Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Levonorgestrel
Rowex Ltd
G03AD; G03AD01
Levonorgestrel
1.5 milligram(s)
Tablet
Product not subject to medical prescription
Emergency contraceptives; levonorgestrel
Marketed
2016-05-26
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ LEVONORGESTREL ROWEX 1.5 MG TABLET Levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Levonorgestrel Rowex carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET 1. What Levonorgestrel Rowex is and what it is used for 2. What you need to know before you take Levonorgestrel Rowex 3. How to take Levonorgestrel Rowex 4. Possible side effects 5. How to store Levonorgestrel Rowex 6. Content of the pack and other information 1. WHAT LEVONORGESTREL ROWEX IS AND WHAT IT IS USED FOR Levonorgestrel Rowex is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed. When should emergency contraception be used? 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). Levonorgestrel Rowex contains a synthetic hormone like active substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day. Levonorgestrel is thought to work by: stopping your ovaries f Citiți documentul complet
Health Products Regulatory Authority 30 September 2019 CRN008TN3 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levonorgestrel Rowex 1.5mg Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.5 mg of levonorgestrel. Excipient with known effect 43.3 mg of lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Levonorgestrel Rowex tablet is round and white, with approximate 6 mm of diameter and marked “C” on one side and “1” on the other 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraception method. 4.2 POSOLOGY AND METHOD OF 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. Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5). Levonorgestrel Rowex 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_ There is no relevant use of Levonorgestrel Rowex for children of prepubertal age in the indication emergency contraception. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 30 Septemb Citiți documentul complet