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.
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.
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.
The active substance is conjugated estrogens. The tablets marked with “0.625” contain 0.625 mg conjugated estrogens. The tablets marked with “1.25” contain 1.25 mg conjugated estrogens.
? The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose, sucrose, hydroxypropyl cellulose and polyethylene glycol. The coating on the maroon tablets contains hypromellose, titanium dioxide (E171), red aluminium lake (E129), macrogol and blue aluminium lake (E132). The coating on the yellow tablets contains hypromellose, titanium dioxide (E171), quinoline yellow aluminium lake (E104), macrogol, polysorbate and sunset yellow (E110).
The polish on the maroon and yellow tablets contains hypromellose and carnauba wax.
The edible white ink on the maroon tablets contains titanium dioxide (E171), propylene glycol, and hypromellose. The edible black ink on the yellow tablets contains iron oxide black, propylene glycol, and hypromellose.
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
? 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
? 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
? nausea, bloating, abdominal pain
? headache, migraine
? 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”
Rare (may affect up to 1 in 1,000 women)
? changes in breast tissue, milky secretion from the breasts
? allergic-like reactions
? 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
? 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
? 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
? 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
? gallbladder disease or gallstones
? migraine or severe headaches
? a disease of the immune system that affects many organs of the body (systemic lupus
? 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
? 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.
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.
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
? if you are seriously overweight.
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 (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
? 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”.
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.
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
? 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, 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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