GALPHARM SIX PLUS PAIN RELIEF

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.

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults It is important to shake the bottle for at least 10 seconds before use.

Adverse effects of Paracetamol are rare. Very rare cases of serious skin reactions have been reported. Very rarely hypersensitivity and anaphylactic 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.

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 the disease improved after paracetamol withdrawal.

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.

Paracetamol Oral Suspension 250mg/5ml should be used with caution in severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease Hydrogenated glucose syrup may have a laxative effect.

93g of hydrogenated glucose syrup. 3 kcal/g of hydrogenated glucose syrup. 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. Patients with rare hereditary problem of fructose intolerance should not take this medicine.