Allopurinol Sandoz tablets 300 mg 50 pcs.

The active substance is allopurinol (one tablet contains 300 mg of allopurinol).

Excipients: powdered cellulose, povidone, macrogol 4000, crospovidone, talc, magnesium stearate, microcrystalline cellulose.

Hypersensitivity to allopurinol or to any of the components of the drug.

Adults

The daily dose is determined individually depending on the level of uric acid in the blood serum. To reduce the risk of adverse reactions, treatment should be started with 100 mg of allopurinol once a day and the dosage should be increased only if the level of uric acid in the blood serum is not sufficiently reduced.

The following dosage regimens are recommended:

• for mild conditions – from 100 mg to 200 mg per day;
• for moderately severe conditions – from 300 mg to 600 mg per day;
• in severe conditions – from 700 mg to 900 mg per day.

When calculating the dose of the drug based on the patient’s body weight, use doses of 2-10 mg/kg of body weight per day.

Children

For children over 15 years of age, the daily dose of allopurinol is 10-20 mg/kg body weight. The maximum daily dose is 400 mg. Allopurinol is rarely prescribed to children, except for malignant conditions (especially leukemia) and certain enzyme disorders, such as Lesch-Nyhan syndrome.

Pregnant women

There are insufficient data on the use of allopurinol during pregnancy. Since allopurinol affects purine metabolism and the potential risk to humans is unknown, allopurinol is not recommended for use during pregnancy.

Allopurinol passes into breast milk, so the drug should not be taken during breastfeeding.

Drivers

Until the individual response to allopurinol is determined, caution should be exercised when driving or operating machinery due to the possibility of dizziness, drowsiness, and ataxia.

Symptoms

After a single dose of 20 g, one patient experienced symptoms such as nausea, vomiting, diarrhea, and dizziness. In another patient, a dose of 22.5 g of allopurinol did not cause any undesirable effects. After prolonged administration of 200-400 mg of allopurinol per day in patients with impaired renal function, severe symptoms of intoxication (skin reactions, fever, hepatitis, eosinophilia, and exacerbation of renal failure) have been described. In case of overdose, allopurinol significantly inhibits the activity of xanthine oxidase, but only in the case of simultaneous use with 6-mercaptopurine and azathioprine is the effect of the drug accompanied by significant side effects.

If an overdose is suspected, especially when 6-mercaptopurine and azathioprine are taken simultaneously, you can flush the stomach, induce vomiting, or take activated charcoal and sodium phosphate if no more than one hour has passed after taking the drug.

Treatment

Treatment is symptomatic. If necessary, hemodialysis. No specific antidote is known.

At the beginning of treatment with allopurinol, reactive attacks of gout may occur. Manifestations of adverse reactions are frequent in renal and/or hepatic insufficiency or with simultaneous use with ampicillin or amoxicillin.

Blood disorders: rarely (≥ 1/10,000, <1/1000) – severe bone marrow damage (thrombocytopenia, agranulocytosis, aplastic anemia), especially in patients with renal failure.

On the part of the immune system: rarely (≥ 1/10,000, <1/1000) – delayed-type hypersensitivity reactions accompanied by fever, skin rashes, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, abnormal liver function tests (reversible increase in transaminases and alkaline phosphatase); acute cholangitis and xanthine stones.

Gastrointestinal tract: rarely (≥ 1/10,000, <1/1000) – nausea, vomiting, diarrhea.

On the part of the liver: rarely (≥ 1/10,000, <1/1000) – liver dysfunction from asymptomatic increase in liver function tests to hepatitis (including liver necrosis and granulomatous hepatitis).

Store at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 5 years.