देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
cyproterone acetate
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate
Oral
20 tablets, 50 tablets
(S4) Prescription Only Medicine
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. APO-CYPROTERONE ACETATE 50mg inhibits the influence of male sex hormones which are also produced by the female. It is thus possible to treat diseases in women caused by either 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 APO-CYPROTERONE ACETATE 50mg 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 ethinyloestradiol taken as well to ensure contraception. This also promotes regular menstruation. MEN: Reduction of drive in sexual deviations. APO-CYPROTERONE ACETATE 50mg 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. APO-CYPROTERONE ACETATE 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social reorientation. Inoperable prostatic carcinoma. To suppress flare with initial luteinising hormone releasing hormone (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 to off white, flat, round tablet with '50' engraved over a break line on one face, the other a plain face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2004-06-22
APO-CYPROTERONE 50 MG TABLETS 1 APO-CYPROTERONE 50 MG TABLETS _Contains the active ingredient cyproterone (as cyproterone acetate) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about cyproterone. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Cyproterone 50 mg. It is an anti- androgen medicine. It contains the active ingredient cyproterone (as cyproterone acetate). It is used to treat: • women who have a problem with facial or chest hair, are balding, have severe acne and/or secrete excess oil from the sweat glands. • men with cancer of the prostate. It can also be used in conjunction with other medications 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. • men with sexual deviations. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescrip पूरा दस्तावेज़ पढ़ें
1 AUSTRALIAN PRODUCT INFORMATION – APO-CYPROTERONE ACETATE (CYPROTERONE ACETATE) 50MG TABLETS 1 NAME OF THE MEDICINE Cyproterone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg cyproterone acetate as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT: Lactose monohydrate For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablets: White to off white, round, flat tablet with 50 engraved over a break line on one face, 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. APO-Cyproterone Acetate 50 mg inhibits the influence of male sex hormones which are also produced by the female. It is thus possible to treat diseases in women caused by either 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 APO-Cyproterone Acetate 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 APO-Cyproterone Acetate 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. 2 Abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. A pre-requisite for therap पूरा दस्तावेज़ पढ़ें