Mebeverini hydrochloridum

Pharmacotherapeutic group: synthetic anticholinergics, esters with a tertiary amino group ATC class: A03AA04 Mechanism of action and pharmacodynamic properties Mebeverine is a musculotropic antispasmodic with a direct action 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, such as reduction of ion channel permeability, blockade of noradrenaline reuptake, a local anaesthetic effect, and alterations in water absorption. Through these mechanisms, mebeverine exerts its antispasmodic effect, restoring 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 1500 patients. Compared with control or baseline groups, clinical studies overall demonstrated significant improvement in the principal symptoms of irritable bowel syndrome (such as abdominal pain and stool parameters). At the recommended dosage regimen, all pharmaceutical forms of mebeverine were generally safe and well tolerated. Paediatric population Clinical studies with tablets or capsules have been conducted only in adults. The clinical efficacy and safety data obtained from clinical trials 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 alleviating the symptoms of irritable bowel syndrome in children. Further open-label studies with mebeverine suspension, conducted against a baseline group, confirmed the efficacy of the active substance. The dosage schedule for the tablet or capsule formulation was derived on the basis of the consistent safety and favourable tolerability of mebeverine.