Instructions for Parafast capsules 500 mg No. 10
Composition
active ingredient: paracetamol;
1 soft capsule contains paracetamol 500 mg;
excipients: macrogol 400 (polyethylene glycol 400); propylene glycol; colloidal anhydrous silicon dioxide; purified water;
capsule shell: gelatin 180 Bloom; sorbitol solution, partially dehydrated (Polysorb® 85/70/00); titanium dioxide; purified water.
Dosage form
Soft capsules.
Main physicochemical properties: white opaque oval soft gelatin capsule containing an off-white to white suspension.
Pharmacotherapeutic group
Analgesics and antipyretics. Anilides. Paracetamol.
ATX code N02B E01.
Pharmacological properties
Pharmacodynamics.
Parafast capsules 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. Age up to 10 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 administered 1 hour before or 4-6 hours after 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 administration has no significant effect. Barbiturates reduce the antipyretic effect of paracetamol.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of liver microsomal enzymes, can 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 drugs on the liver increases. Probenecid halves the clearance of paracetamol by blocking its binding to glucuronic acid, therefore, in the 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.
Concomitant use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.
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 metabolic acidosis with an increased anion gap, especially in patients with risk factors (see section "Special warnings and precautions for use").
Application features
Do not exceed the indicated doses. 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 taken into account that patients with alcoholic non-cirrhotic liver damage have an 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:
Caution is advised when using paracetamol concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA). Patients at high risk of developing HAGMA include those with severe renal impairment, sepsis or malnutrition, especially when using the maximum daily dose of paracetamol.
Patients with severe infections such as sepsis, which are accompanied by a decrease in glutathione levels, are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should seek immediate medical attention if these symptoms occur.
If symptoms persist, consult a doctor. Prolonged use without medical supervision may be dangerous.
The medicine should be used only when clearly necessary.
Keep the drug out of the sight and reach of children.
Use during pregnancy or breastfeeding
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 have not yielded conclusive results. 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.
Paracetamol is excreted in 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 16 years and older: 2 capsules to be taken every 4-6 hours as needed. Do not take more than 4 doses (8 capsules) in 24 hours.
Children 10 to 15 years of age: 1 capsule to be taken every 4 to 6 hours as needed. Do not take more than 4 doses (4 capsules) in 24 hours.
Dose should be taken no more frequently than every 4 hours. Do not take for more than 3 days unless directed by a doctor.
Children.
Not recommended for use in children under 10 years of age unless prescribed by a doctor.
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, elevated levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin, as well as prothrombin levels, are observed 12–48 hours after taking paracetamol. Liver damage is likely in adults who have taken more than the recommended amount of paracetamol. It is believed that the increased amount of paracetamol metabolite (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.
Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage.
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; reduced glutathione levels, for example, in eating disorders, fasting, 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.
Side effects
The frequency of adverse reactions is determined according to the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Information on the following adverse reactions was obtained during post-marketing surveillance.
From the blood and lymphatic system: very rarely - thrombocytopenia, agranulocytosis.
Immune system disorders: very rarely - anaphylaxis, hypersensitivity skin reactions, including skin rash, angioedema.
Skin and subcutaneous tissue disorders: very rarely - Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis, fixed drug erythema.
Respiratory, thoracic and mediastinal disorders: very rarely - bronchospasm in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
On the part of the hepatobiliary system: very rarely - liver dysfunction.
Also, after taking drugs containing paracetamol, the following side effects are possible: skin itching, exudative erythema multiforme, nausea, epigastric pain, hypoglycemia, up to hypoglycemic coma, agranulocytosis, anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia, bruising or bleeding, increased activity of liver enzymes, usually without the development of jaundice.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
10 capsules in a blister; 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Olive Helsker.
Location of the manufacturer and its business address
Unit 2, Plot 163/2, Mahatma Gandhi Udyog Nagar, Dabhel Village, Nani Daman, 396 210, India.
