BRUFEN RETARD
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
IBUPROFEN
Available from:
Abbott Laboratories Ireland Ltd
Dosage:
800 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2004-10-19
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Brufen Retard 800mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg of Ibuprofen.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
A white, pillow-shaped, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Brufen Retard is indicated for its analgesic and anti-inflammatory effect in the treatment of rheumatoid arthritis,
(including juvenile rheumatoid arthritis or Stills' disease) ankylosing spondylitis, osteoarthritis and other non
rheumatoid (seronegative) arthropathies.
In the treatment of nonarticular rheumatic conditions, Brufen Retard is indicated in the periarticular conditions such as
frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low back pain; Brufen Retard can also be used in
soft-tissue injuries such as sprains and strains.
Brufen Retard is also indicated for its analgesic effect in the relief of mild to moderate pain such as
dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including migraine
headache.
Brufen Retard is not suitable for use in children.
4.2 Posology and method of administration
For or
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