APYROL

Symptomatic treatment of mild to moderate intensity pain and/or febrile states.

Not applicable.

Not applicable.

· A few rare cases of hypersensitivity reactions such as anaphylactic shock, Quincke's edema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this medicine and related medicines.

· Very rare cases of serious skin reactions have been reported.

· Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.

· Related to the presence of parabens (methyl and propyl parahydroxybenzoate): urticaria.

· Metabolic and nutritional disorders: high anion gap metabolic acidosis: frequency "undetermined" (cannot be estimated from the available data):

Description of selected adverse effects

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

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. 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