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 suppository contains 0.5 g of methyluracil;

excipient: solid fat.

Pharmaceutical form. Rectal suppositories.

Main physico-chemical characteristics: white suppositories or white with a yellowish or creamy tint.

Pharmacotherapeutic group.

Non-steroidal anabolic agents. ATC code A14B.

Pharmacological properties.

Pharmacodynamics.

The drug has anabolic and anticatabolic effects. It accelerates regeneration and wound healing, stimulates cellular and humoral immune responses, and exerts anti-inflammatory action. A characteristic specific property of the drug is its stimulating effect on erythropoiesis and, especially, leukopoiesis.

Pharmacokinetics.

After administration of the suppository into the rectum, the drug is well absorbed through the mucosa and appears in the blood within 20–30 minutes. Maximum blood concentration is reached within 1–2 hours. The drug is excreted from the body mainly by the kidneys in the form of metabolites and conjugates, and partially in unchanged form with feces.

Clinical characteristics.

Indications.

Inflammatory and ulcerative diseases of the lower parts of the large intestine: erosive and ulcerative colitis, proctosigmoiditis, anal fissures.

Contraindications.

Hypersensitivity to methyluracil or to any of the 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 interaction.

Methyluracil enhances the effect of strophanthin and increases the efficacy of antibiotics and sulfonamide drugs.

Special precautions.

Methyluracil is advisable to prescribe in mild forms of leukopenia. In moderate disease severity, the drug should be taken only after restoration of impaired blood cell regeneration. Methyluracil is contraindicated in severe forms of hematopoietic system disorders.

Use during pregnancy or breastfeeding.

The drug is not used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Until the patient's individual response to the drug is established, driving vehicles or operating machinery should be avoided, considering that adverse reactions from the nervous system, such as dizziness, may occur during methyluracil treatment.

Method of Administration and Dosage.

Remove the suppository from its blister packaging and administer rectally. For adults and children aged 14 years and older: 1 suppository 1–4 times daily. Treatment duration ranges from 7 days to 4 months, depending on the nature of the disease.

Children.

The drug should not be used for the treatment of children under 14 years of age.

Overdose.

Not observed.

Side effects.

Central nervous system side effects: headache, dizziness.

Skin and subcutaneous tissue side effects: allergic reactions, including hyperemia, itching, skin rash, urticaria.

Local reactions at site of administration: transient burning sensation, itching may occasionally occur after rectal administration of the suppository.

Shelf life.

2 years.

Storage conditions.

In original packaging at a temperature not exceeding 15 °C.

Keep out of reach of children.

Packaging.

5 suppositories per strip. 2 strips per cardboard box.

Availability.

Over-the-counter.

Manufacturer.

JSC « Monfarm ».

Manufacturer's address and location of its business activity.

8, Zavodska Street, Avramivka, Uman district, Cherkasy region, 19161, Ukraine.