Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
For fast and effective symptomatic relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.
Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.
Symptomatic relief of influenza, feverishness, feverish colds.
The dose in adults, elderly and children aged 16 years and over, is one or two tablets in water. The dose may be repeated every four hours, as required, with a maximum of eight tablets in 24 hours. Aspirin must not be taken for longer than 3-5 days without consulting a doctor.
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 warnings and special precautions for use”.
Alka-Seltzer tablets must always be dissolved in a glass of water prior to oral administration. The tablets dissolve more quickly in warm 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 principal 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 to 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, hemodialysis 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, asphyxiation | ||
| Cardiovascular: ranging from dysarrhythmias, hypotension to cardiovascular arrest | e.g. Blood pressure, ECG alteration | |
| Fluid and electrolyte loss: dehydration, oliguria to renal failure | e.g. Hypokalaemia, hypernatremia, hyponatremia, 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, hypoprothrombinaemia | |
| Neurologic: Toxic encephalopathy and CNS depression with manifestations ranging from lethargy, confusion to coma and seizures |
Shelf-life of the product as packaged for sale is 3 years.
Do not store above 25°C.
Store in the original package to protect from moisture.
Aluminium foil pouches, each containing two tablets. Available in pack sizes of 10 or 20 tablets.
Primary packaging material: composite aluminium foil laminate consisting of 40g/m² paper, 14g/m² polyethylene and 25µm aluminium foil with 18g/m² surlyn heat-seal.
Not all pack sizes may be marketed.
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product: No special requirements.
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