BRUFEN®

# BRUFEN® Brand Dossier

What it is

BRUFEN® is an ibuprofen-containing medicine registered with the Australian Register of Therapeutic Goods.

Approved indications

BRUFEN® is indicated for the temporary relief of acute (short term) pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu.

Dosing overview

For adults under 65 and children from 12 years, the recommended dose is 1 tablet every 8 hours as necessary, with a maximum of 3 tablets in 24 hours. BRUFEN® should not be used for more than 3 days at a time (or not more than 2 days at a time for adolescents aged 12 to 17 years) unless on medical advice.

Key safety warnings

Gastrointestinal (GI) bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Observational studies have indicated that NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use, and patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk. Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome, Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), which can be life threatening or fatal, have been reported in association with the use of ibuprofen. Most of these reactions occurred within the first month. BRUFEN® can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection, and this has been observed in bacterial community acquired pneumonia and bacterial complications to varicella.

Contraindications

BRUFEN® is contraindicated in patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product, and in patients with a history of hypersensitivity reactions (e.g. bronchospasm, angioedema, rhinitis or urticaria) associated with aspirin or other anti-inflammatory drugs or analgesic drugs. It is contraindicated in patients with a history of, or an existing gastrointestinal ulceration/perforation or bleed, or other stomach disorder. BRUFEN® is contraindicated in patients with impaired hepatic function, impaired renal function or heart failure, in patients with asthma, in patients with conditions that predispose to renal failure, in concomitant use with other NSAIDs or aspirin, in patients aged 65 years and over, and in children under 12 years. BRUFEN® is contraindicated for use during pregnancy.

Regulatory history

BRUFEN® ibuprofen 400 mg tablet was first listed on the Australian Register of Therapeutic Goods on 12 November 2001. A variant containing ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg (BRUFEN PLUS) was registered on 28 March 2018. BRUFEN® PAIN, a 400 mg film-coated tablet formulation, was registered on 3 January 2023.