PARACETAMOL is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of mild to moderate pain in patients who are unable to receive other paracetamol formulations such as lower strength liquid preparations, effervescent tablets or tablets.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration only. Posology Adults and adolescents over 16 years: 500mg (5ml) to 1000mg (10ml) up to three to four times a day, as required. Maximum daily dose should not exceed 4g (40ml). The dose should not be repeated more frequently than every four hours, and not more than four doses should be taken in any 24 hour period.
Method of administration A calibrated oral dosing syringe is supplied with this dosage form for accurate and convenient dose adjustment.
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.
Hepatobiliary disorders:
Hepatic dysfunction Gastrointestinal disorders: Cases of acute pancreatitis have been reported. Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage.
Haematological:
There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Metabolic and nutrition disorders:
High anion gap metabolic acidosis (frequency not known) Immune system: Allergic reactions occur occasionally.
Renal and urinary disorders:
Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.
Skin and subcutaneous tissue disorders:
Very rare cases of serious skin reactions. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed serious or irreversible liver damage. Do not exceed the recommended dose.
Keep out of the sight and reach of children.
Excipient warnings:
This product contains the following excipients: Parahydroxybenzoates (E216 and E218): these may cause allergic reactions (possibly delayed). Sunset yellow (E110): may cause allergic reactions.
1. Patients with severe hepatic dysfunction. Do not use this medicine in children and adolescents under 16 years.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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