Panadol tablets p/o 500mg №12×1

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Panadol tab. plen.ob. 500mg in bl. in pack. No. 12×1
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White film-coated tablets, capsule-shaped with flat edges, marked with a triangular logo on one side and a risk mark on the other side Main active ingredient Paracetamol Release form film-coated tablets Dosage 500 mg Pharmacological action Other analgesics and antipyretics. Anilides. Paracetamol. ATX code: N02B E01. Pharmacodynamics The drug contains paracetamol, an analgesic and antipyretic (analgesic and antipyretic). The mechanism of action of paracetamol includes inhibition of prostaglandin synthesis, predominantly in the central nervous system. Pharmacokinetics Absorption Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. After taking therapeutic doses, the maximum plasma concentration is reached within 30-60 minutes, and the elimination half-life is 1-4 hours. Distribution Plasma protein binding is minimal at therapeutic concentrations. Paracetamol is relatively evenly distributed in most body fluids. The degree of plasma protein binding is low and may vary. Metabolism Paracetamol is metabolized in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates. Withdrawal Less than 5% of paracetamol is excreted unchanged. Indications for use As a short-term analgesic and antipyretic for: headache musculoskeletal pain menstrual pain toothache cold and flu symptoms. May also be used for the symptomatic relief of mild to moderate pain in physician diagnosed osteoarthritis. Dosage and administration The drug is intended for oral administration only. Adults, the elderly and children 12 years of age and older: 1-2 tablets every 4-6 hours as needed. The minimum interval between doses is 4 hours. Do not exceed 8 tablets (4000 mg) in 24 hours. Children (6-11 years): ?-1 tablet every 4-6 hours as needed, at least 4 hours apart. No more than 4 doses in 24 hours. The maximum duration of use without a doctor’s recommendation is 3 days. Children Not recommended for children under 6 years of age. Patients with renal / hepatic insufficiency Patients with severe hepatic or severe renal insufficiency are not recommended to use the drug. Patients who have been diagnosed with renal / hepatic insufficiency should consult a physician before using this drug. Do not exceed the recommended dose. The lowest dose necessary to achieve a therapeutic effect should be used. Use during pregnancy and lactation Pregnancy. Data from clinical and preclinical studies have not revealed a risk to pregnancy or intrauterine development. However, as with any drug, follow your doctor’s instructions and exercise caution when using during the first trimester. Breastfeeding. Data from clinical studies have not identified a risk in relation to breastfeeding or the child who is breastfed. Paracetamol crosses the placental barrier and is excreted in breast milk. Precautions Contains paracetamol. Do not use simultaneously with other paracetamol-containing products. Simultaneous use with other drugs containing paracetamol may lead to an overdose. An overdose of paracetamol can cause permanent liver damage, which can lead to liver transplantation or death. Associated liver disease increases the risk of liver damage while taking paracetamol. Before using the drug, you should consult with your doctor regarding the possibility of using the drug in patients who have been diagnosed with renal or hepatic insufficiency. Hepatic dysfunction/liver failure has been reported in patients with reduced glutathione levels (eg, malnutrition, anorexia, decreased body mass index, chronic alcohol abuse). Patients with conditions that are accompanied by a decrease in glutathione levels (for example, with severe infections such as sepsis) may increase the risk of metabolic acidosis. If symptoms persist, contact your doctor. Keep out of the reach of children. Interaction with other drugs The drug with long-term regular daily intake enhances the effect of anticoagulants (warfarin and other coumarins), which increases the risk of bleeding; single doses do not have a significant effect. The rate of absorption of paracetamol may increase when used together with metoclopramide and domperidone. Absorption of paracetamol may be reduced when used together with cholestyramine. Contraindications Hypersensitivity to paracetamol or any other component of the drug in history, children under 6 years of age. Composition Active substance: paracetamol 500 mg; Excipients: pregelatinized starch, corn starch, povidone (K25), talc, potassium sorbate, stearic acid, hypromellose, triacetin. Overdose Exceeding the recommended dose of paracetamol can lead to liver failure, which in turn can lead to liver transplantation or death. Acute pancreatitis has been observed, most commonly with hepatic dysfunction and hepatotoxicity. The risk of paracetamol intoxication is higher in the elderly, young children, patients with liver disease, chronic malnutrition, people with chronic alcoholism. In these cases, an overdose can be fatal. After a single oral high dose of paracetamol in adults and children, complete and irreversible liver necrosis may develop, leading to hepatocellular insufficiency, metabolic acidosis, encephalopathy, coma and death. 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 risk factors that include: long-term use of carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs that induce liver enzymes; regular alcohol abuse; possible glutathione deficiency (for example, malnutrition, cystic fibrosis, HIV infection, starvation, cachexia). Overdose symptoms usually appear within the first 24 hours and may include: nausea, vomiting, anorexia, skin pallor, abdominal pain. Within 12-48 hours after an overdose, an increase in the level of hepatic transaminases (ACT, ALT), lactate dehydrogenase and bilirubin is possible. Treatment: It is necessary to immediately take the patient to the hospital. In case of acute overdose, the concentration of paracetamol in the blood plasma should be measured no earlier than 4 hours after ingestion. The use of activated charcoal is advisable if no more than 1 hour has passed since the moment of taking the excess dose. The antidote N-acetylcysteine or methionine should be administered as soon as possible in accordance with national guidelines. If necessary, symptomatic treatment is carried out. If the recommended dose is exceeded, seek immediate medical attention, even if there are no symptoms of an overdose. Side effect Very rare (<1/10,000) From the side of the blood and lymphatic system: thrombocytopenia. From the immune system: anaphylaxis, skin hypersensitivity reactions, including skin rash, angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis. From the respiratory system: bronchospasm in patients sensitive to aspirin and other NSAIDs. From the side of the liver and biliary tract: abnormal liver function. Reporting adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions Store at a temperature not exceeding 25 ° C, out of the reach of children. 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