DOLIPRANE

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

Pregnancy

A vast amount of data concerning pregnant women demonstrates the absence of any malformation or any fetal/neonatal toxicity.

Epidemiological studies dedicated to the neurodevelopment of children exposed to paracetamol in utero produce inconclusive results.

If it proves necessary from a clinical point of view, paracetamol can be used during pregnancy; however, it should be used at the lowest effective dose, for the shortest possible duration and at the lowest possible frequency.

Breastfeeding

At therapeutic doses, the administration of this medicine is possible during breastfeeding.

Fertility

Due to the potential mechanism of action on cyclo-oxygenases and prostaglandin synthesis, paracetamol could alter fertility in women, through an effect on ovulation reversible upon discontinuation of treatment.

Effects on male fertility were observed in an animal study. The relevance of these effects in humans is unknown.

Paracetamol has no effect or a negligible effect on the ability to drive vehicles and use machines.

Adverse effects are classified by system-organ class. Their frequencies are defined as follows:

· very frequent (≥1/10),

· frequent (≥1/100 to <1/10),

· uncommon (≥1/1 000 to <1/100),

· rare (≥1/10 000 to <1/1 000),

· very rare (<1/10 000),

· frequency unknown (cannot be estimated on the basis of available data).

Hematological and lymphatic system disorders

Very rare: thrombocytopenia, leukopenia and neutropenia.

Immune system disorders

Rare: hypersensitivity reactions such as anaphylactic shock, Quincke's edema, erythema, urticaria, skin rash. Their occurrence requires the definitive discontinuation of this medicinal product and related medicinal products.

Skin and subcutaneous tissue disorders

Very rare: serious skin reactions. Their occurrence requires discontinuation of treatment.

Metabolism and nutrition disorders

Frequency unknown: high anion gap metabolic acidosis.

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 presenting with 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 suspected adverse effects after authorisation of the medicinal product is important. It allows continuous 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/ .