Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levonorgestrel
Alliance Healthcare (Distribution) Ltd
G03AC03
Levonorgestrel
1.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030500
6148 260560 LEVONORGESTREL 1.5MG TABLETS 280 mm 230 mm PACKAGE LEAFLET: INFORMATION FOR THE USER LEVONORGESTREL 1.5MG TABLETS 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Levonorgestrel 1.5mg tablets are and what they are used for 2. What you need to know before you take Levonorgestrel 1.5mg tablets 3. How to take Levonorgestrel 1.5mg tablets 4. Possible side effects 5. How to store Levonorgestrel 1.5mg tablets 6. Contents of the pack and other information 1. WHAT LEVONORGESTREL 1.5MG TABLETS ARE AND WHAT THEY ARE USED FOR A Levonorgestrel 1.5mg tablet 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 if a condom was penetrated, slipped away or used in the 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 1.5mg tablets contain 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 Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levonorgestrel 1.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.5mg of levonorgestrel Excipient(s) with known effect: Each tablet contains 140.10 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white round shaped tablets, debossed with “LV1” on one side and plain on the other 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 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. Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC (emergency contraception), 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 1.5mg tablets 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 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 Emergency contraception is an occasional method. It shou Belgenin tamamını okuyun