Source: Health Products Regulatory Authority (IE) Revision Year: 2024 Publisher: Bayer Limited, 1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co Dublin, A94 H2K7, Ireland
The symptomatic relief of influenza, feverishness, feverish colds, and of lumbago, sciatica, fibrositis, rheumatic pains, muscular aches and pains.
The relief of mild to moderate pain including headache, migraine, toothache, period pains, sore throat, neuralgia, aches and pains.
2 tablets in half a glass of water every 4 hours as required. Do not exceed 13 tablets in 24 hours unless directed by a doctor. Aspirin must not be taken for longer than 3-5 days without consulting your doctor. If symptoms persist consult your doctor. Medicines should not be taken in pregnancy without consulting your doctor.
As for adults.
Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk.
In case of accidental administration or use in children, see section "Special warning and precautions for use".
Oral.
Tablets must be dissolved in water. The tablets should preferably be taken after meals.
Salicylate toxicity (>100 mg/kg/day over 2 days may produce toxicity) may result from chronic, therapeutically acquired, intoxication, and from, potentially life-threatening, acute intoxications (overdose), ranging from accidental ingestions in children to incidental intoxications.
Chronic salicylate poisoning can be insidious as signs and symptoms are non-specific. Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated use of large doses. Symptoms include dizziness, vertigo, tinnitus, deafness, sweating, nausea and vomiting, headache, and confusion, and may be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations of 150 to 300 micrograms/mL. More serious adverse events occur at concentrations above 300 micrograms/mL.
The principle feature of acute intoxication is severe disturbance of the acid-base balance, which may vary with age and severity of intoxication. The most common presentation for a child is metabolic acidosis. The severity of poisoning cannot be estimated from plasma concentration alone. Absorption of acetylsalicylic acid can be delayed due to reduced gastric emptying, formation of concretions in the stomach, or as a result of ingestion of enteric-coated preparations. Management of acetylsalicylic acid intoxication is determined by its extent, stage and clinical symptoms and according standard poisoning management techniques. Predominant measures should be the accelerated excretion of the drug as well as the restoration of the electrolyte and acid-base metabolism.
Due to the complex pathophysiologic effects of salicylate poisoning, signs and symptoms/investigational findings may include:
| SIGNS AND SYMPTOMS | INVESTIGATIONAL FINDINGS | THERAPEUTIC MEASURES |
| Mild to moderate intoxication | Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis | |
| Tachypnoea, hyperventilation, respiratory alkalosis | Alkalaemia, alkaluria | Fluid and electrolyte management |
| Diaphoresis | ||
| Nausea, vomiting | ||
| Moderate to severe intoxication | Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, haemodialysis in severe cases | |
| Respiratory alkalosis with compensatory metabolic acidosis | Acidaemia, aciduria | Fluid and electrolyte management |
| Hyperpyrexia | Fluid and electrolyte management | |
| Respiratory: ranging from hyperventilation, non-cardiogenic pulmonary oedema to respiratory arrest, asphyxation | ||
| Cardiovascular: ranging from dysarrhythmias, hypotension to cardiovascular a rrest | e.g. Blood pressure, ECG alteration | |
| Fluid and electrolyte loss: dehydration, oliguria to renal failure | e.g. Hypokalaemia, hypernatraemia, hyponatraemia, altered renal function | Fluid and electrolyte management |
| Impaired glucose metabolism, ketosis | Hyperglycaemia, hypoglycaemia (especially in children) Increased ketone levels | |
| Tinnitus, deafness | ||
| Gastrointestinal: GI bleeding | ||
| Haematologic: ranging from platelet inhibition to coagulopathy | e.g. PT prolongation, hypoprothrombina | |
| Neurologic: Toxic encephalopathy and CNS depression with manifestations ranging from lethargy, confusion to coma and seizures |
3 years.
Do not store above 25°C.
Store in the original package to protect from moisture.
Tablets are packed in aluminium foil/polythene blister strips which are packed into cardboard cartons to contain 18 or 30 tablets.
Not all pack sizes may be marketed.
No special requirements.
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