국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gestodene; Ethinylestradiol
Mawdsley-Brooks & Company Ltd
G03AA10
Gestodene; Ethinylestradiol
75microgram ; 30microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030100
THIS AREA MUST BE IDENTICAL ON BOTH SIDES! IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): R They are one of the most reliable reversible methods of contraception if used correctly. R They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks. R Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2.3 ‘Blood clots’). R The Pill may reduce your risk of cancer of the ovary and womb if used in the long term. R The Pill will not protect you against sexually transmitted diseases. R This medicine can increase your risk of problems such as blood clots and breast cancer. R Some women should not take the Pill because of current medical problems or illnesses. Please read this leaflet to make sure Femodene is right for you. R To prevent pregnancy it is important to take Femodene as instructed and start each pack on time. Please make sure that you understand what to do if you miss a pill or if you think you are pregnant. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. R Keep this leaflet. You may need to read it again. R If you have any questions or need more advice, ask your doctor, family planning nurse or pharmacist. R This medicine has been prescribed for you. Do not pass it on to others. It may harm them. R IF ANY OF THE SIDE EFFECTS GETS SEVERE, or if you notice any not listed in this leaflet, please tell your doctor, family planning nurse or pharmacist. IN THIS LEAFLET 1. WHAT FEMODENE DOES 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FEMODENE 2.1 When you should not use Femodene 2.2 When to take special care with Femodene 2.3 Blood clots 2.4 The Pill and cancer 2.5 Psychiatric disorders 2.6 Taking other medicines 2.7 Taking Femodene with food and drink 2.8 Pregnancy and breast-feeding 2.9 Driving and using machines 2.10 Femodene contains lactose and sucrose 3. TAKING FEMODENE 3.1 How 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femodene ® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Gestodene 75 micrograms Ethinylestradiol 30 micrograms Excipients: Lactose 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 Oral contraception and the recognised gynaecological indications for such oestrogen- progestogen combinations. The decision to prescribe Femodene should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Femodene 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 Femodene 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 Femodene 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):_ Femodene should be started after taking the last active tablet from the Every Day Pill pack. The first Femodene tablet is taken the next day. Additional contraceptive precautions are not then required. _Changing from a progestogen-only pill (POP):_ The first tablet of Femodene 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 vagina 전체 문서 읽기