Description
Release form
Effervescent tablets of white color, round, flat, with beveled edges and a notch on one side, when dissolved in water, intense evolution of gas bubbles is observed.
Packaging
16 tab.
Indications
as an antipyretic for ARI and other infectious and inflammatory diseases accompanied by fever
as an anesthetic for mild to moderate pain syndrome: arthralgia, myalgia, neuralgia, migraine, toothache and headache, algal pain with injuries and burns.
Contraindications
severe liver failure or decompensated acute liver disease
sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption
children under 12 years of age.
hypersensitivity to paracetamol, propacetamol hydrochloride (paracetamol prodrug) or any other component of the drug.
Precautions: severe renal failure (CC <30 ml / min), liver failure, chronic alcoholism, anorexia, bulimia, cachexia, hypovolemia, dehydration, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert, Dubinin-Johnson and Rotor syndromes), viral hepatitis, advanced age. Use during pregnancy and lactation The use of the drug in the I and III trimesters of pregnancy and during lactation (breastfeeding) is contraindicated. Composition 1 tab. contains: Active ingredients: paracetamol – 500 mg Excipients: citric acid anhydrous, sodium carbonate anhydrous, sodium bicarbonate, sorbitol, saccharin soluble, srdlp sodium, srdlp sodium, srdlp sodium. Dosage and administration of The drug is taken orally. The tablet should be dissolved in a glass of water (200 ml). Do not chew or swallow tablets. Usually apply 1-2 tab. 2-3 times / day at intervals of at least 4 hours. The maximum single dose is 2 tablets. (1 g), the maximum daily allowance is 8 tablets. (4 g), which corresponds to a single dose of 10-15 mg / kg body weight, the maximum daily – 75 mg / kg body weight. As a rule, there is no need to exceed the recommended daily dose of paracetamol equal to 3 g. The daily dose can be increased to the maximum (4 g) only in case of severe pain. In case of impaired renal function, the time interval between doses of the drug should be at least 8 hours with CC less than 10 ml / min, at least 6 hours with CC 10-50 ml / min. In patients with chronic or compensated active liver diseases, especially those associated with liver failure, in patients with chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver), Gilbert’s syndrome (hereditary hyperbilirubinemia), dehydration or body weight less than 50 kg, the dose should be The interval between receptions should be reduced or increased. The daily dose should not exceed 2 g, i.e. 4 tab. The drug should be used with caution in children and patients weighing less than 50 kg to eliminate the risk of exceeding the recommended dose. The dosage regimen for children over 12 years old and weighing more than 43 kg is the same as for adults, while the interval should preferably be 6 hours (strictly at least 4 hours). Duration of admission without consulting a doctor is not more than 5 days when prescribed as an anesthetic and 3 days as an antipyretic. Side effects of When using the drug, the following side effects were noted (frequency not established). Allergic reactions: hypersensitivity reactions, pruritus, rash on the skin and mucous membranes (erythema or urticaria), Quincke’s edema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylactic shock, acute generalized exanthematous pustulosis. From the respiratory system: bronchospasm. From the nervous system (when taking high doses): dizziness, psychomotor agitation and disorientation in space and time. From the digestive system: nausea, diarrhea, epigastric pain, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect), hepatitis, tenesmus, liver failure. From the kidneys and urinary tract: increased creatinine. From the endocrine system: hypoglycemia, up to hypoglycemic coma. From the hemopoietic system: anemia (cyanosis), hemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia, neutropenia, leukopenia. Other: decreased blood pressure (as a symptom of anaphylaxis), a change in prothrombin time and international normalized ratio (INR). Drug Interaction Inductors of liver microsomal enzymes or potentially hepatotoxic agents (eg, ethanol, rifampicin, isoniazid, hypnotics and antiepileptic agents, including phenobarbital, phenytoin and carbamazepine) increase the toxicity of paracetamol and can lead to liver damage even at non-toxic doses of paracetamol, so liver function should be monitored. Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity, therefore, patients receiving phenytoin should avoid frequent use of paracetamol, especially at high doses. Paracetamol reduces the effectiveness of uricosuric drugs. Paracetamol may increase the risk of increasing chloramphenicol concentration and, as a consequence, may increase the risk of neutropenia, and therefore hematological parameters should be monitored. The simultaneous use of these two drugs is possible only after consultation with a doctor. Probenecid reduces the clearance of paracetamol by almost 2 times, which requires a decrease in the dose of paracetamol. Repeated administration of paracetamol for more than 4 days increases the anticoagulant effect. International normalized ratio (MNO) should be monitored during and after concurrent use of paracetamol (especially at high doses and / or for prolonged periods) and coumarin derivatives. If necessary, adjust the dose of anticoagulants. Irregular intake of paracetamol has no significant effect on the action of anticoagulants. Propantheline and other drugs that delay the evacuation of the stomach reduce the rate of absorption of paracetamol, which may delay or reduce the onset of the effect. Metoclopramide and domperidone increase the rate of absorption of paracetamol and, accordingly, the onset of analgesic and antipyretic action. Prolonged use of barbiturates reduces the effectiveness of paracetamol. Ethanol promotes acute pancreatitis. Prolonged use of paracetamol and other NSAIDs increases the risk of analgesic nephropathy and renal failure. Concurrent long-term administration of high-dose paracetamol and salicylates increases the risk of kidney or bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% – the risk of hepatotoxicity. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. Salicylamide may increase T1 / 2 of paracetamol. Overdose In case of overdose, intoxication is possible, especially in children, patients with liver diseases (caused by chronic alcoholism), patients with malnutrition, and patients receiving enzyme disease, which may develop pulmonary disease. , cytolytic hepatitis, in the above cases, sometimes fatal. The clinical picture of acute overdose develops within 24 hours after administration of paracetamol. Symptoms: Gastrointestinal disorders (nausea, vomiting, decreased appetite, feeling of abdominal discomfort and / or abdominal pain), pale skin, sweating, malaise. At a single injection in adults of 7.5 g or more or in children over 140 mg / kg cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, development of hepatic failure, metabolic acidosis and encephalopathy, which can lead to coma and death. After 12-48 h after administration of paracetamol, there is an increase in the activity of hepatic transaminases, lactate dehydrogenase, bilirubin concentration and a decrease in the concentration of prothrombin. Clinical symptoms of liver damage appear 1-2 days after drug overdose and reach a maximum of 3-4 days. Treatment: immediate hospitalization determination of the quantitative content of paracetamol in the blood plasma before starting treatment at the earliest possible time after overdose gastric lavage introduction of donors of SH-groups and precursors of synthesis of glutathione – methionine and acetylcysteine. The need for additional therapeutic measures (further administration of methionine, in / in the introduction of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time after its introduction symptomatic treatment of liver tests should be carried out at the beginning of treatment and then – every 24 h . In most cases, the activity of hepatic transaminases is normalized within 1-2 weeks. In very severe cases, a liver transplant may be required. Storage conditions Keep out of the reach of children at a temperature not higher than 30 ° C. Expiration 3 years. Active ingredient Paracet ol dosage form dosage form tablets soluble UPSA UPSA CASA France
