VAGIFEM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vagifem 25 micrograms film-coated vaginal tablets
Estradiol hemihydrate Read all of this leaflet carefully, before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. In this leaflet: 1. What Vagifem is and what it is used for 2. Before you use Vagifem 3. How to use Vagifem 4. Possible side effects 5. How to store Vagifem 6. Further information 1. WHAT VAGIFEM IS AND WHAT IT IS USED FOR 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 Hormone Replacement Therapy (HRT). It is intended for postmenopausal women and 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 around the menopause. 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. The experience of treating women older than 65 years is limited. 2. BEFORE YOU USE VAGIFEM Medical check-ups Before you start using Vagifem, your doctor will tell you about the risks and benefits of the treatment (see also Section 4). Before you start using Vagifem and regularly during treatment, your doctor will check whether Vagifem is the right treatment for you. Once youve started on HRT, your doctor will tell you how often to go for regular check-ups. At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT. If you have a close relative (e.g. mother, sister, maternal or paternal grandmother), who has suffered from any serious illness such as blood clots or breast cancer, you might be at a higher risk for serious

illness. Always tell your doctor about any close relative(s) suffering from serious illness. As well as regular check-ups with your doctor, you should: Regularly examine your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel. Tell your doctor if you notice any changes. Go for regular breast screening (mammography) and cervical smear tests. Do not use Vagifem if: You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem (listed in Section 6 below) You have or have ever had, or think you might have breast cancer You have or have had a hormone dependent tumour (e.g. cancer of the lining of the womb) You have unusual vaginal bleeding which you have not told your doctor about You have thickening 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) You have porphyria. This is a rare disease which affects the production of some of your blood pigments. You have active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) You have acute liver disease or history of liver disease as long as liver function tests have failed to return to normal Do not use Vagifem if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine. Take special care with Vagifem Check with your doctor before using Vagifem if you have or have ever had any of the illnesses in the list below. He or she may want to follow you more closely. Asthma Epilepsy Diabetes Gallstones High blood pressure Migraines or severe headaches Liver problems such as liver adenoma (a benign tumour) Endometrial hyperplasia (thickening of the lining of your womb) Otosclerosis. This is when you lose your hearing over a period of time Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys) Blood clots or risk factors for blood clots (see Section 4 Other side effects of systemic HRT) Leiomyoma (benign tumours of the womb) or endometriosis (growth of the womb lining outside the womb) If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Vagifem. Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding Do not use Vagifem if you think you might be pregnant, or if you are breast-feeding If you get pregnant while you are using Vagifem, stop using it and see a doctor straight away. Driving and using machines No known effect. 3. HOW TO USE VAGIFEM Always use Vagifem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Using this medicine 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. 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 use more Vagifem than you should If you have used more Vagifem than you should, talk to a doctor or pharmacist. An overdose of oestrogen could make you feel sick or vomit. If you forget to use Vagifem 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 have any further questions on the use of this product, ask your doctor or pharmacist. General information about treating symptoms of the menopause When using medicines for any menopausal symptoms, use the lowest dose that works. Also, use the medicine for as short a time as you need to. Only continue treatment if the benefit is more than the risk. Talk to your doctor about this. 4. POSSIBLE SIDE EFFECTS Like all medicines, Vagifem can cause side effects, although not everybody gets them. Stop using Vagifem and see a doctor straight away if you notice any of the following side effects: A migraine-type headache you have not had before Yellow colouring of your skin or eyes (jaundice) or other liver problems A big increase in blood pressure Blood clots called deep vein thrombosis (see also Other side effects of systemic HRT) If you develop any of the illnesses listed in Section 2, Do not use Vagifem You become pregnant Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days: Common (may affect more than 1 in 100 women) Headache Passing wind (flatulence) Feeling sick (nausea) or being sick (vomiting) Indigestion Stomach pain, discomfort or distension

Swelling of arms or legs (oedema) Vaginal bleeding, discharge or discomfort An infection of the genitals caused by a fungus or inflamed vagina Breast oedema or breast enlargement, breast pain or breast tenderness. Very rare (may affect less than 1 in 10000 women) Breast cancer Cancer of the lining of the womb (endometrial cancer) Thickening of the lining of your womb (endometrial hyperplasia) Blood clots called deep vein thrombosis Other side effects of systemic HRT are: Allergic reaction (hypersensitivity) Diarrhoea Weight increase Fluid retention Being unable to sleep (insomnia) Feeling depressed Worsening of existing migraine Rash, including itchy, lumpy rash called hives or urticaria Itching of the genitals Vaginal pain, irritation of the vagina, painful spasm of the vagina (vaginismus) or vaginal ulcers Increase in blood oestrogen (shown in blood test) Drug ineffective. Important information on the side effects of HRT Vagifem is used for local treatment in the vagina and contains only a small amount of estradiol. This means that the chances of getting the diseases described below are less likely than with HRT products used for systemic treatment (treatment that affects the body as a whole). As well as benefits, HRT has some risks which you need to consider when youre deciding whether to take it, or whether to carry on taking it. Effects on your heart or circulation Heart disease 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. HRT will not help to prevent heart disease. Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain. 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. Stroke Recent research suggests that systemic HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include: getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat

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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. Compare Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke. For women in their 50s who are taking HRT, the figure would be 4 in 1000. Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke. For women in their 60s who are taking HRT, the figure would be 15 in 1000. 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. Blood clots Systemic HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it. These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse 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: if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if youre off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE If any of these things apply to you, talk to your doctor to see if you should take HRT. Compare Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot. For women in their 50s who are taking HRT, the figure would be 7 in 1000. Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot. For women in their 60s who are taking HRT, the figure would be 17 in 1000. If you get: painful swelling in your leg sudden chest pain difficulty breathing See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot. Code start Code: 100% Direction Length: Max. 29 mm (100%)

If youre going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again. Effects on your risk of developing cancer Breast cancer Women who have breast cancer, or have had breast cancer in the past, should not take HRT Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age whos still having periods over that time and not taking HRT. The extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT. Your risk of breast cancer is also higher: if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight Compare Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65. For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases). If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases). If you notice any changes in your breast, such as: dimpling of the skin changes in the nipple any lumps you can see or feel Make an appointment to see your doctor as soon as possible. Endometrial cancer (cancer of the lining of the womb) Taking oestrogen-only HRT tablets orally for a long time can increase the risk of developing cancer of the lining of the womb (the endometrium). It is possible there may be a similar risk with oestrogen cream/rings/tablets used directly in the vagina for repeated treatments or over a long time. If you get breakthrough bleeding or spotting, its 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. Ovarian cancer Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

5. HOW TO STORE VAGIFEM Keep out of the reach and sight of children. Do not store above 25C. Do not refrigerate. Keep the blisters in the outer carton in order to protect from light. Do not use Vagifem after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Vagifem contains The active substance is estradiol 25 micrograms (as estradiol hemihydrate) Other ingredients are: hypromellose, lactose monohydrate, maize starch and magnesium stearate The film-coating contains: hypromellose and Macrogol 6000. What Vagifem looks like and content of the pack Each Vagifem comes in an applicator which is used once only. There are 15 applicators with vaginal tablets in each box. Vagifem is engraved with NOVO 279. Marketing Authorisation Holder Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark The registered office in the UK is: Novo Nordisk Limited Broadfield Park Crawley West Sussex RH11 9RT Tel: (01293) 613555 This leaflet was last approved in:04/2010 Detailed information on this medicine is available on the web site of www.emc.medicines.org.uk

USER INSTRUCTIONS How to use Vagifem

1. Tear off one single blister pack. Open the end as shown in the picture.

2. Insert the applicator carefully into the vagina. Stop when you can feel some resistance.

3. To release the tablet, gently press the push button until you feel a click. The tablet will stick to the wall of the vagina straight away. It will not fall out if you stand up or walk.

4. Take out the applicator and throw it away

Vagifem is a trademark owned by Novo Nordisk Femcare AG, Switzerland. 1995/2008 Novo Nordisk A/S

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