Mebeverin-LF

General characteristics. Structure:

Active ingredient: 200 mg of a mebeverin of a hydrochloride in the form of pellets.

Excipients: sugar granules, povidone, gipromelloza, ethyl cellulose, macrogoal 6000, magnesium stearate.

Is effective and safe drug in treatment of the abdominal pain syndrome caused by existence of SRK or secondary motor disturbances at many gastrointestinal diseases.

Pharmacological properties:

Pharmacodynamics.
Mebeverin-LF is the myotropic spasmolysant having direct effect on smooth muscles of digestive tract, eliminating a spasm without influence on a normal peristaltics of intestines. Because action does not extend to the autonomic nervous system, usual anticholinergic side effects are absent.

Pharmacokinetics. Absorption. Mebeverin after intake is quickly and completely soaked up. The dosage form with long release allows to use the scheme of dosing 2 times a day. Distribution

At reception of repeated doses of considerable accumulation does not occur.

Metabolism. Mebeverina a hydrochloride is generally metabolized by esterases which at the first stage split ether on the veratric acid and mebeverinovy alcohol. The main metabolite circulating in plasma - demetilirovanny carboxylic acid (DMKK). The elimination half-life in an equilibrium condition of DMKK makes 5,77 h. For capsules of the prolonged action of 200 mg of property of long release are confirmed rather low Stakh and longer t max. At reception of repeated doses (200 mg 2 times a day) Stakh makes DMKK 804 ng/ml, t takh.sostavlyat about 3 hours. Average value of a relative biodosupnost makes 97%.

Removal. Mebeverin per se is not brought from an organism, and metabolized completely, its metabolites are almost completely brought out of an organism. The veratric acid is removed by kidneys, mebeverinovy alcohol is also removed by kidneys, partially in the form of carboxylic acid and partially in the form of DMKK.

Indications to use:

Symptomatic treatment of the pains and discomfort connected with functional disorders of intestines and biliary tract.

Route of administration and doses:

For intake.

About 1 capsule 2 times a day is recommended to accept (in the morning and in the evening), washing down with enough water, not chewing. In case of the admission of one or more doses the patient has to accept the following dose as it is appointed. The passed doses should not be accepted in addition to regular reception. Duration of use is not limited. Special populations.

Researches on dosing at patients of advanced age, patients with renal failures and/or a liver were not conducted. Based on the existing post-marketing data of specific risk for elderly people, patients with renal failures and/or a liver it is not revealed. There is no need for dose adjustment for the above-stated groups of patients.

Features of use:

Researches on animals did not reveal teratogenic influence of a mebeverin. Researches of reproductive toxicity at animals are insufficient. There are no clinical data on influence on male or female fertility, however researches on animals do not demonstrate harmful effects of a mebeverin.

It is not recommended to use drug during the pregnancy period.

It is unknown whether it is excreted мебеверин or its metabolites in breast milk. It is not necessary to accept drug during feeding by a breast.

There are no data on any influence Mebeverina-LF on ability to manage vehicles or work with mechanisms.

Side effects:

Messages on undesirable reactions at use of a mebeverin were received during post-marketing use and had more spontaneous character, for exact assessment of frequency of these cases insufficiently. Allergic reactions preferential with сторонык skin (the cases given not enough for assessment of frequency) are assumed.

From skin and hypodermic fabrics: small tortoiseshell, Quincke's disease, face edema, dieback.

From immune system: hypersensitivity reactions (anaphylactic reactions).

Interaction with other medicines:

There are no data on interaction with other medicines.

Contraindications:

Hypersensitivity to active agent or any of auxiliary components of drug; paralytic intestinal impassability; children's age up to 18 years due to the lack of sufficient data on safety.

Overdose:

Symptoms. At overdose excitement of TsNS is possible. In case of a peredozirovvka mebeveriny symptoms are absent or were lungs and quickly disappeared. Overdose symptoms which were observed were a neurologic or cardiovascular origin.

The symptomatic treatment, specific antidote is absent. The gastric lavage is carried out in case of intoxication by numerous drugs which was diagnosed within 1 hour from the moment of reception of medicines. Measures for decrease in absorption are not necessary.

Storage conditions:

In the place protected from moisture and light at a temperature not above 25 °C. To store in the places protected from children. Period of storage 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in blister strip packagings. On the 3rd blister strip packagings in a cardboard pack together with the application instruction.