Vagifem ® Tablets

Vagifem ® 10 μg vaginal tablet is used to relieve menopausal symptoms in the vagina such as dryness or irritation. It is inserted into your vagina.

Do not use Vagifem ® 10 μg if:

• You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem ® 10 μg (see section 6);
• You have, have ever had, or you have a family history of breast cancer (mother, sister or grandmother);
• You have or have ever had, or think you might have a hormone dependent tumour, e.g. endometrial cancer (cancer of the lining of the womb);
• You have unusual vaginal bleeding which you have not told your doctor about;
• You have been told by your doctor that you have excessive growth of the lining of the womb (endometrial hyperplasia) and you are not being treated for it;
• You have or previously have had a blood clot inside the blood vessels of the legs or lungs (deep vein thrombosis or pulmonary embolism);
• If you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• You have had a heart attack, stroke or have chest pain (angina);
• You have or have had a liver disease and your liver tests have not returned to normal;
• You have porphyria.
• You are pregnant;

Do not use Vagifem ® 10 μg if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist, nurse or other health care provider before using Vagifem ® 10 μg.

Before you use Vagifem ® 10 μg, tell your doctor if:

• You are known to have inherited genetic changes called BRCA1 and/or BRCA2 genes;
• You started your menstrual periods early (before the age of 12 years);
• You have a history of non-cancerous breast diseases, such as atypical hyperplasia or lobular carcinoma in situ;
• You had any previous treatment using radiation therapy to the chest or breast;
• You have been treated or exposed while in your mother's womb to a medicine called diethylstilbestrol (DES).

Do not share medicines prescribed for you with any other person. Always use Vagifem ® 10 μg exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Using this medicine

• You can start using Vagifem ® 10 μg 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 ® 10 μg.

How much to use

• 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 you have the impression that the effect of Vagifem ® 10 μg is too strong or too weak, tell your doctor or pharmacist.

If you use more Vagifem ® 10 μg than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre.

If you forget to use Vagifem ® 10 μg

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 dose.

If you stop using Vagifem ® 10 μg

Do not stop using Vagifem ® 10 μg without talking to your doctor. Your doctor will explain the effects of stopping treatment. He or she will also discuss other possibilities for treatment with you.

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

Vagifem ® 10 μg can have side effects. Not all side effects reported for Vagifem ® 10 μg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Vagifem ® 10 μg, please consult your doctor, pharmacist, nurse or other health care provider for advice.

If any of the following happens, stop taking Vagifem ® 10 μg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Vagifem ® 10 μg. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

The following have been reported but the frequency is unknown:

• Aggravated migraine (severe headaches);
• Blood clot formation in a blood vessel (deep vein thrombosis);

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects include:

• Headache;
• Feeling sick (nausea) or vomiting;
• Stomach pain, swelling or discomfort;
• Indigestion (heartburn);
• Passing wind (flatulence);
• Vaginal bleeding, discharge or discomfort;
• An infection of the genitals caused by a fungus or inflamed vagina (itching, inflammation, discharge);
• Breast pain or tenderness;
• Swelling of your hands, arms, legs or feet.

Less frequent side effects include:

• Anxiety;
• Body mass increased;
• Hot flush;
• High blood pressure.

The following have also been reported but the frequency is unknown:

• Breast cancer;
• Fluid retention;
• Diarrhoea;
• Application site reactions (including a vulvovaginal burning sensation), minor trauma caused by the intravaginal applicator.
• Changes in oestrogen levels when blood tests are done.

Side effects of HRT

The following side effects can occur with systemic oestrogen treatment:

• Myocardial infarction, congestive heart disease;
• Stroke;
• Gall bladder disease;
• Skin disorders including brown patches in the face, skin rashes including red inflammation on the hands or the legs (erythema multiforme), a bruise-like rash and itching;
• Risk of excessive growth of the lining of the womb (endometrial hyperplasia) and developing endometrial cancer (cancer of the lining of the womb) or an increase in size of fibroids (benign lumps) in the womb;
• Being unable to sleep (insomnia);
• Epilepsy;
• Loss of sex drive (libido);
• Deterioration of asthma;
• Loss of memory and other mental powers (dementia).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Vagifem ® 10 μg.

Store at or below 25 °C. Do not refrigerate. Keep the blisters in the outer carton until required for use.

Store all medicines out of reach of children. Do not use Vagifem ® 10 μg after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). The used applicator may be disposed together with household waste.