Paracetamolo 500 mg - antipyretic analgesic 30 tablets

Product Description

Tablets for fever and respiratory tract conditions.

Indications

Paracetamol 500 Mg is used as:

• Antipyretic: symptomatic treatment of febrile conditions such as influenza, exanthematous diseases, acute respiratory tract conditions, etc.
• Analgesic: headaches, neuralgia, myalgia and other moderately severe pain of various origins.

Composition

Active Ingredients
Each tablet contains: paracetamol 500 mg.
Excipients: polyvinylpyrrolidone, sodium starch glycolate, talc, magnesium stearate, colloidal hydrated silica, cellulose microcrystalline.

Directions for use and Dosage

For children, it is essential to respect the dosage defined based on their body weight.
The approximate ages based on body weight are given for information purposes only.
In adults, the maximum oral dosage is 3000 mg of paracetamol per day.
Children weighing between 21 and 25 kg (approximately between 6 and 10 years): 1/2 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day.
Children weighing between 41 and 50 kg (approximately 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
Children weighing more than 50 kg (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
Adults: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours.

Warnings

In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be initiated. Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency. High or prolonged doses of the product can cause high-risk liver disease and even serious kidney and blood changes. Therefore, administration to patients with mild/moderate renal or hepatic insufficiency and to patients with Gilbert's syndrome should be performed only if strictly necessary and under the direct supervision of a doctor.
During treatment with paracetamol, before taking any other medication, check that it does not contain the same active ingredient, as serious adverse reactions may occur if paracetamol is taken in high doses. Instruct the patient to contact the doctor before combining any other medication. Do not administer for more than 3 consecutive days without careful medical evaluation.
Paracetamol-based medicines are contraindicated in patients with severe haemolytic anaemia.
Severe hepatocellular insufficiency:Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh >9), severe hepatic insufficiency, acute hepatitis, concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia.
For further information, read the package leaflet carefully.

Pregnancy and Breastfeeding

Although clinical studies in pregnant or breastfeeding patients have not highlighted any particular contraindications to the use of paracetamol nor caused any adverse effects on the mother or child, It is recommended to administer the product only in cases of real need and under the direct supervision of a doctor. A large amount of data on pregnant women indicate neither malformative nor fetal/neonatal toxicity. Epidemiological studies on the neurological development of children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however, it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency.

Format

30 tablets of 500 mg