Esserre pharma Paracetamol zentiva 500mg fever and pain 30 tablets (damaged package)

Product Description

Short-term symptomatic treatment of mild to moderate pain and/or fever.

Indications

Paracetamol Zentiva 500 mg is intended for adults, adolescents and children weighing more than 21 kg (aged 6 years and over).

Composition

Active ingredients

500 mg of paracetamol.

Excipients

Pregelatinized starch, Maize starch, Talc (E 553), Stearic acid (E 570), Povidone (E 1201), Potassium sorbate (E 202).

Directions for use and Dosage

Dosage The lowest effective dose should be used for the shortest possible duration. The maximum daily dose should not be exceeded. Paracetamol is dosed based on body weight and age, usually 10 - 15 mg/kg body weight as a single dose, up to a maximum daily dose of 60 mg/kg body weight. For dosage based on body weight and age, see the tables. Paracetamol Zentiva 500 mg tablets Paracetamol Zentiva 500 mg tablets are not intended for children under 6 years of age with a body weight less than 21 kg.

*Only after consulting a doctor, the maximum daily dose in patients with a body weight > 60 kg can be increased. be increased to 4 g of paracetamol.

* Only after consulting a doctor, the maximum daily dose in patients with body weight > 60 kg can be increased to 4 g of paracetamol. Renal impairment Paracetamol should be used with caution in patients with renal impairment as a reduced dose and/or a prolonged administration interval is necessary. The maximum single dose should not exceed 500 mg. - A dosage interval of 6 hours is recommended with a glomerular filtration rate of 50 ± 10 ml/min. - A dosage interval of 8 hours is recommended with a glomerular filtration rate less than 10 ml/min. Hepatic impairment Paracetamol should be used with caution in patients with mild to moderate hepatic impairment or Gilbert's syndrome, as the dose should be reduced or the interval between doses extended. In these patients, the daily dose should not exceed 60 mg/kg (maximum 2 g/day). Use of this medicine is contraindicated in patients with severe hepatic impairment. Elderly Experience has indicated that the normal adult dosage of paracetamol is generally appropriate. However, in frail and immobile elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the quantity or frequency of administration may be appropriate. Method of administration For oral use. The tablets should be swallowed with a sufficient amount of liquid.

Warnings

Patients should be advised not to use other paracetamol-containing medicinal products concomitantly. Cases of paracetamol-induced hepatotoxicity, including fatal cases, have been reported in patients taking paracetamol at doses within the therapeutic range. These cases have been reported in patients with one or more risk factors for hepatotoxicity, including low body weight (<50 kg), renal and hepatic insufficiency, chronic alcoholism, concomitant use of hepatotoxic drugs, and acute and chronic malnutrition (low hepatic glutathione reserves). Paracetamol should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, glutathione deficiency, chronic malnutrition, chronic alcoholism, dehydration, the elderly, and patients with mild to moderate hepatic insufficiency and/or renal impairment. Regular monitoring of liver function tests is recommended in patients with impaired liver function and in those receiving high doses of paracetamol over a long period. The risk of serious hepatotoxic effects increases significantly with increasing dose and duration of treatment. Underlying liver disease increases the risk of paracetamol-related liver damage. The risk of overdose is greater in patients with non-cirrhotic liver damage caused by alcohol. Alcohol intake should be avoided during therapy. Long-term alcohol consumption significantly increases the risk of paracetamol-related hepatotoxicity. Measurement of prothrombin time is necessary in concomitant therapy with oral anticoagulants and long-term regular daily intake of paracetamol. The possibility of renal failure cannot be ruled out with long-term treatment. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition, and other sources of glutathione deficiency (e.g., chronic alcoholism), as well as in those using maximum daily doses of paracetamol. Careful monitoring is recommended, including measurement of urinary 5-oxoproline.

Interactions

The rate of absorption of paracetamol may be increased by metoclopramide or domperidone. However, concomitant use does not need to be avoided. Cholestyramine reduces the absorption of paracetamol. Paracetamol should be administered at least 1 hour before or 4-6 hours after cholestyramine. Long-term coadministration with acetylsalicylic acid or other NSAIDs may cause renal damage. The anticoagulant effect of warfarin or other coumarin products may be enhanced, along with an increased risk of bleeding with long-term, regular daily use of paracetamol. Occasional use has no significant effect. Hepatotoxic substances may increase the potential for accumulation and overdose of paracetamol. Paracetamol may influence the pharmacokinetics of chloramphenicol. Therefore, plasma chloramphenicol analysis is recommended in case of combined treatment with injected chloramphenicol. Probenecid reduces paracetamol clearance by almost 50%. Therefore, the dose of paracetamol can be halved during concomitant treatment. Microsomal enzyme inducers (e.g., rifampicin, phenobarbital, phenytoin, carbamazepine, St. John's Wort) reduce the bioavailability of paracetamol through increased glucuronidation, increasing the risk of liver toxicity. Such combinations should be avoided. Concomitant use of paracetamol and zidovudine may increase the risk of neutropenia. Concomitant use of paracetamol and isoniazid may increase the risk of hepatotoxicity. Caution should be exercised when using paracetamol concomitantly with flucloxacillin, as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors.

Contraindications

Hypersensitivity to the active substance or to any of the excipients - Severe hepatic impairment. - Acute hepatitis.

Undesirable effects

The administration of paracetamol can cause the following undesirable effects (classified into MedDRA frequency groups as follows: very common (>1/10); common (from: >1/100 to: <1/10); uncommon (from: >1/1,000 to: <1/100); rare (from: >1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

* In acid-sensitive patients acetylsalicylic acid or other NSAIDs. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

In case of paracetamol overdose, immediate medical attention is required, even if no symptoms of overdose are present. Overdose with even relatively low doses of paracetamol can cause severe liver damage and, sometimes, acute renal tubular necrosis. Nausea, vomiting, lethargy, anorexia, pallor and sweating may occur within 24 hours or patients may be asymptomatic. Abdominal pain may be the first symptom of liver damage and occurs within 1-2 days. Paracetamol overdose can cause necrosis of liver cells, which can lead to complete necrosis and irreversible, resulting in hepatocellular failure, metabolic acidosis, and encephalopathy that can lead to coma and death. Simultaneously, increased levels of liver transaminases (AST, ALT), lactate dehydrogenase, and bilirubin are observed, along with prolonged prothrombin time, which may appear 12 to 48 hours after administration. Prolongation of prothrombin time is one of the indicators of impaired liver function, and therefore monitoring is recommended. Complications of liver failure include cerebral edema, bleeding, hypoglycemia, hypotension, infections, and renal failure. Liver damage is possible in patients who have taken more than the recommended amount of paracetamol. Excessive amounts of the toxic metabolite are believed to bind irreversibly to liver tissue. Some patients may be at increased risk of liver damage due to paracetamol toxicity. Risk factors include:

• Patients with liver disease liver;
• Elderly patients;
• Small children;
• Patients on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other drugs that induce liver enzymes;
• Patients who regularly consume alcohol in excess of recommended amounts;
• Patients with glutathione depletion, e.g., eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Acute renal failure may occur without the presence of severe liver failure. Other manifestations of intoxication are myocardial damage, cardiac arrhythmias, and pancreatitis. Management: Hospitalization is required. Blood sampling should be performed to determine the initial plasma paracetamol concentration. In the event of a single acute overdose, the plasma paracetamol concentration should be measured 4 hours after ingestion. Induction of vomiting, gastric lavage, especially if paracetamol was ingested less than 4 hours previously, then administration of methionine (2.5 g orally) should be undertaken, and supportive measures are also appropriate. The administration of activated charcoal to reduce gastrointestinal absorption is controversial.

The specific antidote N-acetylcysteine ​​should be administered as soon as possible, within 8 ± 15 hours of poisoning, but beneficial effects have also been observed with subsequent administration of acetylcysteine. Acetylcysteine ​​should be administered in accordance with national therapeutic guidelines. It is usually administered to adults, adolescents, and children IV in 5% glucose solution. The initial dose should be 150 mg/kg of body weight over 15 minutes. Additionally, 50 mg/kg in infusion of 5% glucose solution 5% for a period of 4 hours, and then 100 mg/kg up to the 16th or 20th hour after the start of therapy. Acetylcysteine ​​can also be administered orally within 10 hours of ingestion of a toxic dose of paracetamol at a dose of 70 - 140 mg/kg 3 times a day. Hemodialysis or hemoperfusion is performed in case of very severe intoxication. Symptomatic treatment must be implemented.

Pregnancy and breastfeeding

Pregnancy A large amount of data on pregnant women indicate neither malformative nor fetal/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be administered orally within 10 hours of ingestion of a toxic dose of paracetamol at a dose of 70 - 140 mg/kg 3 times a day. Paracetamol cannot be used during pregnancy, however, it should be used at the lowest effective dose for the shortest possible time and as frequently as possible. Breastfeeding: Paracetamol passes into breast milk but is unlikely to affect the infant at therapeutic doses. It is not necessary to stop breastfeeding during short-term treatment with the recommended doses of this medicine. Fertility: No clinical data are available.

Format

30 tablets