Medicinal Products

PARALYOC 500 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Teva Sante

Oral lyophilisate
Box of 16
All forms

Indication

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

Dosage PARALYOC 500 mg Oral lyophilisate Box of 16

Administration mode

Oral way.

Let the oral lyophilisate melt in the mouth (do not chew it) or drink immediately after complete dissolution in a small amount of drink (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.

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 lyophilisate 500 mg per dose, to be renewed if necessary after 6 hours, without exceeding 4 lyophilisates per day .

For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 lyophilisate 500 mg per dose, to be renewed if necessary after 4 hours, without exceeding 6 lyophilisates per day .

For adults and children weighing more than 50 kg (from about 15 years old);

The usual unit dosage is 1 to 2 lyophilisates 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 lyophilisates per day .

However, in case of more severe pain, the maximum dosage can be increased up to 4 g per day, or 8 lyophilisates per day .

Always observe a 4 hour interval between shots.

Recommended maximum doses: (see Warnings and Precautions ) section.

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 case of severe renal insufficiency (clearance of creatine less than 30 ml / min), the interval between 2 doses should be increased and will be at least 8 hours.

The dose of paracetamol should not exceed 3 g per day or 6 oral lyophilisates.

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.

· Phenylketonuria (due to the presence of aspartame).

Paralyoc side effects

· A few rare 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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