Methyluracil

I N S T R U C T I O N for medical use of the medicinal product METHYLURACIL (METHYLURACILUM)

Composition:

Active substance: methyluracil;

1 tablet contains 500 mg (0.5 g) of methyluracil;

Excipients: potato starch, povidone (low-molecular-weight medical polyvinylpyrrolidone), stearic acid.

Pharmaceutical form. Tablets.

Main physico-chemical properties: white tablets with flat surface, bevelled edges and a score line.

Pharmacotherapeutic group.

Anabolic agents. ATC code A14B.

Pharmacological properties.

Pharmacodynamics.

Methyluracil has anabolic and anticatabolic activity. It accelerates cellular regeneration processes, wound healing, stimulates cellular and humoral defense factors, exhibits anti-inflammatory effect, normalizes nucleic metabolism in the mucous membrane of the gastrointestinal tract. A characteristic specific property of the drug is stimulation of erythropoiesis and, particularly, leukopoiesis.

Pharmacokinetics.

After oral administration, it is absorbed in the gastrointestinal tract. It penetrates well into organs, tissues, and body fluids. It is excreted mainly by urine.

Clinical characteristics.

Indications.

Agranulocytic angina, alimentary-toxic aleukia, chronic benzene intoxication, leukopenia caused by chemotherapy of tumors, X-ray or radiation therapy, or other factors. In complex treatment of slowly healing wounds; burns; trophic ulcers; bone fractures; peptic ulcer of the stomach and duodenum.

Contraindications.

Hypersensitivity to methyluracil or to other components of the drug. The drug is contraindicated in acute and chronic (usually myeloid) forms of leukemia, lymphogranulomatosis, and malignant diseases of the bone marrow.

Interaction with other medicinal products and other forms of interactions.

Not described.

Special precautions.

Metiluracil is advisable to prescribe in mild forms of leukopenia. In moderate disease severity, the drug should be taken only after restoration of blood cell regeneration. Metiluracil must not be prescribed in severe forms of hematopoietic system disorders.

Use during pregnancy or breastfeeding.

The drug must not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

There is no information available regarding the effect of the drug on the ability to drive or operate machinery. Until the individual patient's response to metiluracil is established, patients should refrain from driving vehicles or operating machinery, considering that adverse reactions such as dizziness may occur during treatment with metiluracil.

Method of administration and dosage.

Orally, during or after meals, taken with a small amount of water.

For adults, the recommended dose is 500 mg four times daily (if necessary, up to six times daily).

Dosage for children aged 3 to 8 years: 250 mg (1/2 tablet) three times daily; for children aged 8 years and older: 250–500 mg three times daily.

The duration of treatment is determined by a physician depending on the nature and course of the disease.

The treatment course for gastric and duodenal peptic ulcer usually lasts 30–40 days; in other cases, the treatment course may be shorter.

Children.

The drug is not recommended for use in children under 3 years of age.

Overdose.

Not observed.

Side effects.

Central nervous system: headache, dizziness.

Allergic reactions: hyperemia, facial swelling, urticaria, maculopapular rash on the skin of the face and neck.

Shelf life.

2 years.

Storage conditions.

In the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in a strip or blister. One strip together with the instruction for medical use in a paper envelope. Two or ten strips or one, two, or ten blisters, together with the instruction for medical use, are packed in a cardboard consumer package.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

JSC " Monfarm ".

Manufacturer's address and location of its business activity.

8, Zavodska Street, Avramivka, Uman District, Cherkasy Oblast, Ukraine, 19161