DAFALGAN Uses, Dosage, Side Effects, Precautions & Warnings
Generic drug of the Therapeutic class: Analgesics
active ingredients: Paracetamol
Table of Contents
What is Dafalgan used to treat and indication ?
Symptomatic treatment of mild to moderate pain and / or febrile conditions.
This presentation is reserved for adults and children from 50 kg (from about 15 years old).
DAFALGAN Dosage
Administration mode
Oral way.
- The capsules 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.
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 childand 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, to be divided into 4 or 6 doses, approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.
dafalgan dosage child
- For children weighing 27 to 40 kg (approximately 8 to 13 years), the dosage is 1 capsule per dose, to be renewed if necessary after 6 hours, not exceeding 4 capsules per day.
- For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 capsule per dose, to be renewed if necessary after 4 hours, without exceeding 6 capsules per day.
For adults and children weighing more than 50 kg (from about 15 years old);
The usual unit dosage is 1 to 2 capsules 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 capsules per day. However, in case of more intense pain, the maximum dosage can be increased up to 4 g per day, or 8 capsules per day. Always observe a 4 hour interval between shots.
Recommended maximum doses : see section Warnings and precautions for use
Frequency of administration
Systematic catches prevent pain or fever oscillations:
- · In children, they should be evenly spaced, including at night, of preferably 6 hours , and at least 4 hours.
- · In adults, they must be spaced at least 4 hours apart.
Renal failure
Contraindications
- Hypersensitivity to paracetamol or to other constituents.
- Hepatocellular insufficiency.
How it works DAFALGAN?
OTHER Analgesics and ANTIPYRETICS ,
ATC Code: N02BE01 .
N: Central nervous system .
side effects of dafalgan
- · 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.
DAFALGAN Interactions
Associations subject to precautions for use
Oral anticoagulants:
- Risk of an increase in the effect of oral anticoagulant and haemorrhagic risk when taking paracetamol at maximum doses (4 g / d) for at least 4 days. Regular control of the INR.
- Possible adaptation of oral anticoagulant dosage during paracetamol treatment and after discontinuation.
Interactions with paraclinical exams
- Taking paracetamol may interfere with the glucose-glucose oxidase-peroxidase assay at abnormally high concentrations.
- Taking paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method.
DAFALGAN Warnings and Precautions
Special warnings
- To avoid the risk of overdose, check the absence of paracetamol in other medicines.
Maximum recommended doses :
- · In children under 37 kg , the total dose of paracetamol should not exceed 80 mg / kg / day .
- · In children from 38 kg to 50 kg , the total dose of paracetamol should not exceed 3 g per day ( see section Overdose ).
- · In adults and children over 50 kg , the total dose of PARACETAMOL SHOULD NOT EXCEED 4 GRAMS PER DAY .
- The use of tablets and capsules is contraindicated in children under 6 years of age because it can lead to a miscarriage.
Precautions for use
- · In a child treated with 60 mg / kg / day paracetamol, the combination of another antipyretic is justified only in case of ineffectiveness.
Drive and use machines
Not applicable.
DAFALGAN and PREGNANCY / BREAST FEEDING / FERTILITY
DAFALGAN and PREGNANCY
- Studies in animals have not shown any teratogenic or foetotoxic effect of paracetamol.
- Clinically, the results of epidemiological studies seem to exclude a particular malformative or fetotoxic effect of paracetamol.
- As a result, paracetamol, under normal conditions of use, may be prescribed throughout pregnancy.
feeding
- At therapeutic doses, administration of this drug is possible during breastfeeding.
What happens if I overdose from DAFALGAN ?
The risk of severe intoxication may be particularly high in the elderly, in young children, in patients with liver injury, in chronic alcoholism, in patients suffering from chronic malnutrition and in patients receiving inducers. enzyme. In these cases, intoxication can be fatal. Clinical symptoms of liver injury are usually seen after two days, and peak after 4-6 days.
Symptoms:
- Nausea, vomiting, anorexia, paleness, malaise, sweating, abdominal pain usually appear in the first 24 hours.
- Overdose, starting with 10 g of paracetamol in a single dose in adults and 150 mg / kg of body weight in a single dose in children, causes hepatic cytolysis that may result in complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis, encephalopathy that can lead to coma and death.
- At the same time, there is an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and a decrease in the prothrombin level that may occur 12 to 48 hours after ingestion. Clinical symptoms of liver damage are usually seen after 1 to 2 days, and peak after 3 to 4 days.
Emergency driving:
-
- Immediate transfer to hospital.
- Take a tube of blood plasma to the initial dosage of paracetamol as soon as possible from the 4 th hour after ingestion.
- Rapid evacuation of ingested product by gastric lavage.
- Treatment of overdose conventionally comprises the administration as early as possible, the N-acetylcysteine antidote intravenously or orally, if possible before the 10 th hour.
- Symptomatic treatment.
- Liver tests should be performed at the beginning of treatment and repeated every 24 hours. In most cases, hepatic transaminases return to normal in 1 to 2 weeks with complete restitution of liver function. However, in very severe cases, liver transplantation may be necessary.
What is Forms and Composition ?
- Film-coated tablet (white): Box of 8, in blister packs.
- Hospital model: Boxes of 40, in blister packs. Effervescent tablet (white): Tube of 8.
NOT’s
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general information:
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Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.