This booklet gives you some information about Progynova TS. Further advice is available from your doctor or pharmacist.

Progynova TS is used to replace the hormone, oestrogen, which is lost during the "change of life". Such treatments are known as "oestrogen replacement therapy."

The reason why you can only get Progynova TS with a doctor's prescription is that its use needs medical supervision.

Please ask your doctor if you have any doubts or worries about using Progynova TS, either before you start or while you are using it.

"The change of life" (also known as "the climacteric") is a gradual process which usually takes place between the ages of about 45 and 55. The periods usually become irregular, both in timing and amount of bleeding, before they stop altogether.

However, the time at which the periods finally stop - "the menopause" - is not the end of the "change of life", which always continues for some time afterwards. Although the "the change of life" is natural, it often causes distressing symptoms due to the gradual loss of the female hormone, oestrogen, produced by the ovaries.

Progynova TS contains an oestrogen which is absorbed through the skin and into the bloodstream. It can therefore relieve the symptoms caused by the loss of your own oestrogen.

Because it only contains one of the female sex hormones, Progynova TS is not suitable to be used alone for women who have not previously had a hysterectomy. Extra hormone treatment will be needed as well as Progynova TS if this is the case. Your doctor will be able to advise you about this.

The rest of the booklet contains full information about Progynova TS and its use. You should read this information carefully and, if you have any questions about it, talk to your doctor or pharmacist.

The name of your treatment is: Progynova TS.

Active ingredient: oestradiol (estradiol) (an oestrogen ) .

Progynova TS is a patch with an area of 12.5 square centimetres containing 3.9 milligrams of oestradiol (estradiol).

Inactive ingredients: ethyl oleate, isopropyl myristate, glycerol monolaurate and an acrylate copolymer adhesive.

Each sealed pouch contains one Progynova TS patch .

Progynova TS is a form of oestrogen replacement therapy.

The Product Licence for Progynova TS is held by: Schering Health Care Limited, The Brow, Burgess Hill, West Sussex RH15 9NE.

Progynova TS is manufactured by: 3M Pharmaceuticals, 3M Center, St Paul MN 55144 1000, USA.

Oestrogen replacement therapy for the treatment of symptoms associated with the menopause.

clots in the blood vessels (thrombotic disorders) cancers of the breast, ovaries or womb (mammary ovarian or endometrial carcinoma). Other reasons for not using Progynova TS are bleeding from the vagina where no cause is known, a history during pregnancy of (1) itching of the whole body (pruritus of pregnancy), (2) the blister-like rash known as herpes gestationis, (3) worsening of inherited deafness (otosclerosis) or (4) jaundice not explained by infections, poisons or obstruction of the flow of bile (idiopathic jaundice of pregnancy), other types of idiopathic jaundice (Dubin-Johnson or Rotor syndromes),severe heart disease, severe kidney disease, severe disturbances of liver function (including the rare inherited disorder porphyria), previous or existing liver tumours, high blood fats (disturbances of lipid metabolism), severe diabetes affecting the blood vessels, tissue from the womb present in the wrong place (endometriosis), if you have an allergy to any of the ingredients.

Some medical conditions may worsen during oestrogen therapy and require careful observation during treatment, e.g. epilepsy (fits), multiple sclerosis, diabetes, varicose veins, high blood pressure, heart, liver and kidney disease, migraine, asthma, lumpy or painful breasts (benign breast disease),tetany, abnormal limb movements (chorea minor) and inherited deafness (otosclerosis).

Your doctor will carry out gynaecological, blood pressure and other examinations as appropriate both before you start and at least every 6 months during your treatment.

Your doctor will examine your breasts periodically during treatment particularly if there is a history of breast cancer in your family.

It is important that you examine your breasts regularly and tell your doctor if you notice any changes in them.

The risk of gall bladder disease is slightly increased in women taking HRT.

If you continue to get red and itchy skin where the patches have been, talk to your doctor.

If you experience bleeding at unexpected times, talk to your doctor as this may need to be investigated.

During or after the use of hormones such as are contained in Progynova TS, benign liver tumours have rarely occurred, and even more rarely malignant liver tumours. In isolated cases, bleeding from such tumours into the abdominal cavity has endangered life. Although such events are extremely improbable you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.

Some drugs e.g. antibiotics and anti-epileptics, may reduce the effectiveness of Progynova TS. If you have to take any other medicines regularly you should inform your doctor.

If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.

Other oestrogen products should not be used unless the same doctor has prescribed them for use with Progynova TS.

The use of hormone replacement therapy may affect the results of certain laboratory tests. Always tell your doctor or the laboratory staff that you are using hormone replacement therapy.

Oestrogen treatments such as Progynova TS should not be used alone in women who have not previously had a hysterectomy. If you are using Progynova TS and have not had a hysterectomy you will need additional hormone treatment. Your doctor will advise you about this.

Progynova TS is not a contraceptive. Your doctor will be able to advise you about your need for contraception and a suitable method, if appropriate.

Progynova TS must also be stopped at once if you become pregnant, if you develop jaundice, cholestasis (a problem with bile), hepatitis (inflammation of the liver) or pruritus (itching of the whole body), if your doctor finds a significant rise in your blood pressure or an increase in size of existing fibroids of the womb, or if you notice an increase in epileptic seizures.

Ask your doctor for advice on whether you should stop Progynova TS if you are confined to bed, or have an accident or illness, or you need an operation.

If you are not currently taking hormone treatment you can start to use Progynova TS immediately.

If you are already using another type of hormone treatment, start Progynova TS the day after stopping your treatment or when your doctor has told you to.

The patch should be applied to a clean, dry area of skin preferably on the stomach or buttocks. Progynova TS must not be applied on or near the breasts. The area chosen should not be oily, damaged or irritated, and the waistline should be avoided since tight clothing may rub the patch off.

Take the patch out of its packaging. Remove the protective liner. The patch should then immediately be pressed firmly in place with the palm of the hand for about 10 seconds. Make sure there is good contact with the skin, especially around the edges.

The patch should be left in place for 7 days, then removed and replaced with a new patch which should be applied to a different area.

If a patch falls off before 7 days are up, it may be reapplied. If necessary a new patch may be used if it is not possible to reattach the old patch properly. If a new patch is used it should then be kept on for the full 7 days.

Although the patches should usually be applied continuously, your doctor may tell you to apply the patches on a cyclical basis. In this case, a patch should be applied weekly for 3 weeks followed by a 7-dayinterval without a patch application before the next course.

In the unlikely event of overdosage, nausea and vomiting may occur. There may be some bleeding from the vagina after the patch is removed. No specific treatment is necessary but you should consult your doctor if you are concerned.

In some patients the use of Progynova TS may cause some irritation of the skin at the site of application. During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting) and some breast tenderness or enlargement. These are usually temporary and normally disappear with continued treatment. Other occasional side effects may include: nausea, abdominal pain, a sensation of bloating, increased skin pigment especially on the face (chloasma), other skin rashes, growth of existing fibroids, headache, migraine, dizziness, anxiety or depressive moods, rise or fall in weight, fluid retention, high blood pressure, changes in vaginal secretion, altered sex drive.

Tell your doctor if you have any of these symptoms, or indeed any other new symptoms during treatment.

Substances such as are contained in Progynova TS may cause jaundice in people who have an inherited abnormality of bile excretion.

The expiry date for this pack of Progynova TS is shown on the box. The patches must not be used after this date.

The patch must not be removed from the pouch until just before use. Keep out of the reach of children.

16 May 1996.

HRT Helpline Freephone 0500 350340