Riik: Malta
keel: inglise
Allikas: Malta Medicines Authority
DROSPIRENONE; ETHINYLESTRADIOL
Bayer PLC
G03AA12
DROSPIRENONE; ETHINYLESTRADIOL
FILM-COATED TABLET
DROSPIRENONE 3 mg; ETHINYLESTRADIOL 0.03 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2007-07-25
PACKAGING TECHNOLOGY BERLIN SGQWX Bayer AG client: 0021 item-no.: 85674552 PZ: 2536A-4D code-no.: 161 name: LF-BRO-YASMIN FTB 21 country: GB/-/BAG colors: BLACK version: 06.03.2017/02 Restricted Document dimension: 103 X 38 MM page U1 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C PACKAGE LEAFLET: INFORMATION FOR THE USER 0.03 mg / 3 mg film-coated tablets Ethinylestradiol / Drospirenone 52_02.indd cover:1 3/6/2017 9:05:40 AM PACKAGING TECHNOLOGY BERLIN SGQWX Bayer AG client: 0021 item-no.: 85674552 PZ: 2536A-4D code-no.: 161 name: LF-BRO-YASMIN FTB 21 country: GB/-/BAG colors: BLACK version: 06.03.2017/02 Restricted Document dimension: 103 X 38 MM page U2 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C 52_02.indd cover:2 3/6/2017 9:06:06 AM PACKAGING TECHNOLOGY BERLIN SGQWX Bayer AG client: 0021 item-no.: 85674552 PZ: 2536A-4D code-no.: 161 name: LF-BRO-YASMIN FTB 21 country: GB/-/BAG colors: BLACK version: 06.03.2017/02 Restricted Document dimension: 103 X 38 MM page U3 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C 52_02.indd cover:3 3/6/2017 9:06:06 AM PACKAGING TECHNOLOGY BERLIN SGQWX Bayer AG client: 0021 item-no.: 85674552 PZ: 2536A-4D code-no.: 161 name: LF-BRO-YASMIN FTB 21 country: GB/-/BAG colors: BLACK version: 06.03.2017/02 Restricted Document dimension: 103 X 38 MM page U4 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C 85674552 52_02.indd cover:4 3/6/2017 9:06:06 AM PACKAGING TECHNOLOGY BERLIN SGQWX Bayer AG client: 0021 item-no.: 85674552 PZ: 2536A-4D code-no.: 161 name: LF-BRO-YASMIN FTB 21 country: GB/-/BAG colors: BLACK version: 06.03.2017/02 Restricted Document dimension: 103 X 38 MM page 1 BLACK / PANTONE 233 C 1 READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. R Keep this booklet. You may need to read it again. R If you have any further questions, ask your doctor or pharmacist. R This medicine has been prescribed for you only. Do not pass it on Lugege kogu dokumenti
V025.0 Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Yasmin, film-coated tablets, 0.03 mg/3 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3 mg drospirenone and 0.030 mg ethinylestradiol. Excipient with known effect: lactose 46 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Light yellow, round tablets with convex faces, one side embossed with the letters "DO" in a regular hexagon 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Yasmin should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Yasmin compares with other combined hormonal contraceptives (CHCs), see sections 4.3 and 4.4. V025.0 Page 2 of 24 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION_ Oral use _POSOLOGY_ HOW TO TAKE YASMIN The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. 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 time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. HOW TO START YASMIN No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Yasmin preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the Lugege kogu dokumenti