Vagifem -24 Vaginal tablets with Applicators - Estradiol 10 mcg (as estradiol hemihydrate)

Active Ingredients

Each film-coated vaginal tablet contains:

Estradiol 10 mcg (as estradiol hemihydrate)

Indications

Therapeutic group:

Oestrogens

Vagifem contains estradiol. Estradiol is a female sex hormone. It belongs to a group of hormones called oestrogens. It is exactly the same as the estradiol produced by the ovaries of women. Vagifem belongs to a group of medicines called local Hormone Replacement Therapy (HRT). It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause.This medicine is intended for women in postmenopausal age.

Vagifem works by replacing the oestrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed.

Instructions

This medicine is not intended for swallowing! For vaginal use only.

You can start using Vagifem on any day which is best for you.

Insert the vaginal tablet into your vagina with the applicator. The "User instructions" at the end of the leaflet tell you how to do this. Read the instructions carefully before using Vagifem.

The common dosage is:

Use one vaginal tablet each day for the first 2 weeks. Then use one vaginal tablet twice a week. Leave 3 or 4 days between each dose. If your situation did not improve or if you feel worse after 2-4 weeks, or if any other symptoms occur, talk to a doctor.

General information about treating symptoms of the menopause:

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.

Do not exceed the recommended dose.

Warnings

Do not use Vagifem vaginal tablets  if you are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem.

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. 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 internal examination, if necessary. Go for regular breast screening as recommended by your doctor. Once you have initiated the treatment with Vagifem, you should have regular check-ups with your doctor, at least once a year. At these check-ups, you must discuss with your doctor the benefits and risks of continuing the treatment.

Do not use the medicine if any of the following applies to you:

• You have or have ever had breast cancer, or you are suspected of having it.
• You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or 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 ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• You have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have or have ever 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.

Tell your doctor if you have or have ever had any of the following problems before you start the treatment. If so, you should see your doctor more often for check-ups:

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

Stop using Vagifem and see a doctor immediately if you notice any of the following when using HRT:

• Migraine-like headaches which happen for the first time
• 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)
• Any of the conditions mentioned in the ‘Do not use this medicine’ section
• 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.

The following risks apply to HRT medicines which circulate in the blood. It is not known how these risks apply to locally administered treatments such as Vagifem.

Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium). It is uncertain whether long term (more than one year) or repeated use of local vaginally administered oestrogen products possess a similar risk.Vagifem has been shown to have very low systemic absorption initially during treatment, and the addition of a progestagen is therefore not necessary. If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, but you should make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Evidence suggests that taking combined oestrogen-progestagen 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. 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. Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.

Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer. 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 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 using Vagifem® and see a doctor immediately’.

There is no evidence that HRT will prevent a heart attack. Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.

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.

Some medicines may interfere with the effect of Vagifem. 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)

If you are taking or if you have recently taken other medicines, including non-prescription medicines, nutritional supplements, tell the doctor or pharmacist. However, Vagifem is not likely to affect other medicines. This is because Vagifem is used for a local treatment in the vagina and contains a very low dose of estradiol.

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

If you are going to have surgery, tell the surgeon that you are using Vagifem. You may need to stop using Vagifem about 4 to 6 weeks before the operation to reduce the risk of a blood clot. Ask your doctor when you can start using Vagifem again.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.