PATIF,NT INFORMATION LEAFLET

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Each white tablet contains 2mg Oestradiol Valerate USP. Each blue tablet contains 2mg Oestradiol Valerate USP and 20mg Medroxyprogesterone Acetate BP. The yellow tablets contain no active ingredients.

The white tablets also contain lactose, maize starch, gdatine, talc and magnesium stearate. The blue tablets also contain lactose, maize starch, magnesium stearate gelatine and indigo carmine. The yellow tablets contain lactose, maize starch, gelaline, magnesium stearate and yellow iron oxide.

Tridestra tablets are gluten free. Each pack contains 91 tablets, 70 white ones, 14 blue ones and 7 yellow ones. Tndestra is a hormone replacement therapy (HRT) for the treatment of symptoms associated with the menopause and to prevent brittle bones which occur after the menopause.

The Product Licence holder and manufacturer is:

Orion Pharma A/S

B0geskm re; 9

DK-3490 Kvistgard

Denmark

The menopause generally happens to women between the ages of 45 and 55. It is also called the "change of lite" or climactenc. It is a natural process where the body stops making the hormone called oestrogen, which is produced mainly by the ovaries. When this happens your penods become irregular and in time stop altogether.

Some women may feel very well. However, some have unpleasant symptoms. These include hot flushes, night sweats, tiredness, sleeplessness, depression and irritability. After the menopause women' s bones can also become more brittle and are therefore more likely to break.

HRT replaces the hormones that your body is no longer making. This should relieve the unpleasant symptoms associated with the menopause and help to prevent bnttle bones after the menopause.

• are or may be pregnant,

• have breast cancer,

• have vaginal bleeding which has not been checked by a doctor,

• have hormone sensitive cancer,

• have thrombosis or internal blood clots,

• have severe cardiac or renal disease,

• have had jaundice or itching during pregnancy,

If taken with some other medicines the effects of Tridestra or the effects of the other medicine may be changed. Please check with your doctor if you are taking any of the following:

• barbiturates,

• nfampicin.

• phenytoin. If you has e to have a surgical operation, make sure the hospital doctor knows you are taking Tridestra.

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periods you may start the tablets immediately. The pack will help you take your tablets correctly. On the inside cover of the pack you will see a 'start day' indicator and seven boxes, one opposite each row of tablets. Write the day you take your first tablet in the box next to the 'start day' indicator. Wnte the rest of the days of the week in order in the other boxes working downwards. The start day will be the day you take the first tablet of each week and the day you should start your next pack. Take one tablet each day following the arrows and the weeks marked above each row of tablets.

It is best to take your tablet at the same time each day. If you forget, take it within 12 hours. If you do not remember and you are more than 12 hours late, leave the forgotten tablet. You should then continue by taking the nexmablets at your usual time. Irregular use of Tridestra tablets may cause unscheduled or breakthrough bleeding.

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These open disappear with continued treatment.

Tndestra sometimes causes nausea (feeling sick), pain in the stomach, bloating breast tenderness, headache, dizziness, uredness, increased weight, change in mood and sexual desires, problems with eyesight and changes in the blood. If you expenence any of these effects you need not worry but you should tell your doctor about any which become troublesome. Tndestra may cause migraine; frequent or very bad headaches; increased fits in epileptic patients; jaundice (a yellow tint to the skin and whites of the eyes or very dark unne). If you expenence or think you may have any of these effects or if you get any unusual symptoms you should stop taking Tndestra and tell your doctor immediately.

If you have mild liver disease, your doctor should check your liver function regularly. If you have gallstones, make sure your doctor knows. Patients taking Tndestra should expect 3-monthly bleeds. This is quite normal even if you have stopped your penods before. When you first start to take the tablets you may get irregular bleeding and should tell your doctor if this is still happening after a few months. HRT is not currently believed to be associated with an increased risk of breast cancer if taken continuously for up to 10 years but there may be a slightly increased risk if taken continuously for longer than this.

If you were using the contraceptive "pill" before starting to take Tridestra you should change to an alternative method before starting to take Tndestra. If you no longer require contraception you will not need any whilst taking Tndestra even if you have 3 monthb bleeding . Store this medicine at room temperature not exceeding 25°C in a dry place. Do not take this medicine aher the expiry date which you will find on the pack. Date of last revision of leaflet: December 1994.

HRT has a beneficial effect on the fat levels (lipids) in your blood and may in the long term reduce the nsk of you having a heart attack or other problems in the blood vessels.

Tndestra is distributed in the UK by:

Sanofi Winthrop Ltd

One Onslow Street

Guildford

Surrey

GUI 4YS

This leaflet does not contain all the information about your medicine. Pharmaceutical companies are not able to discuss your personal medical case. If you have any questions or are not sure about anything ask your doctor or pharmacist.

Tridestra is a trademark. (01994 Sanoh Winthrop Ltd 320/031