국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gestodene; Ethinylestradiol
Bayer Plc
G03AA10
Gestodene; Ethinylestradiol
75microgram ; 20microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030100; GTIN: 5016703005902
Page 1 of 20 v022_0 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. Package booklet: Information for the user Femodette ® 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 booklet to make sure Femodette is right for you. ▪ To prevent pregnancy it is important to take Femodette 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 BOOKLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. ▪ Keep this booklet. 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 booklet, please tell your doctor, family planning nurse or 전체 문서 읽기
OBJECT 1 FEMODETTE TABLETS Summary of Product Characteristics Updated 21-Nov-2022 | Bayer plc • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Femodette ® 2. Qualitative and quantitative composition Each tablet contains 0.075mg gestodene and 0.02mg ethinylestradiol. Excipients with known effect: Lactose 37.155 mg per tablet. Sucrose 19.660 mg per tablet. For the 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 Femodette should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Femodette 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, 전체 문서 읽기