Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Ibuprofen
Accord Healthcare Limited
M01AE; M01AE01
Ibuprofen
400 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Propionic acid derivatives; ibuprofen
Authorised
2016-10-07
PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 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 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. In adults and children over 12 years (>40 kg): Short term treatment of fever and pain of mild to moderate intensity, including dysmenorrhea. Long term symptomatic treatment of pain and inflammation in chronic inflammatory rheumatic diseases. 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 tendency 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 allergic reactions (e.g. bre Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 400 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen Excipient with known effect: each tablet contains 47 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Ibuprofen 400 mg film-coated tablets: pink coloured, round, approximately 13 mm in diameter, biconvex film coated tablets debossed with ‘DK’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and children over 12 years (>40 kg): Short term treatment of fever and pain of mild to moderate intensity, including dysmenorrhea. Long term symptomatic treatment of pain and inflammation in chronic inflammatory rheumatic diseases. 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. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _Rheumatic diseases_ - initial treatment:2x400 mg tablets, three times daily, i.e. 2400 mg per day - maintenance treatment : 1x400 mg tablets, three to four times daily, i.e. 1200 to 1600 mg per day. An interval of at least 4-6 hours should be allowed between doses. The total daily dose must not exceed 2400mg in divided doses. Some patients can be maintained on 600 – 1200mg daily. _Juvenile Rheumatoid Arthritis_ For Juvenile Rheumatoid Arthritis, the recommended dose is 20mg-30mg/kg body weight daily in 3 to 4 divided doses up to a maximum of 40mg/kg body weight daily in severe cases. In children weighing less than 40 kg, use of a different strength or a liquid formulation of ibuprofen should be considered to aid accurate dosing. H E A L T H P R O D U C T S R E G U Lees het volledige document