Androcur 50 mg/100 mg Tablets

ANDROCUR is a hormone preparation that blocks the effects of androgen, which are sex hormones produced in males but also – to a lesser extent – in females. The active substance is cyproterone acetate. In addition to ANDROCUR, your doctor may prescribe a progestogen-oestrogen contraceptive to provide contraceptive protection and cycle stabilization. During combined treatment ovarian function is blocked. These changes are reversible after stopping treatment.

In women, ANDROCUR 50 mg tablets are used for severe signs of androgenisation such as:

• very severe hirsutism (increased facial and body hair),
• androgen-dependent severe loss of scalp hair eventually resulting in baldness (severe androgenetic alopecia),
• severe forms of acne and/or seborrhoea.

In males, ANDROCUR 50 mg and 100 mg tablets are used for:

• Reduction of drive in sexual deviations
• Antiandrogen treatment in inoperable prostate cancer.

Do not use ANDROCUR

Do not take ANDROCUR if you have any of the conditions listed below. If any of these apply to you, tell your doctor before you start taking ANDROCUR.

In females:

• if you are pregnant or breastfeeding
• if you have a liver disease
• if you had a history of jaundice or persistent itching during a previous pregnancy
• if you had a history of herpes of pregnancy
• if you suffer from hereditary disturbances of liver function with impaired excretion of the red blood cell pigment called bilirubin (“Dubin-Johnson Syndrome” or “Rotor-Syndrome”)
• if you have or ever had a benign or malignant liver tumour
• if you have a wasting disease (a disease-causing decay or loss of strength)
• if you suffer from severe chronic depression
• if you have or ever had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels (thromboembolic process)
• if you have severe diabetes mellitus with blood vessel changes
• if you have sickle-cell anaemia
• if you are hypersensitive (allergic) to cyproterone acetate or any of the other ingredients of ANDROCUR
• If your doctor prescribes a progestogen-estrogen contraceptive in combination with ANDROCUR, attention is also drawn to the information contained in the package insert of the progestogen-estrogen contraceptive.

In males:

• if you have a liver disease
• if you suffer from hereditary disturbances of liver function with impaired excretion of the red blood cell pigment called bilirubin (“Dubin-Johnson Syndrome” or “Rotor-Syndrome”)
• if you have or ever had a benign or malignant liver tumour (only if these are not due to metastases from carcinoma of the prostate).
• if you have or ever had a benign brain tumour (meningioma)
• if you have a wasting disease (a disease-causing decay or loss of strength, with the exception of inoperable carcinoma of the prostate)
• if you suffer from severe chronic depression
• if you have or have had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels (thromboembolic process)
• if you have severe diabetes mellitus with blood vessel changes
• if you have sickle cell anaemia
• if you are hypersensitive (allergic) to cyproterone acetate or any of the other ingredients of ANDROCUR.

Do not share medicines prescribed for you with others. Always take ANDROCUR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take the tablet with some liquid after meals. If you think that the effect of ANDROCUR is too strong or too weak, talk to your doctor or pharmacist. Do not take more than the maximum daily dose of 300 mg. Do not change or interrupt the treatment or dosage prescribed by your doctor once you feel an improvement.

Dosage in women:

For severe signs of androgenisation:

Women of childbearing age:

If you are pregnant, you must not take ANDROCUR. Therefore, pregnancy must be excluded before the start of therapy. ANDROCUR treatment is started on the 1st day of the menstrual cycle (1st day of bleeding). Only women with an absence of periods (amenorrhea) can start ANDROCUR treatment immediately. In this case the first day of treatment will be considered as the 1st day of the cycle and following recommendations the followed as normal. Two ANDROCUR 50 mg tablets (= 100 mg) are to be taken twice daily from the 5th to the 14th day of the cycle (i.e. for ten days). If you are receiving the cyclical combined therapy, you should take the tablets around the same time every day. Every 28 days (the usual duration of a menstrual cycle), after the first cycle of treatment was started, i.e. on the same day of the week, the next cycle of treatment is started, regardless of whether bleeding has stopped or not. Seven inactive tablets are taken once daily after 21 days, during which time a withdrawal bleeding occurs. Exactly 4 weeks after the first cycle of treatment was started, exactly on the same day of the week, the next cycle of combined treatment is started, regardless of whether bleeding has stopped or not. When your doctor notices clinical improvement during the combined treatment with progestogen-estrogen contraceptive, the daily dose of ANDROCUR 50 mg during the first 10 days of the combined treatment with a combined oral contraceptive can be reduced to one or half a tablet of ANDROCUR 50 mg.

Post-menopausal or hysterectomised patients:

The usual dose is one to half a tablet ANDROCUR 50 mg once daily for 21 days, followed by a seven-day tablet-free interval. If you think the effect of ANDROCUR is too strong or too weak, talk to your doctor or pharmacist.

Dosage in males:

Reduction of drive in sexual deviations:

The individual dosage will be determined by the doctor. The tablets are to be taken with some liquid after meals. The usual dose is 1 tablet ANDROCUR twice daily. Once the desired effect is achieved, your dose may be gradually lowered. To stabilise the therapeutic effect, it is necessary to take ANDROCUR over a protracted period of time, if possible, with the simultaneous use of psychotherapeutic measures.

Antiandrogen treatment in inoperable carcinoma of the prostate:

100 mg twice to three times daily (= 200 - 300 mg per day). The tablets are to be taken with some liquid after the meals. The treatment and dosage prescribed by the doctor should not be changed or interrupted after improvement or remissions have occurred.

ANDROCUR can have side effects. Not all side effects reported for ANDROCUR are included in this leaflet. Should your general health worsen while taking ANDROCUR, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor immediately if you notice any of the following symptoms:

• Generally feeling unwell, fever, nausea, vomiting, loss of appetite, itching all over your body, yellowing of your skin and eyes, light coloured bowel movements, dark coloured urine. These symptoms could be signs of liver toxicity, including inflammation of the liver (hepatitis) or liver failure.
• Unusual upper abdominal pains which do not disappear spontaneously within a short time. These symptoms could be signs of benign or malignant liver tumours which may lead to life-threatening internal bleeding (intra-abdominal haemorrhage).
• Swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak. These symptoms could be signs of formation of blood clots (thromboembolic events).

The most serious undesirable effects associated with the use of ANDROCUR are hepatic toxicity, benign and malignant liver tumours which may lead to intra-abdominal hemorrhage and thromboembolic events. It is very common to notice decreased libido (sexual desire), erectile dysfunction (inability to achieve or maintain an erection) and reversible inhibition of sperm formation in men and inhibition of ovulation in women. Common side effects are: gynaecomastia (swelling of the breast gland - in men), fatigue, hot flushes (in men) and sweating (in men). The less common side effect is rash. Rarely, you may experience conditions relating to thrombosis (the formation of a blood clot) in the blood vessels (thromboembolic process), hypersensitivity and an increase in sexual desire (in women). Side effects that may occur with unknown frequency in women are benign and malignant liver tumours, benign brain tumours (meningiomas), allergic reaction (hypersensitivity), weight gain, weight loss, depressed mood, temporary restlessness, reduced sexual drive (decreased libido), increased sexual drive (increased libido), formation of blood clots (thromboembolic events – see section “Take special care with ANDROCUR”), shortness of breath, internal bleeding (intra-abdominal haemorrhage), liver toxicity, including jaundice, inflammation of the liver (hepatitis), liver failure, rash, inhibited ovulation, breast tenderness, spotting, tiredness, fatigue, osteoporosis, anaemia. Under treatment with ANDROCUR, sexual drive and potency are reduced, and the function of the testicles is inhibited. These changes are reversible after ANDROCUR treatment has been discontinued.

Store at or below 30 °C. Keep blister strips in the original carton until use. Do not use ANDROCUR after the expiry date which is stated on the carton and on each blister. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.