METHYLURACIL-PHARMEX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Methyluracil-Pharmex (METHYLURACIL-PHARMEX)

Composition:

Active substance: methyluracilum;

1 suppository contains methyluracil – 500 mg;

Excipient: hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: smooth, white or almost white suppositories of uniform consistency. A funnel-shaped depression and an air core may be present.

Pharmacotherapeutic group. Non-steroidal anabolic agent. ATC code A14B.

Pharmacological properties.

Pharmacodynamics.

The drug has anabolic and anticatabolic properties. It accelerates regenerative processes and wound healing, stimulates cellular and humoral immune responses, and exhibits anti-inflammatory activity. A specific feature of the drug is its stimulatory effect on erythropoiesis and, particularly, on leukopoiesis.

Pharmacokinetics.

After rectal administration of the suppository, 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 primarily excreted by the kidneys in the form of metabolites and conjugates, and partially unchanged in feces.

Clinical characteristics.

Indications.

Methyluracil is indicated for inflammatory-ulcerative processes in the lower segments of the large intestine (erosive-ulcerative colitis, proctitis, sigmoiditis, anal fissures).

Contraindications.

Individual hypersensitivity to the components of the drug. In acute and chronic leukemic forms of leukemia (especially myeloid), lymphogranulomatosis, and malignant diseases of the bone marrow.

Interaction with other medicinal products and other types of interactions.

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

Special precautions for use

The drug is advisable to prescribe for mild forms of leukopenia. In moderate disease severity, the drug should be taken only after recovery of impaired blood cell regeneration. In severe cases of hematopoietic system disorders, methyluracil should not be administered.

Use during pregnancy or breastfeeding

The drug should not be used during pregnancy and/or breastfeeding.

Ability to influence reaction rate while driving or operating machinery

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

Method of Administration and Dosage.

Before using the suppositories, remove them from the blister pack.

The medication is intended for rectal administration. Adults and children aged 14 years and older: 1 suppository 1 to 4 times daily. The treatment course lasts from 7 days to 4 months, depending on the nature of the disease.

Children.

The medication should not be used for treating children under 14 years of age.

Overdose.

Overdose and toxic effects have not been observed with the use of this medication.

Side effects.

From the nervous system: headache, dizziness.

From the skin and subcutaneous tissue: allergic reactions, including hyperemia, itching, skin rash, urticaria.

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

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

5 suppositories per strip, 2 strips per cardboard pack.

Availability category. Over-the-counter (without prescription).

Manufacturer.

LLC "FARMEX GROUP".

Manufacturer's address and place of business.

100 Shevchenka St., Boryspil, Kyiv region, Ukraine, 08301.

All cases of adverse reactions should be reported to the manufacturer:

LLC "Farmex Group", Ukraine, 08301, Kyiv region, Boryspil, Shevchenka St., 100. Tel.: +38(044)391-19-19, fax: +38(044)391-19-18, or via the form on the website: http://www.pharmex.com.ua/farmakonadzor