Дюспаталин®

General characteristics. Structure:

Active agent: a mebeverina a hydrochloride — 200 mg.
Excipients: magnesium stearate — 13,1 mg, methylmethacrylate and ethyl acrylate copolymer [1:2] — 10,4 mg, talc — 4,9 mg, a gipromelloza — 0,1 mg, methacrylic acid and ethyl acrylate copolymer [1:1] — 15,2 mg, triacetin — 2,9 mg.
Solid gelatin capsule: gelatin — 75,9 mg, titanium dioxide (Е 171) — 1,5 mg.
The structure blackened: shellac (Е 904), propylene glycol, ammonia water, potassium hydroxide, dye ferrous oxide black (Е 172).

Description:
The solid gelatin capsules No. 1, opaque, white color with marking "245" on the capsule case. Contents of capsules — white or almost white granules.

Pharmacological properties:

Pharmacodynamics. The spasmolysant of myotropic action, has direct effect on smooth muscles of digestive tract. Eliminates a spasm without influence on a normal peristaltics of intestines. Does not possess anticholinergic action.

Pharmacokinetics. Absorption
 Mebeverin is quickly and completely soaked up after intake. The dosage form of the modified release allows to use the scheme of dosing 2 times a day.
Distribution
 At reception of repeated doses of drug 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 alcohol of a mebeverin. The main metabolite circulating in plasma is demetilirovanny carboxylic acid. The elimination half-life in an equilibrium condition of demetilirovanny carboxylic acid makes about 5,77 h. At reception of repeated doses (200 mg 2 times a day) the maximum concentration of demetilirovanny carboxylic acid in blood (Cmax) makes 804 ng/ml, time of achievement of the maximum concentration of demetilirovanny carboxylic acid in blood (Tmax) — about 3 hours.
Average value of relative bioavailability of drug in the capsule with the modified release makes 97%.
Removal
 Mebeverin per se is not brought from an organism, but completely metabolized; its metabolites are almost completely brought out of an organism. The veratric acid is removed by kidneys. Alcohol of a mebeverin is also removed by kidneys, partially in the form of carboxylic acid and partially in the form of demetilirovanny carboxylic acid.

Indications to use:

Symptomatic treatment of pain, spasms, dysfunction and the discomfort in intestines connected with a syndrome of the angry intestines. A symptomatic treatment of spasms of bodies of digestive tract (including caused by organic diseases).

Route of administration and doses:

For intake.
Capsules need to be swallowed, washing down with enough water (not less than 100 ml). Capsules should not be chewed as their cover provides long release of drug.
On one capsule 2 times a day, one — in the morning and one — in the evening, in 20 minutes prior to food.
Duration of administration of drug is not limited.
If the patient forgot to accept one or several doses, administration of drug should be continued from the following dose. It is not necessary to accept one or several passed doses in addition to a usual dose.

Side effects:

Messages on the following undesirable phenomena were received during post-marketing use and had spontaneous character; for exact assessment of frequency of cases of the available data it is not enough.
Allergic reactions were observed preferential from integuments, but were noted as well other displays of an allergy.
From integuments:
Small tortoiseshell, Quincke's disease, including persons, dieback.
From immune system:
Hypersensitivity reactions (anaphylactic reactions).

Interaction with other medicines:

Only researches on studying of interaction of this drug with alcohol were conducted. Researches on animals showed lack of any interaction between the drug Dyuspatalin® and alcohol.

Influence on ability to driving and other mechanisms:
Researches of influence of drug on ability to driving and other mechanisms were not conducted. Pharmacological properties of drug, and also experience of its use do not demonstrate any adverse influence of a mebeverin on ability to driving and other mechanisms.

Contraindications:

Hypersensitivity to any component of drug.
Age up to 18 years (in connection with insufficiency of data on efficiency and safety).
Pregnancy (in connection with insufficiency of data).

Use at pregnancy and during breastfeeding:
Pregnancy
 Data on use of a mebeverin by pregnant women insufficiently. It is not recommended to apply Dyuspatalin® during pregnancy.
Breastfeeding period
Information on excretion of a mebeverin or its metabolites in breast milk insufficiently. It is not necessary to accept Dyuspatalin® during feeding by a breast.
Fertility
Clinical data on influence of drug on fertility at men or women are absent, however, researches on animals did not show adverse effects of the drug Dyuspatalin®.

Overdose:

Theoretically, in case of overdose increase in excitability of the central nervous system is possible. In cases of overdose of a mebeverin symptoms either were absent, or were insignificant and, as a rule, quickly reversible. Noted symptoms of overdose had neurologic and cardiovascular character.
The specific antidote is unknown. The symptomatic treatment is recommended. The gastric lavage is necessary only if intoxication is revealed within about one hour after reception of several doses of drug. Actions for decrease in absorption are not required.

Storage conditions:

List B. To store at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity:
3 years. Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Capsules of the prolonged action of 200 mg:
On 10 capsules in the blister from aluminum foil and PVC of a film. On 1,2,3,5 blisters in a cardboard pack together with the application instruction.
On 15 capsules in the blister from aluminum foil and PVC of a film. On 2,4,6 blisters in a cardboard pack together with the application instruction.