Patient Information Leaflet

CYPROSTAT®
cyproterone acetate

Please read this leaflet carefully before you start your treatment.

A guide to using Cyprostat 50mg Tablets

This leaflet gives you some information about Cyprostat 50mg. Additional information is available from your doctor or pharmacist.

Cyprostat 50mg contains cyproterone acetate. This substance is an antiandrogen. That is, it blocks the actions of male sex hormones (androgens). It also reduces the amount of male sex hormones produced by the body.

The reason why you can only obtain this medicine on prescription is that it may only be used under careful medical supervision.

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

The name of your medicine is: Cyprostat 50mg (cyproterone acetate)

What does your medicine contain?

Each pack contains 168 tablets, each containing 50mg cyproterone acetate.

Each tablet also contains the inactive ingredients:

maize starch
povidone 25000
aerosil (E 551)
magnesium stearate (E 572)
lactose

Uses

As it blocks the actions of male sex hormones and reduces the amount of male sex hormones produced by the body, cyproterone acetate can be used to treat cancer of the prostate gland which may be dependent on male hormones.

This medicine is used:

• 1. to reduce the possible worsening of the disease which may occur in the early stages of other treatments used for prostate cancer
• 2. in long term treatment when surgery or other medicines are not suitable
• 3. to treat hot flushes which may arise during treatments with other medicines used for prostate cancer or following surgery.

What you should know before taking Cyprostat 50mg tablets

Some patients taking this medicine have noticed breathlessness.

Disturbances of liver function, some of them severe, have been reported with high-dosed cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests during treatment.

As with other sex steroids, benign and malignant liver changes have been reported in isolated cases. In very rare cases, liver tumours may lead to life-threatening bleeding in the abdomen. Tell your doctor if you have any new "stomach" discomfort or pain that does not soon clear up.

Effects on the blood (anaemia) and adrenal glands have also been reported rarely during long-term treatment with cyproterone acetate. Your doctor may arrange for you to have regular blood tests during treatment.

 

Blood clots have been reported in patients taking this medicine. However, these have not been definitely linked to cyproterone acetate. Tell your doctor if any of these apply to you as you may be at an increased risk of getting a blood clot:

• If you have a history of blood clots (thrombosis, embolism or stroke)
• If you have advanced cancer
• If you have abnormalities of your red blood cells (sickle-cell anaemia)
• If you have severe diabetes affecting the blood vessels.

Cyproterone acetate can increase the sugar in your blood, and if you are diabetic you should check this regularly. Your doctor may alter the dose of the medicine used to treat your diabetes.

Some patients with severe depression may notice a worsening of this condition whilst taking this medicine.

How to take your medicine

Read the instructions on the label carefully and take the tablets as instructed. Your doctor will decide how much you need to take. The tablets should be taken after meals and swallowed whole with a drink of water. Do not reduce the dose or interrupt the treatment unless your doctor tells you to.

The normal dose taken is as follows:

• 1. When used to reduce the possible worsening of the disease which may occur in the early stages of other treatments used for prostate cancer the daily dosage is usually 300mg (two tablets three times a day) which may be reduced by your doctor to 200mg (two tablets twice a day)
• 2. In long term treatment, the daily dosage is usually 200-300mg (two tablets two or three times a day)
• 3. To treat hot flushes the daily dosage usually starts at 50mg (one tablet a day) and your doctor may increase this to up to 150mg (one tablet three times a day).

Side-effects

Discomfort or even enlargement of the breasts occurs in some patients and, in rare cases, there may be tender lumps in the breasts and oozing of milky fluid from the nipples.

You will notice a reduction in your sexual desire while you are taking this medicine.

When you have been taking this medicine for some months, you will probably become unable to make anyone pregnant, but note that this does not happen at once, and you should not rely on this medicine for contraception at any time. While the overall number of sperms that you produce will be reduced, more of your sperms than usual will be abnormal in shape. Some people think these abnormal sperms might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children.

Some patients taking this medicine have noticed breathlessness.

If you take this medicine for a long time, you may notice a change in your weight.

The skin and hair become less greasy. Other effects which may occur include temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour and a female type of pubic hair growth.

Thinning of the bones (osteoporosis) has been reported rarely.

You may feel tired, weak or listless during treatment.

Occasionally depressive moods can occur.

Allergic reactions and rashes may occur in rare cases.

You should ask your doctor about any change in health or general sense of well-being that you notice while taking Cyprostat 50mg.

Expiry date:

The expiry date is printed on the pack. Do not use after this date.

Storage:

Keep your medicine out of the reach of children.