Acetamol - syrup for flu treatment in kids 2,5% 100 ml

Product Description

Syrup for early childhood.

Indications

Acetamol is a syrup useful for the symptomatic treatment of fever and mild to moderate pain.

Ingredients

1 ml of syrup contains:

• Active ingredient: paracetamol 25 mg
• Excipients: Macrogol 6000, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, dibasic sodium phosphate dihydrate, monobasic sodium phosphate dihydrate, strawberry cream flavouring, purified water.

Dosage and Directions for Use

Under three months, in case of jaundice, it is advisable Reduce the single dose orally. For children, it is essential to respect the dosage defined based on their body weight and therefore choose the appropriate formulation. Use the medicine only after consulting your doctor and follow his instructions regarding the dose and duration of treatment. The package contains a 5 mL measuring syringe for oral administration, graduated with 0.5 ml marks; one mark corresponds to 12.5 mg of paracetamol.

Dosage of Acetamol Early Childhood Syrup

• Children up to 18 months and weighing more than 3 kg: Normally, you can take 12.5 mg of paracetamol. The dose of 25 mg can be administered for every 2 kg of weight, corresponding to 1 milliliter (mL) of syrup every 6 hours (never less than 4 hours between one dose and the next).
• Children over 18 months and weighing more than 11 kg: Normally, the dose of 25 mg can be administered for every 2 kg of weight, corresponding to 1 milliliter (mL) of syrup every 4 hours (never less than 4 hours between one dose and the next).

Acetamol early childhood 25 mg/mL syrup can be taken by children of any age by calculating the correct dose based on their weight. However, the medicine is identified as Early Childhood because, being packaged in 100 mL bottles, it can be taken by children of any age. may be insufficient for children weighing more than 15 kg and cannot cover an adequate number of days of treatment.

Warnings

Consult your doctor before administering the medicine to a child.

Interactions

The oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, the concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying can lead to a decrease or increase, respectively, in the bioavailability of the product. The concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can lead to an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Concomitant use of paracetamol (4 g daily for at least 4 days) with oral anticoagulants may cause slight variations in INR values. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. The drug should be used with caution in patients undergoing therapy with tranquilizers and antidepressants. 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). The same applies in cases of alcoholism and in patients treated with zidovudine. Paracetamol administration may interfere with the determination of uric acid levels (using the phospho-tungstic acid method) and blood glucose levels (using the glucose-oxidase-peroxidase method). Interactions with substances used as antidotes are known and are reported in section 4.9. Undesirable effects 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. The following undesirable effects have also been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, changes in liver function and hepatitis, changes in kidney function (acute renal failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions, and dizziness. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Overdose Paracetamol in massive doses can cause hepatotoxicity, therefore in cases of suspected accidental ingestion of high doses of the medicinal product, it is advisable to hospitalize the patient. In case of overdose, paracetamol can cause hepatic cytolysis, which can progress to massive and irreversible necrosis. Symptoms of overdose generally appear within 24 hours and include vomiting, anorexia, nausea, and epigastric pain; clinical and laboratory data attesting to hepatotoxicity are evident within 48–72 hours of ingestion. In adults, liver toxicity is rarely reported with acute overdoses of less than 10 g. It is fatal when the overdose is 15 g or more. Children appear to be less sensitive than adults to the hepatotoxic effect of paracetamol. The recommended treatment, in addition to common practices (gastric lavage or induced emesis), consists of administering the antidotes acetylcysteine ​​or methionine, at least within 10 hours of ingestion for best results. Acetylcysteine ​​is administered by intravenous infusion in an initial dose of 150 mg/kg of body weight over 15 minutes, followed by 50 mg/kg over 4 hours and 100 mg/kg during the first 16 hours. Alternatively, methionine can be administered orally at 2.5 g every 4 hours for a total of 4 doses. Determination of plasma paracetamol concentrations reveals the degree of intoxication; With concentrations of 300 mcg/ml after 4 hours, severe liver damage may develop; with plasma concentrations of 120 mcg/ml within 4 hours and 50 mcg/ml at 12 hours, only mild liver damage may develop. Once the acute phase of toxicity has passed, no structural or functional abnormalities of the liver persist. Pregnancy and breastfeeding Although clinical studies in pregnant or breastfeeding patients have not revealed any particular contraindications to the use of paracetamol, nor have it caused any adverse effects on the mother or child, it is recommended to administer the product only in cases of real need and under the direct supervision of a doctor.

Contraindications

Hypersensitivity to the active substance, to any of the excipients, or to other closely related substances from a chemical point of view; in particular towards other analgesics and antipyretics.

Format

100 ml