Instructions Paracetamol film-coated tablets 500 mg No. 10
Composition
active ingredient: paracetamol;
1 tablet contains 500 mg of paracetamol;
Excipients: pregelatinized starch, corn starch, potassium sorbate, povidone, talc, stearic acid, hypromellose, glycerol triacetate (triacetin), carnauba wax.
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, elongated in shape, white or almost white in color, with convex end surfaces.
Pharmacotherapeutic group
Agents acting on the nervous system. Analgesics. Other analgesics and antipyretics. Anilides. Paracetamol. ATC code N02B E01.
Pharmacological properties
Pharmacodynamics.
The tablets contain paracetamol, an analgesic and antipyretic (pain reliever and antipyretic). The effect is based on the inhibition of prostaglandin synthesis in the CNS.
Pharmacokinetics.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract and distributed to most body tissues. Binding of paracetamol to plasma proteins is minimal when administered in therapeutic doses.
Paracetamol is metabolized mainly in the liver and excreted in the urine as transformation products. The average half-life of paracetamol in blood plasma after oral administration is about 2–3 hours.
Indication
Short-term treatment of headache, toothache, muscle pain, menstrual pain, moderate osteoarthritis pain, fever symptoms and pain from colds and flu.
Contraindication
Hypersensitivity to the components of the drug, severe liver and/or kidney dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, Gilbert's syndrome, severe anemia, leukopenia.
Children's age up to 6 years.
Interaction with other medicinal products and other types of interactions
The rate of absorption of paracetamol may be increased by metoclopramide and domperidone and decreased by cholestyramine.
Paracetamol should be taken 1 hour before or 4-6 hours after taking cholestyramine.
The anticoagulant effect of warfarin and other coumarins with an increased risk of bleeding may be enhanced by concomitant long-term use of paracetamol. Intermittent use has no significant effect.
Barbiturates reduce the antipyretic effect of paracetamol.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of liver microsomal enzymes, may enhance the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites. With the simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of the drugs on the liver increases. The simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.
Probenecid halves the clearance of paracetamol by blocking its binding to glucuronic acid, therefore, in case of combination therapy with probenecid, the dose of paracetamol should be reduced.
Paracetamol should be used with caution with chloramphenicol due to the prolongation of the half-life and increased toxicity of the latter.
Paracetamol reduces the effectiveness of diuretics. Do not use simultaneously with alcohol.
Caution should be exercised when using paracetamol with flucloxacillin, as concomitant administration has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section "Special warnings and precautions for use").
Application features
The drug contains paracetamol, so it should not be used together with other drugs containing paracetamol and used, for example, to reduce fever, treat pain, flu and cold symptoms or insomnia. Simultaneous use with other drugs containing paracetamol may lead to overdose. Overdose of paracetamol can cause liver failure, which may require a liver transplant or be fatal.
If you have liver or kidney disease, you should consult a doctor before using the drug.
It should be noted that patients with liver disease are at increased risk of hepatotoxic effects of paracetamol.
Cases of liver dysfunction/liver failure have been reported in patients with reduced glutathione levels, such as those with severe wasting, anorexia, low body mass index, chronic alcoholism, or sepsis.
It is necessary to consult a doctor regarding the possibility of using the drug:
patients with impaired kidney and liver function;
patients taking warfarin or similar drugs that have an anticoagulant effect;
patients who use analgesics for mild arthritis;
if the headache becomes persistent.
Symptoms of metabolic acidosis include deep, rapid, or labored breathing, nausea, vomiting, and loss of appetite. You should seek immediate medical attention if you experience these symptoms.
If symptoms persist, consult a doctor. Prolonged use without medical supervision may be dangerous.
The medicine should be used only when clearly necessary.
During treatment with paracetamol, you should not drink alcoholic beverages.
The medicinal product contains potassium compounds (potassium sorbate). Caution should be exercised when used in patients on a potassium-controlled diet.
Caution is advised when paracetamol is co-administered with flucloxacillin due to the increased risk of high anion gap metabolic acidosis, particularly in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), and those taking maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Use during pregnancy or breastfeeding
Pregnancy. As with all medicines, consult your doctor before taking paracetamol during pregnancy. A large amount of data on pregnant women indicate neither malformative nor feto/neonatal toxicity. Epidemiological studies on the development of the nervous system in children exposed to paracetamol in utero are inconclusive. If clinically necessary, paracetamol can be used during pregnancy, but it should be used at the lowest effective dose for the shortest duration and with the least possible frequency.
Breastfeeding. Paracetamol passes into breast milk, but in clinically insignificant quantities when used in recommended doses. Available published data do not rule out the possibility of taking the drug during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The drug is intended for oral administration.
Do not exceed the recommended dose. The lowest dose of the drug necessary to achieve the treatment goal should be used.
Adults and children over 12 years of age: 1–2 tablets up to 4 times a day (every 4–6 hours) as needed.
The interval between doses is at least 4 hours.
You should not take more than 8 tablets (4000 mg) in 24 hours.
Children (6–11 years): ½–1 tablet up to 4 times a day (every 4–6 hours) as needed.
The maximum period of use for children without consulting a doctor is 3 days.
You should not take more than 4 doses in 24 hours.
The interval between doses is at least 4 hours.
Children.
Not recommended for use in children under 6 years of age.
Overdose
Paracetamol overdose can cause liver failure, which may require liver transplantation or be fatal. Experience shows that clinical signs of liver damage following paracetamol overdose usually appear 24–48 hours after the overdose and reach a maximum after 4–6 days.
There is an increased risk of paracetamol poisoning, particularly in elderly patients, children, patients with liver disease, chronic alcoholism, and chronic malnutrition.
Symptoms of overdose in the first 24 hours: pallor, nausea, vomiting, loss of appetite and abdominal pain, asymptomatic overdose is also possible.
Paracetamol overdose in adults or children with a single dose may cause reversible or irreversible necrosis of liver cells, which may lead to impaired glucose metabolism, metabolic acidosis, hepatocellular failure, encephalopathy, hemorrhage, hypoglycemia, coma and may be fatal. At the same time, there is an increase in the level of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin, as well as the level of prothrombin, which occurs 12–48 hours after ingestion. Liver damage is likely in adults who have taken a larger than recommended amount of paracetamol. It is believed that the increased amount of the metabolite of paracetamol (which is usually neutralized by the action of glutathione when using normal doses of paracetamol) binds irreversibly to liver tissue.
Acute renal failure with acute tubular necrosis may present with severe back pain, hematuria, and proteinuria, and may occur even in the absence of severe liver damage. Cardiac arrhythmias and acute pancreatitis, usually accompanied by liver dysfunction and hepatotoxicity, have also been reported.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic system. When taking large doses, dizziness, psychomotor agitation and disorientation are possible from the central nervous system; nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis) is possible from the urinary system.
Risk factors for paracetamol overdose include:
long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort and other drugs that induce the synthesis of liver enzymes;
regular alcohol abuse;
decreased glutathione levels, for example, in nutritional disorders, starvation, exhaustion, cystic fibrosis, HIV.
In case of overdose, immediate medical attention is required. Treatment of overdose or even suspected overdose should be started immediately, for which the patient should be taken to hospital, even if there are no early symptoms of overdose, since liver damage may not develop immediately. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with activated charcoal should be considered if an overdose of paracetamol greater than 150 mg/kg has been taken within 1 hour. Treatment with N-acetylcysteine or methionine should be considered. Symptomatic treatment should also be provided.
Adverse reactions
In case of adverse reactions, you should stop using the medicine and consult a doctor immediately.
Adverse reactions to paracetamol are rare (< 1/10,000):
Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Gastrointestinal: nausea, epigastric pain.
From the liver and biliary tract: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice.
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the blood and lymphatic system: thrombocytopenia, agranulocytosis, anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia, bruising or bleeding.
Immune system disorders: anaphylaxis, hypersensitivity reactions including pruritus, rash on the skin and mucous membranes (usually generalized rash, erythematous rash, urticaria), angioedema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister; 1 or 2 or 5 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Location of the manufacturer and address of its place of business.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
