Structure and form of release

Structure

Active ingredient: a mebeverina a hydrochloride (mebeverine)

1 capsule supports a mebeverin of a hydrochloride in the form of pellets of the prolonged action of 200.0 mg

Excipients: sverichny sugar, sucrose, ethyl cellulose, magnesium stearate, povidone, polyethyleneglycol (makragol), gipromelloz (hydroksipropilmetltselyuloz).

release Form

Capsule.

Pharmacological properties

Pharmacodynamics. mechanism of action and pharmakodinamichesky effects. mebeverin is myotropic spasmolysant with selective effect 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, typical anticholinergic side effects do not arise.

Clinical performance and safety. Clinical performance and safety of use of various dosage forms of a mebeverin are studied at more than 1500 patients. Considerable reduction of expressiveness of the main symptoms of a syndrome of the angry intestines (for example an abdominal pain, characteristics of a chair) was usually noted 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 use of tablets or capsules carried out only at adults. Given to clinical performance and safety and also post-marketing experience of use of suspension of a mebeverin for patients aged from 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 repeated use of the medicament Mebsin Retard 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. In blood plasma demetilkarboksilny acid (DMKK) is the main metabolite. T _½ DMKK in an equilibrium state — 5.77 h. At repeated use of capsules (on 200 mg 2 times a day) the C _max for DMKK made 804 ng/ml, and t _max — about 3 h. The relative bioavailability of capsules of the prolonged action was 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 emitted with kidneys in the form of carboxyl acid or DMKK.

Children. Pharmacokinetic researches at children were not conducted.

Indication

Adults and children are aged more senior than 10 years:

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

Contraindication

Hypersensitivity to active agent or any component of drug.

by

for oral administration.

should wash down

Capsule with enough water (not less than 100 ml). It is not recommended to chew the capsule as the covering of capsules is intended for the prolonged medicament release.

to Adults and children 10 years are aged more senior than

it is necessary to accept on 1 capsule 2 times a day (in the morning and in the evening).

Duration of use is not limited to

. If one or more doses are passed, the patient should accept the following dose to destination. The passed dose should not be accepted in addition to the following appointed dose.

Special groups of patients. Dosing researches for patients of advanced age, patients with a renal failure and/or a liver were not conducted. Considering the available 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 required.

Special instructions

As medicament contains sugar, to patients with rare hereditary forms, such as intolerance of a galactose or fructose, deficiency of lactase, malabsorption of glucose galactose or insufficiency of invertase-isomaltase, it is not necessary to take this drug.

Use during pregnancy and feeding by a breast

Drug Mebsin Retard is not recommended to be used during pregnancy and feeding by a breast.

Children

to children aged up to 10 years because of the high content of active ingredient in the medicament Mebsin Retard.

to Drivers

Research of influence on ability to drive the car and to work with mechanisms was not carried out. 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 mechanisms.

Overdose

At overdose can theoretically note excitement from central nervous system. in cases of overdose of a mebeverin the symptoms were absent or were lungs and quickly disappeared. the arising symptoms of overdose were neurologic or cardiovascular origin.

Treatment. Specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is recommended only in case of intoxication by several various medicaments which is 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 observation. frequency on the available data precisely cannot be determined.

revealed allergic reactions mainly from skin.

from skin and hypodermic cellulose: urticaria, a Quincke's disease, a face edema, hyperaemia, rash on skin, including hemorrhagic.

from nervous system: headache, dizziness, depression.

from a digestive tract: diarrhea or constipation.

General disorders: hypersensitivity (anaphylactic reactions).

Interaction

Conducted interaction researches only with alcohol. The researches in vitro and in Vivo showed lack of any interaction of medicament and ethanol.

Storage conditions

In original packing at a temperature not above 30 °C.