Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
IBUPROFEN LYSINE
McDermott Laboratories Ltd t/a Gerard Laboratories
M01AE01
IBUPROFEN LYSINE
400 Milligram
Film Coated Tablet
Product not subject to medical prescription
Propionic acid derivatives
Authorised
2013-11-08
PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 200 MG FILM-COATED TABLETS IBUPROFEN 400 MG FILM-COATED TABLETS Ibuprofen (as lysine) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR 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. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days in case of migraine or fever, or after 4 days for the treatment of pain. WHAT IS IN THIS LEAFLET: 1. What Ibuprofen is and what it is used for 2. What you need to know before you take Ibuprofen 3. How to take Ibuprofen 4. Possible side effects. 5. How to store Ibuprofen 6. Contents of the pack and other information. 1. WHAT IBUPROFEN IS AND WHAT IT IS USED FOR Ibuprofen contains the active substance ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain and high temperature. _ _ _[200mg only]_ Ibuprofen tablets are used for the symptomatic treatment of mild to moderate pain, such as headache, dental pain, period pain and fever and pain as the result of a cold. _[400 mg only_] Ibuprofen tablets are used for the symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, dental pain, period pain and fever and pain as the result of a cold. 2. WHAT DO YOU NEED TO KNOW BEFORE Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 400mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of ibuprofen (as lysine) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, film-coated, oval biconvex, bevelled edge tablet imprinted with “M IL2” in black ink on one side of the tablet and blank on the other side Dimension: 17.9mm ± 0.3mm x 9.2mm ± 0.3mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, dental pain, period pain and fever and pain in the common cold. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents 40 kg body weight (12 years of age and above): Initial dose: 400 mg. If necessary, an additional dose of 400 mg may be taken. The corresponding dosing interval should be chosen based on the symptoms and the recommended daily maximum dose. It should not be less than 6 hours for a 400 mg dose. Do not exceed 1200 mg dose in any 24 hour period. For treatment of migraine headache the dose should be one tablet of 400 mg as a single dose, if necessary 400 mg with intervals of 4 to 6 hours. Do not exceed 1200 mg dose in any 24 hour period. _Paediatric population_ Ibuprofen is contraindicated in adolescents under 40 kg body weight or in children under 12 years. If in children aged from 12 years and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If this Прочетете целия документ