Paracetamol Renewal effervescent pills 500mg, 12pcs

Composition

Active ingredient: Paracetamol-500,000 mgsupport Substances: citric acid anhydrous-1114,000 mg sodium bicarbonate-942,000 mg sodium carbonate anhydrous-332,000 mg sorbitol-300,000 mg sodium saccharinate-7,000 mg sodium docusate-0.227 mgpovidone (K 30) – 1,287 mg sodium benzoate-60.606 mg

Pharmacological action

Paracetamol (a derivative of paraaminophenol) has analgesic, antipyretic and weak anti-inflammatory effects. The exact mechanism of analgesic and antipyretic effects of paracetamol has not been established. Apparently, it includes the central and peripheral components. The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of its anti-inflammatory effect. The drug does not have a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa due to the lack of influence on the synthesis of prostaglandins in peripheral tissues.

Indications

Moderate or mild pain syndrome (headache, toothache, migraine pain, neuralgia, muscle pain, lower back pain, pain from injuries and burns, sore throat, painful menstruation). Increased body temperature in colds and other infectious and inflammatory diseases.

Use during pregnancy and lactation

The use of the drug is contraindicated in the first and third trimester of pregnancy and during breastfeeding. The use of the drug in the second trimester of pregnancy is possible after consulting a doctor in order to assess the expected benefit to the mother and the possible risk to the fetus.

Contraindications

Hypersensitivity to paracetamol, propacetamol hydrochloride (a prodrug of paracetamol) or any other component of the drug, severe liver failure or decompensated liver diseases in the acute stage, sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy (I and III trimester) and lactation, children under 12 years of age (body weight not less than 50 kg). Use caution in severe renal insufficiency (creatinine clearance

Side effects

When using the drug, the following side effects were noted (frequency is not established): Allergic reactions: hypersensitivity reactions, pruritus of the skin, rash on the skin and mucous membranes (erythema or urticaria), angioedema, erythema multiforme (including Stephen-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylactic shock, acute generalized exanthematous pustulosis. From the central and peripheral 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 jaundice, hepatonecrosis (dose-dependent effect). From the endocrine system: hypoglycemia, up to hypoglycemic coma. Hematopoietic disorders: anemia (cyanosis), sulfohemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia, neutropenia, leukopenia. Others: reduced blood pressure (as a symptom of anaphylaxis), changes in prothrombin time and international normalized ratio (INR).

Interaction

Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity. Patients taking phenytoin should avoid frequent use of paracetamol, especially in high doses. Probenecid almost halves the clearance of paracetamol by inhibiting its conjugation with glucuronic acid. When co-administered, consideration should be given to reducing the dose of paracetamol. Caution should be exercised when using paracetamol concomitantly with inducers of microsomal liver enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants). Long-term concomitant use of barbiturates reduces the effectiveness of paracetamol. Salicylamide may increase the elimination half-life of paracetamol. INR should be monitored during and after the end of concomitant use of paracetamol (especially in high doses and/or for a long time) and coumarins (for example, warfarin), since paracetamol taken at a dose of 4 g/day for at least 4 days can increase the effect of indirect anticoagulants and increase the risk of bleeding. If necessary, adjust the dose of anticoagulants.

How to take, course of use and dosage

Inside. Dissolve the tablet in a glass of water (200 ml). Do not chew or swallow pills. Usually apply 1-2 tablets 2-3 times a day at intervals of at least 4 hours. The maximum single dose is 2 tablets (1 g), the maximum daily dose is 8 tablets (4 g), which corresponds to a single dose of 10-15 mg/kg of body weight, for a maximum daily dose − 75 mg/kg of body weight. If renal function is impaired, the time interval between doses of the drug should be at least 8 hours with a creatinine clearance of less than 10 ml / min, at least 6 hours – with a creatinine clearance of 10-50 ml/min. In patients with chronic or compensated active liver diseases, especially those accompanied by hepatic insufficiency, in patients with chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver), dehydration or a body weight of less than 50 kg, the daily dose should not exceed 3 g, i. e. 6 tablets. The drug should be used with caution in children and patients weighing less than 50 kg to avoid the risk of exceeding the recommended dose. The duration of admission without consulting a doctor is not more than 5 days when prescribed as an analgesic and 3 days as an antipyretic.

Overdose

Overdose can lead to intoxication, especially in children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking enzyme inducers, which can develop lightning-fast hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases – sometimes with a fatal outcome. The clinical picture of acute overdose develops within 24 hours after taking the drug. Symptoms: gastrointestinal disorders (nausea, vomiting, decreased appetite, abdominal discomfort and / or abdominal pain), pallor of the skin, sweating, malaise. With simultaneous use of 7.5 g or more to adults or more than 140 mg/kg to children, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after paracetamol use, there is an increase in the activity of “hepatic” transaminases, lactate dehydrogenase, bilirubin concentration, and a decrease in prothrombin concentration. A detailed clinical picture of liver damage manifests itself in 1-2 days and reaches a maximum on 3-4 days. Treatment: immediate hospitalization, determination of the quantitative content of paracetamol in blood plasma before starting treatment (as early as possible after overdose), gastric lavage, use of SH-group donors and glutathione – methionine synthesis precursors within 8 hours after overdose. The need for additional therapeutic measures (further use of methionine, intravenous use of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its use. Symptomatic treatment. Liver tests should be performed at the beginning of treatment and then every 24 hours. In most cases, the activity of hepatic transaminases normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required.

Special instructions

To avoid overdose, the content of paracetamol in other medications that the patient takes simultaneously with Paracetamol should be taken into account. Taking paracetamol in doses higher than recommended may cause severe liver damage. If the fever syndrome continues for more than 3 days with the use of paracetamol, and the pain syndrome lasts for more than 5 days, a doctor’s consultation is required. Taking the drug Paracetamol may distort the results of laboratory tests when quantifying the content of glucose and uric acid in blood plasma. In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by people who are prone to chronic alcohol consumption. The risk of developing liver damage increases in patients with alcoholic hepatosis. With prolonged use of the drug, it is necessary to monitor the picture of peripheral blood and the functional state of the liver. Paracetamol can cause serious skin reactions, such as Stephen-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, which can be fatal. At the first appearance of rash or other hypersensitivity reactions, the drug should be discontinued.Also, the use of paracetamol should be discontinued if the patient has acute viral hepatitis. The drug Paracetamol contains 412.4 mg of sodium per tablet, which should be taken into account by patients who are on a strict low-salt diet. Since the drug contains sorbitol, it should not be used for sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. The effect on the ability to drive vehicles and mechanisms The effect on the ability to drive vehicles and work with mechanisms has not been studied. If the patient experiences dizziness, psychomotor agitation and disorientation in space and time, it is not recommended to drive a car or other mechanisms during treatment with the drug.

Storage conditions

In a dry place at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Paracetamol

Dosage form

tablets soluble