Sanofi Doliprane Tabs 500 mg 16 film-coated tablets

Sanofi Doliprane Tabs 500 mg 16 film-coated tablets symptomatic treatment of mild to moderate pain and/or fever.

This presentation is reserved for adults and children weighing 27 kg or more (i.e. from around 8 years of age).

Directions for use Sanofi Doliprane Tabs 500 mg 16 film-coated tablets

Dosage

- In children, it is imperative to respect the dosages defined according to the child's weight, and therefore to choose a suitable presentation.

Approximate ages according to weight are given for information only.

The recommended daily dose of paracetamol is around 60 mg/kg/day, divided into 4 or 6 doses, i.e. around 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

For children weighing 27 to 40 kg (approx. 8 to 13 years), the recommended dose is 1 x 500 mg tablet per dose, repeated if necessary after 6 hours, up to a maximum of 4 tablets per day .

For children weighing 41 to 50 kg (approx. 12 to 15 years), the dosage is 1 x 500 mg tablet per dose, repeated if necessary after 4 hours, not to exceed 6 tablets per day.

- For adults and children weighing over 50 kg (aged 15 and over): The usual unit dose is 1 to 2 500 mg tablets per dose, repeated if necessary after at least 4 hours. It is generally not necessary to exceed 3 g of paracetamol per day, i.e. 6 tablets per day.

However, in the case of more intense pain, the maximum dosage may be increased to 4 g per day, i.e. 8 tablets per day.

Always maintain a 4-hour interval between doses. Maximum recommended doses: see Warnings and Precautions for Use.

Frequency of administration

Systematic dosing avoids oscillations in pain or fever:

- in children, doses should be regularly spaced, including at night, preferably 6 hours apart, and at least 4 hours apart.

- in adults, at least 4 hours apart. Renal insufficiency In cases of severe renal insufficiency (creatinine clearance less than 30 ml/min), the interval between two doses should be at least 8 hours.

The dose of paracetamol should not exceed 3 g/day, i.e. 6 tablets.

Other clinical situations The lowest possible effective daily dose should be considered, not exceeding 60 mg/kg/day (not to exceed 3 g/d) in the following situations:

- adults weighing less than 50 kg,

- Mild to moderate hepatocellular insufficiency - Chronic alcoholism

- Dehydration

- Low glutathione reserves, e.g. chronic malnutrition, fasting, recent weight loss, elderly over 75 or over 65 and polypathological, chronic viral hepatitis and HIV, cystic fibrosis, familial cholemia (Gilbert's disease).

Method of administration

Oral administration.

Tablets should be swallowed whole with a drink (e.g. water, milk, fruit juice). It is contraindicated to take tablets or capsules in children under 6 years of age, as they may cause a false stomach. Use another form.

Composition Sanofi Doliprane Tabs 500 mg 16 film-coated tablets

film-coated tablet: Paracetamol 500 mg.

Excipients : Pregelatinized corn starch, Hydroxypropylcellulose, Talc, Magnesium stearate, Opadry, (Polyvinyl alcohol, Macrogol 3350, Talc), qsp 1 film-coated tablet.