Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levonorgestrel
Bayer Plc
G03AC03
Levonorgestrel
1.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030500; GTIN: 5016703008668
v 003_0 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER LEVONELLE ONE STEP 1500 MICROGRAM TABLET Levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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 Levonelle One Step is and what it is used for 2. What you need to know before you take Levonelle One Step 3. How to take Levonelle One Step 4. Possible side effects 5. How to store Levonelle One Step 6. Contents of the pack and other information 1. WHAT LEVONELLE ONE STEP IS AND WHAT IT IS USED FOR Levonelle One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed. Levonelle One Step contains a synthetic hormone like substance called levonorgetsrel. 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. Levonelle One Step is thought to work by: stopping your ovaries from releasing an egg; preventing sperm from fertilising any egg you may have already released. v 003_0 Levonelle One Step can onl Lugege kogu dokumenti
OBJECT 1 LEVONELLE ONE STEP Summary of Product Characteristics Updated 06-Apr-2017 | Bayer plc 1. Name of the medicinal product Levonelle One Step 1500 microgram tablet (Also available as Boots Emergency Contraceptive 1.5 mg Tablet) 2. Qualitative and quantitative composition The tablet contains 1500 microgram of levonorgestrel Each tablet contains: 142.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet The tablet is round and white 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: 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. The patient should seek advice from her doctor, nurse, family planning clinic or pharmacist. 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). Levonelle One Step 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 Levonelle One Step does not contraindicate the continuation of regular hormonal contraception. _Paediatric population_ There is no relevant use of Levonelle One Step 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 Lugege kogu dokumenti