País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL
Laboratoire HRA Pharma
G03AD01
LEVONORGESTREL
750 Microgram
Tablets
Product subject to prescription which may not be renewed (A)
Emergency contraceptives
Authorised
2004-12-03
NLV0.75_ PI_Final_11.2014_MRP_IE v EN_clean Variation n° FR/H/146/01-02/IA/33 1 PACKAGE LEAFLET: INFORMATION FOR THE USER NORLEVO ® 750 MICROGRAM TABLETS Levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. _ _ _(Statement to be used when product is delivered without a medical prescription)_ This medicine is available without prescription. However, you still need to use NorLevo 750 microgram tablets carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or family planning clinic. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. _(Statement to be used when product is delivered with a medical prescription)_ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or family planning clinic. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What NorLevo 750 microgram tablets is and what it is used for 2. Before you use NorLevo 3. How to use NorLevo 4. Possible side effects 5. How to store NorLevo 6. Further information 1. WHAT NORLEVO 750 MICROGRAM TABLETS IS AND WHAT IT IS USED FOR NorLevo is an oral emergency contraceptive. WHAT IS EMERGENCY CONTRACEPTION? Emergency contraception is a rescue method intended to prevent pregnancy after unprotected intercourse or in case of failure of a contra Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NORLEVO 750 microgram tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 microgram levonorgestrel Excipients: each tablet contains 45.45 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round and biconvex tablet with no marking. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours after an unprotected sexual intercourse or in case of failure of a contraceptive method. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. The treatment necessitates the intake of two tablets in a single administration. The efficacy of the method is higher the sooner after the unprotected intercourse the treatment is initiated. Therefore, the two tablets must be taken AS SOON AS POSSIBLE, PREFERABLY WITHIN 12 HOURS AFTER THE UNPROTECTED INTERCOURSE, and no longer than 72 hours (3 days) after the intercourse. Norlevo can be taken at any moment during the menstrual cycle. If vomiting occurs within three hours of taking the tablets, another two tablets should be taken immediately. After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, cervical cap) until the next menstrual periods resume. The use of Norlevo does not contraindicate the continuation of regular hormonal contraception_._ 4.3 CONTRAINDICATIONS Hypersensitivity to levonorgestrel or any of the excipients. 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 to occur in every instance, especially if uncertainty about the timing of the unprotected int Llegiu el document complet