Country: Malta
Language: English
Source: Medicines Authority
IBUPROFEN
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
M01AE01
IBUPROFEN 600 mg
FILM-COATED TABLET
IBUPROFEN 600 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2013-03-01
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN FAIR-MED600 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 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 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-MEDbelongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines provide relief by changing how the body responds to pain and swelling. Ibuprofen FAIR-MED is used for the symptomatic treatment of pain and inflammation in arthritic diseases, (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful swelling and inflammation after soft tissue injuries. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN FAIR-MED DO NOT TAKE IBUPROFEN FAIR-MED - if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) - if you have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs) - if you have (or have had two or more episodes of ) a stomach ulcer or bleeding of the stomach - if you have a history of gastro-i Read the complete document
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen FAIR-MED 600 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg ibuprofen Ibuprofen FAIR-MED contains 42mg lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White coloured, film coated pillow shaped tablets de-bossed with ‘237’ on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful swelling and inflammation after soft tissue injuries. 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). The ibuprofen dose depends on the patient’s age and body weight. The recommended dose range for adults lies between 1200 mg and 2400 mg ibuprofen per day. The maximum single daily dose for adults should not exceed 800 mg of ibuprofen. AGE SINGLE DOSE IN MG MAXIMUM DAILY DOSE IN MG Adults 600 mg ibuprofen 1200-2400 mg ibuprofen _RHEUMATIC DISEASES _ _Adults:_ Page 2 of 15 The usual dose is 600 mg 3 times a day. Maintenance doses of 600 mg-1200 mg daily may be effective in some patients. In acute and severe conditions the dose may be increased to a maximum of 2400 mg in divided doses. In rheumatic diseases the use of Ibuprofen FAIR-MED can be required for a longer period. The treating physician decides on the duration of treatment. _ _ SPECIAL PATIENT GROUPS Paediatric population: Ibuprofen FAIR-MED is contraindicated in children and adolescents. _ _ _ELDERLY _ NSAIDs should be used with particular caution in elderly pa Read the complete document