CALPOL

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

This presentation is reserved for children weighing 3 to 26 kg (i.e. approximately from birth to 9 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 it proves necessary from a clinical point of view, paracetamol can be used during pregnancy. However, it must be used at the lowest effective dose, for the shortest duration and as infrequently as possible during pregnancy.

Breastfeeding

After oral administration, paracetamol is excreted in breast milk, but in clinically non-significant quantities. At therapeutic doses, 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.

Not applicable.

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 on the basis of available data)

Immune system disorders

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

Skin and subcutaneous tissue disorders

- Rare: erythema, urticaria, skin rash have been reported.

- Very rare cases of serious skin adverse effects have been reported.

- Frequency unknown: fixed pigment erythema.

In the event of the occurrence of at least one of the adverse effects mentioned above, this medicinal product must be definitively discontinued.

Blood and lymphatic system disorders

- Very exceptional: thrombocytopenia, leucopenia and neutropenia.

- Frequency unknown: agranulocytosis, haemolytic anaemia in patients presenting with a glucose-6-phosphate-dehydrogenase deficiency.

Hepatobiliary disorders

- Frequency unknown: increase in transaminases, cytolytic hepatic damage, acute hepatitis, massive hepatitis, particularly during use in a risk situation (see section 4.4).

Respiratory, thoracic and mediastinal disorders

- Frequency unknown: bronchospasm (see section 4.4).

Metabolism and nutrition disorders

- Frequency unknown: high anion gap metabolic acidosis (cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been reported 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 of 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/ .