Kraj: Malta
Język: angielski
Źródło: Medicines Authority
LEVONORGESTREL
NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta
G03AD01
LEVONORGESTREL
TABLET
LEVONORGESTREL 1500 microgram(s)
OTC
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Licence number in the source country: United Kingdom - PL04854/0150
Authorised
2017-01-20
Page 1 of 5 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. 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 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 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. Levonelle 1500 is thought to work by: lising any egg you may have already released. Levonelle 1500 can only prevent you becoming pr Przeczytaj cały dokument
LEVONELLE 1500 MICROGRAM TABLET Summary of Product Characteristics Updated 20-Oct-2014 | Bayer plc 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 excipients see section 6.1 3. PHARMACEUTICAL FORM Tablet Almost white, flat, rimmed tablet of about 8 mm 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 barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Levonelle 1500 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 any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method. Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Levon Przeczytaj cały dokument