Descrizione Clinica
PARACETAMOL MYLAN GENERICS 120 MG/5 ML
active ingredients
100 ml of oral solution contains: Active ingredient: paracetamol 2.4 g Excipients with known effects: sucrose, methyl parahydroxybenzoate, propile parahydroxybenzoate and sodium. For the full list of excipients, see paragraph 6.1.Excellent
Saccarosio, macrogol 6000, citrate sodium, anidro citric acid, sodium saccarin, parahydroxybenzoate methyl, parahydroxybenzoate propile, straw/mandarin aroma, purified water.Therapeutic indications
Mylan Generics Paracetamol is indicated in adults, adolescents and children weighing 7 kg: - as antipyretic: symptomatic treatment of feverish affections such as flu, exantematic diseases, acute affections of the respiratory tract, etc. - as analgesic: cephalee, neuralgies, mialgies and other painful manifestations of medium entity, of various origin.Contraindications
Hypersensitivity to paracetamol or any of the excipients listed in paragraph 6.1. Paracetamol-based products are contraindicated in patients suffering from severe hemolytic anemia or severe hepatocellular insufficiency.Population
Population Under three months, in case of jaundice, the single dose should be reduced by mouth. For children it is essential to respect the defined dosage according to their body weight, and therefore to choose the suitable formulation. Approximate ages according to body weight are indicated as information. In adults, the maximum oral posology is 3000 mg of paracetamol per day (see paragraph 4.9 “Soverradosage”). The doctor must assess the need for treatments for over 3 consecutive days. The Posological scheme of Paracetamol Mylan Generics in relation to body weight and route of administration is as follows: Oral Solution 120 mg/5 ml The packaging is attached to a meassurino-doser with indicated level notches corresponding to the capacity of 2.5, 5 ml, 7.5 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 administrations per day. • Children weighing between 11 and 12 kg (approximately between 18 and 24 months): 5 ml at a time (corresponding to 120 mg paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Children weighing between 13 and 20 kg (approximately between 2 and 7 years): 7,5 - 10 ml at a time (corresponding to 180 and 240 mg of paracetamol respectively), 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 administrations per day. • Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 15-20 ml at a time (corresponding to 360 and 480 mg paracetamol respectively), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. • Children 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 administrations 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 administrations per day. • Adults: 20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations 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. Method of administration The packaging is attached to a meassurino-doser with indicated level notches corresponding to the capacity of 2.5, 5 ml and 10 ml. The package contains a posological rule to facilitate the calculation of the dose of the product according to the body weight.Conservation
No particular condition of conservation.Warnings
In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be established. Use carefully in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic beverages per day), anorexia, bulimia or cachesia, chronic malnutrition (low reserves of liver glutathione), dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure (Child-Pugh>9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate- dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product may result in high-risk hepatopathy and alterations to the kidney and blood even severe, so the administration in patients with kidney failure should only be carried out if effectively necessary and under direct medical control. In case of protracted use it is advisable to monitor the liver and renal function and the blood crasis. During treatment with paracetamol before taking any other medication check that 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 (see paragraph 4.5). It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. Mylan Generics Paracetamol contains 7 g sucrose (sugar) for 20 ml oral solution. To consider in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. Mylan Generics Paracetamol contains 27.4 mg sodium for 20 ml oral solution equivalent to 1.37% of the recommended daily maximum intake by the WHO which corresponds to 2 g sodium for an adult. Paracetamol Mylan Generics also contains p-hydroxybenzoate methyl and p-hydroxybenzoate propile. Such substances may cause allergic reactions (also delayed).Interactions
The oral absorption of the paracetamol depends on the speed of gastric emptying. Therefore, the concomitant administration of drugs that slow (e.g. anti-linergics, opioids) or increase (e.g. procinetics) the speed of gastric emptying can determine respectively a decrease or increase of the bioavailability of the product. Concurrent administration of cholesteramine 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. Concurrent use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values. In these cases a more frequent monitoring of INR values should be conducted during concurrent use and after its interruption. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of liver monoxygenases or in case of exposure to substances that may have such an effect (e.g. rifampin, cimetidine, antiepileptics such as glutethymmides, phenobarbital, carbamazepine). The same applies in cases of ethylism and in patients treated with zidovudine. Paracetaminol administration may interfere with the determination of uricemia (by means of the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).Effects
In very rare cases serious skin reactions were reported. Below are the undesirable effects of the paracetamol organized according to the systemic and organic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Emolinfopoietic system pathologies: thrombocytopenia, leucopenia, anemia, agranulocytosis. Immune system disorders: hypersensitivity reactions (orticaria, angioedema, larynx edema, anaphylactic shock). Diseases of the nervous system: dizziness. Gastrointestinal diseases: gastrointestinal reactions. Hepatobiliary diseases: alterations of liver and hepatitis functionality. Pathologies of skin and subcutaneous tissue: multiform erythema, Stevens Johnson syndrome and epidermal necrolysis, rashes with erythema. Kidney and urinary pathologies: acute kidney failure, interstitial nephritis, hematuria, anuria. Reporting of suspicious adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdose
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. Synonyms In case of accidental intake of very high doses of paracetamol, acute intoxication manifests with anorexia, nausea and vomiting followed by deep decay of general conditions; such symptoms usually appear within the first 24 hours. In case of overdose, paracetamol can cause liver cytolysis that can evolve towards massive and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in levels of hepatic transaminasis, lactic-dedrogenase, and bilirubinemia are observed, and a reduction in levels of protrombine, which can occur in 12-48 hours after ingestion. Treatment The measures to be taken consist of early gastric emptiness and hospital treatment for the case, by administration, as early as possible, of N-acetylcysteine as an antidote: posology is 150 mg/kg e.v. in glucosated solution in 15 minutes, then 50 mg/kg in the next 4 hours and 100 mg/kg in the following 16 hours, for a total of 300 mg/kg in 20 hours.Pregnancy
A large amount of data on pregnant women do not indicate any malformation or fetus/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. Paracetamol can be used during pregnancy if clinically necessary. However it should be used at the lowest effective dose for the shortest time period and the lowest frequency possible.Breastfeeding
Although breastfeeding clinical studies have not shown particular contraindications to the use of paracetamol, it is recommended to administer the product only in case of actual need and under the direct control of the doctor.Source: Farmadati
