Country: Իսրայել
language: անգլերեն
source: Ministry of Health
DROSPIRENONE; ETHINYLESTRADIOL
BAYER ISRAEL LTD
G03AA12
FILM COATED TABLETS
DROSPIRENONE 3 MG; ETHINYLESTRADIOL 0.02 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
DROSPIRENONE AND ESTROGEN
- Oral contraception. - Treatment of moderate acne vulgaris in women who seek oral contraception. - Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in women who have chosen oral contraceptives as their method of birth control. The efficacy of Yaz for PMDD was not assessed beyond 3 cycles. Yaz has not been evaluated for treatment of PMS ( premenstrual syndrome ).
2015-03-29
PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 89115582 PZ: 2642A-4B code-no.: name: LF-BRO YAZ TAFI 3X28 country: IL/MULI/BAG colors: BLACK version: 07.09.2022/06 Restricted Document dimension: 90 X 65 MM page 69 / PANT389C 69 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only YAZ FILM-COATED TABLETS Each pink tablet contains: Drospirenone 3 mg Ethinylestradiol (as betadex clathrate) 0.02 mg The white tablets do not contain active ingredients. Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and 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. 89115582_06.indd 69 07.09.2022 10:32:44 PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 89115582 PZ: 2642A-4B code-no.: name: LF-BRO YAZ TAFI 3X28 country: IL/MULI/BAG colors: BLACK version: 07.09.2022/06 Restricted Document dimension: 90 X 65 MM page 70 / PANT389C 70 ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL CONTRACEPTIVES AND ABOUT THE MEDICINE • When used properly, combined hormonal contraceptives are considered one of the most reliable reversible methods of contraception. • They slightly increase the risk of a blood clot in the veins and arteries, especially in the first year or when resuming treatment with a combined hormonal contraceptive following a break of 4 or more weeks. • You must be alert and refer to the doctor if you think you have symptoms of a blood clot (see “Blood clots” in section 2). 1) WHAT IS THE MEDICINE INTENDED FOR? Yaz is intended to prevent pregnancy and to treat moderat read_full_document
1. NAME OF THE MEDICINAL PRODUCT YAZ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 24 light pink film-coated tablets: Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone. Excipient with known effect: lactose monohydrate 48.18 mg 4 white placebo (inactive) film-coated tablets: The tablet does not contain active substances. Excipient with known effect: lactose monohydrate 23.205 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets The active tablets are light pink, round with convex faces; one side embossed with the letters "DS" in a regular hexagon. The placebo tablets are white, round with convex faces, one side embossed with the letters "DP" in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Oral contraception. • Treatment of moderate acne vulgaris in women who seek oral contraception. • Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been evaluated for treatment of PMS (premenstrual syndrome). The decision to prescribe YAZ should take into considerat ion the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with YAZ 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 YAZ 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. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2-3 after starting the placebo tablets (last row) and may not have finished before the next pack is started. read_full_document