Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 50 mg
Alphapharm Pty Ltd
cyproterone acetate
Tablet, uncoated
Excipient Ingredients: maize starch; magnesium stearate; povidone; colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch
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 androgenetic 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 Cyprone 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,Cyprone 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 treatment.,Cyprone 50 therapy should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social re-orientation. - Inoperable prostatic carcinoma - to suppress "flare" with initial LHRH analogue therapy - in long-term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred - In the treatment of hot flushes in patients treated with LHRH analogues or who have had orchidectomy
Visual Identification: WHITE, CIRCULAR, FLAT-BEVELED WITH BREAKLINE ON ONE SIDE, PLAIN ON THE OTHER DIAMETER: 8.5MM. THICKNESS: 2.7MM.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-06-01
CYPRONE 50 _contains cyproterone acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyprone 50. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Cyprone 50 against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT CYPRONE 50 IS USED FOR Cyprone 50 is an antiandrogenic hormone medication containing the active ingredient cyproterone acetate, 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, Cyprone may slow or stop the growth of cancer. Cyprone 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. Cyprone 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, Cyprone 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. Cyprone 50 is only available on a doctor's prescription. There is no evidence that Cyprone 50 is addictive. BEFORE YOU TAKE CYPRONE _WHEN YOU MUST NOT TAKE IT_ Do not take Cyprone if you have an allergy to: • Cyproterone acetate, the active ingredient in Cyprone • 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 difficulty breathing • Swell Lesen Sie das vollständige Dokument
AUSTRALIAN PRODUCT INFORMATION CYPRONE 50 _Cyproterone acetate tablets _ 1 NAME OF THE MEDICINE Cyproterone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cyprone 50 tablet contains 50 mg of cyproterone acetate as the active ingredient. Excipients with known effect: Contains sugars (as lactose). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Cyprone 50 : 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 androgenization • moderately severe/severe forms of hirsutism • moderately severe/severe androgen ‐ dependent loss of scalp hair (moderately severe/severe androgenetic 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 Cyprone 50 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 ethinylestradiol taken as well to ensure contraception. This also promotes regular menstruation. MEN Reduction of drive in sexual deviations Cyprone 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 treatment. Cyprone 50 th Lesen Sie das vollständige Dokument