What Androcur is and what it is used for
What is Androcur? Androcur is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body. What is Androcur used for? Androcur is used to control sexual desire in men who have an increased sex drive (hypersexuality) and/or sexual deviation.
How to take Androcur
Your doctor will decide what dose you will take depending on your treatment. Always take this
medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
• The usual dose is 1 tablet twice a day. Once the desired effect is achieved, your dose may be gradually lowered.
• Take the tablet after your morning and evening meals and swallow it whole with a drink of water. Androcur is not for use in youths under 18 years old. If you take more Androcur than you should As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much Androcur in a single dose. If you forget to take Androcur If you forget to take a dose, take it as soon as you remember and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose. v017_0 4 If you stop taking Androcur Do not reduce the dose or stop taking your tablets unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction
•contact your doctor or go to a hospital straight away. For information on drinking alcohol while taking this medicine, see under Androcur with food, drink and alcohol in section 2. These are the possible side effects of Androcur, starting with the more common ones:
Very common may affect more than 1 in 10 people reduced sperm count reduced volume of ejaculate
Common may affect up to 1 in 10 people weight decrease or increase, which can be associated with fluid retention depressed mood restlessness breast swelling sometimes with tenderness hot flushes, sweating tiredness shortness of breath liver problems, some of them severe or even fatal, have been reported with dosages of 100 mg and above of cyproterone acetate. Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary
Uncommon may affect up to 1 in 100 people rash
Rare may affect up to 1 in 1,000 people allergic reaction (possibly causing a rash, itching or more rarely shortness of breath. If you have trouble breathing or swallowing, contact your doctor or go to a hospital straight away) 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
Very rare may affect up to 1 in 10,000 people benign (non-malignant) liver tumours, see also section 2 ‘Warnings and precautions’ some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway v017_0 5 Effects of Androcur on sperm After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably be unable to make anyone pregnant, but note that this does not happen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children. Other changes that have been reported include:
• blood clots have been reported in patients taking this medicine but they have not definitely been linked to Androcur. See also section 2 ‘Warnings and precautions’
• the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Androcur at doses of 25 mg per day and above
• dry skin and improvement in acne
• 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, a female type of pubic hair growth
• effects on the blood (anaemia) have been reported during long term treatment with this medicine. Your doctor may arrange for you to have regular blood tests during treatment to monitor this
• thinning of the bones (osteoporosis)
• tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles (often muscle weakness), abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea (suppressed adrenal glands). After stopping treatment After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal
How to Store Androcur
Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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