Mebeverini hydrochloridum

Pharmacotherapeutic group: synthetic anticholinergics, esters with a tertiary amino group ATC group: A03AA04 Mechanism of action and pharmacodynamic properties Mebeverine is a musculotropic antispasmodic that acts directly on the smooth muscle of the gastrointestinal tract, without affecting normal intestinal motility. The precise mechanism of action of mebeverine is not known. Multiple mechanisms may contribute to its local action in the gastrointestinal tract, including reduction of ion channel permeability, blockade of noradrenaline reuptake, a local anaesthetic effect, and alterations in water absorption. Through these mechanisms, mebeverine exerts an antispasmodic effect that restores intestinal motility without inducing sustained relaxation of gastrointestinal smooth muscle cells (so-called hypotonia). Mebeverine does not produce the systemic adverse effects typical of anticholinergic agents. Clinical efficacy and safety The clinical efficacy and safety of various pharmaceutical forms of mebeverine have been evaluated in more than 1,500 patients. Compared with control or baseline groups, clinical studies have demonstrated an overall significant improvement in the principal symptoms of irritable bowel syndrome (such as abdominal pain and stool parameters). All pharmaceutical forms of mebeverine were generally safe and well tolerated at the recommended dosing regimen. Paediatric population Clinical studies with tablets or capsules have only been performed in adults. Clinical efficacy and safety results from both clinical studies and post-marketing experience with mebeverine pamoate suspension in patients aged > 3 years have shown that mebeverine is effective, safe and well tolerated. Clinical studies with mebeverine suspension have shown that mebeverine is effective in relieving the symptoms of irritable bowel syndrome in children. Additional open-label studies with mebeverine suspension, conducted against a baseline group, have confirmed the efficacy of this medicinal product. The dosing regimen for the tablet or capsule form was derived on the basis of the consistent safety and favourable tolerability of mebeverine.