Paracetamol effervescent tablets 500mg, No. 12

• Pain syndrome of weak and moderate intensity of various origins (including headache, migraine, toothache, neuralgia, myalgia, algodismenorrhea; pain with injuries, burns).

• Fever in infectious and inflammatory diseases.

Inside.

Dissolve the tablet in a glass of water (200 ml). Do not chew or swallow tablets. Usually, 1Ц2 tablets are used 2Ц3 times a day at intervals of at least 4 hours.
The maximum single dose is 2 tablets (1 g), the maximum daily dose is? 8 tablets (4 g), which corresponds to a single dose of 10-15 mg / kg of body weight, for a maximum daily dose? 75 mg / kg body weight.
In case of impaired renal function, the time interval between doses of the drug should be at least 8 hours with creatinine clearance less than 10 ml / min, at least 6 hours? with a creatinine clearance of 10-50 ml / min.

One tablet

Active substance:

Paracetamol - 500,000 mg

• Hypersensitivity to paracetamol, propacetamol hydrochloride (paracetamol prodrug) or any other component of the drug,

• severe liver failure or decompensated liver disease in the acute stage,

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption,

• pregnancy (I and III trimester) and lactation period,

• children under 12 years of age (body weight at least 50 kg).

With caution
Severe renal failure (creatinine clearance <30 ml / min), hepatic failure, chronic alcoholism, nutritional deficiency, anorexia, bulimia, cachexia, hypovolemia, dehydration, deficiency of glucose-6-phosphate dehydrogenase, congenital Dubilirubin-Ginberaemia syndrome ( and Rotor), viral hepatitis, old age.

pharmachologic effect

Paracetamol (a derivative of paraaminophenol) has analgesic, antipyretic and mild anti-inflammatory effects. The exact mechanism of the analgesic and antipyretic effects of paracetamol has not been established.
Apparently, it includes central and peripheral components. The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation.
In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of its anti-inflammatory effect.

The drug does not have a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract due to the lack of effect on the synthesis of prostaglandins in peripheral tissues.

Side effects

• Allergic reactions: hypersensitivity reactions, pruritus, rash on the skin and mucous membranes (erythema or urticaria), Quincke's edema, exudative erythema multiforme (including Steven-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, acute generalized exanthematous pustulosis.

• From the side of the central and peripheral nervous system (when
  taking high doses): dizziness, psychomotor agitation and disorientation in space and time.

• On the part of the digestive system: nausea, diarrhea, epigastric pain, increased activity of 'liver' enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).

Interaction

Phenytoin reduces the effectiveness of paracetamol and increases the risk of developing hepatotoxicity.

Patients taking phenytoin should avoid frequent use of paracetamol, especially at high doses.

Probenecid almost halves the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid. With the simultaneous appointment, consideration should be given to reducing the dose of paracetamol.

Care should be taken with the simultaneous use of paracetamol and inducers of liver microsomal enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants).

Overdose

Symptoms: gastrointestinal disorders (nausea, vomiting, loss of appetite, abdominal discomfort
and / or abdominal pain), pallor of the skin, sweating, malaise.
With a single administration of 7.5 g or more to adults or more than 140 mg / kg to children, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death.

In 12Ц48 hours after the introduction of paracetamol, there is an increase in the activity of 'hepatic' transaminases, lactate dehydrogenase, bilirubin concentration and a decrease in the concentration of prothrombin.

A detailed clinical picture of liver damage appears after 1-2 days and reaches a maximum on 3-4 days.