Treatment: symptomatic of pain of mild to moderate and / or febrile states

Oral use.

The tablets are to be swallowed as such with a drink (eg water, milk, fruit juice).
This presentation is reserved for adults and children up to 27 kg (approximately from 8 years old).

In children it is imperative to respect the dosages defined according to the weight of the child and therefore to choose a suitable presentation. The approximate ages according to the weight are given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg / kg / day, divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours. Code>
· For children weighing 27 to 40 kg (approximately 8 to 13 years old), the dosage is 1 tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 tablets per day. Code>
· For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 tablet per dose, to be renewed if necessary after 4 hours, without exceeding 6 tablets per day. Code>
· For adults and children weighing more than 50 kg (from about 15 years), the usual dosage is 1 to 2 tablets to 500 mg, to be renewed if necessary at the end Of 4 hours, minimum.

It is generally not necessary to exceed 3 g of paracetamol per day, ie 6 tablets.

However, in the case of more intense pain, the maximum dosage can be increased to 4 g per day, ie 8 tablets per day. Always respect an interval of 4 hours between the catches.

Recommended maximum dose: see section 4.4 Special warnings and precautions for use.
· Systematic catches help prevent oscillations of pain or fever

· In the child, they must be regularly spaced, including at night, preferably 6 hours, and 4 hours minimum.
· In adults, they must be spaced at least 4 hours apart

In the case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between the two doses should be at least 8 hours The dose of paracetamol should not exceed, in adults , 3 g per day or 6 tablets.

ANTALGIC

ANTIPYRETIC

ATC code: N02 BE01

(N.; Central nervous system)

Not applicable.

· Hypersensitivity to paracetamol or to other constituents

· Hepatocellular insufficiency

Warnings

To avoid a risk of overdose

· Check the absence of paracetamol in the composition of other medicines

· Comply with the maximum recommended doses

Recommended maximum doses

· In children under 40 kg, the total dose of paracetamol should not exceed 80 mg / kg / day (see section 4.3).
· In children from 41 kg to 50 kg, the total dose of paracetamol should not exceed 3 g per day (see section on Overdose).

In adults and children over 50 kg, the total dose of paracetamol should not exceed 4 grams per day (see section 4.3).

Paracetamol should be used with caution in case of

· Weight
Interactions with paraclinic tests: The use of paracetamol may distort the determination of blood uric acid by the phosphotungstic acid method

The use of paracetamol may distort the glucose dosage by the glucose oxidase-peroxidase method in the event of abnormally high concentrations

Association, being the subject of precautions for use

+ Anticoagulant, oral

Risk of increased oral anticoagulant effect and risk of hemorrhage in patients receiving paracetamol at maximum doses (4 g / d) for at least 4 days. More frequent monitoring of INR. Possible adaptation of the dosage of the porcine anticoagulant during treatment with paracetamol and after its discontinuation

Not applicable.

The risk of severe intoxication may be particularly high in elderly patients, in young children, in patients with hepatic impairment, and in chronic alcoholism in patients suffering from chronic malnutrition. In these cases, poisoning can be fatal.

Symptoms: nausea, vomiting, anorexia, pallor, abdominal pain appear, usually within the first 24 hours.



Overdosage from 10 g of single-dose paracetamol in adults and 150 mg / kg of body weight in a single dose in children with hepatic cytolysis likely to result in complete necrosis And is irreversible, resulting in hepatocellular insufficiency, metabolic acidosis, encephalopathy which can lead to coma and death.
Driving, emergency

· Immediate transfer to hospitals

· Collect a blood tube to do the initial plasma paracetamol assay

· Rapid evacuation of the product ingested, by washing, gastric

· Treatment of overdose typically involves administration as early as possible of the antidote, N-acetylcysteine ​​IV or oral if possible before the tenth hour.

· Symptomatic treatment.

Pregnancy

The studies carried out in animals have not demonstrated the teratogenic or fetotoxic effect of paracetamol.




At therapeutic doses, the administration of this drug is possible during breastfeeding.

A few cases of hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this medicinal product and related medicinal products.