SOOTHEZE SIX PLUS 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 5mL spoonfuls (large end) up to 4 times a day.

Adults and children over 16 years:

Two - four 5mL spoonfuls (large end) up to 4 times a day.

In the elderly:

The rate and extent of paracetamol absorption is normal but plasma half- life is longer and paracetamol clearance is longer than in young adults.

Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylactic reactions 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.

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.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon. Papillary necrosis has been reported after prolonged administration. Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol: these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.

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.

Sootheze Six Plus Paracetamol Suspension should be used with caution in moderate to severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Sodium methyl para hydroxybenzoate (E219) and Sodium propyl para hydroxybenzoate (E217) may cause allergic reactions (possibly delayed).

, 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.

• Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor. • For oral use only. • 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 overfill the spoon. • Always use the spoon supplied with the pack. • As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product. • Store below 25°C. Store in the original package.

• Keep this medicine out of sight and reach of children. • Shake the bottle for at least 10 seconds before use • Talk to a doctor at once if your child takes too much of this medicine, even if they feel well The leaflet should contain the following statements: • 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. • If the child needs more doses than shown in the table, or if fever doesn’t go away, speak to your doctor as soon as possible. • Very rare cases of serious skin reactions have been reported.

Symptoms may include: o Skin reddening o Blisters o Rash If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.

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