国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Abbott Laboratories Ireland Ltd
IBUPROFEN
600 Milligram
Granules Effervescent
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER BRUFEN 600 MG EFFERVESCENT GRANULES 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. 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 The full name of your medicine is BRUFEN 600 MG EFFERVESCENT GRANULES. In this leaflet the shorter name Brufen is used. 1. WHAT BRUFEN IS AND WHAT IT IS USED FOR Brufen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ or NSAIDs. Each sachet of medicine contains 600 mg ibuprofen. This medicine is used: to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains. to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN DO NOT TAKE BRUFEN IF: you are allergic to ibuprofen or any 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brufen 600mg Effervescent Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet contains 600 mg ibuprofen. Excipients with known effect: Sodium (150 mg/sachet) Sucrose (1,000 mg/sachet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent granules Brufen Effervescent Granules are white granules with an orange flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brufen Effervescent Granules are indicated for their analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions Brufen Effervescent Granules are indicated in peri-articular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low back pain; Brufen Effervescent Granules can also be used in soft-tissue injuries such as sprains and strains. Brufen Effervescent Granules are also indicated for their analgesic effect in the relief of moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache including migraine headache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). ADULTS: The recommended dosage of ibuprofen is 1,200-1,800 mg daily in divided doses. Some patients can be maintained on 600-1,200 mg daily. Total daily dose should not exceed 2,400 mg. PAEDIATRIC POPULATION: Brufen 600 mg Effervescent Granules are not suitable for use in children and adolescents below the age of 18 years. ELDERLY: The elderly are at increased risk of se 阅读完整的文件