국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL
Medimpex (UK) Limited
LEVONORGESTREL
1500 Microgram
Tablets
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVONELLE 1500 MICROGRAM TABLET Levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - 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 WHAT IS IN THIS LEAFLET: 1. What Levonelle 1500 microgram tablet (hereinafter Levonelle 1500)is and what it is used for 2. What you need to know before you take Levonelle 1500 3. How to take Levonelle 1500 4. Possible side effects 5. How to store Levonelle 1500 6. Contents of the pack and other information 1. WHAT LEVONELLE 1500 IS AND WHAT IT IS USED FOR Levonelle 1500 is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed. It is about the following cases: - No contraception was used during the sexual intercourse. - The contraception measure was used incorrectly, for example as if a condom was penetrated, slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia) Levonelle 1500 contai 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levonelle 1500 microgram Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1500 micrograms of levonorgestrel Excipient with known effect: 142.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Almost white, flat, rimmed tablet of about 8mm diameter with an impressed mark of “G00” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration: Posology One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1). If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately. Levonelle 1500 can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. After using emergency contraception it is recommended to use a local barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the next menstrual period starts. The use of levonorgestrel does not contraindicate the continuation of regular hormonal contraception. _Paediatric population_ Levonelle 1500 is not recommended in children. Very limited data are available in women under 16 years of age. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/03/2014_ _CRN 2129212_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Emergency contraception is 전체 문서 읽기