Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bayer Plc
G03AA10
Not applicable
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 07030100; GTIN: 5016703002994
Page 1 of 19 V028_0 PACKAGE LEAFLET: Information for the user Femodene ® ED Gestodene Ethinylestradiol IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): They are one of the most reliable reversible methods of contraception if used correctly. 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. Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2.3 ‘Blood clots’). The Pill may reduce your risk of cancer of the ovary and womb if used in the long term. The Pill will not protect you against sexually transmitted diseases. This medicine can increase your risk of problems such as blood clots and breast cancer. Some women should not take the Pill because of current medical problems or illnesses. Please read this leaflet to make sure Femodene ED is right for you. To prevent pregnancy it is important to take Femodene ED 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. Keep this leaflet. You may need to read it again. If you have any questions or need more advice, ask your doctor, family planning nurse or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them. 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 ED DOES 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FEMODENE ED 3. TAKING FEMODENE ED 3.3 A missed pill 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FEMODENE ED 6. WHAT IS IN FEMODENE ED AND WHO MAKES IT Page 2 of 19 V028_0 1. WHAT FEMODENE ED DOES Femodene ED is a combined oral contraceptive pill (‘the Pill Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femodene ® ED 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each active tablet contains 75 micrograms gestodene and 30 micrograms ethinylestradiol. Each pack also contains seven placebo tablets which are larger. Excipients with known effect: Active Tablet Lactose 37.43 mg Sucrose 19.660 mg Placebo Tablet Lactose 48.25 mg Sucrose 33.98 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 ED 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 ED 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 28 days, starting on the first day of the menstrual cycle. 21 (small) active tablets are taken followed by 7 (larger) placebo tablets. Contraceptive protection begins immediately_. _ _Subsequent cycles:_ Tablet-taking is continuous, which means that the next pack of Femodene ED follows immediately without a break. A withdrawal bleed usually occurs when the placebo tablets are being taken. _Changing from 21-day combined oral contraceptives:_ The first tablet of Femodene ED 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 pill):_ Femodene ED should be started after taking the last active tablet from the previous Every Day pill pack. The first Femodene ED 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 ED should be taken on th Preberite celoten dokument