Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Ibuprofen
Accord Healthcare Ireland Ltd.
M01AE; M01AE01
Ibuprofen
200 milligram(s)
Film-coated tablet
Propionic acid derivatives; ibuprofen
Not marketed
2016-10-07
IE/H/0755/001-003/IB/018, ver 03, Sep 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 200 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). In adults and children over 6 years (>20 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 previously have had bleeding or perforation in your stomach or intestine when treated with Ibuprofen tablets or a similar product (other NSAIDs). • 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 pr Lire le document complet
Health Products Regulatory Authority 27 October 2023 CRN00DSJD Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen Excipient with known effect: each tablet contains 23 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Ibuprofen 200 mg film-coated tablets: pink coloured, round, approximately 10 mm in diameter, biconvex film coated tablets debossed with ‘DJ’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and children over 6 years (>20 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. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Rheumatic diseases_ - initial treatment of 4x200 mg tablets, three times daily, i.e. 2400 mg per day - maintenance treatment : 2x200 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. If a high daily dose is required a different strength of ibuprofen tablet may be more appropriate. _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 30 kg, Lire le document complet