Mebeverin - instructions for use, doses, side effects, contraindications

mebeverine hydrochloride substance-pellets 80% - 250,000 mg [active substance: mebeverine hydrochloride - 200,000 mg; Excipients: sugar spheres - 25,875 mg; povidone K-30 - 4,125 mg; hypromellose - 0.400 mg; ethyl cellulose 9.250 mg; macrogol 6000 - 1.775 mg; magnesium stearate - 8.575 mg] (weight of the contents of the capsule 250,000 mg);

hard gelatine capsules: titanium dioxide 2.0%; gelatin - up to 100%.

Description:

Hard gelatin capsules № 0 of white color. The contents of capsules are spherical pellets of white or almost white color.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

Mebeverin

Pharmacodynamics:

Mebeverin - an antispasmodic agent of myotropic action, has a direct effect on the smooth muscles of the gastrointestinal tract. Eliminates spasm without affecting normal intestinal motility. The mechanism of action of mebeverin is based on its ability to block the passage of sodium ions into smooth muscle cells. Mebeverin does not cause the development of reflex hypotension of the intestine. Does not possess anticholinergic action.

Pharmacokinetics:

Suction

Mebeverin is quickly and completely absorbed after ingestion. The drug form of prolonged action allows using the dosing regimen 2 times a day.

Distribution

When taking repeated doses of the drug, significant cumulation does not occur.

Metabolism

Mebeverin is mainly metabolized by esterases, which, at the first stage, split the ether into veratric acid and mebeverine alcohol. The main metabolite circulating in the blood plasma is demethylated carboxylic acid. The half-life in the equilibrium state of the demethylated carboxylic acid is about 5.77 hours.When taking repeated doses (200 mg twice daily), the maximum concentration of demethylated carboxylic acid in the blood plasma (C_max) is 804 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in blood plasma (T_max) - about 3 hours.

The average value of the relative bioavailability of the drug in the prolonged-action capsule is 97%.

Excretion

Mebeverin is completely metabolized in the human body. His metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly in the form of a carboxylic acid and partly as a demethylated carboxylic acid.

Even after repeated administration, no cumulation is observed.

Pharmacokinetics in specific patient groups

Studies on dosing in elderly patients, patients with impaired renal and / or liver function were not performed. Based on existing postmarketing data, there is no specific risk for elderly people, patients with impaired renal and / or liver function. There is no need for dose adjustment for the above groups of patients.

Indications:

- Symptomatic treatment of pain, spasms, dysfunction and discomfort in the intestinal tract associated with irritable bowel syndrome;

- symptomatic treatment of spasms of the gastrointestinal tract (including those caused by organic diseases).

Contraindications:

- Hypersensitivity to mebeverin or to any other component of the drug;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption;

- age to 18 years (due to insufficient data on efficiency and safety);

- Pregnancy and the period of breastfeeding (due to insufficient data).

Pregnancy and lactation:

Pregnancy

Data on the use of mebeverin in pregnant women is not enough. It is not recommended to use the drug during pregnancy.

Breastfeeding period

Information on the excretion of mebeverin or its metabolites in breast milk is not enough. Do not take mebeverin in the period of breastfeeding.

Fertility

Clinical data on the effect of the drug on fertility in men or women are not available, however studies in animals have not demonstrated adverse effects of mebeverine.

Dosing and Administration:

Inside, not liquid, squeezed a sufficient amount of water (not less than 100 ml).

One capsule 2 times a day (morning and evening), 20 minutes before meals. The duration of the drug is determined by the doctor.

If the patient forgot to take one or more doses, take the drug with the next dose. Do not take one or more missed doses in addition to the usual dose.

Side effects:

Reports of the following adverse events were obtained during the postmarketing use of mebeverine preparations and were spontaneous; to accurately assess the frequency of the cases of available data is not enough.

Allergic reactions:

mainly from the skin (hives, angioedema, including faces, exanthema), but other manifestations of allergy, hypersensitivity reactions (anaphylactic reactions) were also noted.

Overdose:

Symptoms

Theoretically, in case of an overdose, it is possible to increase the excitability of the central nervous system. In cases of an overdose of mebeverine, the symptoms either were absent, or were insignificant and, as a rule, quickly reversible.The symptoms of overdose were neurological and cardiovascular.

Treatment

The specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is necessary only if intoxication is detected within approximately one hour after taking several doses of the drug. Measures to reduce absorption are not required.

Interaction:

Only studies on the interaction of mebeverine with ethanol were carried out. Studies in animals demonstrated the absence of any interaction between mebeverin and ethanol.

Effect on the ability to drive transp. cf. and fur:Studies of the influence of mebeverin on the ability to drive vehicles and mechanisms were not carried out. The pharmacological properties of the preparation, as well as the experience of its use, do not indicate any adverse effect of mebeverine on the ability to control vehicles and mechanisms.

Form release / dosage:

Capsules of prolonged action 200 mg.

Packaging:

10 or 15 capsules in a contour cell box made of a polyvinylchloride film and aluminum foil.

30 or 60 capsules in a can of high-density polyethylene.

1, 3, 6 or 9 contour cell packs of 10 capsules, 1, 2, 4 or 6 contiguous cell packs of 15 capsules or one bank together with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003540

Date of registration:29.03.2016

Expiration Date:29.03.2021

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp26.03.2018

Illustrated instructions

Instructions

Mebeverin (Mebeverine)