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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 oral administration.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control
symptoms (_see section 4.4, Special warnings and precautions for use_).
_Adults_: Two tablets taken as a single dose, preferably in the early evening well before retiring to bed. The tablets
should be swallowed whole with plenty of fluid. In severe or acute conditions, total daily dosage may be increased to
three tablets in two divided doses.
_Children_: Not recommended for use in children under 12 years.
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