Duspatalin capsules of prolonged action 200mg, No. 30

• symptomatic treatment of bowel pain, spasms, dysfunction and discomfort associated with irritable bowel syndrome;

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

For oral administration. The capsules must be swallowed with a sufficient amount of water (at least 100 ml). The capsules should not be chewed because their shell provides a sustained release of the drug.

Take 1 caps. 2 times / day (1 - in the morning and 1 - in the evening) 20 minutes before meals. The duration of the drug intake is not limited.

If the patient has forgotten to take one or more doses, the drug should be continued with the next dose. One or more missed doses should not be taken in addition to the usual dose.

Dosage regimen studies in elderly patients, patients with renal and / or hepatic impairment have not been conducted. The available data on the post-marketing use of the drug did not reveal specific risk factors for its use in elderly patients and patients with renal and / or hepatic insufficiency. Changes in the dosage regimen in elderly patients and patients with renal and / or hepatic insufficiency are not required.

Active substance:

1 capsule contains 200 mg of mebeverine hydrochloride.

Excipients:

magnesium stearate - 13.1 mg, methyl methacrylate and ethyl acrylate copolymer [2: 1] - 10.4 mg, talc - 4.9 mg, hypromellose - 0.1 mg, methacrylic acid and ethacrylate copolymer [1: 1] - 15, 2 mg, triacetin 2.9 mg.

Hard gelatin capsule: gelatin - 75.9 mg, titanium dioxide (E171) - 1.5 mg.

Ink composition: shellac (E904), black iron oxide (E172), soy lecithin (E322), antifoam.

• hypersensitivity to any component of the drug;

• pregnancy (due to insufficient data);

• age up to 18 years (due to insufficient data on efficacy and safety).

Trade name: DuspatalinЃ

International non-proprietary name or grouping name: mebeverine

Dosage form:

Sustained-release capsules.

Composition:

Active substance:

1 capsule contains 200 mg of mebeverine hydrochloride.

Excipients:

magnesium stearate - 13.1 mg, methyl methacrylate and ethyl acrylate copolymer [2: 1] - 10.4 mg, talc - 4.9 mg, hypromellose - 0.1 mg, methacrylic acid and ethacrylate copolymer [1: 1] - 15, 2 mg, triacetin 2.9 mg.

Hard gelatin capsule: gelatin - 75.9 mg, titanium dioxide (E171) - 1.5 mg.

Ink composition: shellac (E904), black iron oxide (E172), soy lecithin (E322), antifoam.

Description:

Hard gelatin capsules No. 1, opaque, white, marked '245' on

capsule body. The contents of the capsules are white or almost white granules.

Pharmacotherapeutic group:

Antispasmodic

ATX code: A03 AA04

Pharmacological properties:

Pharmacodynamics

Myotropic antispasmodic, has a direct effect on the smooth muscles of the gastrointestinal tract. Eliminates spasm without affecting normal intestinal motility. Has no anticholinergic effect.

Pharmacokinetics

This dosage form allows you to use the dosing regimen 2 times a day. Mebeverine is completely metabolized in the human body. The first stage of metabolism is hydrolysis with the formation of veratric acid and mebeverine alcohol. Mebeverine metabolites (veratric acid and mebeverine alcohol) are excreted by the kidneys. Mebeverine alcohol is excreted partly as carboxylic acid and partly as demethylated carboxylic acid. The main metabolite circulating in plasma is demethylated carboxylic acid. The equilibrium half-life of 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 (Cmax) is 804 ng / ml.the time to reach the maximum concentration of demethylated carboxylic acid in the blood (Tmax) is about 3 hours. This dosage form of mebeverine has sustained release properties, which is evident from its relatively low Cmax value, a longer time in relation to Tmax value and a long half-life with optimal bioavailability.

Indications for use:

• Symptomatic treatment of bowel pain, spasms, dysfunction and discomfort associated with irritable bowel syndrome.

• Symptomatic treatment of spasms of the gastrointestinal tract (including those caused by organic diseases).

Contraindications:

• Hypersensitivity to any component of the drug.

• Age up to 18 years (due to insufficient data on efficacy and safety).

Application during pregnancy and lactation:

There are no clinical data on the treatment of pregnant women. The drug should be prescribed to pregnant women with caution if the intended benefit to the mother outweighs the potential risk to the fetus.

There is insufficient information on the excretion of mebeverine in breast milk. You should not take DuspatalinЃ while breastfeeding.

Method of administration and dosage:

Take orally without chewing with a sufficient amount of water (at least 100 ml).

One capsule (200 mg) 2 times a day, one in the morning and one in the evening, 20 minutes before meals.

Side effect:

From the immune system: hypersensitivity reactions.
Urticaria, angioedema, including of the face, exanthema. There are insufficient data to estimate the incidence.

Overdose:

Symptoms: excitement of the central nervous system. The specific antidote is unknown. Gastric lavage and symptomatic treatment are recommended.

Influence on the ability to drive a car and other mechanisms: DuspatalinЃ does not affect the ability to drive a car and other mechanisms.

Release form:

Sustained-release capsules 200 mg:

10 capsules in a blister made of aluminum foil and PVC foil. For 1,2,3,5 blisters in a cardboard box along with instructions for use.

15 capsules in a blister made of aluminum foil and PVC foil. 2,4,6 blisters in a cardboard box along with instructions for use.

Storage conditions:

List B.

Store at a temperature not exceeding 25 ? C. Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription.