Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Reckitt Benekiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
For the relief of mild to moderate pain in headaches, including migraine headaches, toothache, neuralgia, sciatica, period pains and sore throats.
Reduction of temperature in feverishness, influenza and colds.
Reduction of inflammation in rheumatism and lumbago.
Oral administration after dissolution in water.
Adults (including children 16 years and over): Two to three tablets every 4 hours. Do not exceed 13 tablets in 24 hours.
Do not give to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).
There is no indication that dosage need be modified in the elderly.
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
Three years.
Store below 25°C in a dry place.
Cardboard carton containing tablets in strips of aluminium foil with vinyl heat seal.
Pack sizes: 6, 8, 12, 16, 24, 32, 48, 96 and 500 tablets. (Those pack sizes printed in bold are currently sold).
Oral administration after dissolution in water.
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