Pharmacological properties

Pharmacodynamics. mechanism of action and pharmakodinamichesky effects. spark — myotropic spasmolysant with selective impact on unstriated muscles of a digestive tract. it eliminates spasms without oppression of normal motility of intestines. as this action is not mediated by autonomous nervous system, there are no typical anticholinergic side effects.

Clinical performance and safety. Considerable weakening of the prevailing symptoms of a syndrome of the angry intestines (for example an abdominal pain, characteristics of a chair) was usually observed in the reference and controlled on major importances clinical trials.

All dosage forms of a mebeverin were in general safe and were well transferred at the recommended dosing mode.

Children. Clinical trials of tablets and capsules were carried out only at adults. Given to clinical performance and safety, received from clinical trials and also post-marketing experience of use of suspension of a mebeverin of the pamoat for patients of 3 years was shown that mebeverin is effective safe medicine which is well transferred.

Clinical trials of suspension of a mebeverin showed that it is effective for reduction of expressiveness of symptoms of a syndrome of the angry intestines at children. The further open researches of suspension of a mebeverin controlled on major importances confirmed efficiency of drug.

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 is possible to accept it 2 times a day.

Distribution. At reusable use of a mebeverin of considerable cumulation does not arise.

Biotransformation. Mebeverina a hydrochloride is generally metabolized by esterases which at the first stage of metabolism split radio bonds with formation of veratric acid and mebeverinovy alcohol. In blood plasma demetilkarboksilny acid (DMKK) is the main metabolite. T _½ DMKK in an equilibrium state — 5.77 h. At reusable use of capsules (on 200 mg 2 times in days) the C _max DMKK made 804 ng/ml, and t _max — about 3 h

optimum with an average ratio of 97%.

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 acid or DMKK.

Children. Pharmacokinetic researches at children were not conducted.

Indication

Adults and children at the age of 10 years:

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

Use

For oral administration.

Capsule is washed down with enough water (not less than 100 ml). It is not recommended to chew because the covering of the capsule is intended for ensuring the prolonged release.

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

Special populations. Dosing researches for patients of advanced age, patients with a renal failure and/or a liver were not conducted. Proceeding from post-marketing data, specific risk for patients of advanced age, patients with a renal failure and/or a liver it is not revealed. Dose adjustment for above-mentioned groups of patients is not considered necessary.

Contraindication

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

Side effects

from skin and hypodermic cellulose: urticaria, Quincke's disease, face edema and rash;

from the immune system: hypersensitivity (anaphylactic reactions).

Special instructions

Use during pregnancy and feeding by a breast. there are only very limited data on use of a mebeverin for pregnant women. researches of reproductive toxicity on animals are insufficient. the mebeverin a hydrochloride is not recommended to be applied during pregnancy.

whether it is excreted mebeverin or its metabolites in breast milk of the person. Excretion of a mebeverin in breast milk of animals is not studied. Spark it is not necessary to accept during feeding by a breast.

Clinical data on influence on male or female fertility are absent, however researches on animals do not demonstrate harmful effect of a mebeverin.

Children. Apply at children of 10 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Researches of influence on ability to run vehicles and to work with mechanical devices were not conducted. The Pharmakodinamichesky and pharmacokinetic profile and also post-marketing experience do not testify to any adverse effect on ability to run vehicles and to work with mechanical devices.

Interaction

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

Overdose

At overdose excitement of central nervous system. in cases of overdose of a mebeverin the symptoms were absent or they were lungs and quickly disappeared. the observed 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 by several medicaments during 1 h from the moment of intake of medicines. measures for decrease in absorption are not necessary.

Storage conditions

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