Mebeverin-SZ, 135 mg 50 pcs.

Myotropic antispasmodic, has direct action on the smooth muscles of the gastrointestinal tract without affecting normal intestinal peristalsis.

The exact mechanism of action is unknown, but multiple mechanisms, such as decreased ion channel permeability, norepinephrine reuptake blockade, local anesthetic action, and altered water absorption, may cause local gastrointestinal action of mebeverine. Through these mechanisms, mebeverine has an antispasmodic effect, normalizing intestinal peristalsis and not causing permanent relaxation of gastrointestinal smooth muscle cells (“hypotonia”). There are no systemic side effects, including anticholinergic.

Pharmacokinetics

Intake

Meberine is quickly and completely absorbed after oral administration.

Distribution

There is no significant accumulation with repeated doses of the drug.

Metabolism

Meberine hydrochloride is primarily metabolized by esterases, which first break down the ester into veric acid and meberine alcohol. The main metabolite circulating in plasma is demethylated carboxylic acid. The equilibrium elimination half-life of demethylated carboxylic acid is approximately 2.45 h. When repeated doses are taken, the maximum concentration of demethylated carboxylic acid in the blood (C_max) is 1670 ng/ml, the time to reach the maximum concentration of demethylated carboxylic acid in the blood (T_max) is 1 hour.

Elimination

Meberine as such is not excreted from the body, but is completely metabolized; its metabolites are almost completely excreted from the body. Veratroic acid is excreted by the kidneys. The alcohol of mebeverine is also excreted by the kidneys, partly as carboxylic acid and partly and partly as demethylated carboxylic acid.

Indications

Symptomatic treatment for pain, cramps, dysfunction, and discomfort in the bowel area 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), and changes in stool consistency.

Active ingredient

Composition

1 tablet contains:

the active substance: mebeverine hydrochloride – 135 mg;

excipients (core): lactose monohydrate (milk sugar) –
102.5 mg, potato starch – 45.0 mg, povidone K 30 (polyvinylpyrrolidone medium molecular) – 5.5 mg, talc – 9.0 mg, magnesium stearate – 3.0 mg.

Auxiliary substances (coating): hypromellose – 4.89 mg, talc –
1.37 mg, polysorbate 80 (tween 80) – 1.37 mg, aluminum varnish with quinoline yellow dye – 0.39 mg, titanium dioxide E 171 – 0.98 mg.

How to take, the dosage

For oral administration.

The tablets should be swallowed without chewing, with plenty of water (at least 100 ml).

One tablet 3 times a day, about 20 minutes before a meal.

The duration of the drug is not limited.

If a patient forgets 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.

Dosing regimen studies in elderly patients, patients with renal and/or hepatic impairment have not been conducted. Available data on post-marketing use of the drug have not identified specific risk factors for its use in elderly patients and patients with renal and/or hepatic impairment. There is no need to change the dosing regimen in elderly patients and patients with renal and/or hepatic impairment.

Interaction

There have only been studies on the interaction of this drug with alcohol. Animal studies have shown no interaction between Mebeverin-SZ and ethanol.

Special Instructions

Consult a physician before taking Mebeverin-SZ if:

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

– unintentional and unexplained weight loss;

Contraindications

– Hypersensitivity to any component of the drug.

– Age under 18 years.

– Congenital intolerance of galactose (lactose) or fructose, lactase deficiency, sucrose/isomaltase deficiency, glucose-galactose malabsorption syndrome.

– Pregnancy and period of breastfeeding.

Side effects

The reports of these side effects were spontaneous, and there are insufficient data to estimate the frequency of cases accurately.

Allergic reactions were observed predominantly on the skin, but other manifestations of allergy have also been reported.

Skin disorders:

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

The immune system:

Hypersensitivity reactions (anaphylactic reactions – serious allergic reactions that may include: difficulty breathing, rapid pulse, sharp decrease in blood pressure (weakness and dizziness), sweating).

If you experience any of the side effects, including those not mentioned in these instructions, stop taking Mebeverin-SZ and see your doctor immediately.

Overdose

In case of overdose with Mebeverin-SZ, it is necessary to consult a doctor immediately.

Symptoms

Theoretically, in case of overdose it is possible to increase excitability of the central nervous system. In cases of mebeverine overdose, symptoms were either absent or mild and usually quickly reversible. The observed symptoms of overdose were neurological and cardiovascular in nature.

Treatment

The specific aitidote is unknown. Symptomatic treatment is recommended. Gastric lavage is only necessary if intoxication is detected within approximately one hour after taking several doses of the drug. Absorption reduction measures are not required.

Pregnancy use

Pregnancy

There are only very limited data on the use of mebeverine in pregnant women. Data from animal studies are insufficient to assess reproductive toxicity. It is not recommended to use Mebeverin-SZ during pregnancy.

Breastfeeding

Information on the excretion of mebeverine or its metabolites into breast milk is insufficient. Studies on the excretion of mebeverine into milk in animals have not been conducted. Mebeverin-SZ should not be taken 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 shown no adverse effects of Mebeverin-SZ.

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