Properties
- Form
- tableti
- Dosage mg
- 500
- Pack
- 20
What is it?
Composition Active ingredient: Each tablet contains 500 mg of Paracetamol. Excipients: Sodium starch glycolate (Type A), Povidone, Stearic acid, Talc, Wheat starch, Precipitated silicon dioxide. Pharmacological properties The mechanism of analgesic and antipyretic action of paracetamol is not yet fully understood. Central and peripheral effects are possible. Suppressive effect on cerebral prostaglandin synthesis is approved, although peripheral prostaglandin suppression is slow. In addition, paracetamol enhances the effect of endogenous pyrogens in the thermoregulatory center of the hypothalamus. Pharmacokinetics Generally, paracetamol is completely absorbed after oral administration, and peak plasma levels are reached 30-60 minutes after administration. After rectal administration, 68-88% of paracetamol is absorbed. Peak plasma concentration is reached at least 3-4 hours later. Paracetamol penetrates all tissues rapidly. Blood, plasma, and saliva concentrations are comparable. Binding to plasma proteins is low. Paracetamol is primarily metabolized in the liver by two main pathways: conjugation with glucuronic acid and sulfuric acid. At doses higher than therapeutic, the latter pathway is particularly activated. A small part of metabolism is carried out by the P450 catalyst (mainly CYP2E1), which leads to the formation of the N-acetyl-p-benzoquinone metabolite. It is usually detoxified by glutathione and conjugated with mercapturic acid and cysteine. In cases of massive intoxication, the number of these toxic metabolites increases. Excretion is mainly through urine. 90% of the absorbed substance is excreted within 24 hours, mainly through the kidneys, in the form of glucuronides (60-80%) and sulfate conjugates (20-30%). Less than 5% is excreted unchanged. The half-life is approximately 2 hours. The half-life increases in patients with renal insufficiency, in cases of overdose, and in newborns. Maximum effect and average duration (4-6 hours) are related to plasma concentration. Renal insufficiency In severe renal insufficiency (creatinine clearance < 10 ml/min), the excretion of paracetamol and its metabolites is impaired. Elderly patients Binding capacity does not change. Therapeutic indications Para-Denk 500 is used for the treatment of mild to moderate pain and fever. It is used in children from 3.5 years of age, adolescents, and adults. Dosage and administration Para-Denk 500 should be used as described in these instructions. If you have any questions about its use, consult your doctor or pharmacist. The dose of Para-Denk 500 suppositories depends on age and body weight. Usually, a single dose is 10-15 mg per kg of body weight, and the daily dose is 60 mg/kg. Overdose is not allowed. The interval between doses depends on the daily (24-hour) dose and symptoms and should be at least 6 hours. If symptoms persist for more than 3 days, consult a doctor. Body mass / age Single dose (number of tablets) Maximum daily dose (number of tablets) Children aged 4 to 8 years (17 to 25 kg) 1/2 tab. (250 mg paracetamol) 2 tabs. (1000 mg paracetamol) Children aged 8 to 11 years (26 to 32 kg) 1/2 tab. (equivalent to 250 mg paracetamol) Other forms of the drug will be more effective for patients in this group, as they allow for more precise dosing (max. 400 mg) 2 tabs. (1000 mg paracetamol) In exceptional cases, the daily dose can be increased to 3 tablets, with an interval of at least 4 hours, i.e., 1500 mg paracetamol per day. Children aged 11 to 12 years (33 to 43 kg) 1 tab. (500 mg paracetamol) 4 tabs. (2000 mg paracetamol) Adolescents over 12 years and adults (43 kg and above) 1-2 tabs. (500-1000 mg paracetamol) 8 tabs. (4000 mg paracetamol) Method of administration: Para-Denk 500 should be taken with a large amount of liquid. Duration of treatment: Do not take Para-Denk 500 mg for more than 3 days without consulting a doctor or dentist. Special patient groups: In case of impaired kidney and liver function, as well as in patients with Gilbert's syndrome, the dose should be reduced or the interval between doses increased. Renal insufficiency In acute renal insufficiency (creatinine clearance < 10 ml/min), the interval between doses should be at least 8 hours. There are no special dosage recommendations for elderly patients. Side effects The following table is used to determine the frequency of side effects observed with Para-Denk 500 mg: Very common: more than 1 in 10; Common: more than 1 in 100 but less than 1 in 10; Uncommon: more than 1 in 1000 but less than 1 in 100; Rare: more than 1 in 10,000 but less than 1 in 1000; Very rare: 1 or less in 10,000, including individual cases. In rare cases, an increase in some liver enzymes (serum transaminases) is observed. In very rare cases, allergic reactions in the form of simple rash or urticaria, which can lead to shock, are observed. In this case, seek medical help. Other rare manifestations: Bronchial spasms similar to asthma in people prone to asthma. In very rare cases: Reduction in the number of platelets (thrombocytopenia, agranulocytosis). Please consult your doctor if you experience any side effects not listed in the instructions or if any of the listed side effects worsen. Contraindications - Hypersensitivity (allergy) to paracetamol and components of Para-Denk 500 - Severe renal insufficiency Pregnancy and lactation Paracetamol passes into breast milk. Since there are no reports of harmful effects of paracetamol on newborns, it is not necessary to stop breastfeeding. Special precautions Para-Denk 500 should be used with great caution: - In chronic alcoholism; - In impaired liver function (hepatitis, Gilbert's syndrome) - In impaired kidney function In the presence of the above-mentioned diseases, consult a doctor before taking Para-Denk 500. Combined use of analgesics can cause permanent kidney damage up to renal insufficiency (analgesic nephropathy). Prolonged and incorrect use of high doses of the drug, and sudden discontinuation of treatment may cause headache, fatigue, anxiety, and vegetative symptoms. These symptoms disappear within a few days. After this, it is best to use the drug after consulting a doctor. Para-Denk 500 should not be used for a long time, in high doses, and without consulting a doctor. Children: Para-Denk 500 is not indicated for children under 3.5 years of age and/or weighing less than 17 kg. Other forms of the drug with appropriate concentration are indicated for children in this group. Pregnancy: Consult your doctor before using the drug. During pregnancy, Para-Denk 500 suppositories can only be prescribed after an appropriate risk-benefit assessment. Prolonged, high-dose, or concomitant use of Para-Denk 500 suppositories with other drugs during pregnancy is not recommended, as safety has not been established in this case. Effect on driving and operating machinery: Para-Denk 500 does not affect driving or operating machinery. However, in any case, when using analgesics, attention should be paid. Overdose Dosage depends on the patient's age and/or body weight and should not exceed the norms indicated in the table. For adults weighing more than 43 kg, the total daily dose should not exceed 4000 mg of paracetamol. In case of overdose within 24 hours, nausea, vomiting, loss of appetite, pallor, and abdominal pain are observed. Seek medical help if you take a dose higher than recommended. Do not take a double dose if you have forgotten to take Para-Denk 500. Drug interactions The patient should inform their doctor or pharmacist about any medications they are currently taking or have recently taken, or any over-the-counter preparations. Interactions may occur with drugs such as: Probenecid (gout medication): In such cases, the dose of Para-Denk 500 mg should be reduced. Phenobarbital - sleeping pill), Diphenine, Carbamazepine (for epilepsy treatment), Rifampicin (for tuberculosis treatment) and other drugs that cause liver damage: Drug interactions with Para-Denk 500 mg may cause liver damage. The use of Metapropclamide and Domperidone may accelerate the absorption of Para-Denk 500 mg. Cholestyramine may inhibit the absorption of Para-Denk 500 mg and consequently its effect. Combined use of paracetamol and zidovudine may lead to a decrease in leukocytes (neutropenia). In this case, the medication should be continued only after consulting a doctor. The use of paracetamol may affect laboratory parameters such as urea and blood glucose levels. Para-Denk 500 tablets should not be used with alcohol. Storage conditions and expiry dates Store at a temperature not exceeding 25°C, protected from light and out of reach of children. Do not use after the expiry date.
