Paracetamol Extratab 500 mg+150 mg tablets, 10 pcs.

Paracetamol has analgesic and antipyretic effects. The drug blocks cyclooxygenase 1 and 2 mainly in the central nervous system (CNS), affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains its almost complete lack of anti-inflammatory effect. The drug has no adverse effect on water-salt metabolism (sodium and water retention) and gastrointestinal (GI) mucosa, due to the lack of effect on prostaglandin synthesis in peripheral tissues. The drug in the form of a warm drink is convenient to use in patients with inflammatory diseases of the oropharynx, as taking drugs in solid dosage forms is difficult. The possibility of formation of methemoglobin is unlikely.
Ascorbic acid (vitamin C) is not formed in the human body and comes only with food.
Physiological functions: is a cofactor of some hydroxylation and amidation reactions – transfers electrons to enzymes, providing them with a reducing equivalent. It participates in reactions of hydroxylation of proline and lysine residues of procollagen to form hydroxyproline and hydroxylysine (poststratal modification of collagen), oxidation of lysine side chains in proteins to form hydroxytrimethyllysine (in the synthesis of cartinite), oxidation of folic acid to folin acid, metabolism of drugs in liver microsomes and hydroxylation of dopamine to form noradrenaline.
Increases the activity of amidifying enzymes involved in the processing of oxytocin, antidiuretic hormone and cholitsistokinin. Participates in steroidogenesis in adrenal glands.
The main role at the tissue level is participation in the synthesis of collagen, proteoglycans and other organic components of intercellular substance of teeth, bones and capillary endothelium.

Indications

Pyretic in infectious and inflammatory diseases (SARS, including influenza.Infectious and inflammatory diseases (acute respiratory infections, including influenza); analgesic for mild to moderately expressed pain syndrome (headache, toothache) of non-inflammatory origin, for neuralgia, pain in muscles and joints, algodysmenorrhea.

Active ingredient

Composition

Actives: paracetamol; ascorbic acid

How to take, the dosage

Ingestion. Single dose for adults and children (with body mass more than 50 kg) – 1 tablet or 10-15 mg/kg (in translation to paracetamol), maximum daily dose – 4 tablets, for children aged 6-12 years – 1/2 tablet, maximum daily dose – 2 tablets. The course of treatment – no more than 10 days.

Interaction

Concurrent use of other drugs with Paracetamol Extra should be consulted with a doctor.
Paracetamol reduces the effectiveness of uricosuric drugs.
With long-term and regular use, paracetamol potentiates the effect of warfarin and other coumarin derivatives and increases the risk of bleeding.
Simultaneous use of colestyramine leads to decreased absorption of paracetamol (and weakening of the effects of paracetamol).
Metoclopramide and domperidone increase absorption of paracetamol.
Concomitant use of paracetamol and nonsteroidal anti-inflammatory drugs (sodium metamisole, acetylsalicylic acid, ibuprofen, etc.) increases the risk of “analgesia”.) increases the risk of “analgesic” nephropathy and renal papillary necrosis, terminal renal failure.
Concomitant use of paracetamol and chloramphenicol may be accompanied by an increase in T1/2 of chloramphenicol up to 5 times.
Inducers of microsomal liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase production of hydroxylated active metabolites that causes the possibility of severe intoxications even in case of small overdose.
Salicylamide increases T1/2 of paracetamol that leads to accumulation of paracetamol and thus to increased formation of its toxic metabolites.
Concomitant use of paracetamol and ethanol may increase the hepatotoxicity of paracetamol and also contribute to acute pancreatitis.
Diflunisal increases the plasma concentration of paracetamol by 50% – risk of hepatotoxicity.
Other drugs containing paracetamol and other non-narcotic analgesics should not be used simultaneously.
Ascorbic acid increases the blood concentration of benzylpenicillin and tetracyclines; at a dose of 1 g/day it increases the bioavailability of ethinylestradiol (including the one contained in oral medications). 1 g/day dose increases bioavailability of ethinylestradiol (including oral contraceptives); improves intestinal absorption of Fe (converts trivalent to divalent iron); may increase iron excretion in concomitant use with deferoxamine; decreases efficacy of heparin and indirect anticoagulants.
Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drinking reduce absorption and assimilation of ascorbic acid.
Concomitant use with acetylsalicylic acid increases urinary excretion of ascorbic acid and decreases excretion of acetylsalicylic acid.
Acetylsalicylic acid reduces absorption of ascorbic acid by approximately 30%.
Ascorbic acid increases the risk of crystalluria during treatment with salicylates and short-acting sulfonamides, slows renal excretion of acids, increases excretion of drugs that have an alkaline reaction (including
Quinoline-type drugs, CaCl2, salicylates, GCS during long-term use deplete ascorbic acid.
Concurrent use of ascorbic acid reduces chronotropic effect of isoprenaline.
With long-term use or use at high doses ascorbic acid may prevent the interaction of disulfiram and ethanol; at high doses increases excretion of mexiletine by the kidneys.
Barbiturates and primidone increase excretion of ascorbic acid in the urine.
Ascorbic acid reduces the therapeutic effects of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubal reabsorption of amphetamine and tricyclic antidepressants.

Special Instructions

In case of hyperthermia lasting more than 3 days and pain syndrome of more than 5 days, it is necessary to consult a doctor.
After 5 days of the preparation use the peripheral blood picture and the functional state of the liver should be checked.
Paracetamol distorts the figures of laboratory tests during the quantitative determination of plasma concentration of glucose and uric acid. In order to avoid toxic damage of the liver Paracetamol should not be combined with alcohol-containing drinks, as well as taken by individuals who tend to abuse alcohol.
There is evidence that the frequent use of drugs containing paracetamol leads to aggravation of symptoms of bronchial asthma.
Paracetamol Extra contains sucrose, that is why the drug is not recommended for patients with congenital intolerance to fructose, glucose-galactose malabsorption syndrome or deficiency of sucrose isomaltase.

Contraindications

Deficiency of glucose-6-phosphate dehydrogenase; severe renal, hepatic diseases, including renal and/or hepatic failure; gastrointestinal tract erosive ulcers (in the acute phase), gastrointestinal bleeding; phenylketonuria; children under 6 years of age; fructose intolerance, glucose-galactose malabsorption, sugar-isomaltose deficiency; pregnancy (Ι-ΙΙ trimesters), lactation. Caution: erosive-ulcerative lesions of the gastrointestinal tract (history), congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes). Blood diseases (thrombocytopenia, leukopenia, agranulocytosis), sideroblast anemia, thalassemia. Glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, hyperoxaluria, urolithiasis. Bronchial asthma. Diabetes mellitus. Alcoholism.

Side effects

Ascorbic acid. Allergic reactions: skin rash, skin hyperemia. Laboratory parameters: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophil leukocytosis, hypokalemia, glucosuria. The digestive system: rare – nausea, very rare – vomiting, diarrhea, epigastric pain, jaundice, pancreatitis and increased liver enzymes activity. Allergic reactions: rare – skin rash, itching, urticaria, angioedema). Blood and lymphatic system: very rare – anemia and leukopenia. Other: weakness.

Overdose

Symptoms (caused by ascorbic acid): diarrhea, nausea, irritation of the gastrointestinal mucosa, flatulence, abdominal pain of spastic character, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia. Symptoms (caused by paracetamol): during the first 24 hours after overdose – pale skin, nausea, vomiting; anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis, liver function disorders may appear 12-48 hours after overdose. In severe overdose – hepatic failure with progressive encephalopathy, coma, death; acute renal failure with turbulent necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Hepatotoxic effect in adults occurs at 10 g or more. Rarely, hepatic failure develops fulminantly and may be complicated by renal failure (tubular necrosis). Treatment: administration of SH-group donators and precursors of glutathione synthesis – methionine – within 8-9 hours after overdose and acetylcysteine – within 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after intake, symptomatic, forced diuresis.

Pregnancy use

There are no data on efficacy and safety studies of the combination of paracetamol and ascorbic acid in pregnant and lactating women. Thus, it is not possible to assess the possible risk-benefit ratio, and therefore it is not recommended to use the drug in these categories of patients.