International generic name
Drug form and composition
Tablets. One tablet contains 500 mg Paracetamol. Syrup. 5 milliliters syrup contains
120 mg Paracetamol.
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.
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.
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.
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.
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.
20 or 400 tablets of 500 mg. Vials, containing 125 ml syrup.
Tablets and syrup - 3 years.