البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DROSPIRENONE; ETHINYLESTRADIOL
BAYER ISRAEL LTD
G03AA12
FILM COATED TABLETS
DROSPIRENONE 3 MG; ETHINYLESTRADIOL 0.03 MG
PER OS
Required
BAYER AG, GERMANY
DROSPIRENONE AND ESTROGEN
DROSPIRENONE AND ESTROGEN
Oral contraception.
2021-04-30
PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: 0021,GV15 material-no.: 89280362 PZ: 2536A-4D code-no.: 64 name: LF-BRO YASMIN TAFI 21 country: IL/MULI/BAG colors: BLACK version: 05.09.2022/04 Restricted Document dimension: 103 X 38 MM page 1 / 1 YASMIN® drospirenone 3 mg ethinylestradiol 0.03 mg 89280362_04.indd 1 05.09.2022 06:39:41 PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: 0021,GV15 material-no.: 89280362 PZ: 2536A-4D code-no.: 64 name: LF-BRO YASMIN TAFI 21 country: IL/MULI/BAG colors: BLACK version: 05.09.2022/04 Restricted Document dimension: 103 X 38 MM page 2 / 2 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only YASMIN® FILM-COATED TABLETS 89280362_04.indd 2 05.09.2022 06:39:41 PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: 0021,GV15 material-no.: 89280362 PZ: 2536A-4D code-no.: 64 name: LF-BRO YASMIN TAFI 21 country: IL/MULI/BAG colors: BLACK version: 05.09.2022/04 Restricted Document dimension: 103 X 38 MM page 3 / 3 Each film-coated tablet contains: drospirenone 3 mg ethinylestradiol 0.03 mg Inactive ingredients and allergens: see section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 89280362_04.indd 3 05.09.2022 06:39:42 PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: 0021,GV15 material-no.: 89280362 PZ: 2536A-4D code-no.: 64 name: LF-BRO YASMIN TAFI 21 country: IL/MULI/BAG colors: BLACK version: 05.09.2022/04 Restricted Document dimension: 103 X 38 MM page 4 / 4 Yasmin is not intended for women or adolescent girls who still have not had their first menstrual period. ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL CONTRACEPTIVES AND ABOUT THE MEDIC اقرأ الوثيقة كاملة
1. NAME OF THE MEDICINAL PRODUCT Yasmin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3 mg drospirenone and 0.030 mg ethinylestradiol. Excipient with known effect: lactose monohydrate 48.17 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. 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 woman should start using Yasmin preferably on the day of removal, but اقرأ الوثيقة كاملة