Mebespalin retard - instructions for use, doses, side effects, contraindications

Excipients: 90.0 mg, microcrystalline cellulose - 33.2 mg, cellase - 7.0 mg, silicon colloidal dioxide - 3.4 mg, magnesium stearate - 3.4 mg, polysorbate-80 - 2.3 mg, castor oil ordinary seed oil - 0.7 mg.

Shell composition: hypromellose - 5.8 mg, macrogol-4000 - 1.2 mg, titanium dioxide - 3.0 mg.

Description:

Round, biconvex tablets, covered with a film shell of white or almost white color. On the cross-section - the core of white or yellowish-white color.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.A.04 Mebeverin

A.03.A.A Synthetic holinoblokatory - ethers with tertiary amino group

Pharmacodynamics:Spazmolitik myotropic action, has a direct effect on the smooth muscles of the gastrointestinal tract (GIT). Eliminates spasm without affecting normal intestinal motility. Does not possess anticholinergic action. This dosage form allows to use the dosing regimen 2 times a day.

Pharmacokinetics:

Suction

Mebeverin is quickly and completely absorbed after ingestion.

Distribution

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

Metabolism

Mebeverin is completely metabolized in the human body. The first stage of metabolism - hydrolysis with the formation of veratric acid and mebeverine alcohol.

The main metabolite circulating in the plasma is the demethylated carboxylic acid. The half-life in the equilibrium state of the demethylated carboxylic acid is approximately 5.77 hours. At a multiple dose (200 mg twice daily), the maximum concentration of demethylated carboxylic acid in the blood (C_mOh) is 804 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in the blood (T_mOh) - about 3 hours.This mebverine dosage form has sustained release properties, which is evident from its relatively low C_mOh, a longer time with respect to the value of T_mOh and a long half-life with optimal bioavailability.

Excretion

Metabolites mebeverina (veratric acid and mebeverin alcohol) are excreted by the kidneys. The alcohol of mebeverine is excreted partially as a carboxylic acid and partly as a demethylated carboxylic acid.

Indications:

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

- symptomatic treatment of spasm of the organs of the gastrointestinal tract (including caused by organic diseases).

Contraindications:

- Hypersensitivity to any component of the drug;

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

- pregnancy (due to insufficient data);

lactation period.

Pregnancy and lactation:

Pregnancy

There are only very limited data on the use of mebeverin by pregnant women.Animal studies are not sufficient to assess reproductive toxicity. It is not recommended to apply mebeverin during pregnancy.

Breastfeeding period

Information on the excretion of mebeverin or its metabolites in breast milk is not enough. Studies of the excretion of mebeverin in milk in animals have not been conducted. Do not take mebeverin during lactation.

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 the drug.

Dosing and Administration:

For oral administration.

Tablets should be swallowed with a sufficient amount of water (at least 100 ml). Tablets should not be chewed, as their shell provides a sustained release of the drug.

One tablet 2 times a day, one in the morning and one in the evening, 20 minutes before meals. Duration of the drug is not limited.

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 received during the postmarketing period and were of a spontaneous nature; to accurately assess the frequency of the cases of available data is not enough.

Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted.

From the skin:

Urticaria, angioedema, including face, exanthema.

From the immune system:

Hypersensitivity reactions (anaphylactic reactions).

From the gastrointestinal tract: irritation of the stomach, diarrhea due to the presence of castor oil in the formulation (castor oil ordinary oil).

Overdose:

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 this drug with alcohol were carried out. Studies in animals demonstrated the absence of any interaction between the drug and ethyl alcohol.

Effect on the ability to drive transp. cf. and fur:

Studies of the effect of the drug on the ability to drive and other mechanisms have not been carried out. The pharmacological properties of the preparation, as well as the experience of its use, do not indicate any adverse effect of mebeverin on the ability to drive and other mechanisms.

Form release / dosage:Tablets with prolonged release, film-coated, 200 mg.

Packaging:

By 7, 10, 15, 20, 25 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets in cans of polyethylene terephlate for medicines, sealed with cap screwstheand with control of thefirst opening or by a "push-turn" system of polypropylene or polyethylene or polypropylene cans for drugs sealed with caps tightened with the control of the first opening from polyethylene or cans of polypropylene for medicines sealed with caps tightened with the control of the first opening of high pressure polyethylene.

One jar or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package.

It is allowed to bundle 2 or 3 cardboard packages (packs) into a group package (shipping container) from cardboard for consumer packaging.

Storage conditions:

In the 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 the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003764

Date of registration:04.08.2016 / 27.03.2018

Expiration Date:04.08.2021

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp13.04.2018

Illustrated instructions

Instructions

Mebespalin retard (Mebespalin retard)