Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
DROSPIRENONE; ETHINYLESTRADIOL AS BETADEX CLATHRATE; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM
BAYER ISRAEL LTD
G03CA53
FILM COATED TABLETS
LEVOMEFOLATE CALCIUM 0.451 MG; ETHINYLESTRADIOL AS BETADEX CLATHRATE 0.02 MG; DROSPIRENONE 3 MG; LEVOMEFOLATE CALCIUM 0.451 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
ESTRADIOL, COMBINATIONS
- Oral contraception. - Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in women who choose to use an oral contraceptive as their method of birth control.- Treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. - In women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
2019-09-30
PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 89354609 PZ: 2701A-4 code-no.: name: LF-BRO YAZ PLUS TAFI 3X28 country: IL/MULI/BAG colors: BLACK / version: 03.01.2023/02 Restricted Document dimension: 95 X 66 MM page 54 colors: BLACK / 54 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only YAZ PLUS FILM-COATED TABLETS Each pink tablet contains: Drospirenone 3 mg Ethinylestradiol (as betadex clathrate) 0.02 mg Levomefolate calcium 0.451 mg Each light-orange tablet contains: Levomefolate calcium 0.451 mg Inactive ingredients and allergens: See section 6 “Additional information” and section 2 “Important information regarding some of the ingredients of the medicine”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 89354609 PZ: 2701A-4 code-no.: name: LF-BRO YAZ PLUS TAFI 3X28 country: IL/MULI/BAG colors: BLACK / version: 03.01.2023/02 Restricted Document dimension: 95 X 66 MM page 55 colors: BLACK / 55 This medicine has been prescribed for you to prevent pregnancy. Do not pass it on to others. It may harm them even if it seems to you that the purpose of use is similar. ESSENTIAL INFORMATION ABOUT THE MEDICINE • Do not use Yaz Plus if you smoke and are over 35 years of age. Taking birth control pills while smoking increases your risk of developing serious cardiac side effects (cardiovascular problems), including death due to heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. • Birth control pills lower the chance of becoming pregnant if taken according to the instructions. They do not protect against contraction of AIDS or any other sexually transmitted disease. 1) WHAT IS THIS MEDICINE INTENDED FOR? Yaz Plus is i Citiți documentul complet
1 YAZ PLUS Film coated tablets Drospirenone 3 mg Ethinylestradiol as betadex calthrate 0.02 mg Levomefolate calcium 0.451 mg WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVES (COC) USE. THIS RISK INCREASES WITH AGE, PARTICULARLY IN WOMEN OVER 35 YEARS OF AGE, AND WITH THE NUMBER OF CIGARETTES SMOKED. FOR THIS REASON, COCS SHOULD NOT BE USED BY WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE _[SEE CONTRAINDICATIONS (4)]_. 1 INDICATIONS AND USAGE - Oral contraception. - Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in women who choose to use an oral contraceptive as their method of birth control. - Treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. - In women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. 2 DOSAGE AND ADMINISTRATION 2.1 HOW TO TAKE YAZ PLUS Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, Yaz Plus must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 HOW TO START YAZ PLUS Instruct the patient to begin taking Yaz Plus either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). _Day 1 Start _ During the first cycle of Yaz Plus use, instruct the patient to take one pink Yaz Plus daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink Yaz Plus daily for 24 consecutive days, followed by one light orange tablet Citiți documentul complet