Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
cyproterone acetate
Cipla Australia Pty Ltd
Registered
Pharmacor Cyproterone 50 1 PHARMACOR CYPROTERONE 50 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING PHARMACOR CYPROTERONE 50? Pharmacor Cyproterone 50 contains the active ingredient cyproterone acetate. Pharmacor Cyproterone 50 may slow or stop the growth of cancer and also used to reduce abnormal sex drive in men. Pharmacor Cyproterone 50 tablets may slow or stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff. For more information, see Section 1. Why am I using Pharmacor Cyproterone 50? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PHARMACOR CYPROTERONE 50? Do not use if you have ever had an allergic reaction to cyproterone acetate or any of the ingredients listed at the end of the CMI. Do not take this medicine if you are pregnant or suspect you may be pregnant. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Pharmacor Cyproterone 50? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Pharmacor Cyproterone 50 and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE PHARMACOR CYPROTERONE 50? • The usual daily dose is 50‐300 mg of Pharmacor Cyproterone 50 tablets. Your doctor will advise of the most suitable dose for you to take. Follow all directions given to you by your doctor or pharmacist carefully. More instructions can be found in Section 4. How do I use Pharmacor Cyproterone 50? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PHARMACOR CYPROTERONE 50? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist when you visit that you are using Pharmacor Cyproterone 50. • Your doctor will check your red‐blood cell count to ensure y Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION - PHARMACOR CYPROTERONE 50 (CYPROTERONE ACETATE) 50 MG TABLETS 1 NAME OF THE MEDICINE Cyproterone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pharmacor Cyproterone 50 tablets Each tablet contains 50 mg cyproterone acetate Excipient with known effects Contains lactose For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM White circular flat bevelled tablets, with breakline on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS WOMEN Moderately severe to severe signs of androgenisation moderately severe/severe forms of hirsutism moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe androgenic alopecia) moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation Cyproterone acetate inhibits the influence of male sex hormones, which are also produced by the female. It is thus possible to treat diseases in women caused either by increased production of androgens or a particular sensitivity to these hormones. Hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. If Pharmacor Cyproterone 50 is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. Therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyl oestradiol taken as well to ensure contraception. This also promotes regular menstruation. MEN REDUCTION OF DRIVE IN SEXUAL DEVIATIONS Pharmacor Cyproterone 50 reduces the force of the sexual urge in men with sexual deviations. Whilst under treatment, the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. Abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. A prerequisite for therapy is the desire by the patient for treatme Les hele dokumentet