Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
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.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
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.
Brufen 400mg film-coated tablets are not suitable for use in children under 12 years.
No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case, dosage should be assessed individually.
NSAIDs (Nonsteroidal anti-inflammatories) should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed (see section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.
No dose reduction is required in patients with mild to moderate impairment to renal function (patients with severe renal insufficiency, see section 4.3).
No dose reduction is required in patients with mild to moderate impairment to hepatic function (patients with severe hepatic dysfunction, see section 4.3).
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.
Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults. However, supportive care may be needed in some cases. Children have been observed to manifest signs and symptoms of toxicity after ingestion of 400 mg/kg or greater.
Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours. The most frequently reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsion, and loss of consciousness. Nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea and depression of the CNS and respiratory system have also been rarely reported. Cardiovascular toxicity, including hypotension, bradycardia and tachycardia, has been reported. In cases of significant overdose, renal failure and liver damage are possible.
In serious poisoning, metabolic acidosis may occur.
Large overdoses are generally well tolerated when no other drugs are being taken.
There is no specific antidote for ibuprofen overdose. Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. If necessary, serum electrolyte balance should be corrected. For the most current information, contact the local poison control centre.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Blister pack comprising of transparent polyvinyl chloride (PVC) or polyvinyl chloride/polyvinylidene (PVC/PVDC) film with aluminium foil backing.
Pack size 60 tablets.
No special requirements.
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