Paracetamol Reneval, tablets 500 mg 20 pcs

Pharmacotherapeutic group: analgesic non-narcotic.

ATC code [N02BE01]

Pharmacological properties

Paracetamol has analgesic and antipyretic effect. Paracetamol blocks cyclooxygenase I and II only in CNS, affecting centers of pain and thermoregulation (in inflamed tissues cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase), which explains the almost complete absence of 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. The possibility of methemoglobin formation is unlikely.

Indications

Neuralgia, Toothache, Increased body temperature, Joint pain (arthralgia), SARS, Headache, Flu, Myalgia (muscle pain)

Moderate or mild pain syndrome (headache, toothache, migraine pain, neuralgia, myalgia). Elevated body temperature with colds and other infectious and inflammatory diseases.

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Active ingredient

Paracetamol

Composition

1 tablet contains:

active ingredient:

paracetamol – 0.5 g

excipients:

potato starch – 0,0280 g
stearic acid – 0,0011 g
low-molecular povidone – 0,0165 g
magnesium stearate – 0,0044 g

How to take, the dosage

It is administered orally with plenty of liquid 0.5 g – 1 g 2-3 times a day with intervals of at least 4 hours. Maximal single dose for adults and adolescents over 12 years old (body weight over 40 kg) is 1 g, daily dose – 4 g.

In patients with liver or kidney function disorders, with Gilbert syndrome and in elderly patients the interval between the doses should be at least 8 hours and the daily dose should be decreased. The maximal daily dose for children aged 8 to 9 years old (body weight up to 30 kg) is 1.5 g and up to 12 years old (body weight up to 40 kg) – 2 g.

The therapy duration shall not exceed 5 days if prescribed as an analgesic and 3 days as a antipyretic.

Interaction

Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase production of hydroxylated active metabolites, which causes the possibility of severe intoxication in small overdoses. Prolonged use of barbiturates reduces the effectiveness of paracetamol.

Special Instructions

In order to avoid toxic liver damage paracetamol should not be combined with alcoholic beverages, as well as taken by persons prone to chronic alcohol consumption.
The risk of liver damage increases in patients with alcoholic hepatosis.
Long-term use of the drug requires monitoring of peripheral blood count and functional status of the liver.

Contraindications

• High sensitivity to paracetamol.
• Children under 8 years.

With caution – renal and hepatic failure, benign hyperbilirubinemia (including Gilbert’s syndrome.

With caution – renal failure, liver failure, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, alcoholic liver injury, alcoholism, pregnancy, lactation, old age, glucose-6-phosphate dehydrogenase deficiency.

Side effects

Nausea, vomiting, epigastric pain, allergic reactions (skin rash, pruritus, urticaria, Quincke’s edema).
Rarely – anemia, leukopenia, thrombocytopenia, agranulocytosis.

Overdose

Symptoms: during the first 24 hours after ingestion – pale skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis. Symptoms of liver function abnormality may appear 12-48 hours after overdose.

In severe overdose – liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Hepatotoxic effect in adults is observed after administration of 10 g or more.

Treatment: administration of SH-groups and glutathione synthesis precursors – 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.

Similarities

Efferalgan, Cefekon D, Paracetamol, Paracetamol for children, Paracetamol Renewal, Paracetamol, tablets 500 mg 10 pcs