Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cyproterone (cyproterone acetate), ethinylestradiol
Bayer Pharma AG
cyproterone (cyproterone acetate), ethinylestradiol
2mg+0,035mg
dragee
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Diane-35, 0.035 mg/2 mg dragee 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: ethinylestradiol/cyproterone acetate Each coated tablet contains 0.035 mg of ethinylestradiol and 2 mg of cyproterone acetate. Excipients: Lactose monohydrate 31 mg, sucrose 19 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dragee 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe acne due to androgen sensitivity (with or without seborrhoea) and/or hirsutism in women of childbearing age. Diane-35 should be used only after the failure of topical therapy or systemic antibiotic treatments for acne therapy. As Diane-35 is also a hormonal contraceptive, it must not be used in combination with other hormonal contraceptives (see section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diane-35 inhibits ovulation and thereby has a contraceptive effect. Patients who are using Diane-35 should, therefore, not use an additional hormonal contraceptive, since this leads to an overdose of hormones and is not necessary for effective contraceptive protection. For the same reason, women who desire to become pregnant should not use Diane-35. Diane-35 must be taken regularly in order to develop an adequate therapeutic efficacy and effective contraceptive protection. Method of administration Oral use 2 Posology Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which withdrawal bleeding usually occurs, which often starts on the 2nd-3rd day after taking the last tab Прочитать полный документ