Sanofi Doliprane 300 mg 10 suppositories

Sanofi Doliprane 300 mg 10 suppositories are indicated for the symptomatic treatment of mild to moderate pain and/or fever. This presentation is reserved for children weighing from 15 to 24 kg (approximately 4 to 9 years).

Directions for use Sanofi Doliprane 300 mg 10 suppositories

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, to be divided into 4 administrations, i.e. around 15 mg/kg every 6 hours. Risk of local toxicity: suppositories should not be administered more than 4 times a day, and rectal treatment should be kept as short as possible. In case of diarrhea, suppository administration is not recommended. This presentation is suitable for children weighing 15 to 24 kg (approx. 4 to 9 years): Dosage is 1 suppository at 300 mg, to be repeated if necessary after 6 hours, without exceeding 4 suppositories per day. Maximum recommended doses: see Warnings and precautions for use Frequency of administration Systematic doses help avoid oscillations in pain or fever: - in children, they should be regularly spaced, including at night, preferably 6 hours apart and at least 4 hours apart. - in adults, for information purposes, they should be spaced at least 4 hours apart.

Precautions for use Sanofi Doliprane 300 mg 10 suppositories

Contraindications:

- Hypersensitivity to the active substance or to any of the excipients listed in the Composition section,

- severe hepatocellular insufficiency,

- recent history of rectitis, anitis or rectal discharge.

Special warnings

To avoid the risk of overdosage:

- Check that paracetamol is not included in the composition of other drugs,

- respect maximum recommended doses.

Maximum recommended doses:

- In children weighing less than 40 kg, the total dose of paracetamol should not exceed 80 mg/kg/d (see Overdosage section)

For information,

- in children between 41 kg and 50 kg, the total dose of paracetamol should not exceed 3 g/day (see Overdosage section),

- in adults and children weighing over 50 kg, THE TOTAL DOSE OF PARACETAMOL SHOULD NOT EXCEED 4 GRAMS PER DAY (see Overdose section).

With suppositories, there is a risk of local toxicity, the more frequent and intense the longer the duration of treatment, the higher the rate of administration and the higher the dosage.

As a result, suppositories should not be administered more than 4 times a day, and the duration of rectal treatment should be as short as possible.

Precautions for use

- In children treated with paracetamol 60 mg/kg/day, the combination of another antipyretic is justified only if ineffective.

- In case of diarrhea, the suppository form is not suitable.

- In exceptional cases, paracetamol administration may lead to liver toxicity, even at therapeutic doses, after short-term treatment and in patients with no history of liver disorders (see Adverse reactions).

- Paracetamol should be used with caution, not exceeding 3 g/day, in the following situations (see Dosage and administration):

o dehydration (see Dosage and administration),

o Mild to moderate hepatocellular insufficiency,

o severe renal insufficiency (creatinine clearance < 30 ml/min) (see Pharmacokinetics),

o weight < 50 kg, o chronic alcoholism, o low glutathione reserves such as chronic malnutrition, fasting, recent weight loss, elderly subjects over 75 or over 65 and polypathological, chronic viral hepatitis and HIV, cystic fibrosis, familial cholemia (Gilbert's disease),

o allergy to aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs).

- Consumption of alcoholic beverages during treatment is not recommended.

In the case of recent withdrawal from chronic alcoholism, the risk of liver damage is increased.

- If acute viral hepatitis is discovered, treatment should be discontinued.

- In children, dosage should be adjusted according to weight (see Dosage and administration).

Pregnancy and lactation :

- Pregnancy

Animal studies have not shown paracetamol to be teratogenic or fetotoxic. Epidemiological studies of neurodevelopment in children exposed to paracetamol in utero have produced inconclusive results. If clinically necessary, paracetamol may be used during pregnancy; however, it should be used at the lowest effective dose, for the shortest possible duration and with the least possible frequency.

- Breast-feeding

At therapeutic doses, paracetamol may be administered during breast-feeding.

- Fertility

Due to its potential mechanism of action on cyclo-oxygenase and prostaglandin synthesis, paracetamol may impair fertility in women, through an effect on ovulation which is reversible on discontinuation of treatment.

Effects on male fertility were observed in an animal study. The relevance of these effects in humans is unknown.

Composition Sanofi Doliprane 300 mg 10 suppositories

Suppository: Paracetamol 300 mg.

Excipients : Solid hemisynthetic glycerides, qsp 1 suppository.