PARACETAMOL

Posology Paediatric Population Dosage should be based on the child’s weight, with a recommended dosage of 15mg/kg per administration. Ages presented below are provided as an accompanying guide only. 3 – 12 months (5kg): One suppository Method of administration For rectal use only.

This dose 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. The product should not be used for more than 3 days, except on the advice of a doctor.

Higher doses do not produce any increase in analgesic effect. Only whole suppositories should be administered – do not break the suppository before administration. Hepatic / renal dysfunction Caution should be exercised when administering the product to patients with severe hepatic or renal impairment.

Adverse drug reactions are rare. MedDRA System Organ Class (SOC) Common ≥1/100 to <1/10 Uncommon >1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Immune system disorders Allergic reaction Gastrointestinal disorders Redness or soreness of the rectal mucous membrane Hepatobiliary disorders Liver damage Skin and subcutaneous tissue disorders Exanthema, urticaria, angioedema Very rare cases of serious skin reactions have been reported.

There have been reports of blood dyscrasias including thromocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. 9).

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 suppositories should not be combined with other analgesic medications that contain paracetamol. Paracetamol suppositories should be administered with care to patients with impaired kidney or liver function. The hazards of overdose are greater in those with non-cirrhotic liver disease.

Label and leaflet should state the following warnings:

Label Do not exceed the stated dose. If symptoms persist consult your doctor. Keep out of the reach and sight of children. Leave at least 4 hours between doses. Immediate medical advice should be sought in the case of an overdose, even if the child seems well.

Do not give with 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. g. chronic alcoholism), as well as those using maximum daily doses of paracetamol.

Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

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