Description
Sparex Pharmacodynamics
A myotropic antispasmodic, it has a direct effect 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 reduction of ion channel permeability, blockade of norepinephrine reuptake, local anesthetic action, and changes in water absorption may cause local action of mebeverine on the gastrointestinal tract. Through these mechanisms, mebeverine exhibits 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.
Indications
Symptomatic treatment of pain, cramps, dysfunction and discomfort in the bowel area associated with irritable bowel syndrome.
Symptoms may include: abdominal pain, cramps, bloating and flatulence, stool frequency changes (diarrhoea, constipation or alternation of diarrhoea and constipation), changes in stool consistency.
Contraindications
– Hypersensitivity to any component of the drug;
– Age under 18 years;
– Congenital intolerance to galactose (lactose) or fructose, lactase deficiency, sugar/isomaltase deficiency, glucose-galactose malabsorption syndrome;
– Pregnancy and breastfeeding.
Use in pregnancy and during breast-feeding:
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. The use of mebeverine during pregnancy is not recommended.
Breastfeeding period
There is insufficient information on the excretion of mebeverine or its metabolites into breast milk. Studies on the excretion of mebeverine into milk in animals have not been conducted. Mebeverin should not be taken while breastfeeding.
Fertility
There are no clinical data on the effect of the drug on fertility in men or women, but known animal studies have not demonstrated adverse effects of mebeverine.
Dosage and administration
- 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 from the next dose. Do not take one or more missed doses in addition to the usual dose.
- Dosing 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 any 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.
