Paracetamol 500 mg - pain relief medicament 30 tablets

Product Description

Paracetamol-based medicine indicated for mild to moderate pain and fever.

Indications

Paracetamol is indicated for the symptomatic treatment of mild to moderate pain and fever.

Composition

Active ingredients

Each tablet contains: paracetamol 500 mg.

Excipients

Rice starch, hydroxypropylcellulose, polyvinylpyrrolidone, crospovidone, magnesium stearate, talc, colloidal silica.

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 indicated 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 6 to 10 years): ½ 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 kJ (approximately between 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 kJ (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. 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, 2 500 mg tablets 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 subjects with glucose-6-phosphate dehydrogenase deficiency. High or prolonged doses of the product can cause high-risk liver disease and alterations to the kidneys and blood, even serious ones, therefore, administration to subjects with renal insufficiency must be carried out only if really necessary and under the direct supervision of a doctor. 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, hemolytic anemia.

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 their doctor before combining any other medication. Do not administer for more than 3 consecutive days without careful medical evaluation.

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 excipients listed.

Undesirable effects

Overdose

• Symptoms:In case of accidental ingestion of very high doses of paracetamol, intoxication Acute paracetamol manifests itself with anorexia, nausea, and vomiting, followed by a profound deterioration in general conditions; these symptoms generally appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis, which can progress to massive and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis, and encephalopathy, which can lead to death. Simultaneously, an increase in the levels of hepatic transaminases, lactic dehydrogenase, and bilirubin, and a reduction in prothrombin levels are observed, which can occur within 12–48 hours of ingestion.
• Treatment: The measures to be taken consist of early gastric emptying and hospitalization for appropriate treatment, through administration, as soon as possible, of paracetamol. as early as possible, of N–acetylcysteine ​​as an antidote: the dosage is 150 mg/kg i.v. in glucose solution over 15 minutes, then 50 mg/kg over the next 4 hours and 100 mg/kg over the next 16 hours, for a total of 300 mg/kg over 20 hours.

Pregnancy and breastfeeding

Although clinical studies in pregnant or breastfeeding patients have not highlighted any particular contraindications to the use of paracetamol or caused any side effects for 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.

Format

Pack of 30 tablets.