Paracetamol Sella 500 mg Analgesic Antipyretic 30 Tablets

Paracetamol -based tablets for oral use.

Therapeutic indications

Paracetamol Sella 500 mg can be used:

• as an 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 and posology

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 Overdose).

• Children weighing between 21 and 25 kg (approximately between 6 and 10 years): ½ tablet at a time, to be repeated 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 the case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours.

Overdose

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.

The measures to be adopted consist of early gastric emptying and hospitalization for appropriate treatment, by administering N-acetylcysteine as an antidote as early as possible: the dosage is 150 mg / kg iv in a glucose solution in 15 minutes, then 50 mg / kg in the following 4 hours and 100 mg / kg in the following 16 hours, for a total of 300 mg / kg in 20 hours. In case of accidental ingestion / intake of an excessive dose of Paracetamol Sella, notify your doctor immediately or go to the nearest hospital.

Contraindications

Hypersensitivity to paracetamol or to any of the excipients.

Side effects

Like all medicines, Paracetamol Sella can cause side effects, although not everybody gets them. Below are the side effects of acetaminophen. There are insufficient data to establish the frequency of the individual effects listed:

• System disorders: blood and lymphatic thrombocytopenia, leukopenia, anemia, agranulocytosis
• Immune system disorders: Hypersensitivity reactions (skin rash with erythema or urticaria, angioedema, larynx edema, anaphylactic shock)
• Nervous system disorders: Vertigo
• Gastrointestinal disorders: Gastrointestinal reaction
• Hepatobiliary disorders: Abnormal liver function, hepatitis
• Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson syndrome, epidermal necrolysis, rash
• Renal and urinary disorders: acute renal failure, interstitial nephritis, haematuria, anuria.

Pregnancy and breastfeeding

Ask your doctor for advice before taking any medicine. Although clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol, nor caused undesirable effects affecting the mother or child, it is recommended to administer the product only in cases of actual need and under the direct control of the doctor.

Special warnings

In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted. 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 even serious changes in the kidney and blood, therefore administration in subjects with renal insufficiency must only be carried out if actually necessary and under the direct supervision of the 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, 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. Also, before combining any other drug, contact your doctor. See also “Interactions”. Do not administer for more than 3 consecutive days without consulting your doctor.

Do not administer for more than 3 consecutive days without consulting your doctor.

Important information about some of the ingredients: Lactose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Expiration and retention

Check the expiration date indicated on the package. Store at a temperature not exceeding 30 ° C. The expiry date refers to the product in unopened packaging, properly stored Warning: do not use the medicine after the expiry date indicated on the package.

Composition

One tablet of Paracetamol Sella 500 mg contains

Active principle

Paracetamol 500.

Excipients

Lactose, rice starch, polyvinylpyrrolidone, crospovidone, magnesium stearate, talc, colloidal silica.