Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath., Ireland
Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.
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.
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. Occasional doses have no significant effect.
Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates and other anticonvulsants, may increase the hepatotoxicity of paracetamol, particularly after over-dosage. 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.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4).
There are no data on the effects of paracetamol suppositories on human fertility.
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
Not relevant.
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.
Hepatic necrosis may occur after paracetamol overdose (see Section 4.9).
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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.
Not applicable.
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