Cyproteron-BP

Cyproteronum

Each Cyproterone-BP tablet contains cyproterone acetate 50 mg. Excipient with known effect: lactose monohydrate.

Indication: In women: severe signs of androgenisation (severe hirsutism, severe androgenic alopecia, often accompanied by severe acne and/or seborrhoea), when satisfactory results have not been achieved with low-dose cyproterone products or other treatment options. In men: antiandrogenic treatment of inoperable prostate carcinoma; reduction of libido in sexual deviations, when other interventions are considered inappropriate.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hepatic disorders − Dubin-Johnson syndrome, Rotor syndrome − Previous or current liver tumours − History of or current thromboembolic processes − Wasting conditions − Severe chronic depression − Severe diabetes mellitus with vascular involvement − Sickle cell anaemia − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Special contraindications for women − Pregnancy − Breast-feeding − History of jaundice or persistent pruritus during a previous pregnancy − History of herpes gestationis Special contraindications for men − Current or past meningioma

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Cyproterone-BP should not be administered before completion of puberty, as an unfavourable effect on height growth and on the endocrine function, which is not yet stabilised, cannot be excluded. Liver Direct hepatotoxicity, including jaundice, hepatitis and hepatic failure, has been reported in patients treated with 200-300 mg cyproterone acetate. Fatal cases have been reported at doses of 100 mg or higher. Most of the fatal cases reported occurred in men with advanced-stage prostate carcinoma. Toxicity is dose-dependent and usually manifests several months after the start of treatment. Liver function tests should be performed before starting treatment and whenever signs or symptoms suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, […]