Structure and form of release

Structure

Active ingredient: mebeverine;

1 capsule supports the mebeverin of a hydrochloride, pellets containing substance in terms of a mebeverin a hydrochloride - 200 mg

Excipients which are a part of pellets: sucrose, starch corn, povidone, ethyl cellulose, talc, shellac;

capsule Cover: titan dioxide (E 171), gelatin.

release Form

Capsule.

Pharmacological properties

Pharmacodynamics.

Mechanism of action and pharmakodinamichesky effects. Meverin — myotropic spasmolysant with selective effect on unstriated muscles of a digestive tract. In therapeutic doses medicament blocks natrium channels of membranes of smooth muscle cells, prevents entry of ions of sodium into a cell and a spasm of unstriated muscles of internals. Eliminates a spasm, without influencing a normal vermicular movement of intestines. Unlike cholinolytic means, Meverin does not act on m-holinoretseptory also does not render characteristic of antispasmodics with m-holinoblokiruyushchim action of side effects (feeling of dryness in a mouth, a disorder of vision, an urination delay) that allows to apply it to patients with a prostatauxe or glaucoma. Use of the medicament Meverin is not followed by development of reflex hypotonia of intestines.

Children. Mebeverin also is effective for weakening of symptoms of a syndrome of the angry intestines at children.

on the basis of safety and shipping of a mebeverin.

Pharmacokinetics.

Absorption. Mebeverin is quickly and completely absorbed after oral administration in the form of tablets. Thanks to the prolonged release of medicament from the capsule it can be accepted twice a day.

Distribution. At repeated use of the medicament Meverin no considerable cumulation arises.

Biotransformation. Mebeverina a hydrochloride is mainly metabolized by esterases which at the first stage of metabolism split radio bonds with formation of veratric acid and mebeverinovy alcohol.

Removal. Mebeverin is not excreted in not reversed look, it is metabolized, and metabolites are removed almost completely. Veratric acid is excreted with urine. Mebeverinovy alcohol is also removed by kidneys in the form of the corresponding carboxyl or demetilkarboksilny acid.

Children. Pharmacokinetic researches at children were not conducted.

Indication

to Adults and children aged from 10 years:

• for symptomatic treatment of pain, spasms, intestinal disorders and sensation of discomfort in intestines at a syndrome of the angry intestines;
• for treatment of the gastrointestinal spasms of secondary genesis caused by organic diseases.

Contraindication

Hypersensitivity to active agent or to any of inactive components of drug.

Use

For oral administration.

Capsule with enough water (not less than 100 ml). Not to chew the capsule.

on 1 capsule 2 times a day (in the morning and in the evening). Duration of use is not limited. If one or more doses it is passed, the patient should accept the following dose as it is appointed. The passed dose(s) should not be accepted in addition to a regular dose.

do not have data on specific risk for elderly people, patients with a renal failure and/or a liver. There is no need for dose adjustment for above-mentioned groups of patients.

Children. It is not necessary to apply a mebeverin a hydrochloride to children up to 3 years due to the lack of clinical data to this age category. Also it is not necessary to apply Meverin, capsules, to children are from 3 to 10 years because of the high content of active ingredient.

Special instructions

Due to sucrose content to patients with rare hereditary intolerance of fructose, glyukozo-galaktozny malabsorption or sakharazo-izomaltazny insufficiency does not recommend medicament use.

with a porphyria.

usual anticholinergic side effects, it can be applied at patients with a prostatauxe and glaucoma.

With care to use medicament at patients with the profound liver and renal failure, warm blockade.

Use during pregnancy and feeding by a breast

only very limited data on use of a mebeverin for pregnant women Exist. Researches of reproductive toxicity at animals are insufficient. Meverin is not recommended to apply during pregnancy.

whether are excreted mebeverin or its metabolites in breast milk of the person. Excretion of a mebeverin in breast milk of animals is not investigated. Meverin it is not necessary to apply during feeding by a breast.

clinical data on influence on male or female fertility, however researches on animals do not demonstrate harmful effects of a mebeverin.

Research of influence on ability to drive the car and to work with mechanical devices was not conducted by

. The Pharmakodinamichesky and pharmacokinetic profile and also post-marketing experience do not testify to any adverse effect on ability to drive the car and to work with mechanical devices.

Overdose

At overdose can theoretically arise excitement of central nervous system. in cases of overdose of a mebeverin the symptoms were absent or were lungs and quickly disappeared. noted symptoms of overdose were neurologic or cardiovascular origin. specific antidote is unknown. symptomatic treatment is recommended. gastric lavage is recommended only in case of intoxication numerous medicaments diagnosed during 1 h from the moment of intake of medicines. measures for decrease in absorption are not necessary.

Side effects

It was reported about the following side reactions arising spontaneously during post-marketing use. frequency on the available data precisely cannot be determined.

were Noted by allergic reactions mainly from skin.

Disturbance from skin and hypodermic cellulose: urticaria, Quincke's disease, face edema and rashes.

Disturbance from the immune system: hypersensitivity (anaphylactic reactions).

Interaction

conducted interaction researches with alcohol. the researches in vitro and in Vivo on animals showed lack of any interaction of a mebeverin and ethanol.

Storage conditions

In original packing at a temperature not above 25 °C.