EFFERALGAN * 16CPR EFF 500MG
Symptomatic treatment of mild to moderate pain and febrile conditions in adults and children. Symptomatic treatment of arthritic pain.
Dosage and method of use
Method of administration Oral use. Dissolve the tablet completely in a glass of water. Dosage EFFERALGAN 500 mg effervescent tablets are reserved for adults and children weighing more than 13 kg (approximately 2 years). In children, dosing regimens based on body weight must be respected and therefore the suitable formulation must be chosen. 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 each 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 equal to or greater than 15 kg. Children weighing between 21 kg and 25 kg (aged between 6 and 10 years approximately) The dosage is half a tablet each dose, 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 equal to or greater than 25 kg. Children weighing between 26 kg and 40 kg (aged between 8 and 13 years approximately) The dosage is 1 tablet for each 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 (aged between 12 and 15 years approximately) The dosage is 1 tablet for each administration, to be repeated, if necessary, after an interval of at least 4 hours without exceeding 6 tablets per day. Adults and adolescents with a body weight over 50 kg (about 15 years or older) The usual unit dosage is one tablet for each administration, to be repeated, if necessary, after an interval of at least 4 hours. 3 g of paracetamol per day, or 6 tablets per day, should not be exceeded, respecting an interval of at least 4 hours between doses. Adults In case of more intense pain, two tablets can be taken at a time for a maximum of 3 times a day (3 g of paracetamol), always respecting an interval of at least 4 hours between doses. Frequency of administration Regular dosing avoids fluctuating 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. Kidney failure In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between dosing 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 dosage of paracetamol should not exceed 3 g / day.
Hypersensitivity to paracetamol or propacetamol hydrochloride (precursor of paracetamol) or to any of the excipients.
Skin reactions of various types and severities have been reported with the use of paracetamol including cases of erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis. Hypersensitivity reactions such as angioedema, edema of the larynx, anaphylactic shock have been reported. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness. The table below lists the adverse reactions, some of which have already been mentioned above, associated with the administration of paracetamol, resulting from post-marketing surveillance. The frequency of adverse reactions listed below is unknown.
| Alterations of the blood and lymphatic system ||Thrombocytopenia, neutropenia, leukopenia |
| Alterations of the gastrointestinal system ||Diarrhea, abdominal pain |
| Alterations of the hepatobiliary system ||Increased liver enzymes |
| Alterations of the immune system ||Anaphylactic shock, Quincke's edema, hypersensitivity reactions |
| Diagnostic investigations ||Decrease of INR values, increase of INR values |
| Alterations of the skin and subcutaneous tissue ||Urticaria, erythema, rash |
| Alterations of the vascular system ||Hypotension (as a symptom of anaphylaxis) |
In the event of an overdose, paracetamol can cause hepatic cytolysis which can progress to massive and irreversible necrosis (see also section 4.9).
Paracetamol should be administered with caution to patients with mild to moderate hepatic insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh> 9), acute hepatitis, concomitant treatment with drugs that impair liver function, deficiency of glucose-6-phosphate-dehydrogenase, haemolytic anemia. Do not administer during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect. Paracetamol should be administered with caution in subjects with renal insufficiency (creatinine clearance ≤ 30 ml / min). Use with caution in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low reserves of hepatic glutathione), dehydration, hypovolemia. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions can occur. Instruct the patient to contact the doctor before combining any other medication. See also section 4.5. High or prolonged doses of the product can cause high-risk liver disease and alterations, even serious ones, to the kidney and blood. In case of prolonged use it is advisable to monitor the liver and kidney function and the blood count. In case of allergic reactions the administration should be suspended. Important warnings about some excipients This medicine contains: • 412.4 mg of sodium (equivalent to 18 mEq) per tablet. To be considered for administration in patients with impaired renal function or on a low sodium diet. • sorbitol: use with caution in patients with rare hereditary problems of fructose intolerance.
Pregnancy and breastfeeding
Clinical experience with the use of paracetamol during pregnancy and lactation is limited. Pregnancy Epidemiological data on the use of therapeutic doses of oral paracetamol indicate that no undesirable effects occur in pregnant women or on the health of the fetus or newborns. Reproductive studies with paracetamol did not reveal any malformation or foetotoxic effects. However, paracetamol should only be used during pregnancy after careful consideration of the risk / benefit ratio. In pregnant patients, the recommended posology and duration of treatment should be strictly observed. Feeding time Paracetamol is excreted in small quantities in breast milk. Rash has been reported in breast-fed infants. However, administration of paracetamol is considered compatible with breastfeeding. However, caution should be used when administering paracetamol to breastfeeding women.
Expiration and retention
This medicine does not require any special storage conditions.
Interactions with other drugs
Paracetamol can increase the chance of side effects if given at the same time as other drugs. The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). In the course of therapy with oral anticoagulants it is recommended to reduce the doses. Monooxygenase inducing drugs Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases 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 being treated with phenytoin should avoid 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 dose reduction of paracetamol should be considered when administered concomitantly with probenecid. Salicylamide Salicylamide can prolong the elimination half-life (t½) of paracetamol.
There is a risk of intoxication, especially in patients with liver disease, in the case of chronic alcoholism, in patients with 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 body weight in children causes hepatic cytolysis which can progress to complete and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy, which can lead to coma and death. At the same time, increased levels of hepatic transaminases (AST, ALT), lactic dehydrogenase and bilirubin are observed, together with a decrease in the prothrombin value, which may occur 12 to 48 hours after administration. Clinical symptoms of liver damage usually manifest themselves after a day or two, and peak after 3-4 days. Emergency measures • Immediate hospitalization. • Before starting treatment, take a blood sample to determine plasma paracetamol levels as soon as possible, but not 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. The NAC can, however, give some degree of protection even after 16 hours. • Symptomatic treatment. Liver tests should be performed at the start of treatment and will be repeated every 24 hours. In most cases, hepatic transaminases return to normal within one to two weeks with a full recovery of liver function. In very severe cases, however, liver transplantation may be necessary.
One tablet contains: Active principle: paracetamol 500 mg. For the full list of excipients, see section 6.1.
Citric acid, sodium carbonate, sodium bicarbonate, sorbitol, sodium saccharinate, sodium docusate, povidone, sodium benzoate.