For medical use of a drug

Registration No.:

in Russia:

Trade name: K

International nonproprietary name (INN):
Chemical name:

Dosage form:

Prolonged-release capsules.

Composition:

Active ingredient:

Each retard capsule contains 200 mg of N.

Excipients:

Hard white opaque gelatin capsules No. 1 with «245» imprinted on the shell of a capsule and with «S» and «V» on its cap. The contents of the capsules are white or almost white granules.

Pharmacotherapeutic group:

Spasmolytic.

PHARMACOLOGICAL ACTION:

This is a myotropic spasmolytic that directly affects the smooth

muscles of the gastrointestinal tract (chiefly the large bowel). It eliminates spasm, without exerting any effect on normal intestinal motility. The drug has no anticholinergic activity.

Pharmacokinetics:

When orally used, the drug undergoes presystemic hydrolysis and it is undetectable in the plasma. The drug is hepatically metabolized to veratric acid and mebeverine alcohol. It is mainly excreted by kidneys as metabolites, in small quantities by bile. Capsules of the drug have the properties of prolonged release. Significant accumulation of the drug does not occur even after its multiple use.

INDICATIONS:

Adults

Gastrointestinal spasm (including that caused by an organic disease), intestinal colic, biliary colic, irritable colon syndrome.
Children aged above 12 years

Gastrointestinal functional disorders accompanied by abdominal pain.

CONTRAINDICATIONS:

Hypersensitivity to any components of the drug.

PREGNANCY AND LACTATION:

Animal experiments have revealed no teratogenic effect of the drug. However, it is necessary to compare maternal benefits with potential fetal risks when the drug is administered to pregnant women. When administered in therapeutic doses, the drug does not penetrate into breast milk so this drug may be used during lactation.

DOSAGE AND ADMINISTRATION

The drug should be swallowed whole by taking with water.

A capsule (200 mg) should be orally taken 20 minutes before a meal twice a day (in the morning and in the evening).

ADVERSE REACTIONS

Dizziness has been rarely observed. In extremely rare cases, there may be following hypersensitvity reactions: urticaria, Quincke's, edema, facial edema, and exanthema.

OVERDOSAGE

Theoretically, there may be occasionally hyperexcitability of the central nervous system. The specific antidote of the drug is unknown. Gastric lavage and symptomatic treatment are recommended.