Medicinal Products

DAFALGAN 250 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Bristol Myers Squibb

Effervescent powder for oral solution
Sachets Box of 12
All forms

Indication

Symptomatic treatment of mild to moderate pain and / or febrile conditions.

Dosage DAFALGAN 250 mg Effervescent powder for oral solution Sachets Box of 12

Administration mode

Oral way.

Pour the contents of the sachet into a glass and add a small amount of drink (eg water, milk, fruit juice). Drink immediately after complete dissolution.

Dosage

This presentation is reserved for the child weighing between 13 and 50 kg (about 2 to 15 years).

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

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

· For children weighing 13 to 20 kg (approximately 2 to 7 years), the dosage is 1 sachet per dose, to be renewed if necessary after 6 hours, without exceeding 4 sachets per day.

· For children weighing 21 to 25 kg (approximately 6 to 10 years): the dosage is 1 sachet per dose, to be renewed if necessary after 4 hours, without exceeding 6 sachets per day .

· For children weighing 26 to 40 kg (approximately 8 to 13 years): the dosage is 2 sachets per dose, to be renewed if necessary after 6 hours, without exceeding 8 sachets per day .

· For children weighing 41 to 50 kg (approximately 12 to 15 years): the dosage is 2 sachets per dose, to be renewed if necessary after 4 hours, without exceeding 12 sachets per day .

Maximum recommended doses: see section Warnings and precautions for use .

Frequency of administration

Systematic catches prevent pain or fever oscillations:

· In children, they must be regularly spaced, including at night, preferably 6 hours and at least 4 hours,

· In adults, they must be spaced at least 4 hours apart.

Renal failure

In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between two doses will be at least 8 hours. The total dose of paracetamol should not exceed 3 g per day ie 12 sachets.

Against indications

· Hypersensitivity to paracetamol or other components.

· Hepatocellular insufficiency.

· Phenylketonuria (due to the presence of aspartame).

Dafalgan side effects

· 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 drug and related drugs.

· Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.

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