patient information leaflet cyproterone acetate

PACKAGE LEAFLET

CYPROTERONE ACETATE 50MG TABLETS

CYPROTERONE ACETATE 100MG TABLETS

Cyproterone acetate

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours

In this leaflet:

1. What cyproterone is and what it is used for
2. Before you take cyproterone tablets
3. How to take cyproterone tablets
4. Possible side effects
5. Storing cyproterone tablets
6. Other information about cyproterone tablets

1. WHAT CYPROTERONE ACETATE IS AND WHAT IT IS USED FOR

Cyproterone acetate belongs to a group of medicines called anti-androgens. These medicines work by blocking the actions of male sex hormones (androgens) and reducing the amount of male sex hormones produced by the body.

Cyproterone acetate tablets are used either on their own or in conjunction with other hormone treatment to treat patients with certain prostate problems.

2. BEFORE YOU TAKE CYPROTERONE ACETATE TABLETS

You should not take cyproterone acetate tablets if:-

You have ever had a reaction to or been told that you are allergic to cyproterone acetate or any of the other ingredients in the tablets. Check by reading the list of ingredients above
You are a woman of any age
You are a young male who is not fully developed as an adult, usually under 18 years of age
You are an alcoholic.

Special care should be taken if:

you have liver disease
you have diabetes mellitus (blood sugar levels should be monitored).
you have cancer (other than prostate cancer)
you have a wasting disease (one which has caused you to lose muscles)
you have severe depression
you have sickle cell anaemia
you have a tendency for your blood to clot too easily, are suffering from thrombosis (a clot in a blood vessel) or have had a thrombosis In the past

You may need to have periodic blood tests to check for blood, adrenal gland or liver problems or muscle wasting.

Taking cyproterone acetate tablets with food and drink:

It does not matter when you take your cyproterone acetate tablets in relation to food.

You should avoid drinking alcohol if you are taking these tablets.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine.

You should also discuss with your doctor if you wish to become pregnant.

Breast-feeding

You should not breast-feed while taking cyproterone acetate tablets.

Driving and using machines:

These tablets may cause tiredness or weakness especially when treatment is first started. If affected, you should not drive or operate machinery.

Important information about some of the ingredients of cyproterone acetate tablets:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Taking other medicines:

Taking another medicine while you are taking cyproterone acetate tablets can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you may have bought yourself without a prescription. Please check with your doctor if you are taking any of the following (or any other medication):

other sex hormones
oral antidiabetic medicines or insulin

3. HOW TO TAKE CYPROTERONE ACETATE TABLETS

For adults, including the elderly, the dose for cyproterone acetate tablets is dependent upon the condition for which your doctor has prescribed them.

When treatment in conjunction with other hormone treatment is first started, the usual dose is 300mg daily (may be reduced to 200mg).

For long term treatment with cyproterone acetate alone, the usual dose is 200 - 300mg daily.

For the treatment of hot flushes which may arise in patients who are being treated with other hormones or those who have had orchidectomy (removal of the testes), the usual starting dose is 50mg daily, increasing if necessary to 50-150mg daily.

Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely. Also, follow any instructions or warnings that appear on the label that the pharmacist has put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.

Unless told otherwise, take your tablets with water.

If you take more cyproterone acetate tablets than you should:

If you or anybody else takes too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.

If you forget to take cyproterone acetate tablets:

If you occasionally forget to take a dose do not worry, just take the next dose when it is due. Never double the next dose to make up for the one missed. Do not stop taking the medicine without talking to your doctor first. When it is time to stop taking cyproterone acetate tablets the dose should be reduced gradually.

4. POSSIBLE SIDE EFFECTS

Like many medicines, cyproterone acetate tablets may cause side-effects in some patients, particularly when you first start taking them.

The most common side-effects are impotence and a reduction in sexual desire (libido) and sperm production, resulting in infertility. You may still produce some sperm but more of them than usual will be abnormal, with a possible increased risk of abnormal babies. Your doctor will advise you further if you are thinking of having children.

Side-effects that some other patients have had with cyproterone acetate tablets include stroke, heart attack, raised blood pressure, swelling of the ankles, thrombosis (a clot in a blood vessel), anaemia, development of breasts (which usually lessen as treatment continues), discharge from the nipples, breast lumps, tiredness or sleepiness (usually lessening as treatment continues), headache (also lessening as treatment continues), feeling sick, jaundice (yellowing of the skin) and liver problems, rash, depression, breathing problems, loss of hair or an increase in body hair, dry skin, weight changes and thinning of the bones (osteoporosis).

Rarely allergic reactions can occur. You should tell your doctor immediately if you experience wheezing, difficulty breathing, swelling, rash or itching.

If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

5. STORING CYPROTERONE ACETATE TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container.

Do not use after the expiry date stated on the carton.

Do not take cyproterone acetate tablets if you notice they are discoloured (they should be white).

6. OTHER INFORMATION ABOUT YOUR TABLETS

Cyproterone acetate 50mg tablets are round white tablets marked CPA, breakline and 50 on one face and CP on the reverse.

Cyproterone acetate 100mg tablets are round white tablets marked CPA, breakline and 100 on one face and CP on the reverse.

Cyproterone acetate 50mg tablets are available in blister packs of PVC film and aluminium foil containing 56 or 168 tablets.

The active substance in the tablets is cyproterone acetate.

The other ingredients are lactose, maize starch, povidone, colloidal silicon dioxide and magnesium stearate.

Medicine: cyproterone acetate