Description Doliprane 300 mg powder oral solution 12 dose sachets
Symptomatic treatment of mild to moderate pain and/or fever. This presentation is reserved for children from 16 to 48 kg (approximately 4 to 15 years).
Directions for use Doliprane 300 mg powder drinkable solution 12 sachets-dose
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 16 to 24 kg (approx. 4 to 9 years), the recommended dose is 1 sachet per dose, repeated if necessary after 6 hours, but not exceeding 4 sachets per day. - For children weighing 25 to 30 kg (approx. 8 to 11 years), the dose is 1 sachet per dose, repeated if necessary after 4 hours, but not exceeding 6 sachets per day. - For children weighing 31 to 48 kg (approx. 10 to 15 years), the dosage is 2 sachets per dose, repeated if necessary after 6 hours, up to a maximum of 8 sachets 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, doses should be regularly spaced, including at night. The frequency of administration depends on the child's weight: see "Dosage" section. - in adults, for information purposes, they should be spaced at least 4 hours apart.
Precautions for use
Contraindications:
- Hypersensitivity to the active substance or to any of the excipients listed under "List of excipients".
- Severe hepatocellular insufficiency.
Special warnings
To avoid risk of overdose:
- Check that paracetamol is not included in the composition of other drugs.
- Observe 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 g per day (see Overdosage section).
Precautions for use
- In children treated with paracetamol 60 mg/kg/day, the combination of another antipyretic is justified only if it is ineffective.
The administration of paracetamol may exceptionally 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):
- dehydration (see Dosage and administration),
- mild to moderate hepatocellular insufficiency,
- severe renal insufficiency (creatinine clearance < 30 ml/min) (see Pharmacokinetics),
- weight < 50 kg,
- chronic alcoholism,
- low glutathione reserves, e.g. 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),
- 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).
- This medicine contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) should not take this medicine.
- This medicine contains 0.81 g of sucrose per sachet. This should be taken into account in patients with diabetes mellitus.
- This medicine contains sodium. The sodium content is less than 1 mmol per sachet, i.e. "sodium-free".
Pregnancy and breast-feeding :
Pregnancy
Animal studies have not demonstrated any teratogenic or fetotoxic effect of paracetamol.
Extensive data on pregnant women demonstrate the absence of any malformations or fetal/neonatal toxicity. 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-oxygenases 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.
Effects on ability to drive and use machines :
Not applicable.
Composition Doliprane 300 mg powder for drinkable solution 12 dose sachets
powder for oral solution: Paracetamol 300 mg.
Excipients : Sodium benzoate, Povidone K 30, Acetylated monoglycerides, Titanium dioxide, Orange flavour, (Water, Maltodextrin, Gum arabic, Orange essential oil), Sucrose, qsp 1 sachet-dose.
Notable excipient(s): sodium benzoate, saccharose.
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