Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Malta Medicines Authority
GESTODENE, ETHINYLESTRADIOL
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
G03AA10
GESTODENE ETHINYLESTRADIOL
FILM-COATED TABLET
GESTODENE ETHINYLESTRADIOL
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2006-09-22
Page 1 of 12 Pfleet No.: 2014-0004784 PACKAGE LEAFLET: INFORMATION FOR THE USER MINESSE 60 MICROGRAMS/15 MICROGRAMS, FILM-COATED TABLETS 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 “Blood clots”). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What MINESSE is and what it is used for 2. What you need to know before you take MINESSE 3. How to take MINESSE 4. Possible side effects 5. How to store MINESSE 6. Contents of the pack and other information 1. What MINESSE is and what it is used for MINESSE is an oral contraceptive pill and is used to prevent pregnancy. Each of the 24 pale yellow tablets contains a small amount of two different female hormones, namely gestodene and ethinylestradiol. The 4 white tablets contain no active substances and are called placebo tablets. Contraceptive pills that contain two hormones are called “combination” pills. 2. What you need to know before you take MINESSE _ _ GENERAL NOTES Before you can begin taking MINESSE, your doctor will ask you some questions about your personal health hist Đọc toàn bộ tài liệu
Ref.: MS 6_0 Page 1 of 16 Pfleet number: 2014-0007971 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MINESSE 60 micrograms / 15 micrograms film-coated tablet 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Gestodene : ..... ............ ………60 micrograms Ethinylestradiol: ........... ………15 micrograms For one pale-yellow, film-coated tablet (active tablet) Excipient with known effect: lactose The white, film-coated tablets do not contain any active ingredients (placebo). Excipient with known effect: lactose For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. The active tablet is a pale-yellow round tablet with convex faces embossed with “60”on one side and “15”on the other. The placebo tablet is a white round tablet with convex faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral hormonal contraception. The decision to prescribe Minesse should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Minesse compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Take regularly and without omission, one tablet daily at the same time of the day, for 28 consecutive days (one pale-yellow, active tablet during the first 24 days, one white, inactive tablet during the 4 following days) with no free interval between each blister pack. A withdrawal bleed usually starts on day 2-3 after the last active tablet and may not have finished before the next pack is started. How to start Minesse - No preceding hormonal contraceptive use in the past month: - Take the first tablet on the first day of menstrual bleeding. Ref.: MS 6_0 Page 2 of 16 Pfleet number: 2014-0007971 Changing from another combined oral contraceptive (COC): The woman should start Minesse_ _on the day after the last active tablet of her previous COC. _-_ _ _ Changing from a progestin-only method (m Đọc toàn bộ tài liệu