| Customization: | Available |
|---|---|
| Application: | Surgery |
| Usage Mode: | For external use |
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For the treatment of mild to moderate pain and fever. Paraserts/Paracetamol Suppositories may be especially useful in patients unable to take oral forms of paracetamol, e.g. post-operatively or with nausea and vomiting.
Method of administration: rectal
Children:
1 year - 5 years: 1 -2 suppositories every 4 to 6 hours.
Dosages should be based on the child's age and weight i.e.:
1 year (10 kg) - 125 mg (1 suppository)
5 years (20 kg) - 250 mg (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. The product should not be used for more than 3 days, except on the advice of a doctor. Only whole suppositories should be administered - do not break the suppository before administration.
Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, soy or peanuts.
Undesirable effects
|
Common >1/100 |
Miscellaneous: |
Redness of the rectal mucous membranes |
|
Rare <1/1000 |
General: Skin: Liver: Genitourinary: |
Allergic reactions including skin rashes Exanthema, urticaria Liver damage Increase in creatinine (mostly secondary to hepatorenal syndrome) |
There have been some reports of blood dyscrasias including thrombocytopenia and argranulocytosis, with the use of paracetamol- containing products, but the causal relationship has not been established.
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.
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