Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 50 mg
Sandoz Pty Ltd
cyproterone acetate
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate
Oral
20 and 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. CYPROTERONE SANDOZ 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 CYPROTERONE SANDOZ 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 to drive in sexual deviations. CYPROTERONE SANDOZ 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. CYPROTERONE SANDOZ 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to 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; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2004-11-15
CYPROTERONE SANDOZ ® 1 CYPROTERONE SANDOZ ® _cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyproterone Sandoz. 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 this medicine 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 CYPROTERONE SANDOZ IS USED FOR Cyproterone Sandoz 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, Cyproterone Sandoz may slow or stop the growth of cancer. It can 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. Cyproterone Sandoz 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, Cyproterone Sandoz 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 CYPROTERONE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • cyproterone acetate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. Some of the symptoms of an allergic reac Прочетете целия документ
210303-cyproterone-sandoz-pi Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION CYPROTERONE SANDOZ ® (CYPROTERONE ACETATE) 50 MG TABLETS 1. NAME OF THE MEDICINE Cyproterone acetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cyproterone Sandoz 50 mg tablet contains 50 mg cyproterone acetate. _Excipients with known effect:_ lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Cyproterone Sandoz 50 mg tablet is a white to off white, flat, round tablet with ‘50’ engraved over a break line on one face, the other a plain face 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC 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 seborrhea associated with other features of androgenisation Cyproterone Sandoz 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 Cyproterone Sandoz 50 mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. 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 _ Cyproterone Sandoz 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 behaviour require treatment wh Прочетете целия документ