Please read this carefully before you start your medicine.

This booklet only provides a summary of the information available on your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

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

Please tell your doctor if you have any doubts or worries about taking this medicine, either before you start or while you are taking it.

The "change of life" is a long process, normally occurring between the ages of 45 and 55 during which your reproductive organs are undergoing a slow decline. Although the change of life is natural, it often causes distressing symptoms, which are connected with the gradual loss of the hormones produced by the ovaries.

The name of your medicine is: Progynova 1 mg (oestradiol valerate).

Each tablet contains 1 mg of oestradiol valerate and the following inactive ingredients: lactose, maize starch, povidone 25 000, povidone 700 000, magnesium stearate (E572), sucrose, polyethylene glycol 6 000, calcium carbonate (E170), talc, glycerin (E422), montan glycol wax, titanium dioxide (E171), ferric oxide pigment (E172).

Each pack of Progynova 1 mg contains 3 memo packs (strips) of 28 tablets. Packs containing 1 memo strip of 28 tablets are also available to doctors.

Progynova 1 mg is a hormone replacement therapy.

The product licence is held by Schering Health Care Ltd, The Brow, Burgess Hill, West Sussex, RH15 9NE.

Progynova 1 mg is manufactured by Schering AG, Berlin, Germany.

Progynova 1 mg is used for "hormone replacement therapy" because it contains the principal oestrogen hormone that is lost during the "change of life". Therefore, it replaces the oestrogen that your body can no longer make, and this prevents or improves the troublesome symptoms.

What you should know before taking Progynova 1 mg Diseases that are known to be subject to deterioration during pregnancy might behave similarly during treatment, and require careful observation while you are taking Progynova 1 mg (e.g. the disease of the nervous system called multiple sclerosis, fits (epilepsy), diabetes, high blood pressure (hypertension} lumpy or painful breasts (benign breast disease) certain types of heart or kidney disease, asthma, tetany and inherited deafness (otosclerosis) and the inherited disease called porphyria).

If you have not had a hysterectomy (i.e. you still have a womb), you will need to take another hormone called a progestogen, with Progynova 1 mg. Your doctor will be able to advise you further.

Your doctor will carry out gynaecological, blood pressure and other examinations as appropriate, e.g. if you are known to have any liver disease, your doctor will arrange for your liver function to be checked periodically.

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

During or after the use of hormones such as are contained in Progynova 1 mg, benign liver tumours have rarely occurred, and even more rarely malignant liver tumours. In isolated cases, bleeding from such tumours into the abdomen has endangered life. Although such events are extremely improbable with Progynova 1 mg, you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.

There is not known to be any increased risk of blood clotting (thrombosis) during the use of Progynova 1 mg. However, it should not be used if thrombosis is present, and as a precaution you are therefore advised to stop taking Progynova 1 mg at once and consult your doctor if you experience any of the following: the very first attack of migraine (typically a throbbing headache and nausea, preceded by visual disturbances) that you have ever experienced- worsening of pre-existing migraine- any unusually frequent or unusually severe headaches; sudden disturbances of vision or hearing; inflamed veins (phlebitis); pains in the chest or abdomen; swelling in the limbs; pain, tingling or numbness in any part of the body; unexplained cough; breathlessness; pain on breathing.

Progynova 1 mg must also be stopped at once if you develop jaundice, or if your doctor finds your blood pressure to be significantly raised or if you notice an increase in epileptic seizures.

If you have any of the symptoms listed above you should stop taking the tablets and contact your doctor at once.

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

Some drugs e.g. antibiotics and antiepileptics may reduce the effectiveness of Progynova 1 mg.

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.

If in doubt about any medicines you are taking, ask your doctor.

About the pack: The pack is designed to help you remember to take your medicine. Each pill is placed in a section marked with the day of the week on which it should be taken. The arrows between pills show the order in which they must be taken. To use the pack you must first know the day of the week on which you will take the first tablet. Your doctor may advise you to start immediately.