Mebeverine (Duspatalin) XR 200 mg – [30 capsules]

Description

Duspatalin 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 numerous mechanisms, such as decreased ion channel permeability, blockade of norepinephrine reuptake, local anesthetic action, and altered water absorption, may cause local action of mebeverine on the gastrointestinal tract. Through these mechanisms, mebeverine has an antispasmodic effect, normalizing intestinal peristalsis without causing permanent relaxation of gastrointestinal smooth muscle tissue (“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.
Symptomatic treatment of spasms of the gastrointestinal tract (including those due to organic diseases).

Contraindications .
Hypersensitivity to any component of the drug.
Age under 18 years (due to insufficient data on efficacy and safety).
Pregnancy (due to insufficient data).
Pregnancy and lactation:
Pregnancy
There are only very limited data on the use of mebeverine in pregnant women. There are insufficient animal studies to evaluate reproductive toxicity. Duspataline® is not recommended for use during pregnancy.
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. Duspatalin® should not be taken 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 Duspatalin®.

Dosage and administration regimen

• For oral administration.
• The capsules should be swallowed with enough water (not less than 100 ml). Capsules should not be chewed because their shell ensures prolonged release of the drug.
• One capsule 2 times a day, one in the morning and one in the evening, 20 minutes before a meal,
• The duration of taking the drug is not limited.
• If the patient forgot to take one or more doses, the drug should be continued with 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.