Regulatory Information
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, SUGAR COATED
**Dosage & Administration** **Adults and adolescents older than 12 years (≥ 40kg)** The recommended initial dosage is 1200mg – 1800mg daily in divided doses. Some patients can be maintained on 600 – 1200mg daily. Generally, the maximum total daily dose of Brufen® should not exceed 2400mg in divided doses. **Paediatric population** The recommended dose of Brufen® is 20mg/kg of body weight daily in divided doses, but in juvenile rheumatoid arthritis the dosage may be increased to 40mg/kg body weight daily in divided doses, in severe cases. Not recommended for children weighing less than 7kg. **Elderly population** No special dosage modifications are required for elderly patients unless renal or hepatic function is impaired, in which case the dosage should be assessed individually. Caution should be taken with dosage in this group. **Method of administration** In order to achieve a faster onset of action, the dose may be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food. Take Brufen® tablets with plenty of fluid. Brufen® tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.
ORAL
Medical Information
**Indications** Brufen® is indicated for its anti-inflammatory and analgesic effect in the treatment of rheumatoid arthritis, osteoarthritis and allied conditions, non-articular rheumatism and soft tissue injuries. Brufen® is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental pain, post-operative pain and in the relief of migraine headache. Its antipyretic activity is effective in reducing fever.
**Contraindications** - Known hypersensitivity to the active substance or to any of the inactive ingredients. - Ibuprofen should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. - Severe heart failure (NYHA IV). - Severe liver failure. - Severe renal failure (glomerular filtration below 30mL/min). - Conditions involving a tendency to bleeding. - History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. - Active, or a history of, ulcerative colitis, Crohn’s disease, recurrent peptic ulceration or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). - During the third trimester of pregnancy.
M01AE01
ibuprofen
Manufacturer Information
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
THE BOOTS CO PLC
Active Ingredients
Documents
Package Inserts
Brufen Tablets 200mg PI.pdf
Approved: August 31, 2018