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INSTRUCTION

FOR MEDICAL USE OF A DRUG

Registration No.:

in Russia: No.

in Ukraine:

Trade name:

International nonproprietary name (INN):

Chemical name:

Dosage form: film-coated tablets

Composition:

Active ingredient:

Excipients:

Coating: gastrosoluble acrylic resin, talc, macrogol 6000, film coating (titanium dioxide, yellow san-set, hydroxypropyl cellulose).

Description

Orange round biconvex coated tablets with «50» (50-mg tablets) or «100» (100-mg tablets) being engraved on one face and «N» and above the symbol «» on the other. The cross section of a tablet shows two layers: the white or almost white internal layer coated by the orange one.

Pharmacotherapeutic group: spasmolytic

Pharmacological properties

This is spasmolytic and M-choline-blocking activities. It diminishes visceral muscle smooth spasm and lowers hydrochloric acid secretion. The drug accelerates gastric evacuatory function and has no marked anticholinergic activity.

Pharmacokinetics. With oral administration, less than 10% of the drug is absorbed from the gastrointestinal tract. T_Cmax is 1 h; T_1/2 is 1.5 h.

Its plasma protein binding is 97%. The drug is mainly metabolized in the liver. It is excreted with feces; its minor portion is excreted with urine.

Indications and usage

- Abdominal smooth muscle spasms: colonic dyskinesia, biliary dyskinesia;

- Preparation for gastrointestinal X-ray study using barium

Contraindications

Hypersensitivity to the components of the drug.

Dosage and administration

The drug is intended for oral administration.

Adults:

50-mg coated tablets.

Daily dose: 3 – 4 tablets are daily taken during a meal. In exceptional cases, the daily dose may be increased up to 6 tablets a day.

When prepared for X-ray study, 4 tablets are daily used within 3 days before the study.

100-mg coated tablets.

Daily dose: 1 tablet twice daily, in the morning and evening. In exceptional cases, the daily dose may be increased up to 3 tablets a day.

When prepared for X-ray study, 2 tablets daily within 3 days before the study.

The tablets are taken whole, by drinking a glass of water. They cannot be chewed or sucked. The drug should not be taken before sleep.

Adverse reaction

In rare cases, there may be allergic reactions, dyspepsia, constipation, nausea.

Inform your physician of any undesirable effect.

Special warnings

During pregnancy and lactation, as well as in childhood, the drug is used only if the expected benefit overweighs the possible risk to the fetus or baby.

How supplied

50-mg film – coated tablets:

20 tablets in blister (PVC/aluminum); 1, 2 blisters are placed together with an insert in a cardboard pack.

100-mg film – coated tablets:

20 tablets in blister (PVC/aluminum); 1, 2, or 3 blisters are placed together with an insert sheet in a cardboard pack.

Storage

Store the drug at a temperature not above 30˚ C, without taking any precautions.

Keep out of the reach of children.

Shelf-life

50-mg tablets: 5 years.

100-mg tablets: 3 years.

Do not use the drug after the expiry date given on the pack.

Dispensing

To be prescribed.

Manufacturer

Вариант № 19