Paracetamol, tablets 200 mg 10 pcs

Paracetamol is an analgesic and antipyretic. It blocks the synthesis of prostaglandins in the central nervous system by inhibiting cyclooxygenase 1 and cyclooxygenase 2, affecting the centers of pain and thermoregulation. It has no anti-inflammatory effect.

The lack of effect on prostaglandin synthesis in peripheral tissues determines the absence of its negative effect on water-salt metabolism (sodium and water retention) and gastrointestinal mucosa.

Pharmgroup:

The analgesic non-narcotic.

Pharm Action:

Non-narcotic analgesic, blocks COX1 and COX2 mainly in the CNS, affecting the centers of pain and thermoregulation.

In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of anti-inflammatory effects.

The lack of blocking effect on Pg synthesis in peripheral tissues explains its lack of negative effects on water-salt metabolism (Na+ and water retention) and gastrointestinal mucosa.

Indications

Used for rapid relief of headache, including migraine pain, toothache, neuralgia, muscle and rheumatic pain, as well as algodysmenorrhea, pain from injuries, burns; to reduce fever in colds and flu.

Active ingredient

Composition

Active substance:

paracetamol 200 mg,

Auxiliary substances:

gelatin,

Potato starch,

Stearic acid,

Milk sugar (lactose).

How to take, the dosage

For adults the single dose of paracetamol is 0.35-0.5 g 3-4 times a day, the maximum single dose for adults is 1.5 g, the maximum daily dose is 3-4 g. The drug should be taken after the meal with plenty of water.

For children from 9 to 12 years old the maximum daily dose is 2 g.

For children from 3 to 6 years old the maximum daily dose is 1-2 g of paracetamol at the rate of 60 mg per 1 kg of child weight in 3-4 doses.

Interaction

The drug when taken for a long time increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol promotes acute pancreatitis.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects. Concomitant use with other non-steroidal anti-inflammatory drugs increases the nephrotoxic effect.

The concomitant use of paracetamol in high doses and salicylates increases the risk of kidney and bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% – risk of hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug. Metoclopramide and domperidone increase and cholestyramine decreases the absorption rate of paracetamol. The drug may decrease the activity of uricosuric drugs.

Special Instructions

Consult your doctor before taking this medicine:

to avoid anti-toxic liver damage, do not take paracetamol with alcoholic drinks, or with people who have a tendency to drink alcohol spirits chronically.

In long-term treatment it is necessary to monitor peripheral blood count and liver function.

Contraindications

With caution: Use with caution in benign hyperbilirubinemia (incl.including Gilber’s syndrome), viral hepatitis, alcoholic liver damage, glucose-6-phosphate dehydrogenase deficiency, alcoholism, pregnancy, lactation, old age. The drug should not be taken simultaneously with other paracetamol-containing drugs.

Side effects

In the recommended doses, the drug is usually well tolerated. Paracetamol rarely causes side effects. Allergic reactions (skin rash, pruritus, urticaria, Quincke’s edema), erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), dizziness, nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis; insomnia may sometimes be observed. When prolonged use in high doses – increased likelihood of impairment of liver and kidney function, as well as hematopoietic system.

Digestive system disorders: nausea, epigastric pain, increased liver enzymes activity, hepatonecrosis. Endocrine system disorders: hypoglycemia. In case of unusual symptoms it is necessary to consult a physician.

Overdose

The signs of paracetamol overdose are nausea, vomiting, stomach pain, pale skin, anorexia. After a day or two, signs of liver damage are determined. In severe cases liver failure and coma develop. Specific antidote in paracetamol poisoning is N-acetylcysteine.

Symptoms: pale skin, anorexia, nausea, vomiting; hepatonecrosis (severity of necrosis depends directly on the degree of overdose). If overdose is suspected, seek medical attention immediately. Toxic effects of the drug in adults may be observed after taking over 10-15 g of paracetamol: increased “liver” transaminases activity, increased prothrombin time (12-48 hours after intake); clinical picture of liver damage becomes apparent after 1-6 days. Rarely, liver dysfunction develops fulminantly and may be complicated by renal failure (tubular necrosis).

Treatment: the victim should undergo gastric lavage during the first 4 hours of poisoning, take adsorbents (activated charcoal) and consult a physician, the administration of SH-group donators and precursors of glutathione synthesis – methionine in 8-9 hours after overdose and N-acetylcysteine – in 12 hours. The need for additional therapeutic measures (further methionine administration, intravenous N-acetylcysteine administration) is determined depending on the concentration of paracetamol in blood, as well as on the time elapsed after its administration.

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