PARACETAMOL

5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

5 ml dose • Do not give to babies less than 2 months of age • Leave at least 4 hours between doses • Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.

5ml) 4 times 4 – 6 years 10ml (5ml + 5ml) 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 It is important to shake the bottle for at least 10 seconds before use.

Very rare cases of serious skin reactions have been reported. Very rarely hypersensitivity and anaphylatic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdose with the drug. Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.

A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported 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.

Care is advised in the administration of paracetamol to patients with severe renal impairment 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 to babies less than 2 months of age. • For infants 2-3 months do not give more than 2 doses This is to ensure that fever that may be due to a serious infection is quickly diagnosed.

If your child is still feverish after two doses, talk to your doctor or pharmacist. • 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.

• If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist (leaflet). • 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 sight and reach of children • Talk to a doctor at once if your child takes too much of this medicine, even if they seem well (label). • Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.

This is because too much paracetamol can cause delayed, serious liver damage (leaflet). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Hypersensitivity to Paracetamol or any of the other constituents.