ALGIK

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

Some patients using paracetamol may experience dizziness or drowsiness. Patients should be cautious if they engage in activities requiring alertness.

Related to paracetamol

The listed adverse effects are based on spontaneous reports, so an organization following the CIOMS III frequency categories is not possible.

Hematological and lymphatic system disorders

Changes in blood count, notably thrombocytopenia, thrombocytopenic purpura, leukopenia, and pancytopenia.

Metabolism and nutrition disorders

High anion gap metabolic acidosis with "indeterminate" frequency (cannot be estimated from available data)

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 risk factors and taking paracetamol (see section 4.4). A pyroglutamic acidosis may occur in these patients due to low glutathione levels.

Gastrointestinal disorders

Nausea, vomiting, stomach ache, diarrhea and abdominal pain.

Hepatobiliary disorders

Hepatic impairment, hepatitis, dose-dependent hepatic impairment, hepatic necrosis (including fatal outcome). Non-compliant chronic use may lead to hepatic fibrosis, hepatic cirrhosis, including fatal outcome (see sections 4.4 and 4.9).

Immune system disorders

Allergic reactions, anaphylactic reaction, and anaphylactic shock.

Nervous system disorders

Dizziness, somnolence.

Renal and urinary tract disorders

Renal impairment, particularly in case of overdose.

Respiratory, thoracic and mediastinal disorders

Bronchospasm and asthma, notably analgesic asthma syndrome.

Skin and subcutaneous tissue disorders

Very rare cases of severe skin reactions have been reported.

Rash, pruritus, urticaria, allergic oedema and angioedema, acute generalized exanthematous pustulosis, fixed pigment erythema, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (including fatal outcome)

Related to caffeine

Possibility of excitation, insomnia, palpitations.

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 ratio 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/