Patient Information Leaflet

ANDROCUR®
cyproterone acetate

Please read this leaflet carefully before you start your treatment.

A guide to using Androcur Tablets

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

Androcur 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.

Your doctor may ask you to sign a witnessed agreement to treatment before prescribing the medicine.

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: Androcur (cyproterone acetate)

What does your medicine contain?

Each tablet contains the inactive ingredients:

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

Androcur is an antiandrogen therapy. That is, it blocks the actions of male sex hormones (androgens).

Uses

Androcur is used to control libido in adult males who have increased sex drive (hypersexuality) and/or sexual deviation.

Reasons for not taking Androcur

You should not take Androcur if you have any of the following:

• liver diseases (including previous or existing liver tumours)
• any type of cancer (other than cancer of the prostate gland)
• wasting diseases
• blood clots (thrombosis or embolism) or have ever had these
• severe diabetes that affects your circulation of blood
• abnormal red blood cells (sickle-cell anaemia)
• severe depression which you have had for many months
• you have an allergy or reaction to any of the ingredients in Androcur

You should not use Androcur if you are under 18 years of age or if you are not yet a fully grown adult in every way.

What you should know before taking Androcur tablets

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

Androcur does not work well in men who regularly drink a lot of alcohol.

Cyproterone acetate can increase the sugar in your blood, and if you are diabetic your doctor will check this regularly.

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.

In extremely rare cases, blood clots (thrombosis or embolism) have been reported in patients taking this medicine. However, these have not been definitely linked to cyproterone acetate.

Some patients taking this medicine have noticed breathlessness.

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.

How to take Androcur

Read the instructions on the label carefully and take the tablets as instructed. Your doctor will probably have told you to take one tablet in the morning and one tablet in the evening. The tablets should be taken after meals and swallowed whole with a drink of water.

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. These effects usually disappear if treatment is stopped or if the dose of Androcur is reduced.

When you have been taking Androcur 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 Androcur 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 have to take cyproterone acetate for a long time, you may notice a change in your weight, usually an increase.

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 Androcur.

Expiry date:

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