DOLOSTOP

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

4.8. Undesirable effects

Undesirable 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 from the available data)

Reporting of suspected undesirable effects

Reporting suspected undesirable effects after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected undesirable 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/ .

4.9. Overdose

The risk of serious poisoning (therapeutic overdose or accidental poisoning) may be particularly high in the elderly, in young children, in patients with hepatic or renal impairment, in cases of chronic alcoholism, in patients suffering from chronic malnutrition (see section 4.2), fasting, recent weight loss, familial hyperbilirubinemia (Gilbert syndrome) as well as in patients receiving enzyme-inducing drugs. In these cases, poisoning may be fatal.

Symptoms

Nausea, vomiting, anorexia, pallor, malaise, sweating, abdominal pain generally appear within the first 24 hours.

An overdose can cause hepatic cytolysis which may lead to hepatocellular insufficiency that may require a liver transplant, gastrointestinal bleeding, metabolic acidosis, encephalopathy that can lead to coma and death.

Cases of disseminated intravascular coagulation have been observed in the context of paracetamol overdose.

Simultaneously, an increase in hepatic transaminases, lactico-dehydrogenase, bilirubin and a decrease in prothrombin levels may be observed, appearing 12 to 48 hours after ingestion. Clinical symptoms of hepatic impairment are generally observed after 1 to 2 days, and reach a maximum after 3 to 4 days.

Overdose can also lead to acute pancreatitis, hyperamylasemia, acute renal failure and pancytopenia.

Emergency conduct

· Discontinuation of treatment.

· Immediate transfer to a hospital setting, for emergency medical care, despite the absence of significant early symptoms.

· Rapid evacuation of the ingested product, by aspiration and gastric lavage preferably within 4 hours following ingestion.

· Blood sampling to perform the initial plasma dosage of paracetamol. The plasma concentration of paracetamol must be measured at least 4 hours after ingestion (a dosage performed earlier is not reliable).

· Treatment of overdose classically includes the administration as early as possible of the antidote N-acetylcysteine by I.V. route or orally if possible before the tenth hour. Although less effective, a protective effect of the antidote can be obtained up to 48 hours post-ingestion. In this case, the antidote must be administered for longer.

· Symptomatic treatment.

· Liver tests must be performed at the start of treatment and repeated every 24 hours. In most cases, hepatic transaminases return to normal in 1 to 2 weeks with full restitution of liver function. However, in very serious cases, a liver transplant may be necessary.

· Taking other measures will depend on the severity, nature and evolution of the clinical symptoms of paracetamol poisoning and must follow standard intensive care protocols.