Vagifem

• Used to relieve menopausal symptoms
• Tablet for vaginal use
• Contains an oestrogen hormone
• For postmenopausal women only

Vagifem is used to relieve menopausal symptoms caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause. During menopause, women’s bodies produce less and less oestrogen hormones. This can cause vaginal symptoms such as dryness or irritation.

Vagifem belongs to a group of medicines called vaginal Hormone Replacement Therapy (HRT). It contains the active ingredient estradiol, which is an oestrogen. Vagifem works by replacing the oestrogen which is normally produced in the ovaries of women. This helps relieve discomfort in the vagina. The tablet is inserted into the vagina, so the hormone is released where it is needed.

Vagifem is for vaginal use only. Insert the vaginal tablet into your vagina with the applicator. The user instructions in the package leaflet tell you how to do this. You can start using Vagifem on any day which is best for you.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The general dosage guidelines are as follows:

• Adult women: use one vaginal tablet each day for the first two weeks.

Then use one vaginal tablet twice a week. Leave three or four days between each dose.

When using medicines for any menopausal symptoms, it is recommended to use the lowest dose that works, and to use the medicine for as short a time as it is needed. Treatment should only be continued if the benefit is greater than the risk. Talk to your doctor about this.

Alcohol/driving

This medicine does not interact with alcohol. Vagifem does not affect your ability to drive safely.

If you use too much/forget to use/stop using Vagifem

If you have used more Vagifem than you should, consult your doctor or pharmacist.

If you forget a dose, use the medicine as soon as you remember. Do not use a double dose to make up for a forgotten one.

Do not stop using Vagifem without talking to your doctor.

Do not use Vagifem if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Vagifem contains').
• You have, or have had, breast cancer, or if you are suspected of having it.
• You have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium) or if you are suspected of having it.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• You have, or have had, a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
• You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
• You have, or recently have had, a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have, or have had, a liver disease and your liver function tests have not returned to normal.
• You have a rare blood problem called porphyria which is passed down in families (inherited).

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

When should this medicine be used with caution?

The use of HRT tablets is linked to a slight increased risk of serious side effects, such as certain types of cancer and heart and vascular disease (e.g., thrombosis). For more information on the above, see the package leaflet.

Tell your doctor if you have ever had any of the following problems before you start the treatment:

• Attacks of shortness of breath caused by tightening of the muscles that line the airways and swelling of the inner lining of the airways (asthma).
• Epilepsy.
• Diabetes.
• Gallstones.
• High blood pressure.
• Migraine or severe headaches.
• A liver disorder, such as a benign liver tumour.
• Growth of womb lining outside your womb (endometriosis) or excessive growth of the womb lining (endometrial hyperplasia).
• A disease affecting the eardrum and hearing (otosclerosis).
• Systemic lupus erythematosus (SLE), a disease of the immune system that affects many organs of the body.
• Increased risk of getting an oestrogensensitive cancer (such as mother, sister or grandmother who has had breast cancer).
• Increased risk of developing blood clots (see the package leaflet for more information).
• Fibroids inside your womb.
• A very high level of fat in your blood (triglycerides).
• Fluid retention due to cardiac or kidney problems.

If you experience any of the following, stop using Vagifem immediately and contact your doctor:

• Migrainelike headaches which happen for the first time.
• Yellow discolouration of the skin and white of the eye (jaundice). These may be signs of a liver disease.
• A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness).
• Any of the conditions mentioned in the ‘When not to use Vagifem’ section.
• You become pregnant.
• You notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain and/or difficulty in breathing.

Pregnancy and breastfeeding

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

Other medicines and Vagifem

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

As Vagifem is used for a local treatment in the vagina and contains a very low dose of estradiol, it is not likely to affect other medicines.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with Vagifem include:

Common (may affect up to 1 in 10 users):

• Headache.
• Stomach pain.
• Vaginal bleeding, discharge or discomfort.

Uncommon (may affect up to 1 in 100 users):

• An infection of the genitals caused by a fungus.
• Feeling sick (nausea).
• Skin rash.
• Weight gain.
• Hot flashes.
• Increased blood pressure.

Very rare (may affect up to 1 in 10,000 users):

• Diarrhoea.
• Fluid retention (oedema).
• Migraine aggravated.
• Generalised hypersensitivity (e.g., anaphylactic reaction/shock).

For more side effects associated with the use of HRT, please refer to the package leaflet. If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance is estradiol (as estradiol hemihydrate). Each vaginal tablet contains 10 micrograms estradiol (as estradiol hemihydrate).

Read the package leaflet before use. The official package leaflet of Vagifem is available for download here.