Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Abbott Laboratories Ireland Ltd
IBUPROFEN
600 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Patient Information Leaflet BRUFEN 600 MG FILM-COATED TABLETS Ibuprofen IMPORTANT INFORMATION Please read this leaflet carefully before you start taking your medicine. Keep this leaflet as you may need to read it again. This leaflet provides a summary of the information currently available on Brufen 600mg Tablets. For further information or advice ask your doctor or pharmacist. This medicine is for you and should never be given to anyone else, even if they appear to have the same symptoms as you. Tell your doctor or pharmacist if you experience any side effects. In this leaflet: 1. What are Brufen 600mg Tablets and what are they used for? 2. What should you know before taking Brufen 600mg Tablets? 3. How should you take Brufen 600mg Tablets? 4. Possible side effects of Brufen 600mg Tablets 5. How should you store Brufen 600mg Tablets? 6. Further information about Brufen 600mg Tablets 1. WHAT ARE BRUFEN 600MG TABLETS AND WHAT ARE THEY USED FOR? Brufen 600mg Tablets belong to a group of medicines called anti-inflammatory pain killers. They can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendonitis, tenosynovitis, lower back pain, sprains and strains. Brufen 600mg Tablets can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine. The active ingredient in Brufen 600mg Tablets is ibuprofen and each tablet contains 600mg of ibuprofen. 2. WHAT SHOULD YOU KNOW BEFORE TAKING BRUFEN 600MG TABLETS? DO NOT TAKE BRUFEN 600MG TABLETS IF; • you are sensitive (allergic) to any of the ingredients in the tablets. These are listed in Section 6 • you previously experience Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brufen 600mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg of ibuprofen. Excipients: each tablet contains 40.0mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). A white, pillow-shaped, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brufen is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments. Brufen is also used as an analgesic in the relief of mild to moderate pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4, _special warnings and special precautions for use_). Adults: The recommended dosage of Brufen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. The total daily dose should not exceed 2400 mg. Children: The recommended dose of Brufen is 20-30 mg/kg bodyweight daily in divided doses but in juvenile rheumatoid arthritis, the daily dosage may be increased to 40 mg/kg bodyweight in severe cases. In children weighing less than 30 kg, the total daily dose of Brufen should not exceed 500 mg (the liquid formulation should be used). Elderly: No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case, dosage should be assessed indivi Prečítajte si celý dokument