Anterone 50 Tablets

Cyproterone acetate 50mg Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Anterone 50 tablets. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Anterone 50 tablets against the benefits the medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

1. What Anterone 50 tablets are used for

Anterone 50 tablets are an antiandrogenic hormone medication containing the active ingredient cyproterone acetate, which is used to treat cancer of the prostate gland.

It can also be used in conjunction with other medications or following surgical removal of the testes to treat side effects such as "sweats" or "hot flushes" and to prevent any initial worsening of the disease.

Androgenic hormones are generally required for cancer of the prostate gland to grow. Anterone 50 tablets work in two ways.

Firstly they stop the androgenic hormones (testosterone) present in your body from being able to attach to the cancer cells.

Secondly they decrease the amount of androgen hormone present in your blood stream by an effect on the hormonal mechanisms that control androgen production by the body, Anterone 50 tablets can be used to reduce the sex drive of men with sexual deviations.

It is also used in the treatment of women who have a problem with facial or chest hair, are balding or have severe acne.

Anterone 50 tablets are only available on a doctor's prescription.

There is no evidence that Anterone 50 tablets are addictive.

2. Before you take Anterone 50 tablets

Anterone 50 tablets can rarely cause severe damage to your liver, resulting in jaundice and hepatitis.

Your doctor should perform a blood test to check your liver before starting you on Anterone 50 tablets and again if liver disease is suspected.

Yellowing of the skin/eyes, darkening of the urine and abdominal pain or swelling should be all reported immediately to your doctor.

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 into the stomach. You must inform your doctor of the occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time.

Anterone 50 tablets have been observed to attach itself to the genetic material in animal and human liver cells. It would appear, however, that this does not lead to an increase in liver cancer. Female patients should be aware that the long term effects of Anterone 50 tablets on fertility are not known. A doctor should carry out a thorough gynaecological examination before starting treatment.

Anterone 50 tablets cause a decrease in sperm count. It may take between 3 to 20 months for the sperm count to return to normal once therapy has been stopped. Male patients may need to have a sperm count.

3. Using Anterone 50

Tell your doctor if:

  • You are pregnant or breastfeeding, '" You have a history of herpes of pregnancy.
  • You suffer from or have a history of jaundice or persistent itching during a previous pregnancy.

Anterone 50 tablets should not be taken during pregnancy as it may lead to the development of female characteristics in male babies.

  • You have in the past suffered from blood clots in the leg, stroke or heart attack.
  • You are allergic to any other medicines or other substances such as foods, dyes or preservatives or any of the ingredients in the tablet.
  • You have severe diabetes that has damaged your blood vessels.
  • You have sickle-cell anaemia.