Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: myHealthbox
cyproterone acetate, ethinylestradiol
Morningside Healthcare Ltd
G03HB01
cyproterone acetate, ethinylestradiol
2000/35microgram
Film-coated tablets
Oral use
Packs of 21, 63 and 126 Tablets
POM - Prescription Only Medicine
Morningside Pharmaceutical Ltd
cyproterone and estrogen
Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, co-cyprindiol should only be used after topical therapy or systemic antibiotic treatments have failed.
Authorised
2015-03-03
------------------------- DOCUMENT OUTLINE * Page 1 Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teragezza 2000/35 microgram film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Cyproterone acetate 2.00 mg Ethinylestradiol 35 micrograms Excipients: Lactose monohydrate 57.44mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, co-cyprindiol should only be used after topical therapy or systemic antibiotic treatments have failed. Since co-cyprindiol is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Co-cyprindiol inhibits ovulation and thereby prevents conception. Patients who are using co-cyprindiol 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 contraceptive action of co-cyprindiol is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started. When changing from an oral contraceptive and relying on the con Đọc toàn bộ tài liệu