Paracetamol Mylan 120 mg / 5 ml

Syrup

Composition:

100 ml of oral solution contain: Active ingredient: paracetamol 2.4 g For the full list of excipients, see section 6.1.

Excipients

Sucrose, macrogol 6000, sodium citrate, anhydrous citric acid, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, strawberry / mandarin flavor, purified water.

Therapeutic indications

As antipyretic: symptomatic treatment of febrile diseases such as flu, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other painful manifestations of medium entity, of various origins.

Contraindications

Hypersensitivity to paracetamol or to any of the excipients. Paracetamol products are contraindicated in patients with severe haemolytic anemia. Severe hepatocellular insufficiency.

Dosage

Below three months, in case of jaundice, it is advisable to reduce the single oral dose. For children it is essential to respect the dosage defined according to their body weight, and therefore to choose the suitable formulation. Approximate ages as a function of body weight are given for information only. In adults, the maximum oral dosage is 3000 mg of paracetamol per day (see section 4.9 “Overdose”). 120 mg / 5 ml oral solution The package includes a measuring cup with indicated level marks corresponding to the capacities of 2.5, 5 ml and 10 ml; Children weighing between 7 and 10 kg (approximately between 6 and 18 months) 5 ml at a time (corresponding to 120 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 doses per day. Children weighing between 11 and 12 kg (approximately between 18 and 24 months) 5 ml at a time (corresponding to 120 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighing between 13 and 20 kg (approximately between 2 and 7 years) 7.5 - 10 ml at a time (corresponding respectively to 180 and 240 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Children weighing between 21 and 25 kg (approximately between 6 and 10 years) 10 ml at a time (corresponding to 240 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighing between 26 and 40 kg (approximately between 8 and 13 years) 15-20 ml at a time (corresponding respectively to 360 and 480 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Boys weighing between 41 and 50 kg (approximately between 12 and 15 years) 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighing more than 50 kg (approximately over 15 years) 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Adults 20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. The package contains a dosage rule to facilitate the calculation of the dose of the product as a function of body weight.

Warnings and Precautions

In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted. Use with caution in subjects with glucose-6-phosphate-dehydrogenase deficiency. High or prolonged doses of the product can cause high-risk liver disease and even severe changes in the kidney and blood, therefore administration in subjects with mild / moderate renal or hepatic insufficiency and in patients with Gilbert's syndrome must be carried out only if actually necessary and under direct medical supervision. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses. Instruct the patient to contact the doctor before combining any other drugs (see section 4). Paracetamol Mylan Generics contains 42 g of sucrose: this should be taken into account in diabetic patients and in patients who follow low-calorie diets. When the product is taken according to the recommended doses, 1 measuring spoon of 10 ml contains 3.5 g of sucrose. The medicine is not suitable for people with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase deficiency. The product also contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate. These substances can cause allergic reactions (even delayed). Do not administer for more than 3 consecutive days without consulting your doctor.

Interactions

The oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of elevating its toxicity. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may induce slight variations in the INR values. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its discontinuation. 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) . The same is true in cases of alcoholism and in patients treated with zidovudine. 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).

Side effects

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 skin rash with erythema or urticaria, angioedema, larynx edema, 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.

Pregnancy and breastfeeding

Although clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol or caused unwanted effects affecting the mother or child, it is recommended to administer the product only in cases of real need and under the direct supervision of the doctor. .