PANADOL BABY Oral suspension Ref.[108763] Active ingredients: Paracetamol

Contains paracetamol. Do not give with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose.

Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Caution in patients with glutathione depleted states such as sepsis; the use of paracetamol may increase the risk of metabolic acidosis.

Never give more medicine than shown in the table. Do not overfill the measuring device.

Always use the measuring device supplied with the pack. Do not give to babies less than 2 months of age.

For infants 2-3 months no more than 2 doses should be given. 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.

As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

Keep out of the sight and reach of children. If symptoms persist, consult your doctor.

Prolonged use except under medical supervision may be harmful.

If your baby was born prematurely and is less than 3 months old consult your doctor prior to use.

If your child has a known intolerance to some sugars, contact your doctor before use as this product contains maltitol syrup and sorbitol.

Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of irreversible liver damage.

Contains parahydroxybenzoates (E216 and E218) which may cause allergic reactions, possibly delayed.

Maltitol & Sorbitol liquid:

Patients with rare hereditary problems of fructose intolerance should not take this medicine. Each 120mg/5 ml suspension contains sorbitol (E420) at 750 mg per 5 ml suspension. This medicine may have a mild laxative effect and cause gastrointestinal discomfort.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. 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).

This product is intended for use in children.

Pregnancy

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.

Lactation

Paracetamol is excreted in breast milk. However, the level of paracetamol present is not considered to be harmful. Available published data do not contraindicate breastfeeding.

None.

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

The frequency of adverse events associated with paracetamol is tabulated below.

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance website: www.hpra.ie.

Not applicable.