Duspatalin - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Spazmolitik myotropic action, has a direct effect on the smooth muscles of the gastrointestinal tract without affecting the normal peristalsis of the intestine.The exact mechanism of action is unknown, but multiple mechanisms such as lower ion permeability, norepinephrine reuptake blockade, local anesthetic action, and changes in water absorption can cause local action of mebeverine on the gastrointestinal tract. Through these mechanisms mebeverin has an antispasmodic effect, normalizing peristalsis of the intestine and not causing a constant relaxation of smooth muscle cells of the gastrointestinal tract ("hypotension"). Systemic side effects, including anticholinergic, are absent.

Pharmacokinetics:

Suction

Mebeverin is quickly and completely absorbed after ingestion.

Distribution

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

Metabolism

Mebeverina hydrochloride is mainly metabolized by esterases, which in the first stage split the ether into 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 2.45 parts.When taking repeated doses, the maximum concentration of demethylated carboxylic acid in the blood (C_mOh) is 1670 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in the blood (T_max) - 1 hour.

Excretion

Mebeverin as such is not excreted from the body, 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 in the form of 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.

Symptoms may include: abdominal pain, spasms, bloating and flatulence, changes in stool frequency (diarrhea, constipation or alternation of diarrhea and constipation), change in stool consistency.

Contraindications:

- Hypersensitivity to any component of the drug;

- atozrast to 18 years;

- atborn intolerance to galactose (lactose) or fructose, lactase deficiency, sugarase / isomaltase deficiency. syndrome of glucose-galactose malabsorption;

- bPregnancy and the period of breastfeeding.

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. Do not use Duspatalin ® 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 Duspatalin® while breastfeeding.

Fertility

Clinical data on the effect of the drug on fertility in men or women are not available, however, known animal studies have not demonstrated adverse effects of Dupastalin®.

Dosing and Administration:

For oral administration.

Tablets should be swallowed without chewing, squeezed with enough water (at least 100 ml).

One tablet 3 times a day, about 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.

Studies of the dosing regimen in elderly patients, patients with renal and / or liver failure were not performed. Available data on post-marketing use of the drug did not reveal specific risk factors for its use in elderly patients and patients with renal and / or liver failure. Changes in the dosing regimen in elderly patients and patients with renal and / or liver failure are not required.

Side effects:

The reports of these side effects were spontaneous, and it is not enough to accurately estimate the frequency of the available data.

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

From the skin:

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

From the side immune systems:

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

If you have any of the side effects, including those not listed in this manual, stop taking Duspatalin^® and consult a doctor immediately.

Overdose:

In case of an overdose of Dupaspaline®, the doctor should be consulted immediately.

Symptoms

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 minor 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 the level of absorption are not required.

Interaction:

Only studies on the interaction of this drug with alcohol were carried out. Animal studies have demonstrated the absence of any interaction between the drug Duspatalin® and ethyl alcohol.

Special instructions:

Before taking Duspatalin^®it is necessary to consult a doctor, in the case of:

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

- unintentional and unexplained weight loss;

- anemia;

- rectal bleeding or admixture of blood in the stool;

- fevers;

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

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

- recent use of antibiotics.

Consult a doctor if the condition worsens or the symptoms do not improve after 2 weeks of use.

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 were not carried out. The pharmacological properties of the preparation, as well as the experience of its use, do not indicate any adverse effect of mebeverine on the ability to drive and othermechanisms.

Form release / dosage:Tablets, coated with a coating, 135 mg.

Packaging:

For 10 tablets in a blister of PVC / aluminum foil. For 1, 5 blisters together with instructions for use in cardboard pack.

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

For 20 tablets in a blister of PVC / aluminum foil. For 1, 2, 3, 5, 6 blisters together 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 expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001454

Date of registration:25.01.2012 / 23.06.2016

Expiration Date:25.01.2017

The owner of the registration certificate:Abbott Helskea Products BVAbbott Helskea Products BV Netherlands

Manufacturer: & nbsp

ABBOTT BIOLOGICALS, B.V. Netherlands

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp20.08.2016

Illustrated instructions

Instructions

Duspatalin® (Duspatalin®)