Mebsin ретард

General characteristics. Structure:

Active ingredient: 100 mg of a mebeverin

Excipients: the tselyulloza is microcrystallic, a mannitol (Е 421), sucrose, sodium lauryl sulfate, an etiltselyulloz.

The safest drug. It is applied to a symptomatic treatment of pain, spasms at an irritable colon (persistent diarrhea, alternation of diarrhea and a lock, pain and postprandialny discomfort); the gastrointestinal spasms caused by organic diseases; the dispepsichesky phenomena at a diverticulitis, enterita and other inflammatory processes of a GIT; functional disorders of biliary tract and liver.

Pharmacological properties:

Pharmacodynamics. Mebeverin is a 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 an autonomous nervous system, typical anticholinergic side effects do not arise.

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.

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 мебеверин is effective safe medicine which is well transferred.

Pharmacokinetics. Mebeverin is quickly and completely absorbed after oral administration in the form of tablets. Thanks to the prolonged release of drug from the capsule it is possible to accept it 2 times a day.

At repeated use of drug Mebsin Retard no considerable cumulation arises.

Mebeverina a hydrochloride is mainly metabolized by esterases which at the first stage of metabolism split radio bonds with formation of the veratric acid and mebeverinovy alcohol. In a blood plasma demetilkarboksilny acid (DMKK) is the main metabolite. _{T½ DMKK} in an equilibrium state — 5,77 h. At repeated use of capsules (on 200 mg 2 times a day) _Cmax for DMKK made 804 ng/ml, and _tmax is about 3 h. Relative bioavailability of capsules of the prolonged action was optimum with an average ratio of 97%.

Mebeverin is not excreted in not reversed look, it is metabolized, and metabolites are removed almost completely. The veratric acid is excreted with urine. Mebeverinovy alcohol is also emitted with kidneys in the form of carboxyl (KK) or DMKK.

Indications to use:

Symptomatic therapy of an irritable colon (persistent diarrhea, alternation of diarrhea and lock, pain and postprandialny discomfort); the gastrointestinal spasms caused by organic diseases. Functional disorders of biliary tract and a gall bladder on hypertensive and hyperkinetic type.

Route of administration and doses:

Drug is intended for oral administration.

Capsules should be washed down 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 drug release.

To adults and children 10 years are aged more senior 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. 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.

Features of use:

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

Long-term use of drug by patients with hereditary diseases of blood can cause different adverse symptoms, including disturbance from the central nervous system.

Mebsin Retard is not recommended to use drug during pregnancy and feeding by a breast.

Do not appoint to children aged up to 10 years because of the high content of active ingredient.

During treatment the speed of psychomotor reactions therefore it is necessary to avoid control of motor transport and works with other mechanisms is weakened.

Mebsin ретард patients can appoint with glaucoma or a prostatauxe as he has no atropinopodobny effect.

The specific risk for patients of advanced age, patients with a renal failure and/or a liver is not revealed. Dose adjustment for above-mentioned groups of patients is not required.

Side effects:

It was reported about the following side reactions arising spontaneously during post-marketing observation. Frequency according to the available data precisely cannot be determined.

Allergic reactions are revealed preferential from skin.

From skin and hypodermic cellulose: a small tortoiseshell, a Quincke's disease, a face edema, a hyperemia, rash on skin, including hemorrhagic.

From a nervous system: headache, dizziness, depression.

From a digestive tract: diarrhea or lock.

General frustration: hypersensitivity (anaphylactic reactions).

Interaction with other medicines:

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

Contraindications:

Hypersensitivity to active agent or any component of drug; do not apply to children.

Overdose:

At overdose can theoretically note excitement from TsNS. In cases of overdose of a mebeverin symptoms were absent or were lungs and quickly disappeared. The arising symptoms of overdose were a neurologic or cardiovascular origin.

The specific antidote is unknown. The symptomatic treatment is recommended. The gastric lavage is recommended only in case of intoxication by several various drugs which is diagnosed during 1 h from the moment of reception of medicines. Measures for decrease in absorption are not necessary.

Storage conditions:

To store in the place, unavailable to children, at a temperature not above 25 degrees Celsius.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in the blister, on 3 blisters in cardboard packaging.