Efferalganmed - fever treatment 16 effervescent tablets

Product Description

Symptomatic treatment of arthritic pain.

Indications

Efferalganmed symptomatic treatment of mild to moderate pain and feverish conditions 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 Efferalganmed effervescent tablets are 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 (approximately 2 to 7 years old) 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 21 kg to 25 kg (approximately 6 to 10 years old) 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 26 kg to 40 kg (approximately 8 to 13 years old) 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 41 kg to 50 kg (approximately 12 to 15 years old) 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 or older) The usual dosage is one tablet per administration, to be repeated, if necessary, after an interval of at least 4 hours. The dose should not exceed 3 g of paracetamol per day, i.e. 6 tablets per day, respecting an interval of at least 4 hours between administrations. Adults: In case of more intense 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 administrations. Frequency of administration Regular administrations avoid fluctuations in pain levels or fever. 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 between administrations should always be respected. Renal impairment In case of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between administrations must 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.

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, haemolytic anaemia. Do not administer 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. 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, or hypovolemia. During treatment with paracetamol, before taking any other medication, check that it does not contain the same active ingredient, as serious adverse reactions may occur if paracetamol is taken in high doses. Instruct the patient to contact their 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, 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 excipients This medicine contains: 412.4 mg of sodium (equivalent to 18 mEq) per tablet. To be taken into consideration when administering it to patients with reduced renal function or on a low-sodium diet. Sorbitol: use with caution in patients with rare hereditary problems of fructose intolerance.

Contraindications and side effects

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

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. Additionally, 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 evolve into massive and irreversible necrosis

Interactions

Paracetamol can increase the possibility of adverse effects if administered simultaneously with other drugs. The administration of paracetamol can increase the possibility of adverse effects if administered simultaneously with other drugs. interfere with the determination of uric acid (using the phosphotungstic acid method) and blood glucose (using the glucose-oxidase-peroxidase method). During therapy with oral anticoagulants, it is advisable to reduce the dose. Monooxygenase-inducing drugs Use 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 (t12) of paracetamol.

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 can be fatal. 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 appear 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, 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. 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 malformative 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 medicinal product does not require any special storage conditions.

Format

16 effervescent tablets.