Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
ETHINYLESTRADIOL; GESTODENE
BAYER ISRAEL LTD
G03AA10
COATED TABLETS
ETHINYLESTRADIOL 0.020 MG; GESTODENE 0.075 MG
PER OS
Required
BAYER PHARMA AG, GERMANY
GESTODENE AND ESTROGEN
Oral contraceptive.
2019-12-08
PACKAGING TECHNOLOGY BERLIN SGQCL page 2 Bayer AG client: 0021,GV15 material-no.: 87038688 PZ: 2773C-3 code-no.: name: LF-INS-MELIANE SCT 21 country: IL/-/BPH colors: BLACK version: 14.05.2020/01 Restricted Document dimension: 398 X 798 MM 87038688 MELIANE ® MELIANE ® COATED TABLETS PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Each tablet contains: Gestodene 0.075 mg Ethinylestradiol 0.02 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 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. 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 clots” in section 2). • If taken for prolonged periods, oral contraceptive pills may reduce your risk of cancer of the ovaries and womb. • Contraceptive pills do not protect against sexually transmitted diseases, such as AIDS or chlamydia. Only a condom can help with this. • This medicine can 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 Meliane is suitable for you. • To prevent pregnancy, it i Baca dokumen lengkapnya
1 RESTRICTED PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Meliane 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.075mg gestodene and 0.02mg ethinylestradiol 3. PHARMACEUTICAL FORM Sugar - coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS. Oral contraception. The decision to prescribe Meliane should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Meliane 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 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 Meliane 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 Meliane 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):_ Meliane should be started after taking the last active tablet from the Every Day Pill pack. The first Meliane tablet is taken the next day. Additional contraceptive precautions are not then required. _ _ _Changing from a progestogen-only pill (POP):_ The first tablet of Meliane 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. 2 RESTRICTED _ _ _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 contraceptive precautions will be required for the first 7 da Baca dokumen lengkapnya