国家: 以色列
语言: 英文
来源: Ministry of Health
ETHINYLESTRADIOL; GESTODENE
BAYER ISRAEL LTD
G03CA01
COATED TABLETS
ETHINYLESTRADIOL 0.03 MG; GESTODENE 0.075 MG
PER OS
Required
BAYER AG, GERMANY
ETHINYLESTRADIOL
ETHINYLESTRADIOL
Hormonal contraception.
2020-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS PREPARATIONS – 1986 The edi i e is dispe sed ith a do tors pres riptio o ly Gynera® Coated Tablets Each tablet contains: Ethinylestradiol 0.03 mg Gestodene 0.075 mg Inactive ingredients and allergens in the preparation: See se tio Further Ifor atio and in section 2 Important information regarding some of the components of the medicine . 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 your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 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 may have symptoms of a blood clot (see Blood lots i se tio 2. • If taken for prolonged periods, 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 or chlamydia. Only a condom can help with this. • This medicine may increase your risk of effects such as blood clots and breast cancer. • Oral contraceptive pills are not suitable for some women due to their medical condition. Please read this leaflet to make sure Gynera is suitable for you. • To prevent pregnancy, it is important to take Gynera as instructed and to start each new strip on time. Please make sure that you understand what to do if you miss a pill or if you think you are preg 阅读完整的文件
1. NAME OF THE MEDICINAL PRODUCT Gynera 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Gestodene 75 micrograms Ethinylestradiol 30 micrograms Excipients: Lactose monohydrate 37.43 mg Sucrose 19.66 mg For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Sugar-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormonal contraception. The decision to prescribe Gynera should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Gynera compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _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 Gynera is continued after a 7-day interval, beginning on the same day of the week as the first pack. _Changing from 21-day combined oral contraceptives: _ The first tablet of Gynera 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): _ Gynera should be started after taking the last active tablet from the Every Day Pill pack. The first Gynera tablet is taken the next day. Additional contraceptive precautions are not then required. _Changing from a progestogen-only pill (POP): _ The first tablet of Gynera 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 then required. The remaining progestogen-only pills should be discarded. _Post-partum and post-abortum use: _ After pregnancy, oral contraception can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contracep 阅读完整的文件