国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Ibuprofen
Mylan IRE Healthcare Limited
M01AE; M01AE01
Ibuprofen
100 mg/5ml
Oral suspension
Oral use
200ml bottle
Product subject to prescription which may be renewed (B)
AbbVie
Propionic acid derivatives
Propionic acid derivatives; ibuprofen
It is indicated in the management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s Disease) and osteoarthritis, fibrositis, ankylosing and other muscular syndromes such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments. As an analgesic in the relief of mild to moderate pain. For the treatment of pyrexia in children
Marketed
1981-03-02
Package leaflet: Information for the user BRUFEN ® PAEDIATRIC 100MG/5ML ORAL SUSPENSION 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 further questions ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it 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, pharmacist or nurse. 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 The full name of your medicine is BRUFEN PAEDIATRIC ORAL SUSPENSION. In this leaflet, the shorter name Brufen is used. 1. WHAT IS BRUFEN AND WHAT IT IS USED FOR Brufen belongs to a group of medicines called anti-inflammatory pain killers. The active ingredient in Brufen is ibuprofen and each 5ml spoonful contains 100mg of ibuprofen. It can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendonitis, tenosynovitis, lower back pain, sprains and strains. Brufen can also be used to lower temperature and to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine and to reduce fever in children. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN DO NOT TAKE BRUFEN • if you are allergic to ibuprofen or any of the ingredients of this medicine(listed in section 6) • if you previously experienced stomach bleeding or perforation after taking ibuprofen or other non-steroidal anti-inflammatory drugs (NS 阅读完整的文件
Health Products Regulatory Authority 11 November 2022 CRN00D753 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brufen Paediatric 100mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 100mg ibuprofen Excipients with known effect: Each 5ml also contains: 5mg methyl parahydroxybenzoate (E218) 2.5mg propyl parahydroxybenzoate (E216) 500mg sorbitol solution non-crystallising (E420) 3.3 g sucrose 0.5mg sunset yellow FC edicol (E110) 12.5mg sodium benzoate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. Orange-coloured and flavoured syrup-like suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brufen Paediatric Oral Suspension is indicated in the management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s Disease) and osteoarthritis, fibrositis, ankylosing and other muscular syndromes such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments. As an analgesic in the relief of mild to moderate pain. Ibuprofen is indicated for the treatment of pyrexia in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). ADULTS AND ADOLESCENTS OLDER THAN 12 YEARS (≥ 40KG) The recommended dosage of Brufen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. Total daily dose should not exceed 2400 mg. PAEDIATRIC POPULATION The recommended dose of Brufen is 20-30 mg per kg of bodyweight daily in divided doses. This can be achieved by using the suspension as follows: Age/weight Frequency Single dose 3-6 months (~5-7kg) Up to 3 times a day 2.5ml (50mg) 6-12 months (~7-10kg) 3 times a day 2.5ml (50mg) 1 to 2 years 3 to 4 times a day 2.5ml Health Products Regulatory Authority 11 November 2022 CRN00D753 Page 2 of 12 (~10-14.5kg) (50mg) 3 to 7 years (~14.5-25kg) 阅读完整的文件