“Composition
Active ingredients
Each tablet contains: paracetamol 500 mg.
Excipients
Rice starch, hydroxypropyl cellulose, polyvinylpyrrolidone, crospovidone, magnesium stearate, talc, colloidal silicon dioxide.
Directions
Paracetamol is indicated for the symptomatic treatment of mild to moderate pain and fever.
Method of administration and dosage
For children, it is important to follow the dosage determined based on body weight. The approximate age calculated based on body weight is for information purposes only. For adults, the maximum oral dose is 3000 mg of paracetamol per day.
Children weighing 21 to 25 kg (approximately 6 to 10 years): ½ tablet at a time, repeat after 4 hours if necessary, up to a maximum of 6 doses per day.
Children weighing 26 to 40 kg (approximately 8 to 13 years): 1 tablet at a time, repeat if necessary after 6 hours, up to a maximum of 4 doses per day.
Children weighing 41 to 50 kg (approximately 12 to 15 years): 1 tablet at a time, repeat if necessary after 4 hours, up to a maximum of 6 doses per day.
Children weighing over 50 kg (approximately over 15 years): 1 tablet at a time, repeat if necessary after 4 hours, up to a maximum of 6 doses per day.
Adults: 1 tablet at a time, repeat if necessary after 4 hours, up to a maximum of 6 doses per day. For severe pain or high temperature – 2 tablets of 500 mg, repeat if necessary after at least 4 hours.
Warnings
In rare cases of allergic reactions, discontinue the drug and prescribe appropriate treatment. Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency. High or prolonged doses of the drug can cause high-risk liver disease and even serious changes in the kidneys and blood, so its administration to people with renal failure should be carried out only in case of real need and under direct medical supervision. Paracetamol should be prescribed with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome), severe liver failure (Child-Pugh class> 9), severe liver failure, acute hepatitis, concomitant treatment with drugs that change liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia.
During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active substance, as serious side effects may occur when taking paracetamol in high doses. Ask the patient to consult a doctor before combining any other medicines. Do not use for more than 3 days in a row without a thorough medical examination.
Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Contraindications
Hypersensitivity to the active substance or to any of the listed excipients.”
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