Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 50 mg
Bayer Australia Ltd
cyproterone acetate
Tablet, uncoated
Excipient Ingredients: povidone; maize starch; lactose monohydrate; colloidal anhydrous silica; magnesium stearate
Oral
20 tablets, 50 tablets
(S4) Prescription Only Medicine
WOMEN:Moderately severe to severe signs of androgenization. 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 androgenization.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 Cyprostat 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. Therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. This also promotes regular menstruation MEN:Reduction o
Visual Identification: Round white scored tablets marked with "BV" inside a hexagon.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2009-01-08
CYPROSTAT ® CMI vx1.0 Page 1 of 5 CYPROSTAT ® (SIGH·PRO·STAT) _ _ _cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyprostat. 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 Cyprostat against the benefits they expect it will 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. WHAT CYPROSTAT IS USED FOR Cyprostat is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones which are also produced, to a slight extent, in females. MEN: In men, androgens may help cancer cells to grow in some types of prostate cancer. By blocking these hormones, Cyprostat may slow or stop the growth of cancer. Cyprostat may also be used in combination with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease. Cyprostat is also used to reduce abnormal sex drive in men. WOMEN: In women, androgens may increase hair growth, loss of scalp hair and secretion of oil from the sweat glands. By blocking these hormones, Cyprostat may slow or stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CYPROSTAT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CYPROSTAT IF YOU HAVE AN ALLERGY TO: • cyproterone acetate, the active ingredient in Cyprostat • any of the ingredients listed at the end of this leaflet _ _ Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or di Lire le document complet
Cyprostat 50 PI VX1.0; CCDS 13 ♂ , CCDS 14 ♀ Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION - CYPROSTAT ® 50 MG (CYPROTERONE ACETATE) TABLET 1 NAME OF THE MEDICINE Cyproterone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cyprostat 50 mg tablets Each Cyprostat 50 mg tablet contains 50 mg cyproterone acetate. Excipients with known effect: sugars as lactose monohydrate. For a full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Cyprostat 50 mg tablets Round, white, scored tablets marked with “BV” inside a hexagon. 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 alopaecia) • 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 Cyprostat 50 mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. Therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. This also promotes regular menstruation. MEN _REDUCTION OF DRIVE IN SEXUAL DEVIATIONS _ Cyprostat 50 mg 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 Cyprostat 50 PI VX1.0; CCDS 13 ♂ , CCDS 14 ♀ Page 2 of 14 behaviour require Lire le document complet