Medicinal Products

PARACETAMOL ACTAVIS FRANCE 500 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Actavis Group Ptc Ehf

Divisible coated tablet
Box of 16
All forms

Indication

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

Dosage PARACETAMOL ACTAVIS FRANCE 500 mg Film-coated tablet scored box of 16

Administration mode

Oral way.

The tablets are swallowed as is with a drink (eg water, milk, fruit juice).

Taking tablets or capsules is contraindicated in children under 6 years of age because it can lead to a wrong course. Use another form.

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 1 500 mg 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 1 500 mg 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 (from about 15 years old);

The usual unit dosage is 1 to 2 tablets at 500 mg per dose, to be renewed if necessary after at least 4 hours.

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 observe a 4 hour interval between shots.

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

Frequency of administration

Systematic catches prevent pain or fever oscillations:

· In children, they should 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 cases of severe renal impairment (creatinine clearance less than 10 ml / min), the interval between two doses should be increased to 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

· Hypersensitivity to paracetamol or other components.

· Hepatocellular insufficiency.

Paracetamol side effects Actavis France

· 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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