Kliofem Tablets (84 tablets)

Kliofem tablets are a type of hormone replacement therapy (HRT) prescribed to women after menopause to replace the oestrogen no longer produced by the body. This relieves menopause symptoms and restores the oestrogen’s protective effect against cardiovascular disease.

Kliofem is a continuous combined HRT used to treat postmenopausal women who have not had their natural period for at least 12 months. It should be taken daily.

Kliofem is only intended for women who have not had a hysterectomy. Women who have undergone a hysterectomy, should seek an HRT that does not contain progestogen.

Kliofem is manufactured by Novo Nordisk and contains two female hormones, estradiol (a synthetic form of oestrogen) and norethisterone acetate (a synthetic form of progesterone). These hormones behave similarly to the natural hormones produced by the female body.

During menopause, the amount of oestrogen produced by a woman’s body declines. This can result in symptoms such as a hot face, chest or neck. Doctors prescribe Kliofem to alleviate these symptoms if they begin to interfere with daily activities and routine.

After menopause, many women are diagnosed with osteoporosis. The condition is marked by weak bones and an increased risk of fractures. Kliofem helps prevent osteoporosis after menopause.

The medicine is prescribed to women whose periods have stopped for more than a year and who have not undergone a hysterectomy. If you have fibroids in the uterus, gallstones, migraine, diabetes, epilepsy, asthma, otosclerosis, Systemic Lupus Erythematosus (SLE), triglycerides, increased risk of developing clots, high blood pressure, growth of the womb lining, fluid retention due to kidney or cardiac problems, inform your GP about before starting Kliofem. This medicine is not suitable for pregnant and breastfeeding women.

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

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

Women who have not had a hysterectomy need a progestogen as part of their HRT. This is because in women with an intact uterus, oestrogen stimulates the growth of endometrium (uterine lining), which can increase the chance of endometrial cancer occurring if the growth goes unrestricted. Progestogen opposes oestrogen’s effect on endometrium and reduces the risk of cancer though does not eliminate it entirely. This is known as combined HRT.

HRT is also used to prevent osteoporosis in postmenopausal women. Declining levels of oestrogen during menopause can affect the bones, causing them to become thinner and more prone to breaks. Oestrogen supplements help prevent bone loss and fractures that may occur in women in the years after menopause.

Women at risk for fractures after menopause include those who have had an early menopause, those who have had recent prolonged corticosteroid therapy (e.g. prednisolone), those who have a small, thin frame and smokers.

You will find more information about HRT and medications for preventing osteoporosis in the factsheets linked below.

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

Some Non-Medicinal Alternatives for the symptoms of Menopause are;

For Night Sweats and Hot Flushes

• Using A fan
• Cool Showers
• Wearing light clothing

Vaginal Dryness

• Lubricants

Other Alternatives

• Healthy diet and regular exercise
• Stopping Smoking

Read the enclosed leaflet carefully before starting a course of Kliofem tablets.

One tablet should be taken each day, at around the same time, either before or after eating. Take the tablets continuously, without a break between packs.

Side effects can include:

Very common side effects, may affect more than 1 in 10 people:

• vaginal bleeding
• breast tenderness or pain

Common side effects, may affect up to 1 in 10 people:

• headache
• weight gain caused by water retention
• vaginal inflammation
• migraine, new or worse than before
• fungal vaginal infection
• depression, new or worse than before
• nausea
• abdominal pain, swelling or discomfort
• breast enlargement or swelling
• leg cramps
• back pain
• Uterine fibroid aggravation, occurrence or recurrence
• swollen arms and legs
• weight gain

If you are concerned about these effects, or if the product affects you in a different way, stop using it and talk to your doctor or pharmacist.

Active ingredients:

 Estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.

Inactive ingredients:

lactose monohydrate, maize starch, talc, hydroxypropylcellulose and magnesium stearate.

The film-coating contains: hypromellose, triacetin and talc.

Read the following warnings carefully to ensure you are selecting an appropriate product.

Medical history and regular check-ups

Treatment with HRT carries risks which you should consider before deciding to start it or to continue taking it.

There is limited experience in treating women with premature menopause. If you have premature menopause, the risks of using HRT may be different for you. Talk to your doctor.

Before starting or restarting HRT, your doctor will ask about your and your family’s medical history. You may need to have physical examination of your breasts and/or an internal examination, if necessary.

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

Schedule regular breast screenings, as recommended by your doctor.

Do not take Kliofem

If any of the following applies to you:

• if you have, have had or suspect that you have breast cancer
• if you have, have had or suspect that you have cancer of the uterus lining (endometrial cancer), or any other oestrogen- dependent cancer
• if you have unexplained vaginal bleeding
• if you have excessive thickening of the uterus lining that is untreated
• if you have or have ever had a blood clot in a vein such as in the legs or the lungs.
• if you have a blood clotting disorder
• if you have had a angina, heart attack, or stroke
• 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, hereditary blood problem called porphyria
• if you are allergic to any of the other ingredients of Kliofem.

Warnings and precautions

Before you start treatment, inform your doctor if you have or have had any of the following conditions since they may return or worsen during treatment with Kliofem:

• fibroids inside your uterus
• endometriosis or a history of excessive growth of the uterus lining
• elevated risk of developing blood clots
• elevated risk of developing an oestrogen-sensitive cancer
• a liver disorder
• high blood pressure
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus, SLE
• epilepsy
• asthma
• otosclerosis
• a very high level of triglycerides in your blood.
• fluid retention as part of cardiac or kidney problems
• if you take medication for an underactive thyroid gland, your doctor will test you during your treatment with HRT to ensure that your hormone levels remain acceptable
• a hereditary condition causing recurrent episodes of severe swelling or if you have experienced rapid swelling of the hands, face, lips, feet, eyes, throat, tongue, or digestive tract
• lactose intolerance.

Stop taking Kliofem and see a doctor immediately

If you notice any of the following:

• any of the conditions mentioned in the Warnigs section
• signs of jaundice. This may signal liver disease
• a significant rise in your blood pressure. Symptoms include headache, tiredness, dizziness.
• Headaches which happen for the first time that resemble migraines
• if you become pregnant
• if you notice signs of a blood clot, such as:
• painful swelling and redness in the legs
• pain in the chest which comes on suddenly
• difficulty in breathing

Note: Kliofem is not a contraceptive. If it has been less than a year since your last menstrual period or you are under 50 years old, you may still need additional contraception. Consult your doctor for advice.

HRT and cancer

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

Taking an HRT with oestrogen only will increase your risk of developing excessive thickening of endometrium and endometrial endometrium.

The progestagen in Kliofem® protects you from this extra risk.

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On average, in women who have not had a hysterectomy and do not take HRT, 0.5% will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women aged 50 to 65 who have not had a hysterectomy and who take oestrogen-only HRT, between 1% and 1.6% will be diagnosed with endometrial cancer, depending on the dose and the length of treatment.

Irregular bleeding

You may experience irregular bleeding or spotting during the first 3-6 months of taking Kliofem. However, if the irregular bleeding:

• continues after the first 6 months,
• begins after you have been taking Kliofem for over 6 months
• continues after you have stopped Kliofem

contact your your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined oestrogen-progestagen and possibly oestrogen-only HRT increase patients’ risk of developing breast cancer. This risk depends on how long you take HRT. However, the risk returns to normal a few years after stopping treatment.

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On average, of women aged 50 to 79, 9 to 17 women in 1,000 women who are not taking HRT will be diagnosed with breast cancer over a 5-year period. There will be 13 to 23 cases in 1,00 women aged 50 to 79 who take oestrogen-progestagen HRT for over 5 years.

Check your breasts regularly. Talk to your doctor if you notice any changes such as:

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

Additionally, you are advised to schedule regular mammogram screenings During the screening, inform the nurse or healthcare professional about your use of HRT, as this medication may increase the density of your breasts and affect the mammogram’s outcome. Where breast has increased density, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare, however the use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slight increase in the risk of ovarian cancer.

The risk varies with age. For example, about 2 women in 2,000 aged 50 to 54 who are not taking HRT will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users.

HRT’s effect on heart and circulation

Blood clots

The risk of developing blood clots in the veins is higher in HRT users than in non-users, especially during the first year of taking the medication.

Blood clots can be serious, and if a clot enters the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to develop a blood clot in your veins as you age and if any of the following applies to you:

• you are unable to walk for an extended period of time due to major surgery, injury or illness.
• if any of your close relatives has had a blood clot in the leg, lung or another organ
• you are overweight (BMI > 30 kg/m2)
• you have systemic lupus erythematosus (SLE)
• you have a blood clotting problem that requires long-term treatment with a medication used to prevent blood clots
• you have cancer

Talk to your doctor if you have any of these conditions prior to taking Kliofem.

For signs of a blood clot, see Stop taking Kliofem® and see a doctor immediately.

Compare

On average, 4 to 7 women in 1,000 in their 50s who are not taking HRT, would be expected to get a blood clot in a vein over a 5-year period.

For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there are 9 to 12 cases in 1,000 users.

Heart disease (heart attack)

Women over the age of 60 who take oestrogen-progestagen HRT have a slightly higher risk of developing heart disease than those not taking HRT. There is no evidence that HRT will prevent a heart attack.

Stroke

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

Compare

On average, 8 in 1,000 women in their 50s who are not taking HRT are likely to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases of stroke in 1,000 users over 5 years.

Other conditions

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

Using other medications

Some medicines may interfere with Kliofem. This might lead to irregular bleeding and applies to the following medications:

• Medications for epilepsy
• Medications for tuberculosis
• Medications for HIV infection (
• Medications for hepatitis C infections
• remedies containing St John’s Wort (Hypericum perforatum).

Some medicines increase the effects of Kilofem these e include

• Medicines containing ketoconazole.

Please tell your doctor or pharmacist if you take or have recently taken any other medications, including over-the-counter, herbal medications or other natural products.

Taking Kliofem with food and drink

Kliofem tablets can be taken with or without food and drink.

Laboratory tests

If you need take a blood test, tell your doctor or the laboratory staff that you are taking Kliofem, since it can affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy: If you become pregnant speak to your doctor. Kilofem is to be used in postmenopausal women only.

Breastfeeding: Do not take Kliofem if you are breast-feeding.

Driving and operating machinery

Kliofem has no studied effect on a person’s ability to drive or operate machinery.

Important information about some of the ingredients in Kliofem

If you have an intolerance to some sugars, you should be aware that Kliofem contains lactose monohydrate contact your doctor before taking Kliofem.

Read all packaging and the Product Information Leaflet before taking any new medicine and inform your doctor of medications you take or intend to take.

UK ORDERS

We offer FREE standard tracked delivery on orders over £40.

The following delivery options are available:

• Standard Tracked Delivery - 2/3 day delivery - £2.95
• Express Tracked Delivery - 1/2 day delivery - £4.45
• Special Delivery (Guaranteed before 1pm) - £8.95
• Saturday Guaranteed before 1pm - £10.45

All our orders are sent out using Royal Mail. We always aim to dispatch all orders received before 4pm the same working day. Any orders received after 4pm or over the weekend will be dispatched the next working day. Orders will not be dispatched on weekends or bank holidays.

All orders can be fully tracked in your account.

We ensure all parcels are in plain packaging for discreet delivery of your medicines and pharmacy goods.

Deliveries containing pharmacy-only or prescription medicines may require a signature on receipt. 

Delivery is free for all NHS prescriptions.

Please note: Royal Mail do not deliver on Sundays or Bank Holidays - this should be taken into account when ordering. 

If you are not home to accept your delivery, a card should be left by the Royal Mail representative. This card will provide details of where you can collect the order or how to arrange re-delivery.

Should you be unable to collect your missed delivery or arrange for your medication to be redelivered by Royal Mail, the pharmacy can resend your medication to the same, or a different address provided it has been returned to us and this happens within a 30 day window.

Once a package has been shipped with Royal Mail we advise that you are bound to the terms and conditions of their use together with the terms and conditions contained herein.

You have the right to cancel your order up to the point when your treatment is dispatched. The pharmacist must destroy any medication within 30 days of it being returned, even un-opened boxes, so we are not able to offer refunds once your treatment has been dispatched.

REMOTE AREAS

Please be aware that Royal Mail Guaranteed services are not available to all customers in the UK, especially those that live in remote postcodes. Royal Mail advise customers of the following:

We deliver by 5.30pm the next working day in the following postcode areas:
AB30 - 39, 41 - 45, 51 - 56
GY9 Alderney (Channel Islands)
HS1, 3 - 9
IV21 - 28, 40 - 49, 51 - 56
KA27, 28
KW1 - 3, 5 - 15
KW16 Stromness Town only
PA20 (0&9)
PA28 - 38, 41 - 49, 76, 77
PH15, 17 - 26, 31 - 40, 49, 50
ZE1

We deliver within two working days by 5.30pm to the following postcodes areas:
GY1 Herm (Channel Islands)
GY9 Sark (Channel Islands)
GY10
HS2
PA60 - 75, 78
ZE2, 3

We deliver within three working days by 5.30pm to the following postcode areas:
KW16 - non-Town
KW17
PH30, 41 - 44

Please note: This applies to our 'Special Delivery' and 'Saturday Guaranteed' services.

INTERNATIONAL ORDERS

We are currently unable to ship orders outside of the UK.

We are unable to ship orders to mailing or forwarding houses for onwards shipping to locations outside of the UK.