Sparex, 135 mg 60 pcs

Pharmacodynamics

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 effects of mebeverine.

By these mechanisms, mebeverine exhibits an antispasmodic effect, normalizing intestinal peristalsis without 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. With repeated doses, the maximum concentration of demethylated carboxylic acid in the blood (Cmax) is 1670 ng/ml, the time of reaching the maximum concentration of demethylated carboxylic acid in the blood (Tmax) is 1 hour.

Elimation

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 as demethylated carboxylic acid.

Indications

Symptomatic treatment of pain, cramps, dysfunction and discomfort in the bowel area associated with irritable bowel syndrome.

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

Active ingredient

Mebeverin

Composition

Active ingredient: mebeverine hydrochloride 135.00 mg;

excipients: Potato starch 42.00 mg, lactose monohydrate 88.00 mg, magnesium stearate 5.50 mg, methylcellulose 16.00 mg, talc 6.50 mg, microcrystalline cellulose type 102 7.00 mg;

film coating composition: Opadray II Yellow (85F32410) 21.000 mg, including: polyvinyl alcohol 8.400 mg, macrogol-4000 (polyethylene glycol-4000) 4.242 mg, talc 3.108 mg, titanium dioxide 4.935 mg, iron oxide yellow dye 0.315 mg.

How to take, the dosage

Tablets should be swallowed without chewing, with plenty of water (at least 100 ml).
One tablet 3 times a day, about 20 minutes before meals.

The duration of preparation intake is not limited.

If the patient forgot to take one or more doses the preparation should be continued from the next dose. One or more missed doses should not be taken in addition to the usual dose.

Dosing studies in elderly patients, patients with renal and/or hepatic impairment have not been conducted.

Available data on post-marketing use of the drug did not identify 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

Only studies on the interaction of this drug with alcohol have been conducted. Animal studies have shown no interaction between mebeverine and ethanol.

Special Instructions

Consult your doctor before taking Sparex® if:

• if symptoms occur for the first time;
• unintentional and unexplained weight loss;
• anemia;
• reproctal bleeding or blood in the stool;
• fever;
colorectal cancer, celiac disease, or inflammatory bowel disease in your family;
• over 50 years of age and if symptoms occur for the first time;
• previous use of antibiotics.

Check with your doctor if the condition worsens or symptoms do not improve after 2 weeks of treatment.