ANDOL

Symptomatic treatment of mild to moderate pain and fever.

Adults and children from 27 kg (approximately 8 years).

Pregnancy

Studies conducted in animals have not demonstrated any teratogenic or foetotoxic effect of paracetamol.

A vast amount of data concerning pregnant women demonstrates the absence of any malformation or any foetal/neonatal toxicity. Epidemiological studies dedicated to the neurodevelopment of children exposed to paracetamol in utero produce inconclusive results. If this 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

After administration, paracetamol is eliminated in small quantities in breast milk. 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 have been 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 common ( ≥ 1/10)

· Common ( ≥ 1/100 to < 1/10)

· Uncommon ( ≥ 1/1000 to < 1/100)

· Rare ( ≥ 1/10 000 to < 1/1000)

· Very rare (< 1/10 000)

· Frequency unknown (cannot be estimated based on available data)

Hematological and lymphatic system disorders

· Very rare: thrombocytopenia, leucopenia and neutropenia

Immune system disorders

· Rare: hypersensitivity reactions.

· Frequency unknown: anaphylactic reaction (including hypotension), anaphylactic shock, angioedema (Quincke's edema).

Their occurrence requires the immediate and permanent discontinuation of this medicinal product and related medicinal products.

Respiratory, thoracic and mediastinal disorders

· Frequency unknown: bronchospasm (cases of bronchospasm have been identified with paracetamol, mostly in asthmatic patients sensitive to aspirin or other non-steroidal anti-inflammatory drugs).

Metabolism and nutrition disorders

· Frequency unknown: pyroglutamic acidosis in patients with factors predisposing to glutathione depletion, metabolic acidosis with high anion gap.

Gastrointestinal disorders

· Frequency unknown: diarrhoea, abdominal pain.

Hepatobiliary disorders

· Frequency unknown: increased liver enzymes.

Skin and subcutaneous tissue disorders

· Rare: erythema, urticaria, skin rash. Their occurrence requires the immediate and permanent discontinuation of this medicinal product and related medicinal products.

· Rare: purpura. The occurrence of this effect requires the immediate discontinuation of this medicinal product. The medicinal product may be reintroduced only on medical advice.

· Very rare: serious skin reactions. Their occurrence requires the immediate and permanent discontinuation of this medicinal product and related medicinal products.

· Frequency unknown: fixed pigmented erythema.

Description of selected adverse effects

Metabolic acidosis with high anion gap

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

Reporting of suspected adverse effects

Reporting suspected adverse effects after the medicinal product has been authorised 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 .