International generic name

Paracetamol

Drug form and composition

Tablets. One tablet contains 500 mg Paracetamol. Syrup. 5 milliliters syrup contains 120 mg Paracetamol.

Indications

The preparation is indicated in diseases manifesting with pain and fever: headache, toothache, mild and moderate postoperative and injury pain, high temperature, infectious diseases and chills (acute catarrhal inflammations of the upper respiratory tract, flu, small-pox, parotitis, etc.).

Dosage and administration

In adults - 500 mg (1 tablet), 3-4 times daily. In children: aged from 3 months to1 year - 60-120 mg (2.5-5 ml syrup), 3-4 times daily; 1-6 years - 120-240 mg (5-10 ml syrup), 3-4 times daily; children older than 6 years - 250-500 mg, 3-4 times daily. In children younger than 3 months the preparation should be used only on doctor’s prescription. Duration of the treatment in children should not exceed 5 days, whereas in adults it may be continued up to 10 days.

Contraindications

Paracetamol should not be used in hypersensitivity to the preparation and in severe liver diseases.

Special warnings and precautions

The preparation should be used with care in patients with liver and renal diseases. The treatment with Paracetamol may change the laboratory tests of uric acid and blood glucose analysis. In severe renal failure the interval between two consecutive takings should not be shorter than 8 hours. The treatment with the preparation is not advisable during the first trimester of the pregnancy. In nursing women the preparation should be used with strictly observation of the therapeutic dose and duration of the treatment.

Drug interactions

Concomitant treatment with aminophenazone may lead to an increase of the effects of both medicines. Paracetamol potentiates effects of the anticoagulant medicines. Phenobarbital increases the harming effect of Paracetamol on the liver. Contraceptive preparations and rifampicin reduce the effectivity of Paracetamol. Cimetidin reduces toxicity and potentiates the analgesic effect of the preparation. Paracetamol potentiates the action of the Chloramphenicol. Concomitant usage of alcohol and medicines harming the liver, enhances the risk of severe liver disorders.

Adverse reactions

In rare cases hypersensitivity reactions, predominantly skin allergy (itching and rash), may appear. Long-term treatment with high doses may cause a toxic hepatitis with following initial symptoms: nausea, vomiting, sweating, and discomfort. Occasionally a gastrointestinal discomfort may be seen.

Pharmacological mechanisms

Paracetamol possesses prominent antipyretic and analgesic effects. Its anti-inflammatory activity is weak and has no clinical significance. The mechanism of action is related to depression of the prostaglandin synthesis by inhibition of the specific cell cyclooxygenase, and depression of the thermoregulatory center in the medulla oblongata.

Supplied

20 or 400 tablets of 500 mg. Vials, containing 125 ml syrup.

Expiry

Tablets and syrup - 3 years.