Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 50 mg
Bayer Australia Ltd
cyproterone acetate
Tablet, uncoated
Excipient Ingredients: magnesium stearate; lactose monohydrate; maize starch; colloidal anhydrous silica; povidone
Oral
50 tablets, 20 tablets
Medicine Registered
(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 Androcur 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 Androcur 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 pre-requisite for therapy is the desire by the patient for treatment.Androcur 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: 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; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2009-01-08
ANDROCUR ® CMI vx1.0 Page 1 of 5 ANDROCUR ® (ANNE·DRO·CUR) _ _ _cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Androcur. 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 Androcur 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 ANDROCUR IS USED FOR Androcur 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, Androcur may slow or stop the growth of cancer. Androcur 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. Androcur 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, Androcur 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 ANDROCUR _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ANDROCUR IF YOU HAVE AN ALLERGY TO: • cyproterone acetate, the active ingredient in Androcur • 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 breat Đọc toàn bộ tài liệu
Androcur 50 PI VX2.0; CCDS 13♂, CCDS 14♀ Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – ANDROCUR ® 50 MG (CYPROTERONE ACETATE) TABLET 1 NAME OF THE MEDICINE Cyproterone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Androcur 50 mg tablets Each Androcur 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 Androcur 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 Androcur 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 _ Androcur 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 pre-requisite for therapy Đọc toàn bộ tài liệu