Paracetamol Zeta 500mg Analgesic 20 Tablets

Therapeutic indications

As antipyretic: symptomatic treatment of febrile diseases such as flu, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other painful manifestations of medium entity, of various origins.

Dosage

For children it is essential to respect the dosage defined according to their body weight. Approximate ages as a function of body weight are given for information only. In adults, the maximum oral dosage is 3000 mg of paracetamol per day (see section 4.9). Children weighing between 21 and 25 kg (approximately between 6 and 10 years) ½ tablet at a time, repeat if necessary after 4 hours, without exceeding 6 doses 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 doses per day. Boys weighing between 41 and 50 kg (approximately between 12 and 15 years) 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses 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 doses per day. Adults 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses 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.

Overdose

Symptoms In case of accidental intake of very high doses of paracetamol, acute intoxication is manifested by anorexia, nausea and vomiting followed by a profound deterioration of the general conditions; these symptoms usually appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can evolve towards massive and irreversible necrosis, with consequent hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactic dehydrogenase and bilirubin levels, and a reduction in prothrombin levels are observed, which can occur in the 12-48 hours following ingestion. Treatment The measures to be taken consist of early gastric emptying and hospitalization for appropriate treatment, by administering, as early as possible, N-acetylcysteine as an antidote: the dosage is 150 mg / kg iv in a glucose solution in 15 minutes. , then 50 mg / kg in the next 4 hours and 100 mg / kg in the next 16 hours, for a total of 300 mg / kg in 20 hours.

Contraindications

Hypersensitivity to paracetamol or to any of the excipients.

Side effects

The following are the side effects of acetaminophen organized according to the MedDRA systemic and organic classification. Insufficient data are available to establish the frequency of the individual effects listed.

Pregnancy and breastfeeding

Although clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol or caused unwanted effects affecting the mother or child, it is recommended to administer the product only in cases of real need and under the direct supervision of the doctor. .

Special warnings

In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted. 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, concomitantly treated with drugs that alter the liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anemia. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses. Instruct the patient to contact the physician before associating any other medication. See also section 4.5. Do not administer for more than 3 consecutive days without careful medical evaluation.

Expiry and Retention

Store in the original container, protected from light.

Active principles

Each tablet contains: Active ingredient: paracetamol 500 mg. For the full list of excipients, see section 6.1.

Excipients

Magnesium stearate, corn starch, povidone.