Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CYPROTERONE ACETATE ETHINYLESTRADIOL
Generics (UK) Limited
CYPROTERONE ACETATE ETHINYLESTRADIOL
2mg/35ug %v/v
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyproterone Acetate/Ethinylestradiol Tablets 2mg/0.035mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One coated tablet contains: Cyproterone acetate 2.000 mg Ethinylestradiol 0.035 mg and also contains 31.115 mg of Lactose Monohydrate and 19.371 mg of Sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated Tablet. Each tablet is round, beige in colour with no markings. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cyproterone Acetate/ Ethinylestradiol Tablets 2mg/0.035mg is recommended for use in women only for the treatment of: - severe acne, refractory to prolonged antibiotic therapy or - moderately severe hirsutism. Although Cyproterone Acetate/Ethinylestradiol is recommended for use in women only for the treatment of (a) severe acne, refractory to prolonged oral antibiotic therapy; (b) moderately severe hirsutism. Although Cyproterone Acetate/Ethinylestradiol also acts as an oral contraceptive, it should not be used in women solely for contraception, but should be reserved for those women requiring treatment for the androgen-dependent conditions described. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cypterone Acetate/Ethinylestradiol inhibits ovulation and thereby prevents conception. Patients who are using Cyproterone Acetate/Ethinylestradiol should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception. _First treatment course: _One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1). _Subsequent courses: _Each subsequent course is started after 7 tablet-free days have followed the preceding course. When the Прочитать полный документ