Cyclo-Progynova^®

1 mg

Please read this leaflet carefully before you start your medicine

This leaflet 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 doctors prescription is that its use needs medical supervision

Please tell your doctor it you have any doubts or worries about taking this medicine, either before you start or while you are taking 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, but 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 change of life is natural, it often causes distressing symptoms These symptoms are due to the gradual loss of the female sex hormones produced by the ovaries.

Cyclo-Progynova 1 mg

Each strip of Cyclo-Progynova 1 mg has 11 beige tablets each containing 1 mg oestradiol valerate and 10 pale brown tablets each containing 1 mg oestradiol valerate and 250 micrograms levonorgestrel

Cyclo-Progynova 1 mg also contains the following inactive ingredients: lactose, maize starch, povidone, magnesium stearate (E 572) sucrose polyethylene glycol 6000, calcium carbonate (E170), glycerin (E422), talc, montan glycol wax, titanium dioxide (E171), yellow and red ferric pigments (E172).

Each pack of Cyclo-Progynova 1 mg contains 3 memo-packs (strips) of 21 tablets.

Cyclo-Progynova 1 mg is a hormone replacement therapy.

Schering Health Care Ltd

The Brow

Burgess Hill

West Sussex RH15 9NE

Product licence number: 0053/0108

Cyclo-Progynova 1 mg is manufactured by

Schering AG, Berlin, Germany

Cyclo-Progynova 1 mg contains both types of hormone that are lost during the change of life: oestrogen and progestogen. Therefore, it replaces the hormones that the body no longer makes, and prevents or relieves the troublesome symptoms. Cyclo-Progynova 1 mg can control heavy or irregular periods, and is likely to produce regular monthly bleeding even if you have already passed the menopause. Cyclo-Progynova 1 mg will not make you able to have children, but, on the other hand, if you are still fertile, Cyclo-Progynova 1 mg will not prevent pregnancy.

irregular vaginal bleeding; a history during pregnancy of (1) itching of the whole body (pruritus of pregnancy), (2) the blister-like rash known as herpes gestationis, (most commonly on the palms and soles) (3) deterioration 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 disturbances of liver function; previous or existing liver tumouns, lumpy, painful breasts (mastopathy) the presence of tissue of the lining of the womb in places of the body where it is not normally found (endometriosis).

Diseases that are known to be subject to deterioration during pregnancy might behave similarly during treatment, and require careful observation while you are taking Cyclo-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).

Substances such as those contained in Cyclo-Progynova 1 mg (steroids) may cause jaundice in people who have an inherited abnormality of bile excretion

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 0 breast cancer in your family

During or after the use of hormones such as are contained in Cyclo-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 Cyclo-Progynova 1 mg, you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.

It is important to note that Cyclo-Progynova 1 mg is not an oral contraceptive if you still have the ability to become pregnant, Cyclo-Progynova 1 mg is unlikely to alter it. If you are taking contraceptive precautions other than oral (or other hormonal) contraceptives when you start Cyclo-Progynova 1 mg, continue to do so until your doctor tells you that you no longer require contraceptive protection. If you have been taking an oral (or other hormonal) contraceptive, you must change to an alternative (non-hormonal) form of contraception before starting Cyclo-Progynova 1 mg. On the other hand, your doctor has already advised you that you need no longer use any contraceptive you need not do so while taking Cyclo-Progynova 1 mg, despite the fact that you again have regular monthly bleeding.

There is not known to be any increased risk of blood-clotting (thrombosis) during the use of Cyclo-Progynova 1 mg. However, it should not be used if thrombosis is present, and as a precaution you are therefore advised to stop taking Cyclo-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 disturbance of vision or hearing: inflamed veins (phlebitis); pains in the chest or abdomen, swelling in the limbs, pain, tingling or numbness in any pan of the body, unexplained cough; breathlessness; pain on breathing.