Efferalgan 500 mg 30 paracetamol coated tablets

The paracetamol It is the most used painkiller and fever reducer in the world, and the reason lies in what it does not do: unlike NSAIDs it does not act on the stomach mucosa, so it is the usual choice for those who have problems with aspirin or ibuprofen. Efferalgan is paracetamol 500 mg in film-coated tablets, to be swallowed whole with a glass of water.

The RCP sets two numbers that are worth keeping in mind. The first is theminimum interval between one administration and another: four hours for adults and adolescents over 40 kg, six hours for children between 26 and 40 kg. The second is the daily cap: three grams per day in adults, i.e. six tablets, and two grams in those weighing less than 50 kg, in those with liver problems, in Gilbert's syndrome, in chronic alcoholism, in malnutrition and dehydration.

There is a third number, and it is the most important: 26kg. Under that weight, which corresponds to approximately eight years of age, this formulation should not be used, because the dose of one tablet is too high and forms designed for small children are needed.

The warning that the RCP repeats several times concerns the involuntary double dosage. Paracetamol is in many over-the-counter products for colds and flu, often without the name telling it: adding two different packages is the most common way to go over the top without realizing it, and the damage to the liver from an overdose of paracetamol can be serious. It is worth looking at the composition of everything you are taking.

This is the pack from 30 tablets.

INDICATIONS

Why is Efferalgan 500 mg 30 paracetamol coated tablets used? What is it for?

Symptomatic treatment of mild to moderate pain and febrile conditions in adults and children.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Efferalgan 500 mg 30 paracetamol coated tablets?

Composition

One tablet contains active ingredient: paracetamol 500 mg.

Excipients

Hypromellose, povidone, croscarmellose sodium, microcrystalline cellulose, glyceryl benate, magnesium stearate.

DOSAGE

How to take Efferalgan 500 mg 30 paracetamol coated tablets?

To avoid the risk of overdose, check that other medicines administered (with or without a prescription) do not contain paracetamol ((see the section "What are the warnings of Efferalgan 500 mg 30 paracetamol coated tablets?" and "Which medicines or foods can modify the effect of Efferalgan 500 mg 30 paracetamol coated tablets?")). An accidental overdose of paracetamol can cause serious liver damage and death ((see the section "What are the warnings of Efferalgan 500 mg 30 paracetamol coated tablets?")). Dosage Efferalgan 500 mg tablets are reserved for adults and children weighing more than 26 kg (approximately 8 years or more). In children, the dosage schedules based on body weight must be respected and therefore it is necessary to choose the suitable formulation. The correspondence between age and weight is only indicative. Adults 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. In case of more intense pain, 2 tablets can be taken each administration for a maximum of 3 times a day, always respecting an interval of at least 4 hours between administrations. Pediatric population Children with a body weight between 26 kg and 40 kg (age between approximately 8 and 13 years): 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 with a body weight greater than 40 kg (approximately 12 years or more): the dosage is 1 tablet each administration, to be repeated, if necessary, after an interval of at least 4 hours without exceeding 6 tablets per day. Frequency of administration Regular administrations avoid fluctuations in pain or fever levels. • In children the interval between administrations must 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 between administrations must always be respected. Maximum recommended dosage In adults and adolescents weighing more than 40 kg, the total dosage of paracetamol should not exceed 3 g per day. Renal insufficiency In case of severe renal insufficiency (creatinine clearance less than 10 ml/min), the interval between administrations must be at least 8 hours. Hepatic impairment In patients with hepatic impairment, the dose should be reduced or the interval between administrations prolonged. The maximum daily dose of paracetamol must not exceed 2 g in the following cases: • adults weighing less than 50 kg; • chronic or compensated active liver disease, particularly those with mild to moderate hepatic impairment; • Gilbert's syndrome (familial hyperbilirubinemia); • chronic alcoholism; • chronic malnutrition (low hepatic glutathione reserves); • dehydration. Duration of treatment After 3 consecutive days of treatment, medical evaluation is necessary. Method of administration Oral use. Swallow the tablet whole with a glass of water.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Efferalgan 500 mg 30 coated tablets paracetamol not be used and what side effects can it cause?

Contraindications

Hypersensitivity to paracetamol or propacetamol hydrochloride (precursor of paracetamol) or to any of the excipients (see section "What is the composition of Efferalgan 500 mg 30 coated tablets paracetamol?").

Side effects

The table below lists the adverse reactions associated with the administration of paracetamol, resulting from post-marketing surveillance. Adverse reactions are listed by System Organ Class, using MedDRA terminology (including PT). The frequency of the adverse reactions listed below is not known. System and Organ Classification MedDRA Terms Pathologies of the blood and lymphatic system Thrombocytopenia, Neutropenia, Agranulocytosis, Leukopenia, Anemia Gastrointestinal disorders Diarrhoea, Abdominal pain, Gastrointestinal reactions Hepatobiliary disorders Hepatic failure, Hepatic necrosis, Hepatitis, Impaired liver function Immune system disorders Anaphylactic reaction, Anaphylactic shock, Angioedema, Hypersensitivity, Laryngeal edema Diagnostic tests Abnormal INR ((see section "Which medicines or foods can modify the effect of Efferalgan 500 mg 30 coated tablets paracetamol?")), Increased liver enzymes Pathologies of the skin and subcutaneous tissue Urticaria, Erythema, Erythema multiforme, Rash, Acute generalized exanthematous pustulosis, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Purpura Nervous system disorders Headache Ear and labyrinth disorders Vertigo Vascular pathologies Hypotension (especially following anaphylaxis) Renal and urinary disorders Acute renal failure, Interstitial nephritis, Hematuria, Anuria Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.

INTERACTIONS

Which medicines or foods can modify the effect of Efferalgan 500 mg 30 paracetamol coated tablets?

Paracetamol may increase the chance of side effects if administered at the same time as other medications. Diagnostic tests The administration of paracetamol can interfere with the determination of uricemia (using the phosphotungstic acid method) and with that of glycemia (using the glucose-oxidase-peroxidase method). Anticoagulants Concomitant use of paracetamol with coumarins, including warfarin, may lead to changes in INR values. In such cases, stricter monitoring of INR values should be carried out during concomitant use and after discontinuation of treatment with paracetamol. Monooxygenase-inducing drugs Use with extreme caution and under close control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have such an effect (e.g. rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). Phenytoin Concomitant administration of phenytoin may result in decreased efficacy of paracetamol and an increased risk of hepatotoxicity. Patients being treated with phenytoin should avoid taking high and/or chronic doses of paracetamol. Patients should be monitored for evidence of hepatotoxicity. Probenecid Probenecid causes an at least two-fold reduction in paracetamol clearance through inhibition of its conjugation with glucuronic acid. A reduction in the dose of paracetamol should be considered if administered simultaneously with probenecid. Salicylamide Salicylamide can prolong the elimination half-life (t1/2) of paracetamol. Flucloxacillin Caution is required when paracetamol is administered concomitantly with flucloxacillin, due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with a risk factor for glutathione deficiency such as severe renal impairment, sepsis, malnutrition and chronic alcoholism. Careful monitoring is recommended for the onset of acid-base disorders, particularly HAGMA, including testing for urinary 5-oxoproline. Concomitant administration with chloramphenicol may induce an increase in the half-life of paracetamol, with the risk of increasing its toxicity. Drugs that slow gastric emptying (e.g. anticholinergics) can cause antral stasis, delaying the absorption of paracetamol and therefore the onset of the analgesic effect. Use with extreme caution in patients treated with zidovudine.

PREGNANCY AND BREASTFEEDING

Can Efferalgan 500 mg 30 paracetamol coated tablets be used during pregnancy and breastfeeding?

Clinical experience with the use of paracetamol during pregnancy and breastfeeding is limited. Pregnancy A large amount of data on pregnant women indicates neither malformation nor fetal/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Breastfeeding Paracetamol is excreted in small quantities 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 used when administering paracetamol to breastfeeding women.

WARNINGS

What are the warnings of Efferalgan 500 mg 30 paracetamol coated tablets?

Warnings and precautions

During treatment with paracetamol, before prescribing any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Invite the patient to contact the doctor before combining any other medicine (with or without a medical prescription) ((see the section "Which medicines or foods can modify the effect of Efferalgan 500 mg 30 paracetamol coated tablets?")). In case of chronic treatment with drugs that can cause the induction of hepatic monooxygenases or exposure to substances that can have this effect (see the section "Which medicines or foods can modify the effect of Efferalgan 500 mg 30 paracetamol coated tablets?"). High or prolonged doses of the product can cause high-risk liver disease and alterations, even serious, of the kidney and blood. In case of prolonged use it is advisable to monitor liver and kidney function and blood count. Paracetamol should be administered with caution in the following cases: • patients with mild to moderate hepatic insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh >9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia; • patients with renal failure; • chronic alcoholism, anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia. Consumption of alcohol during therapy is not recommended. Prolonged (continued or repeated) use of analgesics (>3 months) in patients with chronic headache may increase or worsen headache. Medication-Overuse Headache (MOH) should not be treated by increasing the dosage. In these cases, medical evaluation is necessary. Paracetamol can cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Patients should be informed of the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Important information about some excipients Efferalgan film-coated tablets contain less than 1 mmol (23 mg) sodium per tablet, i.e. essentially "sodium-free".

Overdose

There is a risk of intoxication, especially in patients with liver disease, in cases of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal. Symptoms generally appear within the first 24 hours and include: nausea, vomiting, anorexia, paleness, 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 which may progress to complete and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy, which may lead to coma and death. At the same time, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed, together with a decrease in the prothrombin value, which can appear 12 to 48 hours after administration. Clinical symptoms of liver damage usually appear after 1 or 2 days, and reach a maximum after 3 or 4 days. Rare cases of acute pancreatitis have been observed. Emergency measures: • Immediate hospitalization; • Before starting treatment, take a blood sample to determine plasma levels of paracetamol, as soon as possible, but not earlier than 4 hours after the overdose; • Rapid elimination of paracetamol through 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 can, however, give some degree of protection even after 16 hours; • Symptomatic treatment. Liver tests should be carried out at the start of treatment and will be 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, a liver transplant may be necessary.

Driving vehicles and using machinery

The medicine does not alter the ability to drive or use machines.

CONSERVATION

How is Efferalgan 500 mg 30 paracetamol coated tablets stored?

This medicinal product does not require any special storage conditions.

FORMAT

What is the format of Efferalgan 500 mg 30 paracetamol coated tablets?

30 film-coated tablets of 500 mg, in AL/PVC blister.

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

Please note

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