BRUFEN Film Coated Tablet 400 Milligram
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Karakteristik produk
(SPC)
19-04-2024
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Bahan aktif:
IBUPROFEN
Tersedia dari:
Abbott Laboratories Ireland Ltd
Dosis:
400 Milligram
Bentuk farmasi:
Film Coated Tablet
Tanggal Otorisasi:
2004-10-19
Karakteristik produk
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brufen 400mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Brufen Tablet contains 400 mg of Ibuprofen.
Excipients: each tablet contains 26.7mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film – coated Tablet.
A white, pillow-shaped, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brufen is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular
syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and
ligaments.
Brufen is also used as an analgesic in the relief of mild to moderate pain.
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 special precautions for use_).
Adults: The recommended dosage of Brufen is 1200-1800 mg daily in divided doses. Some patients can be maintained
on 600-1200 mg daily. The total daily dose should not exceed 2400 mg.
Children: The recommended dose of Brufen is 20 mg/kg bodyweight daily in divided doses but in juvenile rheumatoid
arthritis, the daily dosage may be increased to 40 mg/kg bodyweight in severe cases.
In children weighing less than 30 kg, the total daily dose of Brufen should not exceed 500 mg (the liquid formulation
should be used).
Elderly: No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired,
in which case, dosage
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