Country: Malta
Language: English
Source: Medicines Authority
IBUPROFEN
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
M01AE01
IBUPROFEN 600 mg
FILM-COATED TABLET
IBUPROFEN 600 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2016-07-14
PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 600 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Ibuprofen tablets is and what it is used for 2. What you need to know before you take Ibuprofen tablets 3. How to take Ibuprofen tablets 4. Possible side effects 5. How to store Ibuprofen tablets 6. Contents of the pack and other information 1. WHAT IBUPROFEN TABLETS IS AND WHAT IT IS USED FOR Ibuprofen tablets belong to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Ibuprofen tablets reduces fever, relieves pain and has an anti-inflammatory effect. They can be used in symptomatic treatment of pain and inflammation in rheumatoid arthritis (including systemic Juvenile Idiopathic Arthritis [sJIA]), osteoarthritis, seronegative arthropathies and in painful swelling and inflammation after soft tissue injuries. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS DO NOT TAKE IBUPROFEN TABLETS: • if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6). • if you are in the last three months of pregnancy. • if you have an increased tendenc Y to bleed . • if you have severe liver and kidney disease. • if you have severe heart failure or coronary heart disease. • if you have a stomach ulcer, duodenal ulcer, or if you have had a stomach ulcer or duodenal ulcer previously when treated with ibuprofen or a similar product. • if you have experienced allerg Read the complete document
Page 1 of 14 S UMMARY OF P RODUCT C HARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Ibuprofen 600 mg film-coated tablets 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each film-coated tablet contains 600 mg ibuprofen Excipient with known effect: each tablet contains 70 mg lactose. For the full list of excipients, see section 6.1. 3. P HARMACEUTICAL F ORM Film-coated tablet Ibuprofen 600 mg film-coated tablets: pink coloured, oblong shape, approximately 19 mm in length, 8 mm in width, biconvex, film coated tablets debossed with ‘DL’ separated by break line on one side and plain on other side. The score line is not intended for breaking the tablet. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain and inflammation in rheumatoid arthritis (including systemic Juvenile Idiopathic Arthritis [sJIA]), osteoarthritis, seronegative arthropathies and in painful swelling and inflammation after soft tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. In long-term treatment a low maintenance dose should be the aim. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Adults and adolescents (12 years and older, >40kg): _ _Rheumatic diseases_ One 600 mg tablet three times daily. An interval of at least 4-6 hours should be allowed between doses. Some patients can be maintained on 600-1200mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400mg in divided doses. This tablet cannot be halved and in some instances a different strength or formulation of ibuprofen must be used. _Juvenile Rheumatoid Arthritis _ Adolescents over 12 years of age (>40 kg): The recommended dose is 20-30mg/kg body weight daily Read the complete document