Medicinal Products

EFFERALGANVITAMINEC 500 mg / 200 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol, Ascorbic acid (E300)
laboratory: Bristol Myers Squibb

Effervescent tablet
Box of 2 tubes of 8
All forms

Indication

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

Dosage EFFERALGANVITAMINEC 500 mg / 200 mg effervescent tablet Box of 2 tubes of 8

Administration mode

Oral way.

Allow the tablet to dissolve completely in a glass of water.

Dosage

This presentation is reserved for adults and children from 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. 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 27 to 40 kg (approximately 8 to 13 years), the dosage is 1 tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 tablets per day.

· 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.

· For adults and children weighing more than 50 kg (starting at about 15 years of age), the usual dosage is 1 to 2 tablets at 500 mg per dose, to be renewed if necessary after 4 hours minimum.

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

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

Recommended maximum doses (see section 4.4 Special 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 4 hours minimum,

· 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 2 doses will be at least 8 hours. The dose of paracetamol should not exceed 3 g per day or 6 tablets.

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

· Adults under 50 kg,

· Mild to moderate hepatocellular insufficiency,

· Chronic alcoholism,

· Chronic malnutrition,

· Dehydration.

Against indications

· Hypersensitization to paracetamol or other components.

· Severe hepatocellular insufficiency.

· Renal lithiasis when using high doses of vitamin C, greater than 1 g.

Adverse effects Efferalganvitaminec

Paracetamol-related

· 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.

Linked to ascorbic acid

High doses of vitamin C (greater than 1 g) favor the development of oxalic and uric lithiases in some subjects and may increase haemolysis in G6PD deficient subjects in chronic hemolysis.

Due to the presence of sorbitol, possibilities of digestive disorders and diarrhea.

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