Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - cyproterone acetate 2mg; ethinylestradiol 0.035mg - film coated tablet - active: cyproterone acetate 2mg ethinylestradiol 0.035mg excipient: calcium carbonate glycerol glycol montanate iron oxide yellow lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone   purified talc   sucrose titanium dioxide calcium carbonate glycol montanate lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone   purified talc   sucrose - · the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate - indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.,estelle-35ed will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications),if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

eris pharmaceuticals (australia) pty ltd - i tablet-cyproterone (cyproterone acetate), ethinylestradiol, ii tablet-inactive - tablets film-coated - 2mg+ 0.035mg

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - cyproterone acetate -

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate - indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. tyra-35ed will also provide effective oral contraception in this patient group. if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate - indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. danica-35ed will also provide effective oral contraception in this patient group. if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate - indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. ava-35ed will also provide effective oral contraception in this patient group. if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate - indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. amelia-35ed will also provide effective oral contraception in this patient group. if the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdowell pharmaceuticals - cyproterone acetate ethinylestradiol - coated tablets - 2mg/35mcg