PARACETAL

Short-term symptomatic treatment of mild to moderate pain and/or fever.

PARACETAMOL ZENTIVA LAB 500 mg, scored tablet suitable for adults, adolescents and children weighing more than 21 kg (aged 6 years and over).

The absorption rate of paracetamol may be increased by metoclopramide or domperidone. However, it is not necessary to avoid their concomitant use.

Cholestyramine reduces the absorption of paracetamol. Paracetamol must be administered at least 1 hour before or 4 to 6 hours after cholestyramine.

Prolonged co-administration with acetylsalicylic acid or other NSAIDs may lead to renal impairment.

The anticoagulant effect of warfarin or other coumarin derivatives may be increased, as well as the risk of bleeding, in case of regular daily prolonged intake of paracetamol. Occasional use has no significant effect.

Hepatotoxic substances may increase the potential accumulation and overdose of paracetamol.

Paracetamol may affect the pharmacokinetics of chloramphenicol. Dosage of chloramphenicol plasma levels is therefore recommended in case of concomitant treatment with injectable chloramphenicol.

Probenecid reduces the clearance of paracetamol by nearly 50 %. The dose of paracetamol may thus be reduced by half in case of concomitant treatment.

Microsomal enzyme inducers (for example, rifampicin, phenobarbital, phenytoin, carbamazepine, St John's wort) decrease the bioavailability of paracetamol by an increase in glucuronidation and increase the risk of hepatic toxicity. These associations must be avoided.

Concomitant use of paracetamol and zidovudine may lead to an increase in the risk of neutropenia.

Concomitant use of paracetamol and isoniazid may lead to an increase in the risk of hepatotoxicity.

Caution should be exercised when using paracetamol and flucloxacillin concomitantly, as simultaneous intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, particularly in patients presenting with risk factors (see section 4.4).

Pregnancy

A large amount of data in pregnant women has not shown any malformative effect or fetal/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, but it must be used at the lowest effective dose possible for the shortest duration possible and at the lowest frequency possible.

Breastfeeding

Paracetamol passes into breast milk, but it should not have a negative effect on the child at therapeutic doses. It is not necessary to interrupt breastfeeding in the case of short-term treatment at the recommended doses of this medicine.

Fertility

No clinical data is available.

PARACETAMOL ZENTIVA LAB has no effect on the ability to drive vehicles and use machines.

Administration of paracetamol may cause the following adverse effects (classified into groups according to MedDRA terminology with indication of frequency of occurrence, as follows: very frequent (≥ 1/10); frequent (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000); very rare (< 1/10 000); unknown frequency (cannot be estimated on the basis of available data).

*In patients sensitive to acetylsalicylic acid or other NSAIDs.

Description of selected adverse effects

High anion gap metabolic acidosis

Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors taking paracetamol (see section 4.4). Pyroglutamic acidosis may occur in these patients due to low glutathione levels.

Reporting of suspected adverse effects

Reporting suspected adverse effects after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .