evorel patch on within 5 days of the start of your bleed or put a patch on at the end of your cycle or one week after you finish using another HRT product. 

The patch should be changed twice a week. Do not leave a break between each patch to ensure a regular supply of hormones is delivered. Change your patch the same two days every week. Most women prefer to wear the patch on the thigh or bottom. Do not apply on or near the breasts. Do not apply the patch on the same area of skin twice in a row. Do not wear the patch under elasticated areas or a tight waistband. Apply the patch to clean, dry cool skin as soon as you open the protective pouch. 

Open and peel- using the notches as a guide, tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and feel off half the backing. Do not touch the sticky side, it may not stick properly. Apply and press- apply the open half of the patch to your skin. Remove the remaining backing and press down the rest of the path. Press the patch with the palm of your hand to make sure it is firmly stuck down.

Evorel belongs to a group of medicines called HRT (hormone replacement therapy). Evorel contains the active ingredient Oestrogen (Estradiol) which is a female hormone. It comes in 4 different sizes Evorel 25, Evorel 50, Evorel 75 and Evorel 100. The hormone is spread evenly in each patch and slowly passes into your body through your skin. 

Evorel is used for the symptoms of the menopause and can also be used to prevent Osteoporosis (Fragile Bones) in women who have had the menopause and are most likely to have bone problems. Evorel, 50, 75 and 100 are only used if other medicines for Osteoporosis have been tried first and they have not worked. 

Evorel works by replacing the Oestrogen which is normally released by the ovaries. However in women who still have a womb, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker. This means it is necessary to add a progestogen hormone to the oestrogen. This helps shed the lining of the womb and stop any problems happening.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who use Evorel

  • application site problems such as redness, itching, rashes or oedema

Common: More than 1 in 100 people who use Evorel

  • breast pain
  • depression
  • diarrhoea
  • feeling dizzy
  • headaches– seek immediate medical advice if you have an unusually bad headache
  • itching
  • jointpain
  • menstrual problems including painful, heavy or long menstrual periods, bleeding or spotting between menstrual periods - some of these problems may happen within the first few months of starting treatment with Evorel or if you forget to apply your patch. If this continues to happen once Evorel has been used for some time or after you have stopped using Evorel you must contact your prescriber
  • migraine– seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • pain
  • skin rash or rashes
  • stomachpain
  • weight gain

Keep out of the reach and sight of children. Use as directed by your doctor. Do not use Evorel if you are allergic to any of the ingredients, ever had breast cancer, if you have a thickening of the lining of the womb, vaginal bleeding which you cannot explain, ever had blood clots, if you have liver disease, blocked arteries. Tell your doctor if you are taking any other medication. Do not use if you are pregnant or you might become pregnant and do not use if you are breast feeding.

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Evorel Patches 50
Pack Size: 8 patches
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Use Evorel as advised by your doctor. If you are unsure seek medical advice. The highest dose you should have is 100 mg of Estradiol in a day. Put an Evorel patch on within 5 days of the start of your bleed or put a patch on at the end of your cycle or one week after you finish using another HRT product. 

The patch should be changed twice a week. Do not leave a break between each patch to ensure a regular supply of hormones is delivered. Change your patch the same two days every week. Most women prefer to wear the patch on the thigh or bottom. Do not apply on or near the breasts. Do not apply the patch on the same area of skin twice in a row. Do not wear the patch under elasticated areas or a tight waistband. Apply the patch to clean, dry cool skin as soon as you open the protective pouch. 

Open and peel- using the notches as a guide, tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and feel off half the backing. Do not touch the sticky side, it may not stick properly. Apply and press- apply the open half of the patch to your skin. Remove the remaining backing and press down the rest of the path. Press the patch with the palm of your hand to make sure it is firmly stuck down.

Evorel belongs to a group of medicines called HRT (hormone replacement therapy). Evorel contains the active ingredient Oestrogen (Estradiol) which is a female hormone. It comes in 4 different sizes Evorel 25, Evorel 50, Evorel 75 and Evorel 100. The hormone is spread evenly in each patch and slowly passes into your body through your skin. 

Evorel is used for the symptoms of the menopause and can also be used to prevent Osteoporosis (Fragile Bones) in women who have had the menopause and are most likely to have bone problems. Evorel, 50, 75 and 100 are only used if other medicines for Osteoporosis have been tried first and they have not worked. 

Evorel works by replacing the Oestrogen which is normally released by the ovaries. However in women who still have a womb, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker. This means it is necessary to add a progestogen hormone to the oestrogen. This helps shed the lining of the womb and stop any problems happening.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who use Evorel

  • application site problems such as redness, itching, rashes or oedema

Common: More than 1 in 100 people who use Evorel

  • breast pain
  • depression
  • diarrhoea
  • feeling dizzy
  • headaches– seek immediate medical advice if you have an unusually bad headache
  • itching
  • jointpain
  • menstrual problems including painful, heavy or long menstrual periods, bleeding or spotting between menstrual periods - some of these problems may happen within the first few months of starting treatment with Evorel or if you forget to apply your patch. If this continues to happen once Evorel has been used for some time or after you have stopped using Evorel you must contact your prescriber
  • migraine– seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • pain
  • skin rash or rashes
  • stomachpain
  • weight gain

Keep out of the reach and sight of children. Use as directed by your doctor. Do not use Evorel if you are allergic to any of the ingredients, ever had breast cancer, if you have a thickening of the lining of the womb, vaginal bleeding which you cannot explain, ever had blood clots, if you have liver disease, blocked arteries. Tell your doctor if you are taking any other medication. Do not use if you are pregnant or you might become pregnant and do not use if you are breast feeding.

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Evorel Patches 75
Pack Size: 8 patches
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Use Evorel as advised by your doctor. If you are unsure seek medical advice. The highest dose you should have is 100 mg of Estradiol in a day. Put an Evorel patch on within 5 days of the start of your bleed or put a patch on at the end of your cycle or one week after you finish using another HRT product. 

The patch should be changed twice a week. Do not leave a break between each patch to ensure a regular supply of hormones is delivered. Change your patch the same two days every week. Most women prefer to wear the patch on the thigh or bottom. Do not apply on or near the breasts. Do not apply the patch on the same area of skin twice in a row. Do not wear the patch under elasticated areas or a tight waistband. Apply the patch to clean, dry cool skin as soon as you open the protective pouch. 

Open and peel- using the notches as a guide, tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and feel off half the backing. Do not touch the sticky side, it may not stick properly. Apply and press- apply the open half of the patch to your skin. Remove the remaining backing and press down the rest of the path. Press the patch with the palm of your hand to make sure it is firmly stuck down.

Evorel belongs to a group of medicines called HRT (hormone replacement therapy). Evorel contains the active ingredient Oestrogen (Estradiol) which is a female hormone. It comes in 4 different sizes Evorel 25, Evorel 50, Evorel 75 and Evorel 100. The hormone is spread evenly in each patch and slowly passes into your body through your skin. 

Evorel is used for the symptoms of the menopause and can also be used to prevent Osteoporosis (Fragile Bones) in women who have had the menopause and are most likely to have bone problems. Evorel, 50, 75 and 100 are only used if other medicines for Osteoporosis have been tried first and they have not worked. 

Evorel works by replacing the Oestrogen which is normally released by the ovaries. However in women who still have a womb, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker. This means it is necessary to add a progestogen hormone to the oestrogen. This helps shed the lining of the womb and stop any problems happening.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who use Evorel

  • application site problems such as redness, itching, rashes or oedema

Common: More than 1 in 100 people who use Evorel

  • breast pain
  • depression
  • diarrhoea
  • feeling dizzy
  • headaches– seek immediate medical advice if you have an unusually bad headache
  • itching
  • jointpain
  • menstrual problems including painful, heavy or long menstrual periods, bleeding or spotting between menstrual periods - some of these problems may happen within the first few months of starting treatment with Evorel or if you forget to apply your patch. If this continues to happen once Evorel has been used for some time or after you have stopped using Evorel you must contact your prescriber
  • migraine– seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • pain
  • skin rash or rashes
  • stomachpain
  • weight gain

Keep out of the reach and sight of children. Use as directed by your doctor. Do not use Evorel if you are allergic to any of the ingredients, ever had breast cancer, if you have a thickening of the lining of the womb, vaginal bleeding which you cannot explain, ever had blood clots, if you have liver disease, blocked arteries. Tell your doctor if you are taking any other medication. Do not use if you are pregnant or you might become pregnant and do not use if you are breast feeding.

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Evorel Sequi Patches
Pack Size: 8 patches
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RRP*: £28.00
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Use Evorel as advised by your doctor. If you are unsure seek medical advice. You can apply an Evorel patch anytime if you have not been using another form of HRT treatment, your menstrual cycles are not regular or changing from HRT that does not give you a withdrawal bleed. 

The patch should be changed twice a week. Do not leave a break between each patch to ensure a regular supply of hormones is delivered. Change your patch the same two days every week. Week 1 and 2 use the four Evorel 50 patches one at a time and week 3 and 4 use the four Evorel conti patches one at a time. Most women prefer to wear the patch on the thigh or bottom. Do not apply on or near the breasts. Do not apply the patch on the same area of skin twice in a row. Do not wear the patch under elasticated areas or a tight waistband. Apply the patch to clean, dry cool skin as soon as you open the protective pouch. 

Open and peel- using the notches as a guide, tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and feel off half the backing. Do not touch the sticky side, it may not stick properly. Apply and press- apply the open half of the patch to your skin. Remove the remaining backing and press down the rest of the path. Press the patch with the palm of your hand to make sure it is firmly stuck down.

Evorel Sequi belongs to a group of medicines called hormone replacement therapy (more commonly known as HRT). Evorel Sequi contains two medicines: Oestrogen (Estradiol) and Progestogen (Norethisterone), of which are both female hormones. They come in a memory pack to assist you to remember when to change your patches. Each pack contains eight patches; 4x Evorel 50 patches containing Estradiol only and 4x Evorel conti patches containing both Estradiol and Norethisterone. The hormones are spread evenly in each patch. 

Evorel Sequi is used for the symptoms of the menopause. It is only used in women who still have a womb. It is suitable for women who have had the menopause or who are around the time of the menopause. Evorel is also taken to prevent Osteoporosis (fragile bones) in women who have had the menopause and are most likely to have bone problems. Evorel Sequi is only used if other medicines for Osteoporosis have been tried first and they have not worked. 

Evorel Seuqi is known as continuous sequential HRT. This is because two hormones are used one after another. Estradiol is used by itself for two weeks then the Estradiol and Norethisterone are used together for the next two weeks. Evorel Sequi patches replace te oestrogen that is normally released by the ovaries. However taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker. This means it is necessary to add a progestogen hormone to the oestrogen. This helps shed the lining of the womb and stop any problems happening.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who use Evorel

  • application site problems such as redness, itching, rashes or oedema

Common: More than 1 in 100 people who use Evorel

  • breast pain
  • depression
  • diarrhoea
  • feeling dizzy
  • headaches– seek immediate medical advice if you have an unusually bad headache
  • itching
  • jointpain
  • menstrual problems including painful, heavy or long menstrual periods, bleeding or spotting between menstrual periods - some of these problems may happen within the first few months of starting treatment with Evorel or if you forget to apply your patch. If this continues to happen once Evorel has been used for some time or after you have stopped using Evorel you must contact your prescriber
  • migraine– seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • pain
  • skin rash or rashes
  • stomachpain
  • weight gain

Keep out of the reach and sight of children. Use as directed by your doctor. Do not use Evorel if you are allergic to any of the ingredients, ever had breast cancer, if you have a thickening of the lining of the womb, vaginal bleeding which you cannot explain, ever had blood clots, if you have liver disease, blocked arteries. Tell your doctor if you are taking any other medication. Do not use if you are pregnant or you might become pregnant and do not use if you are breast feeding.

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Kliofem Tablets
Pack Size: 84
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RRP*: £27.00
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Guarantee

If you find it cheaper we will refund the difference

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Same day dispatch on orders before 4pm

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It’s important to read the enclosed leaflet carefully before using Kliofem Tablets.

The dose is one tablet to be taken each day, at around the same time each day. It can be taken before or after food. The tablets are taken continuously without a break between packs.

Kliofem tablets contain two active ingredients, estradiol (previously spelt oestradiol in the UK) and norethisterone acetate. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone acetate is a synthetic form of progesterone.

Womens’ ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result. The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching.

Oestrogen (in this case in the form of estradiol) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor.

A progestogen (in this case in the form of norethisterone acetate) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, oestrogen stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of cancer, though it does not eliminate this risk entirely. This is known as combined HRT.

Kliofem is a continuous form of combined HRT. Each tablet contains both estradiol and norethisterone, so that a dose of both hormones is taken daily. This type of HRT does not produce a monthly withdrawal bleed, and so is more suitable for women whose periods have already stopped, eg for postmenopausal women who are more than 12 months after their menopause.

HRT is also sometimes used to prevent osteoporosis in postmenopausal women. The declining level of oestrogen at menopause can affect the bones, causing them to become thinner and more prone to breaking. Oestrogen supplements help prevent bone loss and fractures that may occur in women in the years after menopause.

However, in December 2003, a review of the available evidence on the risks and benefits of HRT by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) in the UK, concluded that the risks of using HRT long-term to prevent osteoporosis in women aged over 50 years exceed the benefits. As a result, this medicine should not be used as a first-line option for preventing postmenopausal osteoporosis in women over 50. However, it may be used as a second-line option for women at high risk of fractures who cannot take other medicines that are licensed for preventing osteoporosis.

Women considered to be at risk of developing fractures following the menopause include those who have had an early menopause, those with a family history of osteoporosis, those who have had recent prolonged corticosteroid therapy (eg prednisolone), those with a small thin frame, and smokers.

You can read more about the risks and benefits of HRT and other medicines for preventing osteoporosis in the factsheets about menopause and osteoporosis linked below.

 

  • Hormone replacement therapy to relieve symptoms of the menopause
  • Second-line option for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot take other medicines licensed for preventing osteoporosis



Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

  • Breast pain, tenderness or enlargement
  • Breakthrough bleeding and spotting
  • Vaginal thrush
  • Excessive fluid retention in the body tissues, resulting in swelling (oedema)
  • Headache/migraine
  • Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion
  • Leg cramps
  • Weight gain
  • Nervousness
  • Depression
  • Skin reactions such as rash and itch
  • Hair loss
  • Abnormal hair growth
  • Dizziness
  • Visual disturbances
  • Changes in sex drive
  • Rise in blood pressure
  • Steepening of corneal curvature which may make contact lenses uncomfortable.
  • Disturbance in liver function
  • Irregular brown patches on the skin, usually of the face (chloasma)
  • Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.




  • Women taking any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.
  • It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. You should discuss these with your doctor before starting HRT. Women on HRT should have regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.
  • It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history, smoking, obesity, certain blood disorders - see cautions below) and needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. Discuss these with your doctor before starting treatment.
  • The risk of blood clots forming in the veins (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over five hours). For this reason, your doctor may recommend that you stop taking HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.
  • Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms while taking this medicine: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression.
  • This medicine will not usually cause a monthly withdrawal bleed. However, you may experience spotting or breakthrough bleeding during the first few months of treatment. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting. If any breakthrough bleeding continues after a few months of taking the medicine, or after stopping treatment, you should consult your doctor.
  • A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.

Use with caution in

  • Close family history of breast cancer (eg mother, sister or grandmother has had the disease)
  • History of benign breast lumps (fibrocystic breast disease)
  • History of fibroids in the womb
  • History of endometriosis
  • History of overgrowth of the lining of the womb (endometrial hyperplasia)
  • Personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism)
  • Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden
  • Women taking medicines to prevent blood clots (anticoagulants), eg warfarin
  • Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)
  • Personal or family history of recurrent miscarriage
  • Severe obesity
  • Varicose veins
  • Smokers
  • History of high blood pressure (hypertension)
  • Raised levels of fats called triglycerides in the blood (hypertriglyceridaemia)
  • History of liver disease, eg liver cancer
  • Decreased kidney function
  • Heart failure
  • History of diabetes
  • History of gallstones
  • History of migraines or severe headaches
  • History of epilepsy
  • History of asthma
  • History of an ear disorder that may cause hearing loss (otosclerosis)
  • History of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.



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When can you start taking Livial?

Wait before taking Livial (see Section 2.1)

  • If it is not yet 12 months since your last natural period

Start taking Livial straight away

  • If you are changing over from a period free HRT… (see note below)…
  • If you have never used HRT before
  • If you were prescribed HRT because you have had ahysterectomy…
  • If you are being treated for endometriosis (a condition in which parts of the womb lining move around the body)…

Wait for your next period. Start taking Livial as soon as your period ends

  • If you are changing over from another type of HRT with which you have periods… (see the note below)…

If you are changing over from another type of HRT

There are several different types of HRT, such as tablets patches and gels. Most contain either oestrogen, or oestrogen and progestogen. With some you still have periods, and with some you don't (these are called period-free HRT).

3.2 How to take Livial

The usual dose is one tablet every day. Take this dose unless your doctor or pharmacist told you to do something different.

Press the tablet so that it comes through the foil. Swallow the tablet with some water or other drink, without chewing. Take Livial at the same time each day.

The strips of tablets are marked with the days of the week. Start by taking a tablet marked with the current day. For example, if it is Monday, take a tablet marked Monday on the top row of the strip. Follow the arrows until the strip is empty. Start the next strip the next day. Do not leave a break between strips or packs.

Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

3.3 If you take more Livial than you should

It is unlikely that taking more than one tablet will do you any harm, but you may feel sick, be sick or have some vaginal bleeding.

3.4 If you forget to take Livial

If you forget to take a tablet, take it as soon as you remember, unless you are more than 12 hours late. If you are more than 12 hours late, just skip it, and take your next tablet at the usual time.Don't take a double dose.

3.5 If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Livial. You may need to stop taking Livial about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, 'Blood clots in a vein'). Ask your doctor when you can start taking Livial again.

This medicine is a Hormone Replacement Therapy (HRT). It contains tibolone, a substance that has favourable effects on different tissues in the body, such as brain, vagina and bone. This medicine is used in postmenopausal women with at least 12 months since their last natural period.

This medicine is used for:

Relief of symptoms occurring after menopause

During the menopause, the amount of the oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Livial alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Livial to prevent osteoporosis after menopause.

There are three different kinds of HRT:

  • Oestrogen-only HRT
  • Combined HRT, containing two kinds of female hormone, an oestrogen and a progestogen.
  • Livial, which contains a substance called tibolone

Livial is different from other HRT. Instead of actual hormones (such as oestrogen and progestogen) it contains tibolone. Your body breaks down tibolone to make hormones. Its effects and benefits are similar to combined HRT.

The following diseases are reported more often in women using HRT compared to women not using HRT:

  • breast cancer
  • abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
  • ovarian cancer
  • blood clots in the veins of the legs or lungs (venous thromboembolism)
  • heart disease
  • stroke
  • probable memory loss if HRT is started over the age of 65

For more information about these side effects, see section 2.

Like all medicines, Livial may have side effects, although not everybody gets them. Most side effects are mild.

  • Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Livial. (see also section 2.3, 'Stop taking Livial and see a doctor immediately')

4.1 Serious side effects - see a doctor straight away

If you think you may have signs of a serious side effect, see a doctor straight away.

You may need to stop taking Livial:

  • If your blood pressure rises
  • If your skin or the whites of your eyes go yellow (jaundice)
  • If you suddenly have migraine-type headaches (see section 2.5 above)
  • If you have signs of a blood clot (see section 2.5 above)
  • If you get any of the problems listed in section 2.1 (Do not take Livial)

4.2 Other side effects

Common (affect up to 1 in 10 women):

  • breast pain
  • stomach or pelvic pain
  • unusual hair growth
  • vaginal bleeding or spotting.

This is usually nothing to worry about in the first few months of taking HRT. If bleeding continues, or starts after you have been on HRT for a while See Section 2.4.

  • vaginal problems such as more secretions, itching, irritation and thrush
  • thickening of the lining of the womb or the lining of the cervix
  • weight gain.

Uncommon (affects up to 1 in 100 women):

  • swollen hands, ankles or feet - a sign of fluid retention
  • stomach upset
  • acne
  • painful nipples or breasts feeling uncomfortable
  • vaginal infections

Medical History and regular check-ups

The use of HRT or Livial carries risks that need to be considered when deciding whether to start taking it, or whether to carry on taking it. This is especially important if you are more than 60 years old.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT or Livial may be different. Please talk to your doctor.

Before you start taking or restart HRT or Livial

Your doctor will ask about your own and your family's medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and /or an internal examination, if necessary.

  • Tell your doctor if you have any medical problems or illnesses.

Regular check-ups

Once you have started on Livial, you should see your doctor forregular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Livial.

Go for regular breast screening, as recommended by your doctor.

Be sure to

  • go for regular breast screening and cervical smear tests
  • regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel

2.1 Some women should not take Livial

Do not take Livial

If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking this medicine

  • If you have or have ever had breast cancer, or if you are suspected of having it
  • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
  • If you have any unexplained vaginal bleeding
  • If you have excessive thickening of the womb lining(endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein(thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attackstroke orangina
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal
  • If you have a rare blood problem called "porphyria" which is passed down in families (inherited)
  • If you are allergic (hypersensitive) to tibolone or any of the other ingredients of Livial (listed in section 6 More about Livial)
  • If you are pregnant or think you might be pregnant.
  • If you are breastfeeding.

If any of the above conditions appear for the first time while taking this medicine, stop taking it at once and consult your doctor immediately.

If you have started the menopause you should not take Livial until12 months after your last natural period. If you take it sooner than this you may have irregular bleeding.

2.2 When to take special care with Livial

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Livial. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of the womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")
  • increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems

2.3 Stop taking Livial and see a doctor immediately

If you notice any of the following when taking HRT or Livial:

  • any of the conditions mentioned in the "Do not take Livial" section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
  • migraine-like headaches which happen for the first time
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
    • painful swelling and redness of the legs
    • sudden chest pain
    • difficulty in breathing

For more information, see "Blood clots in a vein (thrombosis)".

Note: Livial is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

2.4 HRT and Cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

There have been reports of an increased cell growth or cancer of the lining of the womb in women using Livial. The risk of cancer of the lining of the womb increases the longer you take the medicine.

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Livial. But if the bleeding or spotting:

  • Carries on for more than the first 6 months
  • Starts after you have been taking Livial for more than 6 months
  • Carries on even after you've stopped taking Livial
  • see your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

Compare

Women taking Livial have a lower risk than women using combined HRT and a comparable risk with oestrogen-only HRT.

Regularly check your breasts. See your doctor if you notice any changes such as:

  • Dimpling or sinking of the skin
  • Changes in the nipple
  • Any lumps you can see or feel
  • Make an appointment to see your doctor as soon as possible

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Compare

For women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

With use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.

2.5 Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations apply to you:

  • you are pregnant or recently had a baby
  • you use oestrogens
  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer.

For signs of a blood clot, see "Stop taking Livial and see a doctor immediately".

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5 year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

With use of Livial, the increased risk of getting a blood clot in a vein is lower than with other types of HRT.

Heart disease (heart attack)

There is no evidence that HRT or Livial will prevent a heart attack.

Women over the age of 60 who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT. As the risk of heart disease strongly depends on age, the number of extra cases of heart disease due to use of oestrogen-progestogen HRT is very low in healthy women close to menopause, but will rise with more advanced age.

There is no evidence to suggest that the risk of myocardial infarction with Livial is different to the risk of other HRT.

Stroke

Recent research suggests that HRT and Livial slightly increases the risk of having a stroke. The increased risk is seen mainly in women over 60 years old. Other things that can increase the risk of stroke include:

  • Getting older
  • High blood pressure
  • Smoking
  • Drinking too much alcohol
  • An irregular heartbeat

If you are worried about any of these things, talk to your doctor to see if you should take HRT

Compare

Looking at women in their 50s who are not taking Livial - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking Livial, the figure would be 7 in 1000 (i.e. an extra 4 cases).

Looking at women in their 60s who are not taking Livial - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking Livial, the figure would be24 in 1000 (i.e. an extra 13 cases).

2.6 Other conditions

HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

2.7 Using other medicines

Some medicines may interfere with the effect of Livial. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines against blood clotting (such as warfarin)
  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
  • Medicines for tuberculosis (such as rifampicin)
  • Herbal remedies containing St John's Wort (Hypericum perforatum).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

2.8 Having an Operation

If you are going to have an operation, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

2.9 Taking Livial with Food and Drink

You can eat or drink normally while you are taking Livial.

2.10 Pregnancy and Breast-Feeding

Livial is for use in postmenopausal women only. If you become pregnant, stop taking Livial and contact your doctor.

2.11 Driving and Using Machines

Livial has no known effect on the ability to drive or use machines.

2.12 Livial contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Livial.

If you are worried about anything in this section, talk to your doctor about the risks and benefits of HRT.

Premarin Tablets 0.625mg
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  1. How to take it

    Swallow tablets whole with a full glass of water. Do not divide, crushed, chew, or dissolve the tablet in your mouth.

    When to take PREMARIN

    If you are not already using any type of HRT you can start PREMARIN on

any convenient day. However, it is recommended you start PREMARIN after your last period. If you do not have predictable periods, then start PREMARIN on a Monday as this matches the directions on the calendar pack.

If you are already using a different type of HRT, your doctor can advise you when to start PREMARIN.

It does not matter if you take PREMARIN before or after food.

How much to take

For symptoms of menopause and prevention of osteoporosis, take one tablet daily.

For women with a uterus, your doctor will also prescribe a progestogen tablet to be taken with your PREMARIN. For some women with a history of endometriosis, who have had a hysterectomy, a progestogen may also be needed. Your doctor will advise you.

For women without fully-functioning ovaries, your doctor will prescribe PREMARIN according to your needs. The dose may be higher or lower than that prescribed for the treatment of menopause symptoms.

Take all tablets in a blister pack before starting a new pack.

How long to take it

Continue to take your medicine for as long as your doctor tells you.

Your doctor can discuss the risks and benefits of long-term treatment with HRT in your particular case.

If you forget to take your tablets

If less than 12 hours has passed from the time you normally take PREMARIN, take the missed tablet.

Take the next tablet at the usual time.

If more than 12 hours has passed, discard the missed tablet and take the next tablet when you normally would.

Do not take a double dose to make up for the one you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone: 0800 POISON or 0800 764 766) or go to Accident and Emergency at the nearest hospital if you think you or anybody else has taken too much PREMARIN.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include:

? feeling sick or vomiting ? dizziness
? feeling sleepy or tired
? breast tenderness

? stomach pain
? women may also experience

menstrual bleeding.

While you are taking PREMARIN

Things you must do

Tell any doctors, dentists and pharmacists who are treating you that you are taking PREMARIN.

If you are about to take any new medicines, tell your doctor or pharmacist that you are taking PREMARIN.

If you become pregnant while taking PREMARIN, see your doctor immediately.

PREMARIN should not be taken while you are pregnant.

See your doctor at least every six months for a check up.

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PREMARIN

3

Some women may need to go more often.

Your doctor will at regular intervals:

  • ?  check your breasts

  • ?  send you to have a mammogram

  • ?  check your uterus and cervix

  • ?  Do a Pap smear

  • ?  check your blood pressure.

    Your doctor may also take blood to check your blood fats, sugar levels and liver function.

    This helps to monitor for any unwanted effects of HRT.

    If you need to have blood tests tell the doctor that you are taking PREMARIN.

    PREMARIN can affect the results of some tests. These include hormone and liver function tests.

    Check your breasts regularly.

    Your doctor or nurse can show you how to check your breasts properly. If you notice any changes to your breasts, see your doctor.

    Include foods that are good sources of calcium and Vitamin D in your daily diet, and exercise regularly.

    Calcium, Vitamin D and exercise may help prevent thinning of the bones. Your doctor can advise you on which foods and types of exercise are best for you.

    Tell your doctor well in advance (at least 4 to 6 weeks) of any expected hospitalisation or surgery.

    If you go to hospital unexpectedly, tell the doctor who admits you that you are taking PREMARIN.

    The risk of developing blood clots in your blood vessels may be temporarily increased as a result of an operation, serious injury or having to stay in bed for a prolonged period.

    Tell your doctor if you have any breakthrough bleeding or spotting, which persists after 2 to 3 months of treatment with PREMARIN.

    Breakthrough bleeding or spotting may occur during the first few

months of treatment and then stop. However, if the bleeding continues, your doctor may wish to check why it is happening.

Things you must not do

Do not take PREMARIN to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else even if they have the same condition as you.

Do not stop taking PREMARIN, or change the dosage without checking with your doctor. 

PREMARIN is a type of treatment called hormone replacement therapy (HRT) and contains the hormone oestrogen in the form known as conjugated oestrogens.

PREMARIN helps to relieve the discomfort many women feel during and after menopause, including symptoms such as "hot flushes", sweating and vaginal dryness. It helps to prevent thinning of the bones (osteoporosis), which can cause fractures.

PREMARIN is also used to treat women where either the ovary does not function properly or has been removed.

If your doctor thinks you will need to take oestrogens for a long time,

including for the prevention of osteoporosis, he or she will have considered the benefits and risks of other treatments before prescribing PREMARIN for you.

How it works

Menopause occurs naturally in women, typically between the ages of 45 and 55. During menopause, your body produces less oestrogen than it did beforehand. This can cause symptoms such as "hot flushes". Some women also have problems with dryness of the vagina causing discomfort during or after sexual intercourse. Some women develop osteoporosis during or after menopause. This is a thinning of the bones making them weaker and more likely to break, especially the bones of the spine, hip and wrist.

Conjugated oestrogens are like the hormones produced by the ovaries before menopause. When given during or after menopause, they can help control the symptoms.

Oestrogen is used treat women who have had their uterus or "womb" removed. If you have not had your uterus or "womb" removed, you will need to take an oestrogen with a progestogen.

Ask your doctor if you have any questions why PREMARIN has been prescribed for you.

Your doctor may have prescribed PREMARIN for another use.

This medicine is available only with a doctor's prescription.

PREMARIN is not habit-forming.

PREMARIN is not suitable for birth control and it will not restore fertility.

This medicine is not expected to affect your ability to drive a car or operate machinery. 

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PREMARIN.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects.

It can be difficult to tell whether side effects are the result of taking PREMARIN or are side effects of another medicine you are taking.

Do not be alarmed by the list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may

  • vaginal thrush
  • stomach pain
  • stomach swelling or passing wind
  • nausea or vomiting
  • headache or migraine
  • loss of hearing
  • loss of memory
  • irregular, rapid jerky movements
  • dizziness
  • depression or anxiety
  • problems sleeping or sleepiness
  • moodiness or irritability
  • changes in sex drive
  • swelling of the lower legs, ankles or fingers
  • swelling and redness along a vein which is extremely tender to touch
  • weight changes
  • acne, itchy skin, or skin
  • discolouration ? skin rash
  • hair loss or extra hair growth
  • intolerance to contact lenses
  • worsening of porphyria.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following: 

Tell your doctor if you notice any of the following and they worry signs that clots may have formed, such as sudden severe headache, you: sudden loss of coordination, abnormal genital bleeding or spotting (if bleeding is heavy check with your doctor as soon as possible) 

tender, painful or swollen breasts,or secretions from the breasts

blurred vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood.

sudden partial or complete loss of vision or other problems with your eyesight.

period-like pain or pelvic pain ? vaginal discharge or change in secretions 

pain or tenderness in the abdomen, which may be signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or accompanied by fever, loss of appetite, nausea and vomiting

a yellow colour to the skin or eyes, itching, dark coloured urine or light coloured bowel motions. bloody diarrhoea, abdominal pain or tenderness, fever, nausea or vomiting

Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. 

When you must not take PREMARIN

HRT should only be used if you have been fully informed of the risks.

The decision to use HRT should be based on your particular needs and health, and made after a careful medical evaluation.

Talk regularly with your doctor about whether you still need treatment with PREMARIN.

Treatment with oestrogens, with or without progestogens should be used at the lowest effective dose and for the shortest period of time.

Do not take PREMARIN either alone or with a progestogen to prevent heart attacks, stroke or dementia.

Do not take PREMARIN if you have an allergy, or think you have an allergy, to:

page1image37624 page1image37784 page1image37944 page1image38104 page1image38264 page1image38424 page1image38584

? ?

any medicine containing conjugated oestrogens, the active ingredient in PREMARIN

any of the ingredients listed at the end of this leaflet

page1image41016

PREMARIN

1

? any other similar medicines, such as other HRT medicines or oral contraceptives ("birth control pill").

Some of the symptoms of an allergic reaction may include:

  • ?  shortness of breath

  • ?  wheezing or difficulty breathing

  • ?  swelling of the face, lips, tongue or other parts of the body

  • ?  rash, itching or hives on the skin.

    Do not take PREMARIN if you have or have had any of the following medical conditions:

  • ?  breast cancer

  • ?  endometrial or cervical cancer

  • ?  abnormal genital bleeding, which your doctor has not investigated

  • ?  a problem with blood clots forming in your blood vessels, such as painful inflammation of the veins (thrombophlebitis) or the blockage of a blood vessel in the legs (deep vein thrombosis or DVT), or lungs (pulmonary embolism)

  • ?  heart disease or stroke

  • ?  very high blood pressure that is

    not properly controlled

  • ?  problems with your breasts that your doctor has not investigated

  • ?  liver disease

  • ?  blood clotting problems.

    If you are not certain whether these may apply to you, or you are worried about anything in this list tell your doctor.

    Do not take this medicine if you are pregnant or think you are pregnant.

    Pregnancy must be excluded before you take PREMARIN.

    Do not give PREMARIN to a child.

    This medicine is not suitable for use in children.

    Do not take PREMARIN if you are breast feeding.

Oestrogens have been found in breast milk, and may reduce the production of breast milk.

Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.

If it is expired or damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take PREMARIN

You must have a thorough medical check-up before starting PREMARIN for the first time or if you are taking it again after a break.

Tell your doctor if you are allergic to any foods, dyes preservatives or any other medicines.

Tell your doctor if you have:

? a family history of breast cancer

? nodules, lumps or cysts in your breasts or any other benign breast condition (not cancer)

? fibroids or other benign tumours of the uterus (not cancer)

? unusual or irregular genital bleeding or spotting

? endometriosis (material similar to the uterine lining growing outside the uterus, causing pain or bleeding)

? high blood pressure

? liver problems

? a condition called porphyria

? hearing difficulties

? yellowing of the whites of the eyes or skin (jaundice) during pregnancy or when taking oestrogen (e.g. birth control pill or HRT)

? fluid retention
? kidney problems ? heart problems ? diabetes

? migraine

? asthma

? epilepsy

? Lupus (systemic lupus erythematosus)

? hereditary angioedema (swelling of the face, lips, tongue or throat that may cause difficulty swallowing or breathing)

? gall bladder disease

? a high level of blood fats

? high or low levels of calcium in the blood

? underactive thyroid gland ? obesity.

Tell your doctor if anyone in your immediate family has had blood clots in the deep veins of the legs or blood vessels of lungs, a stroke or heart attack.

Taking Other Medicines

Tell your doctor if you are taking birth control pills.

PREMARIN is not a contraceptive. Since pregnancy may be possible early in the menopause, while you are still having menstrual periods, you should ask your doctor about another (non-hormonal) method of birth control.

Tell your doctor or pharmacist if you are taking any other medicines including:

  • ?  all prescription medicines

  • ?  all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.

    Some medicines may be affected by PREMARIN or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.

    Tell your doctor or pharmacist if you are taking any of the following:

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PREMARIN

2

  • ?  herbal medicines containing St John's Wort

  • ?  some medicines for epilepsy such as phenytoin, phenobarbitone and carbamazepine

  • ?  some antibiotics and anti- infectives such as rifampicin, erythromycin and clarithromycin

  • ?  anti-fungal agents such as ketoconazole and itraconazole

  • ?  thyroid replacement therapy

  • ?  corticosteroids, such as

    dexamethasone

  • ?  ritonavir for the treatment of HIV infection

  • ?  cyclosporin used to prevent organ rejection.

    Grapefruit juice may also affect how well PREMARIN works.

    If you have not told your doctor about any of the above, tell them before you start taking PREMARIN.

    Your doctor and pharmacist have more information on medicines to be careful with or avoid while you are taking this medicine. 

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If you have had a hysterectomy you are not expected to have a period. However, if you have not had a hysterectomy, you may be taking an additional progestogen tablet for 12-14 days each month, and you will probably have a "period", or withdrawal bleed each month at about the time you finish the additional progestogen tablets. This is caused by the hormones in the HRT and is perfectly natural. Some women taking "combined HRT" (estrogen plus the additional progestogen) may experience a gradual reduction in withdrawal bleeding and it may eventually stop; this is quite normal. If you have heavy or irregular bleeding you should tell your doctor.

Do not to try to take off the coating or crush the tablets, as this could affect the way Premarin works.

Dosage

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

The recommended dose is one tablet per day (0.625 mg or 1.25 mg), to be swallowed with a drink of water.

You may start your first pack at any convenient time. However, for women with a uterus if you are transferring from a sequential HRT product (an HRT product that gives you a monthly bleed), treatment should begin the day following completion of the prior product unless instructed otherwise by your doctor.

Do not leave a break between packs unless your doctor tells you to. Do not stop taking Premarin without first discussing it with your doctor.

Duration of treatment

That really depends on why you and your doctor have decided on a course of treatment. If you are taking HRT to relieve your immediate menopausal symptoms like hot flushes and night sweats, you may be prescribed HRT for a relatively short period of time.

If, however, you or your doctor are worried about osteoporosis you may be prescribed HRT for longer.

3.2 If you take more Premarin than you should

If you take too many tablets do not worry, Premarin contains natural hormones and it is unlikely that serious problems will occur. If in any doubt consult your doctor or pharmacist.

You may feel some nausea (sickness), or experience a short period of vaginal bleeding (unless you have had a hysterectomy) if you take too many tablets.

3.3 If you forget to take Premarin

If you forget to take a dose, take it as soon as you remember, then go on as before. If more than one tablet has been missed take the tablet for the day that you remember and continue as normal. Do not take extra tablets to try to make up for the missed tablets. Missed pills may cause breakthrough bleeding in women with a uterus (womb).

3.4 If you need to have surgery

If you are going to have surgery, make sure your doctor and/or your surgeon knows that you are taking Premarin. You may need to stop taking Premarin about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see section 2.3 - Blood Clots in a vein (thrombosis). Ask your doctor when you can start taking Premarin again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

Premarin is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Premarin is used to treat some of the symptoms and conditions associated with the menopause. Premarin is usually prescribed for women who have had their womb removed (hysterectomy). However women who have not had this operation can still take Premarin and their doctor may prescribe a second type of tablet containing another hormone called a progestogen to be taken 12-14 days per month as well as the Premarin tablets.

Premarin is used for:

Relief of symptoms occurring after menopause

During the menopause, the amount of the estrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Premarin alleviates these symptoms after menopause. You will only be prescribed Premarin if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may be at risk of developing fragile bones (osteoporosis). You should discuss all available treatment options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Premarin 0.625 mg or 1.25 mg Prolonged-release Tablets to prevent osteoporosis after menopause. 

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following diseases are reported more often in women using HRT compared to women not using HRT:

  • ?  breast cancer

  • ?  abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)

  • ?  ovarian cancer

  • ?  blood clots in the veins of the legs or lungs (venous thromboembolism)

  • ?  heart disease

  • ?  stroke

  • ?  probable memory loss (dementia) if HRT is started over the age of 65

For more information about these side effects, see Section 2.
In addition to those discussed in Section 2, the following side effects have been reported in women taking HRT:

Common (may affect up to 1 in 10 women)

  • ?  breakthrough bleeding or spotting, vaginal inflammation

  • ?  breast tenderness, swollen breasts, nipple discharge, breast pain

  • ?  depression

  • ?  hair loss

  • ?  muscle and joint aches, leg cramps

  • ?  weight change (increase or decrease)

  • ?  changes in your triglyceride levels (fatty substances in the blood)

    Uncommon (may affect up to 1 in 100 women)

  • ?  changes in menstrual flow, inflammation of the vagina resulting in discharge

  • ?  thrush

  • ?  nausea, bloating, abdominal pain

  • ?  headache, migraine

  • ?  dizziness

  • ?  changes in mood including nervousness/anxiety

  • ?  changes in your interest in sex (increased or decreased libido)

  • ?  memory loss (dementia)

  • ?  visible swelling of the face or ankles

  • ?  itchiness, acne

  • ?  minor eye changes which may cause difficulties if you wear contact lenses

  • ?  gallbladder disease (e.g. gallstones)

  • ?  abnormal turning out of the cervix

  • ?  change in cervical mucus

  • ?  increase in hair growth

  • ?  discoloration of the skin especially of the face or neck known as “pregnancy patches”

    (chloasma)

    Rare (may affect up to 1 in 1,000 women)

  • ?  vomiting

  • ?  changes in breast tissue, milky secretion from the breasts

  • ?  allergic-like reactions

  • ?  irritability

  • ?  a worsening of glucose tolerance

  • ?  a worsening of asthma

  • ?  increase the growth of existing benign meningioma (a tumour of the membranes around the

    brain or spinal cord)

  • ?  inflammation of the pancreas

  • ?  inflammation of the colon (part of the intestine) which may present as lower left sided

    abdominal pain and/or bloody diarrhoea

  • ?  inflammation of veins just under the skin

  • ?  worsening of epilepsy

  • ?  heart attack

  • ?  increased size of fibroids

? dysmenorrhoea (lower back or abdominal pain during menstruation) Very rare (may affect up to 1 in 10,000 women)

jaundice (e.g. yellowing of the skin)
a worsening of chorea (an existing neurological disorder characterised by involuntary

spasmodic movements of the body)
a worsening of hypocalcaemia (low blood levels of calcium) in patients who already have a

known risk of low levels of calcium in their blood enlargement of liver tumours
worsening of porphyria (a rare inherited metabolic disorder) blood clots in the veins of the eye

thickening of the lining of the uterus
increase in blood pressure
painful reddish skin nodules (erythema nodosum)
rash with target-shaped reddening or sores (erythema multiforme)

These side effects are usually temporary and should get better over time. 

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Premarin you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Premarin.

Go for regular breast screening, as recommended by your doctor.

2.1 Do not take Premarin
if any of the following applies to you. If you are not sure about any of the points below, talk to

your doctor before taking Premarin.

Do not take Premarin:

  • ?  If you have or have ever had breast cancer, or if you are suspected of having it.

  • ?  If you have cancer which is sensitive to estrogens, such as cancer of the womb lining

    (endometrium) or if you are suspected of having it.

  • ?  If you have any unexplained vaginal bleeding.

  • ?  If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not

    being treated.

  • ?  If you have or have ever had a blood clot in a vein (thrombosis) such as in the legs (deep

    vein thrombosis) or the lungs (pulmonary embolism).

  • ?  If you have a blood clotting disorder (such as protein C, protein S or antithrombin

    deficiency).

  • ?  If you have or recently have had a disease caused by blood clots in the arteries, such as a

    heart attack, stroke or angina.

  • ?  If you have or have ever had a liver disease and your liver function tests have not returned

to normal.

  • ?  If you are allergic (hypersensitive) to conjugated estrogens or any of the other ingredients of Premarin tablets (listed in Section 6).

  • ?  If you have a rare blood problem called “porphyria” which is passed down in families (inherited).

  • ?  If you know or suspect you are pregnant, or you are breast-feeding.
    If any of the above conditions appear for the first time while taking Premarin, stop taking it at

    once and consult your doctor immediately.

    When to take special care with Premarin

    Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Premarin. If so, you should see your doctor more often for check-ups:

    • ?  fibroids inside your womb

    • ?  growth of womb lining outside your womb (endometriosis) or a history of excessive

      growth of the womb lining (endometrial hyperplasia)

    • ?  increased risk of developing blood clots (see section 2.3 Blood clots in a vein

      (thromobosis) for more detail)

    • ?  increased risk of getting a estrogen-sensitive cancer (such as having a mother, sister or

      grandmother who has had breast cancer)

    • ?  high blood pressure

    • ?  a liver disorder, such as a benign liver tumour

    • ?  diabetes

    • ?  gallbladder disease or gallstones

    • ?  migraine or severe headaches

    • ?  a disease of the immune system that affects many organs of the body (systemic lupus

      erythematosus, SLE)

    • ?  epilepsy

    • ?  asthma

    • ?  a disease affecting the eardrum and hearing (otosclerosis)

    • ?  a very high level of fat in your blood (triglycerides)

    • ?  fluid retention due to cardiac or kidney problems

    • ?  hypocalcaemia (low calcium levels)

    • ?  thyroid deficiency

      Stop taking Premarin and see a doctor immediately

      If you notice any of the following when taking HRT:

    • ?  any of the conditions mentioned in the “Do not take Premarin” section

    • ?  yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver

      disease

    • ?  a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)

    • ?  migraine-like headaches which happen for the first time

    • ?  if you become pregnant

    • ?  have an allergic reaction, signs of which include a rash, itching, shortness of breath,

      difficulty in breathing and a swollen face

    • ?  if you notice signs of a blood clot, such as:

o painful swelling and redness of the legs o sudden chest pain
o difficulty in breathing

For more information, see section 2.3 Blood Clots in a vein (thrombosis).

Note: Premarin is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

2.2 HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking estrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

Taking a progestogen in addition to the estrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take estrogen-only HRT, between 10 and 60 women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Premarin 0.625 mg and 1.25 mg prolonged-release tablets contain a higher dose of estrogens than other estrogen-only HRT products. The risk of endometrium cancer when using Premarin 0.625 mg and 1.25 mg prolonged-release tablets together with a progestogen is not known.

If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.

Your product, Premarin, is an estrogen-only product.

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Premarin. However if the irregular bleeding:

? carries on for more than the first 6 months

? starts after you have been taking Premarin for more than 6 months ? carries on after you have stopped taking Premarin
? see your doctor as soon as possible.

Breast Cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Evidence suggests that taking combined estrogen-progestogen and possibly also estrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

For women who have had their womb removed and who are using estrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.

Your risk of breast cancer is also higher:
? if you have a close relative (mother, sister or grandmother) who has had breast

cancer
? if you are seriously overweight.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking estrogen- progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

Regularly check your breasts. See your doctor if you notice any changes such as:

? dimpling of the skin
? changes in the nipple
? any lumps you can see or feel.

Ovarian Cancer

Ovarian cancer (cancer of the ovaries) is rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years. Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

2.3 Effect of HRT on heart and circulation Blood Clots in a vein (thrombosis)

The risk of blood clots in the veins (also called deep vein thrombosis, or DVT), is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death. This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

  • ?  you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)

  • ?  you are seriously overweight (BMI>30 kg/m2)

  • ?  you have any blood clotting problem that needs long-term treatment with a medicine used

    to treat blood clots

  • ?  if any of your close relatives has ever had a blood clot in the leg, lung or another organ

  • ?  you have any blood clotting problem that needs treatment with a medicine used to prevent

    blood clots

  • ?  you have systemic lupus erythematosus (SLE)

  • ?  you have cancer

  • ?  you are pregnant or have recently had a baby.

    For signs of a blood clot, see “Stop taking Premarin and see a doctor immediately”.

    Compare

    Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
    For women in their 50s who have been taking estrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

    For women in their 50s who have had their womb removed and have been taking estrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).

    Heart Disease (heart attack)

    HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

    There is no evidence that HRT will prevent a heart attack.

    Women over the age of 60 who use estrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

    For women who have had their womb removed and are taking estrogen-only therapy there is no increased risk of developing a heart disease.

    If you get:

    ? a pain in your chest that spreads to your arm or neck
    ? See a doctor as soon as possible and do not take any more HRT until your doctor

    says you can. This pain could be a sign of heart disease.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Other things that can increase the risk of stroke include:

  • ?  getting older

  • ?  high blood pressure

  • ?  smoking

  • ?  drinking too much alcohol

  • ?  an irregular heartbeat.

    If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

    Compare

    Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

    If you get:

    ? unexplained migraine-type headaches, with or without disturbed vision
    ? See a doctor as soon as possible and do not take any more HRT until your doctor

    says you can. These headaches may be an early warning sign of a stroke.

    2.4 Other conditions

    HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

    Women with pre-existing hypertriglyceridaemia (high levels of fat in the blood) may experience large increases of their plasma triglycerides, which can lead to inflammation of the pancreas (pancreatitis). If you have this condition your doctor will monitor you closely.

    2.5 Other medicines and Premarin

    Some medicines may interfere with the effect of Premarin. This might lead to irregular bleeding. This applies to the following medicines:

  • ?  Medicines for epilepsy (such as phenobarbital, phenytoin, carbamazepine).

  • ?  Medicines for tuberculosis (such as rifampicin, rifabutin).

  • ?  Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, nelfinavir).

  • ?  Herbal remedies containing St. John’s Wort (Hypericum perforatum).

  • ?  Metyrapone (most commonly used in the treatment of Cushing’s syndrome).

    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

    2.6 Laboratory tests

    If you need a blood test, tell your doctor or the laboratory staff that you are taking Premarin, because this medicine can affect the results of some tests.

2.7 Pregnancy and breast-feeding

Premarin is for use in postmenopausal women only. You should stop taking Premarin and tell your doctor immediately if you know or suspect you are pregnant, or if you are breast-feeding.

2.8 Driving and using machines

There is no evidence to suggest that taking Premarin will affect your ability to drive or to operate machinery.

2.9 Premarin contains

Premarin tablets contain lactose monohydrate and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The colouring agent E110, which is present in the yellow tablets may cause allergic reactions. 

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Premique Low Dose Tablets
Pack Size: 84 tablets (3 months supply)
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Always take Premique Low Dose exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one tablet every day.

Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms.

Take your tablet at the same time each day as this will help to remind you to take your medicine.

If you are not currently taking HRT or you are taking another period-free HRT, you may start your first pack of Premique Low Dose at any convenient time.

If you are changing from an HRT product that gives you a monthly bleed, start Premique Low Dose the day after you finish the course of the previous product, unless instructed otherwise by your doctor.

While you are taking Premique Low Dose you will have no tablet-free days. You should start your next pack the day after you finish the previous one.

17 August 2010

Doc Id : 61948 (from 61947)

an anticonvulsant (e.g. phenobarbital, phenytoin, carbamazepine)
an anti-infective (e.g. rifampicin, rifabutin, nevirapine, efavirenz, erythromycin, ketoconazole, ritonavir, nelfinavir)
a herbal preparation such as St. John’s wort (Hypericum perforatum) metyrapone (most commonly used in the treatment of Cushing’s syndrome) aminoglutethimide (most commonly used in the treatment of breast cancer and Cushing’s syndrome).

that Premique Low Dose works may be altered if other medicines are used at the

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

While you are taking Premique Low Dose

HRT may affect some medical tests. If you visit a hospital or clinic for any medical tests, you should tell the doctor concerned that you are taking HRT.

Premique Low Dose is not a contraceptive. It is important that you use a reliable form of non-hormonal contraception (e.g. condom or diaphragm) if there is any possibility that you may still become pregnant. You should discuss this with your doctor.

Premique Low Dose does not cause periods. However, you may experience some irregular bleeding or light bleeding (spotting) during your first few months of taking Premique Low Dose. If the bleeding is troublesome, or continues beyond the first 3 months of treatment you should discuss this with your doctor (see section titled ‘endometrial cancer’ above).

Do not try to take off the coating or crush the tablets as this could affect the way Premique Low Dose works.

If you take more Premique Low Dose than you should

If you take too many tablets don’t worry. You may feel some nausea (sickness), breast tenderness, dizziness, abdominal pain, drowsiness, fatigue or experience a short period of vaginal bleeding, but it is unlikely that serious problems will result. If you are concerned talk to your doctor or pharmacist.

If you forget to take Premique Low Dose

If you forget to take a tablet don’t worry. Take it as soon as you remember and then carry on taking the remaining tablets at the usual time.

If more than one tablet has been forgotten, do not take extra to try to make up for the missed tablets.

Missed tablets may cause a short period of light bleeding in women with a uterus (womb).

17 August 2010

Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

Reasons to stop taking Premique Low Dose

If you:

  •  experience a migraine type headache for the first time

  •  develop signs of jaundice (yellowing of the skin or the whites of the eyes)

  •  become pregnant

  •  experience a significant increase in your blood pressure

  •  have an allergic reaction, signs of which include rash, itching, shortness of breath,

    difficulty breathing and a swollen face

  •  develop a contraindication (see section titled ‘Reasons for not taking Premique Low

    Dose’)

  •  Stop taking Premique Low Dose and tell your doctor immediately.

    Do not take any more tablets until your doctor says you can. 

Premique Low Dose is one of a group of medicines known as Hormone Replacement Therapy (HRT). It is used to treat some of the symptoms and conditions associated with the menopause.

Your periods will stop once menopause is reached. This change is due to lowered levels of the hormones estrogen and progesterone. You may experience a number of unpleasant symptoms, including hot flushes, night sweats and vaginal dryness, around the time of menopause. Premique Low Dose can relieve some of these symptoms by replacing some of the lost estrogen. 

    1. Like all medicines, Premique Low Dose can cause side effects, although not everybody gets them.

      Serious side effects

      Stop taking Premique Low Dose and tell your doctor immediately if you:

      •  have an allergic reaction, signs of which include rash, itching, shortness of breath, difficulty breathing and a swollen face

      •  experience a migraine type headache (typically a throbbing headache and nausea preceded by visual disturbances) for the first time

      •  develop signs of jaundice (yellowing of the skin or the whites of the eyes)

      •  become pregnant

      •  experience a significant increase in your blood pressure

      •  develop a contraindication i.e. circumstances which make treatment inadvisable (see

        section 2 Before you take Premique Low Dose) Do not take any more tablets until your doctor says you can.

        HRT can also increase the risk of heart disease, stroke, blood clots, breast cancer, endometrial cancer and ovarian cancer. Please see Section 2 - Before you take Premique Low Dose.

        Other side effects
        Very common (affect more than 1 in 10 women)

• breast pain

Common (affect less than 1 in 10 women)

    • breakthrough bleeding or spotting, vaginal inflammation, period pain

    • breast tenderness, swollen breasts, nipple discharge

    • depression

    • muscle and joint aches, leg cramps

      17 August 2010

      Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

  • weight change (increase or decrease)

  • changes in your triglyceride levels (fatty substances in the blood)

    Uncommon (affect less than 1 in 100 women)

  • changes in menstrual flow, vaginal discharge

  • thrush

  • nausea, bloating, abdominal pain

  • headache, migraine

  • blood clots in the veins

  • dizziness

  • changes in mood including anxiety

  • changes in your interest in sex (increased or decreased libido)

  • visible swelling of the face or ankles

  • itchiness, acne

  • difficulty wearing contact lenses

  • gallbladder disease (e.g. gallstones)

  • hair loss

    Rare (affect less than 1 in 1000 women)

    • vomiting

    • changes in breast tissue, milky secretion from the breasts

    • irritability

    • allergic reactions including swelling, rash or red patches on the skin

    • increase in hair growth

    • an intolerance to glucose

    • a worsening of asthma

    • increased size of fibroids

    • ovarian cancer

    • worsening of epilepsy

    • heart attack, stroke

    • inflammation of veins just under the skin

    • inflammation of the pancreas

    • irregular dark spots (usually on the face)

      Very rare (affect less than 1 in 10000 women)

    • jaundice (e.g. yellowing of the skin)

    • a worsening of chorea (an existing neurological disorder characterised by

      involuntary spasmodic movements of the body)

    • a worsening of hypocalcaemia (low blood levels of calcium)

    • blurred vision or loss of vision

    • worsening of porphyria (a rare inherited metabolic disorder)

    • growth of benign liver tumours

      These side effects are usually temporary and should get better over time.

      17 August 2010
      Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

Other side effects that may occur while taking an estrogen-progesterone combined HRT are: • memory loss (dementia)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 

Do not take Premique Low Dose if:

  •  you have or have had breast cancer

  •  you have endometrial cancer (cancer of the lining of the womb) or have been told

    you have another type of estrogen-dependent cancer

  •  you have been told you have a blood circulation disorder or have had a blood clot

  •  you have a blood clotting disorder (thrombophilic disorder, such as protein C,

    protein S, or antithrombin deficiency)

  •  you have a heart condition such as angina or have had a heart attack

  •  you are allergic to any of the ingredients in Premique Low Dose; the ingredients

    are listed at the beginning of this leaflet

  •  you have porphyria (a rare inherited metabolic disorder).

    If any of the following applies to you discuss this with your doctor before taking Premique Low Dose, as it may not be suitable for you:

    •  you have recently had unexpected or very heavy vaginal bleeding

    •  you have been told that you have endometrial hyperplasia (abnormal growth of

      the lining of the womb)

    •  you have or have previously had liver disease

    •  you are pregnant, or you are breast-feeding.

      3) WHAT YOU SHOULD KNOW BEFORE TAKING PREMIQUE LOW DOSE

      Before you start taking HRT, your doctor should ask about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination — but only if these examinations are necessary for you, or if you have any special concerns.

      Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

      17 August 2010

      Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

You are advised to:-

  •  go for regular breast screening and cervical smear tests

  •  regularly check your breasts for any changes such as dimpling of the skin,

    changes in the nipple, or any lumps you can see or feel.

    Some diseases may be made worse by HRT. Therefore, if you have or have ever had any of the following remind your doctor as he or she may want to monitor you more closely:-

  •  uterine fibroids or endometriosis

  •  risk factors for blood clots (see section titled ‘blood clots’ below)

  •  a close relative who has had breast cancer or an estrogen dependent cancer, such as

    cancer of the womb or ovaries

  •  high blood pressure

  •  heart disease

  •  kidney disease

  •  diabetes

  •  gallbladder disease or gallstones

  •  migraine

  •  systemic lupus erythematosus (SLE – a rare chronic inflammatory disease)

  •  epilepsy

  •  asthma

  •  otosclerosis (hearing loss due to a problem with the bones in your ear)

  •  low blood calcium levels (hypocalcaemia)

  •  high levels of fatty substances in the blood (hypertriglyceridaemia).

    If there is a change in any of the above conditions whilst taking Premique Low Dose tell your doctor.

    As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

    Effects on your heart or circulation

    Heart Disease

    HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

    HRT will not help to prevent heart disease.

    Studies with one type of HRT (containing conjugated estrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

    17 August 2010

    Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

If you get:

a pain in your chest that spreads to your arm or neck
See a doctor as soon as possible and do not take any more HRT until your

doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older
high blood pressure
smoking
drinking too much alcohol an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT — on average, over a 5-year

period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:
unexplained migraine-type headaches, with or without disturbed vision
See a doctor as soon as possible and do not take any more HRT until your

doctor says you can. These headaches may be an early warning sign of a stroke.

Blood Clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

17 August 2010

Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

You are more likely to get a blood clot:

  •  if you are seriously overweight

  •  if you have had a blood clot before

  •  if any of your close family have had blood clots

  •  if you have had one or more miscarriages

  •  if you have any blood clotting problem that needs treatment with a medicine such as warfarin

  •  if you’re off your feet for a long time because of major surgery, injury or illness

  •  if you have a rare condition called SLE (systemic lupus erythematosus)

    If any of these things apply to you, talk to your doctor to see if you should take HRT. Looking at women in their 50s who are not taking HRT — on average, over a 5-year

    period, 3 in 1000 would be expected to get a blood clot.
    For women in their 50s who are taking HRT, the figure would be 7 in 1000.

    Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

    For women in their 60s who are taking HRT, the figure would be 17 in 1000.

    If you get:

    painful swelling in your leg
    sudden chest pain
    difficulty breathing
    See a doctor as soon as possible and do not take any more HRT until your

    doctor says you can. These may be signs of a blood clot.

    If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

    Effects on your risk of developing cancer

    Breast Cancer

    Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

    Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestogen HRT is higher than for estrogen-only HRT (but estrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).

    17 August 2010

    Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping.

Your risk of breast cancer is also higher:
if you have a close relative (mother, sister or grandmother) who has had breast

cancer
if you are seriously overweight.

Looking at women aged 50 who are not taking HRT – on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

For women who start taking estrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).

If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).

If you notice any changes in your breast, such as: dimpling of the skin
changes in the nipple
any lumps you can see or feel

Make an appointment to see your doctor as soon as possible.

Endometrial Cancer (cancer of the lining of the womb)

Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the estrogen helps to lower the extra risk.

If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.

Your product, Premique Low Dose, contains a progestogen.

17 August 2010

Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long they take it.

The addition of a progestogen to estrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:

carries on for more than the first few months
starts after you’ve been on HRT for a while
carries on even after you’ve stopped taking HRT
Make an appointment to see your doctor. It could be a sign that your

endometrium has become thicker.

Ovarian Cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

Other Conditions

HRT will not help prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.

Women with hypertriglyceridaemia may experience large increases of their plasma triglycerides, which can lead to inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis include sudden sharp abdominal pains, abdominal swelling, fever and feeling or being sick.

If you are taking thyroid hormone replacement therapy (e.g. thyroxine), your doctor may monitor your thyroid function more often when you start treatment.

Driving and using machines

There is no evidence to suggest that Premique Low Dose will affect your ability to drive or to operate machinery.

17 August 2010

Doc Id : 61948 (from 61947)

Type IB (C.I.3) variation Update to section 4.3 Version 1.0

Important information about some of the ingredients in Premique Low Dose

Premique Low Dose contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you have bought yourself. 

Enlarge
Premique Tablets
Pack Size: 84 tablets (3 months supply)
Order in for Next Day Delivery
RRP*: £38.99
Saving: £2.00
Our Price: £36.99
Out of Stock 
  • Reasons to Shop
  • Similar Products
  • Directions
  • Description
  • Side Effects
  • Warnings

Easy Online Consultations

Takes less than 3 minutes to complete

Price
Guarantee

If you find it cheaper we will refund the difference

Fast, Discreet Delivery

Same day dispatch on orders before 4pm

Safe &
Secure

All data is safe & encrypted

UK Doctors & Pharmacists

Run by experienced, registered healthcare professionals