Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
As an anti-inflammatory, analgesic and antipyretic for short term management of mild to moderate pain such as is associated with headache, dental pain, fever, period pain, muscular strain, backache and for the management of the symptoms of head colds and influenza.
For the symptomatic treatment of osteoarthritis.
For oral administration and short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
The patients should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Adults and children over 12 years: Initial dose is 400mg and subsequently if necessary, 200 to 400mg every four hours with a maximum of 1200mg in a 24 hour period.
If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Not suitable for children under 12 years of age.
NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events.
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half life in overdose is 1.5-3 hours.
Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as vertigo, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning hyperkalaemia and metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur. Exacerbation of asthma is possible in asthmatics.
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal or gastric emptying if the patient presents within 1 hour of ingestion of a potentially toxic amount. If ibuprofen has already been absorbed, alkaline substances may be administered to promote the excretion of acid ibuprofen in the urine. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
3 years.
This medicinal product does not require any special storage precautions.
A push through laminate blister tray consisting of opaque, white 250 micron PVC/40 gsm PVdC heat-sealed to 20 micron aluminium foil and containing 4, 6 or 12 tablets. The blister trays are packed into cardboard cartons, containing 4, 6, 10, 12, 14, 18, 20, 22, 24, 30, 36, 40 or 48 tablets.
A push through laminate blister tray consisting of opaque, white 250 micron PVC heat-sealed to 20 micron aluminium foil and containing 4, 6 or 12 tablets.
The blister trays are packed into cardboard cartons, containing 4, 6, 10, 12, 14, 18, 20, 22, 24, 30, 36, 40 or 48 tablets.
An HDPE bottle fitted with an HDPE cap that is internally wadded with expanded polyethylene, containing 12, 14, 18, 20, 22, 24, 30, 36, 40 or 48 tablets.
Not all pack sizes or types may be marketed.
No special requirements.
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