Composition
Composition per tablet
Active ingredient:
paracetamol-500 mg;
excipients: Â
potato starch,
croscarmellose sodium (sodium croscarmellose),
povidone (polyvinylpyrrolidone low molecular weight medical),
stearic acid,
talc.
Pharmacological action
Pharmaceutical group:
analgesic non-narcotic drug.
Pharmaceutical action: Â
Non-narcotic analgesic, blocks COX 1 and COX 2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of an anti-inflammatory effect.
The absence of a blocking effect on Pg synthesis in peripheral tissues means that it has no negative effect on water-salt metabolism (Na+ and water retention) and the gastrointestinal mucosa.
Indications
It is used to quickly relieve headaches, including migraine pain, toothache, neuralgia, muscle and rheumatic pain, as well as for algodismenorrhea, pain from injuries, burns; to reduce fever in colds and flu.
Contraindications
- hypersensitivity to paracetamol or any other ingredient of the drug;
- severe liver or kidney function disorders;
- children (up to 6 years)
With caution: Â use with caution in patients with benign hyperbilirubinemia( including Gilbert’s syndrome), viral hepatitis, alcoholic liver damage, glucose-6-phosphate dehydrogenase deficiency, alcoholism, pregnancy, lactation, and the elderly. The drug should not be taken simultaneously with other paracetamol-containing drugs.
Side effects
At the recommended doses, the drug is usually well tolerated. Paracetamol rarely causes side effects. Sometimes allergic reactions (skin rash, pruritus, urticaria, Quincke’s edema), erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), dizziness, nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis; insomnia may occur. Long-term use in large doses increases the likelihood of impaired liver and kidney function, as well as the hematopoietic system.
From the digestive system: Â nausea, epigastric pain, increased activity of liver enzymes, hepatonecrosis. Endocrine system disorders: hypoglycemia. If you experience unusual symptoms, you should consult a doctor.
Interaction
The drug, when taken for a long time, increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone, and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses.
Long-term use of barbiturates reduces the effectiveness of paracetamol.
Ethanol contributes to the development of acute pancreatitis.
Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects. Combined use with other nonsteroidal anti-inflammatory drugs increases the nephrotoxic effect.
Concomitant long-term use of high-dose paracetamol and salicylates increases the risk of kidney and bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% – the risk of developing hepatotoxicity.
Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. The drug may reduce the activity of uricosuric drugs.
How to take, course of use and dosage
Inside, before a meal or 1-2 hours after a meal, with plenty of liquid. For adults and adolescents over 12 years of age (body weight more than 40 kg), a single dose is 500 mg; the maximum single dose is 1 g. The maximum daily dose is 4 g. For children, the dose of paracetamol is calculated depending on age and body weight.
Children aged 6-9 years (weight up to 30 kg): single dose-250 mg (1/2 tablet); maximum daily dose-1 g; at the age of 9-12 years (weight from 30 to 40 kg): single dose – 250-500 mg (1/2 tablet – 1 tablet), maximum daily dose – 2 g (4 tablets). The frequency of reception is no more than 4 times a day with an interval of at least 4 hours.
In patients with impaired liver and kidney function, with benign hyperbilirubinemia, and in the elderly, the daily dose should be reduced and the interval between doses increased.
The duration of treatment is no more than 3 days as an antipyretic and no more than 5 days as an analgesic. Continuation of treatment with the drug is possible only after consulting a doctor!!!Do not exceed the prescribed dose! An overdose of paracetamol may cause liver failure.
Overdose
Signs of paracetamol overdose include nausea, vomiting, stomach pain, pallor of the skin, and anorexia. After a day or two, signs of liver damage are detected. In severe cases, liver failure and a comatose state develop. A specific antidote for paracetamol poisoning is N-acetylcysteine.
Symptoms: Â pallor of the skin, anorexia, nausea, vomiting; hepatonecrosis (the severity of necrosis directly depends on the degree of overdose). If an overdose is suspected, seek immediate medical attention. The toxic effect of the drug in adults is possible after taking more than 10-15 g of paracetamol: an increase in the activity of “liver” transaminases, an increase in prothrombin time (12-48 hours after use); a detailed clinical picture of liver damage is manifested in 1-6 days. Rarely, liver dysfunction develops rapidly and can be complicated by renal failure (tubular necrosis).
Treatment: Â the victim should be given gastric lavage during the first 4 hours of poisoning, take adsorbents (activated charcoal) and consult a doctor, administer SH-group donors and glutathione – methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine – 12 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 taking it.
Special instructions
Please consult your doctor before taking this medicine if: :
- You have severe liver or kidney disease.
- You are taking anti-nausea and vomiting medications (metoclopramide, domperidone), as well as cholesterol-lowering medications (cholestyramine).
- You are taking anticoagulants and need painkillers every day for an extended period of time. Paracetamol in this case can be taken occasionally;
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.
During long-term treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver.
Form of production
Pills.
Storage conditions
Store in a dry place, protected from light and out of reach of children, at a temperature not exceeding + 25 ° C.
Shelf
life is 4 years.
Active ingredient
Paracetamol
Dosage form
Tablets
Description
Pregnant women as prescribed by a doctor, Children over 6 years of age, Nursing mothers, For adults
Indications
Burns, Migraines, Headache, Myalgia, Myositis, Toothache, Otitis media, Infectious Diseases, Fever, Neuritis, Flu, Osteoarthritis and Arthritis, Sciatica, Osteoarthritis, Neuralgia, Cold, Sciatica, Acute respiratory viral infections, Joint pain
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Side effects of Paracetamol pills 500mg, 20pcs.
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