Descrizione Clinica
EFFERALGAN 500 MG COMPRESENT EFFERENCES
active ingredients
An effervescent tablet contains Active ingredient: 500 mg paracetamol. Excipients with known effects: sodium 412,27 mg; sorbitol (E420) 300 mg; benzoate sodium (E211) 60,606 mg. For the full list of excipients, see paragraph 6.1.Excellent
Citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E420), , sodium docusato, povidone, sodium sactarinated, sodium benzoate (E211).Therapeutic indications
Symptomatic treatment of mild to moderate pain and fever conditions in adults and children.Contraindications
Hypersensitivity to paracetamol or acetamol hydrochloride (paracetamol precursor) or any of the excipients listed in paragraph 6.1.Population
To avoid the risk of overdose, check that other medications administered (with or without a prescription) do not contain paracetamol (see paragraph 4.4 and 4.5). An accidental overdose of paracetamol can cause severe liver damage and death (see paragraph 4.9). Population Efferalgan 500 mg effervescent tablets is reserved for adults and children weighing more than 13 kg (about 2 years). In children the posologic patterns must be respected according to body weight and therefore it is necessary to choose the suitable formulation. The correspondence between age and weight is only an orientation. Adults The dosage is 1 effervescent tablet each administration, to be repeated, if necessary, after a interval of at least 4 hours without exceeding the 6 tablets per day. In case of more intense pain, 2 effervescent tablets may be taken for up to 3 times a day, always respecting a range of at least 4 hours between administrations. Pediatric population Body weight children between 13 kg and 20 kg (age between 2 and 7 years): the dosage is half-compressed effervescent every administration to be repeated, if necessary, after a interval of at least 6 hours, without exceeding the 3 half tablets effervescent per day for children weighing less than 15 kg and the 4 half tablets effervescent per day for children weighing equal to or greater than 15 kg. Bodyweight children between 21 kg and 25 kg (age between 6 and 10 years): the dosage is half-compressed effervescent every administration to be repeated, if necessary, after a interval of at least 6 hours, without exceeding the 5 half tablets effervescent per day for children weighing less than 25 kg and the 6 half tablets effervescent per day for children weighing equal to or greater than 25 kg. Bodyweight children between 26 kg and 40 kg (age between 8 and 13 years): the dosage is of 1 effervescent tablet each administration to be repeated, if necessary, after a interval of at least 6 hours, without exceeding the 4 effervescent tablets per day. Teenagers weighing more than 40 kg (about 12 years or more): the dosage is 1 effervescent tablet each administration to be repeated, if necessary, after a interval of at least 4 hours without exceeding the 6 effervescent tablets per day. Frequency of administration Regular administrations avoid the oscillation of pain or fever levels. • In children the interval between administrations must be regular, both day and night, and must be preferably at least 6 hours. • In adults and adolescents, a range of at least 4 hours between administrations is always required. Recommended maximum dosage In adults and adolescents weighing more than 40 kg, the total dose of paracetamol should not exceed 3 g per day. Renal insufficiency In case of severe renal failure (creatiny clearance less than 10 ml/min), the interval between administrations must be at least 8 hours. Epathetic Comprogation In patients with liver impairment, the dose must be reduced or the interval between prolonged administrations. The maximum daily dose of paracetamol should not exceed 2 g in the following cases: • adults weighing less than 50 kg; • chronic or compensated active hepatopathy, especially those with mild to moderate liver failure; • Gilbert syndrome (family hyperbilirubinemia); • chronic alcoholism; • chronic malnutrition (low liver glutathione reserves); • dehydration. Duration of treatment After 3 consecutive days of treatment, medical evaluation is required. Method of administration Oral use. Dissolve completely the effervescent tablet in a glass of water. Do not chew or swallow the whole tablet.Conservation
This medicine does not require any special condition of conservation.Warnings
During treatment with paracetamol before prescribing any other medication, check that it does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medication (with or without a prescription) (see paragraph 4.5). In case of chronic treatment with drugs that can determine the induction of liver monooxidases or exposure to substances that may have such an effect, see paragraph 4.5. High or prolonged doses of the product may result in a high-risk hepatopathy and even serious alterations to the kidney and blood. In case of protracted use it is advisable to monitor the liver and renal function and the blood crasis. Paracetamol should be given with caution in the following cases: • patients with mild to moderate liver failure (including Gilbert syndrome), severe liver failure (Child-Pugh >9), acute hepatitis, in treatment with drugs that alter liver function, glucose-6-phosphate-dehydrogenase deficiency, hemolytic anemia; • patients with kidney failure; • chronic alcoholism, anorexia, bulimia or cachessia, chronic malnutrition (low liver glutathione reserves), dehydration, hypovolemia. Alcohol consumption during therapy is not recommended. Prolonged (continuous or repeated) use of analgesics (>3 months) in patients with chronic headache can increase or worsen cephalea. The headache induced by excessive use of analgesics (MOH - Medication-Overuse Headache) should not be treated with an increase in dosage. In these cases, medical evaluation is necessary. Paracetamol can cause severe skin reactions such as generalized acute acute exantelosis, Stevens-Johnson syndrome and epidermal toxic necrolysis, which can be fatal. Patients should be informed about signs of severe skin reactions, and the use of the drug should be stopped at the first appearance of skin rash or any other sign of hypersensitivity. In case of allergic reactions, the administration must be suspended. Important information about some excipients This medicine contains: • 412.27 mg of sodium per tablet, equivalent to about 20% of the maximum daily intake recommended by WHO, which corresponds to 2 g sodium for an adult. This medicine is therefore considered to be high in sodium. To be considered in patients who follow 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 given this medicine; • 60,606 mg of benzoate sodium (E211) per tablet, equivalent to 60,606 mg/3257 mg.Interactions
Paracetamol may increase the possibility of undesirable effects if administered simultaneously to other drugs. Diagnostic examinations Paracetamol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Antiagulants Concurrent use of paracetamol with cumarinics, including warfarin, can lead to variations of INR values. In such cases, a more rigid monitoring of INR values must be carried out during concurrent use and after termination of treatment with paracetamol. Monooxidase inductors Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of liver monooxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutethymids, phenobarbital, carbamazepine). Fenitoin Concurrent administration of phenytoin may result in a decreased effectiveness of paracetamol and in an increased risk of hepatotoxicity. Patients in treatment with phenytoin should avoid high doses and/or paracetamol chronics. Patients must be monitored in case of evidence of hepatotoxicity. Probenecid The probenecid causes a reduction of at least twice of paracetamol clearance through the inhibition of its conjugation with glucuronic acid. A reduction in the dose of paracetamol should be considered if administered simultaneously to probenecid. Salicilamide Salicylamide can prolong elimination half-life (t1/2Paracetamol. Flucloxacillin Precaution is required when paracetamol is administered in conjunction with flucloxacillin, due to increased risk of metabolic acidosis with high anionic gap (HAGMA), especially in patients with a risk factor for glutathione deficiency as severe kidney failure, sepsis, malnutrition and chronic alcoholism. Careful monitoring is recommended to detect the occurrence of acid-base balance disorders, especially HAGMA, including the search for 5-oxoproline urinary. Concurrent administration with chloramphenicol can induce an increase in the half-life of paracetamol, with the risk of increasing its toxicity. Drugs that slow gastric emptying (p.e. anticholinergics) can determine antral stasis by delaying the absorption of the paracetamol and therefore the onset of the analgesic effect. Use with extreme caution in patients treated with zidovudine.Effects
The table below lists adverse reactions associated with paracetamol administration, resulting from surveillance after marketing. Adverse reactions are listed according to the Classification for System and Organs, using the MedDRA terminology (inserting the PT). The frequency of adverse reactions shown below is not known.| Classification for Systems and Organs | Terms MedDRA |
| Emolinfopoietic system pathologies | Trombocytopenia, Neutropenia, Agranulocytosis, Leucopenia, Anemia |
| Gastrointestinal diseases | Diarrhea, abdominal pain, gastrointestinal reactions |
| Hepatobiliary diseases | Hepatic insufficiency, Hepatic Necrosis, Hepatitis, Alteration of liver function |
| Immune system disorders | Anaphylactic reaction, Anaphylactic shock, Angioedema, Hypersensitivity, Laryngeal edema |
| Diagnostic examinations | Abnormal INR (see paragraph 4.5), increased liver enzymes |
| Pathologies of skin and subcutaneous tissue | Orticaria, Eritema, Multiform Erythema, Eruption of the skin, Acute Exantematic Pustolosis Generalized, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Porpora |
| Nervous system disorders | Cefa |
| Ear and labyrinth pathologies | Vertigo |
| Vascular diseases | Hypotension (especially as a result of anaphylaxis) |
| Kidney and urinary pathologies | Acute renal insufficiency, Interstitial Nephritis, Ematuria, Anuria |
Overdosing
There is a risk of intoxication, especially in patients with liver disease, in case of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inductors. 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 body weight in children causes liver cytolysis that can evolve towards complete and irreversible necrosis, which involves hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. At the same time, increased levels of hepatic transaminasis (AST, ALT), dehydrogenase lactic and bilirubin are observed, along with a decrease in the value of protrombine, which can be shown from 12 to 48 hours after administration. Clinical symptoms of liver damage usually occur after one or two days, and reach the maximum after 3-4 days. Rare cases of acute pancreatis have been observed. Emergency measures • Immediate Ospedalization; • Before starting the treatment take a blood sample to determine the plasma levels of paracetamol as soon as possible, but not before 4 hours after overdose; • Quick removal of the paracetamol by gastric lavender; • Treatment following overdose includes the administration of antidote, N-acetylcysteine (NAC), intravenous or oral, if possible, within 8 hours of ingestion. The NAC can, however, give a certain degree of protection even after 16 hours; • Syntomatic treatment. Hepatic tests must be carried out at the beginning of the treatment, which will be repeated every 24 hours. In most cases, hepatic transaminers return to the norm in one or two weeks with a full resumption of liver function. In very serious cases, however, liver transplant may be necessary.The clinical experience with the use of paracetamol during pregnancy and nursing is limited.
Pregnancy
A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible.Food
Paracetamol is excreted in small amounts in breast milk. It was reported rash in breast milk breast-feededed children. However, paracetamol administration is considered compatible with breast milk. It must, however, be used caution in administering paracetamol to nursing women.Source: Farmadati
