Paracetamol tablets 500mg №10

Name:
Paracetamol. Forms of release Tablets. INN Paracetamol. FTGA analgesic non-narcotic agent.
Description:
Tablets of white or white color with a creamy tinge, flat-cylindrical, with a risk and a chamfer. Composition 1 tablet contains: active ingredient – paracetamol – 200 mg or 500 mg; excipients: povidone, croscarmellose sodium, stearic acid, potato starch. Pharmacotherapeutic group Other analgesics and antipyretics. Anilides. ATX code N02BE01. Pharmacological properties Pharmacokinetics Rapidly and almost completely absorbed from the gastrointestinal tract, TSmax is achieved in 0.5-1 h; Cmax – 5-20 mcg / ml. Communication with plasma proteins – 20-30%. Penetrates through the BBB. Less than 1% of the dose of paracetamol taken by a nursing mother passes into breast milk. A therapeutically effective plasma concentration of paracetamol is achieved when it is administered at a dose of 10–15 mg/kg. Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in the metabolism of the drug. The half-life (T½) is 1-4 hours. It is excreted by the kidneys (90-100% of the accepted therapeutic dose on the first day) in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases. Pharmacodynamics Paracetamol is an analgesic and antipyretic (analgesic and antipyretic). It blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. The anti-inflammatory effect is practically absent. Indications Symptomatic therapy as a moderate analgesic and antipyretic for most pain syndromes and febrile conditions: – headache (including migraine and tension headaches), toothache, sore throat, lower back pain, muscle pain, rheumatic pain (non-severe arthritis ), painful menstruation; – at elevated body temperature against the background of “cold” diseases and influenza. Dosage and administration The drug is intended for oral administration. Adults and adolescents over 12 years of age: 400–500 mg (2 200 mg tablets or 1 500 mg tablet) every 4–6 hours as needed. The interval between doses is at least 4 hours. The maximum daily dose of paracetamol should not exceed 4 g. For children aged 6–12 years, the dose of paracetamol is calculated depending on age and body weight. A single dose is 10-15 mg/kg of body weight, the maximum daily dose is 60 mg/kg of body weight. Typically used at a dose of 250-500 mg (½-1 500 mg tablet) 3-4 times daily as needed. Do not take the drug more often than every 4 hours and more than 4 times a day. Do not continue taking more than 3 days without consulting a doctor. Paracetamol tablets are not recommended for use in children under 6 years of age due to difficulty in swallowing solid dosage forms. Side effects Immune system disorders: anaphylaxis, skin hypersensitivity reactions, including skin rash, angioedema, Stevens-Johnson syndrome / toxic epidermal necrolysis. Hematopoietic disorders: anemia, methemoglobinemia, thrombocytopenia, agranulocytosis. Respiratory disorders: Bronchospasm in patients sensitive to aspirin and other NSAIDs. Liver disorders: Liver dysfunction, including cases of acute liver failure requiring liver transplantation or death. In the event of adverse reactions, including those not listed in this leaflet, you should stop taking the drug. Contraindications – hypersensitivity to paracetamol; – age up to 6 years. Do not take simultaneously with other paracetamol-containing medicines, combined medicines for the treatment of symptoms of colds and flu. With caution Use with caution in benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, alcoholic liver damage, in old age, during pregnancy and lactation. Interaction with other drugs Long-term combined use of paracetamol and other NSAIDs increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, the onset of end-stage renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. The drug, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding, single doses do not have a significant effect. Inducers of microsomal oxidation enzymes in the liver (barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine, diphenin, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in overdoses. Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. Ethanol contributes to the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs. Precautions If the patient suffers from arthritis of more than moderate severity or requires regular use of painkillers, the appointment of paracetamol should be carried out only after consulting a doctor. The drug is not recommended for more than 3 days without a doctor’s prescription. Do not exceed the recommended dose. If pain or fever persists for more than 3 days, stop treatment and contact your doctor. In order to avoid toxic liver damage, it is necessary to warn patients about the inadmissibility of drinking alcohol during treatment. Do not take simultaneously with other paracetamol-containing products. The patient should be warned about the obligatory visit to the doctor in case of exceeding the recommended doses, even if the patient feels well, as there is a risk of delayed serious liver damage, and also, in cases of signs of an allergic reaction (swelling of the face, mouth, throat, shortness of breath, itching or rash). There have been reports of cases of serious liver dysfunction after taking paracetamol, including cases of acute liver failure that required liver transplantation or ended in death. It should be used with caution in individuals with glucose-6-phosphate dehydrogenase deficiency, with renal and hepatic insufficiency. The risk of paracetamol overdose is higher in patients with non-cirrhotic alcoholic liver disease. Rare cases of anaphylaxis and other hypersensitivity reactions have been reported after taking paracetamol. Application in children. The tablets are not intended for use in children under 6 years of age. Use in persons with impaired liver and kidney function. Special dose adjustment and frequency of administration in this group of people is not required, however, due to the high likelihood of overdose in this group of people, it is not recommended to exceed the maximum dose of paracetamol of 2.5 g per day (5 tablets of 500 mg or 12 tablets of 200 mg). mg). Use in the elderly. Special dose adjustment and frequency of administration in this group of people is not required, however, due to the high likelihood of overdose in this group of people, it is not recommended to exceed the maximum dose of paracetamol of 2.5 g per day (5 tablets of 500 mg or 12 tablets of 200 mg). mg). Impact on laboratory parameters. During treatment with paracetamol, it is possible to increase the level of glucose in the blood plasma and distort the results of determining the glycemic profile. It is necessary to tell the patient about the need to inform the doctor about the use of paracetamol during tests for the determination of uric acid and blood sugar levels. Glutathione deficiency due to eating disorders, cystic fibrosis, HIV infection, starvation, malnutrition causes the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more). Use during pregnancy or lactation Pregnancy. The appointment of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. breastfeeding period. Paracetamol passes into breast milk, but in clinically insignificant amounts. Available published data do not contain contraindications for breastfeeding. Influence on the ability to drive vehicles and control mechanisms Taking paracetamol does not affect the ability to drive vehicles or other mechanisms. Overdose It is necessary to warn the patient about the obligatory visit to the doctor in case of exceeding the recommended doses, even if the patient feels well, as there is a risk of delayed serious liver damage. An overdose of paracetamol is especially dangerous in elderly patients and in young children. Overdose resulting from incorrect dosing or accidental poisoning can be fatal. Liver damage in adults is possible when taking 10 or more grams of paracetamol. Taking 5 grams or more of paracetamol can lead to liver damage in patients with the following risk factors: – prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort or other drugs that stimulate liver enzymes; – regular consumption of alcohol in excessive quantities; – possibly existing glutathione deficiency (malnutrition, cystic fibrosis, HIV infection, starvation, malnutrition). Signs of acute poisoning with paracetamol in the first 24 hours are nausea, vomiting, stomach pain, sweating, pallor of the skin. Liver damage may become apparent 12-48 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, bleeding, hypoglycemia, cerebral edema, and death. Acute renal failure with acute tubular necrosis may present with severe low back pain, hematuria, proteinuria, and develop even in the absence of severe liver damage. Cardiac arrhythmia and pancreatitis were also noted. Treatment: Overdose requires immediate medical attention. The patient should be immediately taken to the hospital, even if there are no early symptoms of an overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Treatment with activated charcoal should be considered if an overdose of paracetamol was taken within 1 hour. Plasma concentrations of paracetamol should be assessed 4 hours and later after taking the drug (early determination of the concentration is unreliable). Treatment with N-acetylcysteine can be carried out within approximately 24 hours after taking paracetamol, but the maximum protective effect is obtained when it is used for 8 hours after taking it. The effectiveness of the antidote drops sharply after this time. If necessary, N-acetylcysteine is administered intravenously to the patient according to the established list of doses. In the absence of vomiting, oral methionine can be used as an appropriate alternative in remote areas outside the hospital. Upakovka10 tablets (for tablets with a dosage of 200 mg or 500 mg) in a planimetric non-cell package from a material combined on a paper and cardboard basis. 1 contour non-cell packaging together with a leaflet is placed in a pack of cardboard. 10 tablets (for tablets with a dosage of 200 mg or 500 mg) in a blister pack made of PVC film and aluminum foil. 2 or 5 blister packs, together with the leaflet, are placed in a pack of cardboard. 10 tablets with a dosage of 200 mg in a blister-free contour package made of a combination material on a paper and cardboard basis. 800 blister packs, along with 10 instructions for use, are placed in a cardboard box. 10 tablets with a dosage of 200 mg in a blister pack made of PVC film and aluminum foil. 500 blisters, together with 10 instructions for use, are placed in a cardboard box. 10 tablets with a dosage of 500 mg in a blister-free contour package made of a combination material on a paper and cardboard basis. 390 blister packs, along with 10 instructions for use, are placed in a cardboard box. 10 tablets with a dosage of 500 mg in a blister pack made of PVC film and aluminum foil. 300 blisters, together with 10 instructions for use, are placed in a cardboard box. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ºС. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date. Conditions for dispensing from pharmaciesWithout a prescription. Buy Paracetamol tablets 500mg No. 10 Price for Paracetamol tablets 500mg No. 10 Instructions for use for Paracetamol tablets 500 mg No. 10