Country: Malta
Language: English
Source: Medicines Authority
IBUPROFEN
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
M01AE01
IBUPROFEN 200 mg
FILM-COATED TABLET
IBUPROFEN 200 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2013-03-01
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN FAIR-MED 200 MG FILM-COATED TABLETS IBUPROFEN FAIR-MED 400 MG FILM-COATED TABLETS Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. - 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. - If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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, pharmacist or nurse have 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. - You must contact a doctor if your symptoms worsen or do not improve after 3 days if you have fever or migraine headache and after 4 days for the treatment of pain. WHAT IS IN THIS LEAFLET: 1. What Ibuprofen FAIR-MED is and what it is used for 2. What you need to know before you take Ibuprofen FAIR-MED 3. How to take Ibuprofen FAIR-MED 4. Possible side effects 5. How to store Ibuprofen FAIR-MED 6. Contents of the pack and other information 1. WHAT IBUPROFEN FAIR-MED IS AND WHAT IT IS USED FOR Ibuprofen FAIR-MED belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs Read the complete document
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen FAIR-MED 200 mg film-coated tablet Ibuprofen FAIR-MED 400 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen. Each film-coated tablet contains 400 mg ibuprofen Ibuprofen FAIR-MED contains 14mg lactose. Ibuprofen FAIR-MED contains 28mg lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 200mg White coloured, film coated pillow shaped tablets debossed with ‘235’ on one side and plain on the other. 400mg White coloured, film coated pillow shaped tablets debossed with ‘236’ on one side and plain on the other. 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, period pain, dental pain, and fever and pain in the common cold._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4)._ _ 200 mg strength: Suitable for adult and children from 20kg (around 6 years old) 400 mg strength: Suitable for adults and adolescents from 40 kg (12 years and older) If this product is required for more than 3 days in the case of fever or migraine headache, or for more than 4 days for pain relief, or if the symptoms worsen the patient is advised to consult a doctor. Page 2 of 16 ADULTS AND ADOLESCENTS ≥40 KG: Initial dose, 200 mg or 400 mg ibuprofen. If necessary additional doses of 200 mg or 400 mg of ibuprofen can be taken. The respective dosing interval should be chosen in line with the observed symptoms and the maximum recommended daily dose. It should not be below 6 hours for the 400 mg dose and not below Read the complete document