VETOPAR

Posology:

Recommended Doses and Dosage Schedules Adults and young persons 16 years and over: The Optimal dosage range is 500mg (5ml) to 1000mg (10ml) up to three to four times a day, as required, to a maximum of 4 g paracetamol/ day (40 ml paracetamol oral solution).

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.

Elderly:

In older people, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults. Paediatric Population Do not use this medicine in children and adolescents under 16 years.

Method of administration For oral administration only. It is important to shake the bottle for at least 10 seconds well before use.

The information below lists reported adverse reactions, ranked using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse Events Blood and lymphatic system disorders Not known Blood dyscrasia including thrombocytopenia and agranulocytosis1 Immune system disorders Not known Anaphylactic shock, angioedema, anaphylactic reaction, urticaria, hypersensitivity, rash Metabolism and nutrition disorders Not known High anion gap metabolic acidosis4 Gastrointestinal disorders Not known Acute Pancreatitis2 Skin and subcutaneous disorders Very Rare Serious skin reactions Renal and urinary disorders Uncommon Nephropathy toxic3 1But these were not necessarily causally related to Paracetamol.

2Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage. 3Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.

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 severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non- cirrhotic) alcoholic liver disease. Do not take with any other paracetamol-containing products.

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. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

This is because too much paracetamol can cause delayed, serious 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: these may cause allergic reactions (possibly delayed). Propylene glycol: this medicine contains 1530 mg propylene glycol in each 5ml. Therefore, this medicine should be used with caution in pregnancy, breastfeeding, liver or kidney disease.

Glycerol: may cause headache, stomach upset and diarrhoea. 18 mmol) of sodium which is essentially ‘sodium free’.

1. Patients with severe hepatic dysfunction. Do not use this medicine in children and adolescents under 16 years.