Special Warning : אזהרת שימוש

Warnings
Paracetamol can cause accidental poisoning in toddlers and infants. Paracetamol- containing products should be kept well out of reach of children.
Potentially fatal hepatotoxicity can result from paracetamol overdosage. However, in rare cases, hepatotoxicity has occurred in patients receiving high or excessive doses within therapeutic doses. Certain patients may be more susceptible to paracetamol hepatotoxicity, e.g., chronic alcoholics, patients with liver disease, or those who are malnourished or taking other drugs that induce hepatic enzymes.


Acamol TC,         9.   4. 2008, RH
Because of the risk of hepatotoxicity, patients should be cautioned against the inadvertent administration of excessive doses of paracetamol by using multiple paracetamol-containing product at once, such as cough and cold remedies, analgesics or arthritic formulations, antipyretics or products for relief of menstrual symptoms or muscle spasm. Administration of paracetamol to children may be especially prone to error due to the many concentrations and strengths of products available. To avoid dosing errors, all product labels should be checked carefully to ensure calculation of the amount of paracetamol to be given.

Use in Pregnancy
Safety of use in pregnancy has not been established.

Use in Breastfeeding
Although paracetamol appears in very low concentration in breast milk, risk-benefit must be considered before this drug is given to nursing mothers.

Adverse Reactions
Adverse reactions of paracetamol are rare and usually mild.
Hepatotoxicity: see Warnings.
Hematologic: neutropenia and thrombocytopenia purpura have been reported and rarely agranulocytosis.
Hypersensitivity: reactions including skin eruptions, laryngeal edema, bronchospasm, and/or anaphylaxis have occurred rarely. Dose-dependent cross-sensitivity to paracetamol may occur in aspirin-sensitive asthmatics. Low initial doses of paracetamol (less than 1000 mg) are recommended in these patients, with monitoring for about 3 hours following initial doses.
Renal: nephropathy, including papillary renal failure has been reported following consumption of large amounts of paracetamol. Renal tubular necrosis has been associated occasionally with hepatic injury produced by paracetamol overdose.

Precautions
If a sensitivity reaction occurs, discontinue use.
Paracetamol should be given with care to patients with impaired kidney or liver function.
Risk-benefit ratio should be taken into consideration in the presence of viral hepatitis and alcoholism, since there is an increased risk of hepatotoxicity.

Effects on Driving