Država: Malta
Jezik: angleščina
Source: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
M01AE01
IBUPROFEN 400 mg
FILM-COATED TABLET
IBUPROFEN 400 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2019-04-10
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER BRUFEN 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 Brufen is and what it is used for 2. What you need to know before you take Brufen 3. How to take Brufen 4. Possible side effects 5. How to store Brufen 6. Contents of the pack and other information 1. WHAT BRUFEN IS AND WHAT IT IS USED FOR Brufen contains the active substance ibuprofen and belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Brufen reduces fever, relieves pain and has an anti- inflammatory effect. Brufen is used for pain of mild to moderate intensity, fever, rheumatic conditions (rheumatic arthritis, arthrosis) and menstrual pain, by adults and adolescents (12-18 years old, 40 kg and above). Children 6-12 years (over 20 kg) can be treated with Brufen 200 mg tablets during acute painful conditions and fever associated with common cold. The effect of Brufen is achieved usually within 30 minutes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN DO NOT TAKE BRUFEN: - if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) - if you have stomach ulcer or duodenal ulcer or have had recurrent ulcer or bleeding in the stomach or intestine - if you have severe liver or kidney disease - if you have severe heart failure - if you have an increased tendency to bleed - if you previously have had bleeding or perforation in your stomach or intestine when treated with Brufe Preberite celoten dokument
Page 1 of 13 S UMMARY OF P RODUCT C HARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Brufen 400 mg film-coated tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION One tablet contains 400 mg ibuprofen Excipients with known effect: lactose monohydrate 26 mg For the full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Film-coated tablet White, oval tablet 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis, arthrosis. Dysmenorrhoea with no organic cause. Pain of mild to moderate intensity. Fever in adults and adolescents. Children 6–12 years (>20 kg): Acute pain and fever associated with the common cold. The indications for children apply only to the 200 mg tablets. 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). _Adults and adolescents older than 12 years (≥ 40 kg): _ _Rheumatic diseases_ One 400 mg tablet three times daily or one 600 mg tablet three times daily. An interval of at least 4-6 hours should be allowed between doses. For more rapid relief of the morning stiffness, the first dose may be given on a fasting stomach. The dose should be reduced in the event of renal insufficiency. The maximum dose in a 24-hour period is 2,400 mg. _ _ _Dysmenorrhoea_ One 400 mg tablet one to three times daily, as needed. An interval of at least 4-6 hours should be allowed between doses. Treatment is started at the first sign of menstruation problems. _ _ Page 2 of 13 _Pain of mild to moderate intensity:_ One 200 mg tablet or one 400 mg tablet in a single dose or three to four times daily. An interval of at least 4-6 hours should be allowed between doses. Single doses exceeding 400 mg have not been Preberite celoten dokument