PARACETAMOL

5 ml spoonful (small end) 4 times 10 – 12 years Two 5 ml spoonfuls (large end) 4 times • Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist • Do not give to children under the age of 6 years Children aged 12 - 16 years: Two – three 5 ml spoonfuls (large end) up to 4 times a day.

Adults and children over 16 years:

Two – four 5 ml spoonfuls (large end) up to 4 times a day. It is important to shake the bottle for at least 10 seconds before use.

Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to Paracetamol.

With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported. 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.

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. 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.

The label should contain the following statements: • Contains paracetamol. • Do not give this medicine with any other paracetamol-containing product. • For oral use only. • Never give more medicine than shown in the table. • Do not overfill the spoon.

• Always use the spoon supplied with the pack. • Do not give more than 4 doses in any 24 hour period. • Leave at least 4 hours between doses. • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product. • Do not store above 25°C. Store in the original package. • Keep all medicines out of the reach and sight of children.

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label). • Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage (leaflet).

Hypersensitivity to Paracetamol or any of the other constituents.