Source: Health Products Regulatory Authority (IE) Revision Year: 2024 Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Brufen is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, Brufen is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low back pain; Brufen can also be used in soft-tissue injuries such as sprains and strains.
Brufen 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 the symptomatic relief of headache including migraine headache.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control 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. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided doses.
The daily dosage of Brufen is 20 mg/kg of body weight in divided doses.
For young children, more suitable formulations are available.
In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.
Not recommended for children weighing less than 7 kg.
The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually.
Patients with mild to moderate renal impairment, (see section 4.4 – Special warnings and precautions for use) and patients with severe renal insufficiency (see section 4.3 – Contraindications)
For patients with mild to moderate hepatic impairment (see section 4.4 Special warnings and precautions for use) and patients with severe hepatic dysfunction (see section 4.3 – Contraindications).
For oral administration. It is recommended that patients with sensitive stomachs take Brufen with food. If taken shortly after eating, the onset of action of Brufen may be delayed. To be taken preferably with or after food, 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.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
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, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system have also been rarely reported. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.. Disorientation, excitation, fainting and cardiovascular toxicity, including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Large overdoses are generally well tolerated when no other drugs are being taken.
Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness (see section 4.4 and section 4.8).
Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.
PVC or PVC/PVDC blister packs: 36 months.
PVC or PVC/PVDC blister packs: Do not store above 25°C, store in the original package.
Blister pack comprising of transparent polyvinyl chloride (PVC) with aluminium foil backing – pack size 60 tablets or 100 tablets.
Blister pack comprising of transparent polyvinyl chloride (PVC) film coated on one face with polyvinylidene chloride (PVDC) with aluminium foil backing – pack size 60 or 100 tablets.
Not all pack sizes are marketed.
None.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
