Duspatalin tablets p / o 135mg, No. 50

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

• Symptoms may include: abdominal pain cramps bloating and flatulence changes in stool frequency (diarrhea constipation or alternating diarrhea and constipation) changes in stool consistency.

For oral administration.

The tablets must be swallowed without chewing with a sufficient amount of water (at least 100 ml).

One tablet 3 times a day, approximately 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 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.

1 coated tablet contains:

Active ingredient: mebeverine hydrochloride - 135.0 mg.

Excipients : lactose monohydrate - 97.0 mg, potato starch - 45.0 mg, povidone-K25 - 5.5 mg, talc - 12.0 mg, magnesium stearate - 5.5 mg.

Sheath : talc - 40.0 mg, sucrose - 79.0 mg, gelatin - 0.4 mg, acacia gum - 0.4 mg, carnauba wax - 0.3 mg.

• Hypersensitivity to any component of the drug;

• age under 18;

• congenital intolerance to galactose (lactose) or fructose lactase deficiency sucrase / isomaltase deficiency glucose-galactose malabsorption syndrome

• pregnancy and breastfeeding period.

Trade name of the drug

DuspatalinЃ

International non-proprietary name

Mebeverin

Dosage form

film-coated tablets

Composition

1 coated tablet contains:

Active ingredient: mebeverine hydrochloride - 135.0 mg.

Excipients : lactose monohydrate - 97.0 mg, potato starch - 45.0 mg, povidone-K25 - 5.5 mg, talc - 12.0 mg, magnesium stearate - 5.5 mg.

Sheath : talc - 40.0 mg, sucrose - 79.0 mg, gelatin - 0.4 mg, acacia gum - 0.4 mg, carnauba wax - 0.3 mg.

Description

Round film-coated tablets, white.

Pharmacotherapeutic group

Antispasmodic

ATX code

A03AA04

Pharmacodynamics:

Myotropic antispasmodic has a direct effect on the smooth muscles of the gastrointestinal tract without affecting the normal intestinal motility.

The exact mechanism of action is unknown, but multiple mechanisms such as decreased permeability of ion channels, blockade of norepinephrine reuptake, local anesthetic action, and altered water absorption can cause local action of mebeverine on the gastrointestinal tract.

Through these mechanisms, mebeverine has an antispasmodic effect, normalizing intestinal motility and not causing permanent relaxation of smooth muscle cells of the gastrointestinal tract ('hypotension').

There are no systemic side effects, including anticholinergic ones.

Pharmacokinetics:

Suction

Mebeverine is rapidly and completely absorbed after oral administration.

Distribution

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

Metabolism

Mebeverine hydrochloride is mainly metabolized by esterases, which at the first stage break down the ester into veratric acid and mebeverine alcohol. The main metabolite circulating in plasma is demethylated carboxylic acid.

The equilibrium half-life of demethylated carboxylic acid is approximately 245 hours.

When taking repeated doses, the maximum concentration of demethylated carboxylic acid in the blood (Cmax) is 1670 ng / ml; the time to reach the maximum concentration of demethylated carboxylic acid in the blood (Tmax) is 1 hour.

Withdrawal

Mebeverine as such is not excreted from the body but is completely metabolized; its metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly as carboxylic acid and partly as demethylated carboxylic acid.

Indications:

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

• Symptoms may include: abdominal pain cramps bloating and flatulence changes in stool frequency (diarrhea constipation or alternating diarrhea and constipation) changes in stool consistency.

Contraindications:

• Hypersensitivity to any component of the drug;

• age under 18;

• congenital intolerance to galactose (lactose) or fructose lactase deficiency sucrase / isomaltase deficiency glucose-galactose malabsorption syndrome

• pregnancy and breastfeeding period.

Pregnancy and lactation:

Pregnancy

There are only extremely limited data on the use of mebeverine by pregnant women. Animal data are insufficient to assess reproductive toxicity. It is not recommended to use DuspatalinЃ during pregnancy.

Breastfeeding period

There is insufficient information on the excretion of mebeverine or its metabolites in breast milk. Studies of the excretion of mebeverine into milk in animals have not been conducted. You should not take DuspatalinЃ while breastfeeding.

Fertility

There are no clinical data on the effect of the drug on fertility in men or women, however, known animal studies have not demonstrated the adverse effects of DuspatalinЃ.

Method of administration and dosage:

For oral administration.

The tablets must be swallowed without chewing with a sufficient amount of water (at least 100 ml).

One tablet 3 times a day, approximately 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 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.

Side effects:

The reported side effects were spontaneous and the available data are insufficient to accurately estimate the incidence.

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

From the side of the skin:

Urticaria (an allergic rash) Angioedema (a serious allergic reaction that may include: difficulty breathing, swelling of the face, neck, lips of the tongue of the throat), edema of the face, exanthema (skin rash).

From the immune system:

Hypersensitivity reactions (anaphylactic reactions - serious allergic reactions that may include: difficulty breathing, rapid heart rate, a sharp drop in blood pressure (weakness and dizziness), sweating).

If you have any of the side effects, including those not listed in this leaflet, stop taking DuspatalinЃ and consult your doctor immediately.

Overdose:

In case of an overdose with DuspatalinЃ, you should immediately consult a doctor.

Symptoms

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

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. No absorption measures are required.

Interaction:

Only studies have been conducted on the interaction of this drug with alcohol. Animal studies have shown that there is no interaction between DuspatalinЃ and ethyl alcohol.

Special instructions:

Before taking DuspatalinЃ, you should consult your doctor if:

- if the symptoms of the disease have arisen for the first time;

- unintentional and unexplained weight loss;

- anemia;

- rectal bleeding or blood in the stool;

- fever;

- if someone in your family has been diagnosed with colon cancer, celiac disease or inflammatory bowel disease;

- over 50 years of age and if the symptoms of the disease have arisen for the first time;

- recent use of antibiotics.

Consult a doctor if, while taking the drug, the condition worsened or the symptoms did not improve after 2 weeks of use.

Impact on the ability to drive vehicles. Wed and fur .:

Studies of the effect of the drug on the ability to drive a car and other mechanisms have not been conducted. The pharmacological properties of the drug, as well as the experience of its use, do not indicate any adverse effect of mebeverine on the ability to drive a car and other mechanisms.

Release form / dosage:

Coated tablets 135 mg.

Packaging:

10 tablets in a PVC / aluminum foil blister. 1 5 blisters with instructions for use in a cardboard box.

15 tablets in a PVC / aluminum foil blister. 1 2 6 blisters with instructions for use in a cardboard box.

20 tablets in a PVC / aluminum foil blister. 1 2 3 5 6 blisters with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 30 ? C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date indicated on the package.

Vacation conditions

Without recipe