国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
DESOGESTREL MICRONIZED
Actavis Group PTC ehf
G03AC09
DESOGESTREL MICRONIZED
75 Microgram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
desogestrel
Not Marketed
2013-09-13
PACKAGE LEAFLET: INFORMATION FOR THE USER ISANIVA 75 MICROGRAM FILM-COATED TABLETS DESOGESTREL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, or pharmacist, or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It is not suitable for all women, so you should not give it to anyone else as it may harm them. • If you get any side effects, talk to your doctor, or pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Isaniva is and what it is used for 2. What you need to known before you take Isaniva 3. How to take Isaniva 4. Possible side effects 5. How to store Isaniva 6. Contents of the pack and other information 1. WHAT ISANIVA IS AND WHAT IT IS USED FOR • Isaniva contains a small amount of one type of female sex hormone, the progestogen desogestrel. • Isaniva is used to prevent pregnancy. • There are 2 main kinds of hormone contraceptive. - The combined pill, "The Pill", which contains 2 types of female sex hormone: an oestrogen and a progestogen - The progestogen-only pill, POP or mini-pill, which doesn't contain an oestrogen. • Isaniva is a progestogen-only-pill (POP), or a mini-pill. • Most POPs or minipills work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the main way that combined pills work. • Isaniva is different from other mini-pills in having a dose that in most cases prevents the egg cell from ripening. As a result, Isaniva is a highly effective contraceptive. • In contrast to the combined pill, Isaniva can be used by women who do not tolerate oestrogens and by women who are breast-feeding. • A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Isaniva. On the othe 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isaniva 75 microgram film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 microgram of desogestrel Excipients with known effect: Lactose monohydrate 55.07 mg, soybean oil (maximum 0.026 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKE ISANIVA Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. HOW TO START ISANIVA No preceding hormonal contraceptive use [in the past month] Tablet taking has to start on day 1 of the woman’s natural cycle (day 1 is the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet- taking. Following first-trimester abortion: After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception. Following delivery or second-trimester abortion: Contraceptive treatment with Isaniva after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed pregnancy ought to be ruled out and an additional method of contraception should be used for the first week. For additional information for breastfeeding women see section 4.6. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 阅读完整的文件