البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ETHINYLESTRADIOL; LEVONORGESTREL
BAYER ISRAEL LTD
G03AA
COATED TABLETS
LEVONORGESTREL 150 MCG; ETHINYLESTRADIOL 30 MCG
PER OS
Required
BAYER AG, GERMANY
PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS
Oral contraceptive.
2022-07-31
22 Description MICROGYNON Size 103x38 mm (W) x (H) Customer Font (type & min. size / language) BayerSans 7 p (eng) Arial 7 p (heb) 89520002_template_01.pdf Arial 7 p (arb) Color BLACK (inside pages) Type LEAFLET Pantone 368 c Date 02/08/23 Artwork operator Sima Agam_Oso Bayo Studio Job no . SO23000703 Technical reference MICROGYNON ® 30 LEVONORGESTREL 0.15 MG ETHINYLESTRADIOL 0.03 MG 89520002 1 MICROGYNON 30 1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only MICROGYNON ® 30 Film-coated Tablets 2 Each tablet contains: levonorgestrel 0.15 mg ethinylestradiol 0.03 mg Inactive and allergenic ingredients: see section 6 “Further information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS 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 to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 3 ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL CONTRACEPTIVES AND ABOUT THE MEDICINE When used correctly, 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 after a break of 4 or more weeks. Be alert and refer to a doctor if you think you have symptoms of a blood clot (see “Blood clots” in section 2). 4 When taken for an extended period, oral contraceptive pills may reduce your risk of cancer of the ovaries and womb. Oral contraceptive pills do not protect against sexually transmitted diseases such as AIDS (HIV) or chlamydia; only a condom can help with this. This medicine may increase your risk of effects such as blood clots and breast cancer. There are some women for whom oral contrace اقرأ الوثيقة كاملة
1. NAME OF THE MEDICINAL PRODUCT Microgynon 30 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Levonorgestrel 150 mcg Ethinylestradiol 30 mcg Excipients: Lactose monohydrate 32.820 mg Sucrose 19.371 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Sugar-coated tablets Each tablet is beige 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Microgynon 30 should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Microgynon 30 compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary. _ _ _First treatment cycle: _ 1 tablet daily for 21 days, starting on the first day of the menstrual cycle Contraceptive protection begins immediately. _ _ _Subsequent cycles: _ Tablet-taking from the next pack of Microgynon 30 is continued after a 7-day tablet-free interval, beginning on the same day of the week as the first pack. A withdrawal bleed usually occurs during the tablet-free interval. _ _ _Changing from 21-day combined oral contraceptives: _ The first tablet of Microgynon 30 should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required. _Changing from a combined Every Day pill (28 -day tablets): _ 2 Microgynon 30 should be started after taking the last active tablet from the Every Day Pill pack. The first Microgynon 30 tablet is taken the next day. Additional contraceptive precautions are not then required. _Changing from a progestogen-only pill (POP): _ The first tablet of Microgynon 30 should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not اقرأ الوثيقة كاملة