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. Several mechanisms, such as reduction of ion channel permeability, blockade of noradrenaline reuptake, a local anaesthetic effect, and changes in water absorption, may contribute to mebeverine's local activity in the gastrointestinal tract. Through these mechanisms, mebeverine exerts its antispasmodic effect, restoring intestinal motility without producing 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 the various pharmaceutical forms of mebeverine have been evaluated in more than 1,500 patients. Compared with control or baseline, clinical studies overall demonstrated a 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 been conducted in adults only. Efficacy and safety data from clinical studies and post-marketing experience with mebeverine pamoate suspension in patients aged > 3 years have shown mebeverine to be 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. Further open-label studies with mebeverine suspension, conducted against baseline, have confirmed the efficacy of this medicinal product. The dosing regimen for the tablet and capsule forms was derived on the basis of mebeverine's consistent safety and favourable tolerability profile.