Each suppository contains Paracetamol 60, 125 or 250 mg.

Suppositories.

For the treatment of mild to moderate pain and pyrexia in children: up to the age of 1 year - 60 mg suppositories aged 1-5 years - 125 mg suppositories aged 6-12 years - 250 mg suppositories Alvedon suppositories may be especially useful in patients unable to take oral forms of paracetamol, e.g. post-operatively or with nausea and vomiting.

60 mg suppositories

Children 3 months to 1 year, 1-2 suppositories:

The dosage should be based on age and weight i.e.

3 months (5 kg) - 60mg (1 suppository)

1 year (10 kg) - 120mg (2 suppositories)

Infants under 3 months:

One suppository (60 mg) is suitable for babies who develop a fever following immunisation at 2 months. Otherwise only use in babies aged less than 3 months on a doctor's advice.

125 mg suppositories

Children 1-5 years, 1-2 suppositories:

The dosage should be based on age and weight i.e.

1 year (10 Kg) - 125mg (1 suppository)

5 years (20 Kg) -250mg (2 suppositories)

250 mg suppositories

Children 6 to 12 years 1-2 suppositories:

The dosage should be based on age and weight i.e.

6 years (20 Kg) - 250mg (1 suppository)

12 years (40 Kg) - 500mg (2 suppositories)

These doses may be repeated up to a maximum of 4 times in 24 hours. The dose should not be repeated more frequently than every 4 hours. The recommended dose should not be exceeded. Higher doses do not produce any increase in analgesic effect. Only whole suppositories should be administered – do not break suppository before administration.

60 mg suppositories

Children 3 months to 1 year, 1-2 suppositories:

The dosage should be based on age and weight i.e.

3 months (5 kg) - 60mg (1 suppository)

1 year (10 kg) - 120mg (2 suppositories)

Infants under 3 months:

One suppository (60 mg) is suitable for babies who develop a fever following immunisation at 2 months. Otherwise only use in babies aged less than 3 months on a doctor's advice.

125 mg suppositories

Children 1-5 years, 1-2 suppositories:

The dosage should be based on age and weight i.e.

1 year (10 Kg) - 125mg (1 suppository)

5 years (20 Kg) -250mg (2 suppositories)

250 mg suppositories

Children 6 to 12 years 1-2 suppositories:

The dosage should be based on age and weight i.e.

6 years (20 Kg) - 250mg (1 suppository)

12 years (40 Kg) - 500mg (2 suppositories)

These doses may be repeated up to a maximum of 4 times in 24 hours. The dose should not be repeated more frequently than every 4 hours. The recommended dose should not be exceeded. Higher doses do not produce any increase in analgesic effect. Only whole suppositories should be administered – do not break suppository before administration.

Hypersensitivity to paracetamol or hard fat

Alvedon Suppositories should not be combined with other analgesic medications that contain paracetamol. Paracetamol should be given with care to patients with impaired kidney or liver function.

Label and Leaflet will state the following warnings:

Label: “Immediate medical advice should be sought in the event of an overdose, even if the child seems well”.

“Do not give with any other Paracetamol-containing products.”

Leaflet: “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.”

Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates and other anticonvulsants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.

The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. The effect appears to increase as the dose of paracetamol is increased, but can occur with doses as low as 1.5 – 2 g paracetamol per day for at least 5 – 7 days. Occasional doses have no significant effect.

Enzyme-inducing medicines, such as some antiepileptic drugs (phenytoin, phenobarbital, carbamazepine) have been shown in pharmacokinetic studies to reduce the plasma AUC of paracetamol to approx. 60 %. Other substances with enzyme-inducing properties, e.g. rifampicin and St. John's wort (hypericum) are also suspected of causing lowered concentrations of paracetamol. In addition, the risk of liver damage during treatment with maximum recommended doses of paracetamol will be higher in patients being treated with enzyme-inducing agents.

Side-effects at therapeutic doses are rare.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Hepatic necrosis may occur after overdosage.

AstraZeneca UK Limited

(P- pharmacy)

04 June 2009