Product/Composition:- | Otilonium Bromide tablets |
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Strength:- | 40 mg |
Form:- | Tablets |
Reference Brands:- | Spasmomen(EU) |
MOQ | As per the manufacturer batch size |
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Otilonium bromide is an antispasmodic that blocks calcium channels in smooth muscle cells, reducing colonic spasms and abdominal pain. It effectively relieves symptoms of irritable bowel syndrome, supporting bowel comfort and reducing cramping. Benefits include decreased gastrointestinal motility, improved digestive comfort, and relief from abdominal cramps
Otilonium bromide tablets, marketed as Spasmomen, are approved in the EU for irritable bowel syndrome (IBS) and colonic spasms, with regional dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, it is not widely marketed and mainly available as a generic or compounded product. Regulatory approval in the EU ensures regional safety and efficacy compliance, supporting gastrointestinal symptom management. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and broad availability, helping patients worldwide manage gastrointestinal motility disorders effectively across regions.