Efferalgan 500mg 16 effervescent tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

Hypersensitivity to paracetamol or propacetamol hydrochloride (precursor of paracetamol) or to any of the excipients listed in section 6.1.

WARNINGS AND PRECAUTIONS FOR USE

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 drug (with or without a prescription) (see section 4.5). 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 section 4.5. 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. In case of allergic reactions, administration should be suspended. Important information about some excipients This medicine contains: • 412.27 mg sodium per tablet, equivalent to approximately 20% of the WHO recommended maximum daily intake, which corresponds to 2 g sodium for an adult. This medicine is therefore considered to be high in sodium. To be taken into consideration in patients following a low sodium diet; • 300 mg of sorbitol (E420) per tablet equivalent to 300 mg/3257 mg: patients with hereditary fructose intolerance should not be administered this medicine; • 60.606 mg sodium benzoate (E211) per tablet, equivalent to 60.606 mg/3257 mg.

INTERACTIONS

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 uric acid (using the phosphotungstic acid method) and with that of blood sugar (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, closer monitoring of INR values ​​should be performed during concomitant use and after discontinuation of paracetamol treatment. Monooxygenase-inducing drugs Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example 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 may prolong the elimination half-life (t_1/2) 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.

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 | INR abnormal (see section 4.5), Liver enzymes increased

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”.