Paracetamolo 500 mg - analgesic antipyretic 16 effervescent tablets

Product Description

Symptomatic treatment of pain due to fever or arthritic causes.

Indications

Efferalgan 500 mg is indicated for the symptomatic treatment of mild to moderate pain and fever in adults and children.

Composition

Active ingredients

Paracetamol 500 mg.

Excipients

Citric acid, sodium carbonate, sodium bicarbonate, sorbitol, sodium saccharinate, sodium docusate, povidone, sodium benzoate.

Directions for use and dosage

Method of administration Oral use. Dissolve the tablet completely in a glass of water.
Dosage Efferalgan 500 mg effervescent tablets is reserved for adults and children weighing more than 13 kg (approximately 2 years).
In children, dosage schedules based on body weight must be followed and therefore it is necessary to choose the appropriate formulation. The correspondence between age and weight is only indicative.  ​​
Children weighing between 13 kg and 20 kg (aged between 2 and 7 years approximately) The dosage is half a tablet per administration, to be repeated, if necessary, after an interval of at least 6 hours, without exceeding 3 half tablets per day for children weighing less than 15 kg and 4 half tablets per day for children weighing 15 kg or more.
Children weighing between 21 kg and 25 kg (approximately 6 to 10 years of age) The dosage is half a tablet per administration, to be repeated, if necessary, after an interval of at least 6 hours, without exceeding 5 half tablets per day for children weighing less than 25 kg and 6 half tablets per day for children weighing 25 kg or more.
Children weighing between 26 kg and 40 kg (approximately 8 to 13 years of age) The dosage is 1 tablet per administration, to be repeated, if necessary, after an interval of at least 6 hours, without exceeding 4 tablets per day.
Adolescents weighing between 41 kg and 50 kg (approximately 12 to 15 years of age) The dosage is 1 tablet per administration, to be repeated, if necessary, after an interval of at least 4 hours, without exceeding 6 tablets per day. 
Adults and adolescents weighing more than 50 kg (approximately 15 years of age or older) The usual unit dosage is one tablet per administration, to be repeated, if necessary, after an interval of at least 4 hours. 3 g of paracetamol per day, i.e. 6 tablets per day, should not be exceeded, respecting an interval of at least 4 hours between administrations.
Adults For more severe pain, two tablets can be taken at a time up to 3 times a day (3 g of paracetamol), always respecting an interval of at least 4 hours between doses. 
Frequency of administration Regular administrations prevent fluctuations in pain or fever levels:

• In children, the interval between administrations should be regular, both day and night, and should preferably be at least 6 hours.
• In adults and adolescents, an interval of at least 4 hours should always be respected between administrations.

Renal impairment In case of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between administrations should be at least 8 hours.
Do not exceed 3 g of paracetamol per day, i.e. 6 tablets.
Maximum recommended dosage In adults and adolescents weighing more than 40 kg, the total dose of paracetamol should not exceed 3 g/day.

Warnings

Paracetamol should be administered with caution to patients with mild to moderate hepatic impairment (including Gilbert's syndrome), severe hepatic impairment (Child-Pugh >9), acute hepatitis, concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, or hemolytic anemia.
Do not administer during chronic treatment with drugs that can induce hepatic monooxygenase activity or in case of exposure to substances that can have this effect.
Paracetamol should be administered with caution in patients with renal insufficiency (creatinine clearance ≤ 30 ml/min).
Use with caution in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia.
During treatment with paracetamol, before taking any other medication, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions can occur.
Instruct the patient to contact their doctor before combining any other medication.
High or prolonged doses of the product can cause high-risk liver disease and alterations, even serious, to the kidneys and blood.
In case of prolonged use, it is advisable to monitor liver and kidney function and blood count.
In case of allergic reactions, administration must be suspended.
Important warnings about some of the excipients This medicine contains:

• 412.4 mg of sodium (equivalent to 18 mEq) per tablet. To be taken into consideration when administering this medicine to patients with reduced kidney function or on a controlled sodium diet.
• Sorbitol: Use with caution in patients with rare hereditary problems of fructose intolerance.

Contraindications

Hypersensitivity to paracetamol or propacetamol hydrochloride (paracetamol precursor) or to any of the excipients.

Interactions

Paracetamol may increase the likelihood of adverse effects when administered concomitantly with other drugs.
The administration of paracetamol may interfere with the determination of uric acid levels (using the phosphotungstic acid method) and blood glucose levels (using the glucose-oxidase-peroxidase method).
During therapy with oral anticoagulants, it is advisable to reduce the doses.
Drugs that induce monooxygenaseUse with extreme caution and under close supervision during chronic treatment with drugs that can induce hepatic monooxygenase or in case of exposure to substances that can have this effect (for example, rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine).
Phenytoin Concomitant administration of phenytoin may result in decreased efficacy of paracetamol and an increased risk of hepatotoxicity.
Patients treated with phenytoin should avoid taking high and/or chronic doses of paracetamol. Patients should be monitored for evidence of hepatotoxicity.
Probenecid Probenecid causes at least a two-fold reduction in paracetamol clearance by inhibiting its conjugation with glucuronic acid.
A reduction in the paracetamol dose should be considered if administered concomitantly with probenecid.
Salicylamide Salicylamide may prolong the elimination half-life (t_½) of paracetamol.

Undesirable effects

Skin reactions of various types and severity have been reported with the use of paracetamol, including cases of erythema multiforme, Stevens-Johnson syndrome, and epidermal necrolysis.
Hypersensitivity reactions such as angioedema, laryngeal edema, and anaphylactic shock have been reported.
In addition, the following adverse reactions have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, renal disorders (acute renal failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions, and dizziness.

The table below lists adverse reactions, some of which have already been mentioned, associated with the administration of paracetamol, resulting from post-marketing surveillance.
The frequency of the adverse reactions listed below is unknown.

In case of overdose, paracetamol can cause hepatic cytolysis, which can progress to massive and irreversible necrosis.

Overdose

There is a risk of intoxication, especially in patients with liver disease, chronic alcoholism, chronically malnourished patients, and patients receiving enzyme inducers.
In these cases, overdose can be fatal.
Symptoms generally appear within the first 24 hours and include nausea, vomiting, anorexia, pallor, malaise, and diaphoresis.
Overdose with acute ingestion of 7.5 g or more of paracetamol in adults and 140 mg/kg of body weight in children causes hepatic cytolysis that can progress to complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis, and encephalopathy, which can lead to coma and death.
Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase, and bilirubin are observed, along with a decrease in prothrombin time, which can occur 12 to 48 hours after administration. Clinical symptoms of liver damage usually appear after one or two days and reach a maximum after 3–4 days.
Emergency measures:

• Immediate hospitalization.
• Before starting treatment, draw a blood sample to determine plasma paracetamol levels as soon as possible, but no earlier than 4 hours after the overdose.
• Rapid elimination of paracetamol by gastric lavage.
• Treatment following an overdose includes administration of the antidote, N-acetylcysteine ​​(NAC), intravenously or orally, if possible, within 8 hours of ingestion. NAC may, however, provide some degree of protection even after 16 hours.
• Symptomatic treatment. Liver tests should be performed at the start of treatment and repeated every 24 hours. In most cases, liver transaminases return to normal within one to two weeks, with full recovery of liver function. In very severe cases, however, liver transplantation may be necessary.

Pregnancy and breastfeeding

Clinical experience with the use of paracetamol during pregnancy and breastfeeding is limited.
Pregnancy Epidemiological data on the use of therapeutic doses of oral paracetamol indicate that no adverse effects occur in pregnant women or on the health of the fetus or newborns.
Reproductive studies with paracetamol have not revealed any malformations or fetotoxic effects.
Paracetamol should, however, be used during pregnancy only after careful risk/benefit assessment.
In pregnant patients, the recommended dosage and duration of treatment must be strictly observed.
Breastfeeding Paracetamol is excreted in small amounts in breast milk.
Rash has been reported in breast-fed infants.
However, the administration of paracetamol is considered compatible with breastfeeding.
Caution should, however, be exercised when administering paracetamol to breastfeeding women.

Storage

This medicine does not require any special storage conditions.

Format

16 effervescent tablets.