Registered Rwanda · Rwanda FDA

SPASMOMEN TABLETS

Otilonium Bromide 40mg

Rwanda FDA-HMP-MA-1045 Film-coated tablet 40mg

What it does

Otilonium is used to relieve stomach and bowel pain by relaxing the muscles in the gut.

Commonly used for: stomach cramps, irritable bowel syndrome (IBS)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1045
Registration date
28/02/2024
Expiry date
27/02/2029
Status
Registered
Active ingredient
Otilonium Bromide 40mg
Dosage form
Film-coated tablet
Strength
40mg
Pack size
10 tablets or 30 tablets
Therapeutic class
-
Manufacturer / MAH
Berlin Chemie
Country of origin
GERMANY
Manufacturer location
Glienicker Weg 125, 12489 Berlin, Germany

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:19 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Otilonium is used to relieve stomach and bowel pain by relaxing the muscles in the gut.

What it treats

  • stomach cramps
  • irritable bowel syndrome (IBS)

How it works

It works by relaxing the muscles in the digestive tract, which helps reduce pain and discomfort.

Who it's for

It is for adults and may be prescribed for those experiencing stomach or bowel issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: otilonium

BNF-referenced

Otilonium is an antispasmodic agent primarily used to relieve smooth muscle spasms in the gastrointestinal tract. It is a quaternary ammonium compound that works by inhibiting the contraction of smooth muscle, thus alleviating symptoms associated with various gastrointestinal disorders.

Indications

  • Irritable bowel syndrome
  • Functional gastrointestinal disorders
  • Abdominal pain related to gastrointestinal spasm

Dosage

Children: Refer to the BNF for Children for appropriate dosing information for pediatric patients.

Adults: The usual adult dose is 40 mg taken three times daily, with an increased dose of 80 mg three times daily in more severe cases, as directed by a healthcare professional.

Mechanism of action

Otilonium acts as a selective antagonist of the muscarinic acetylcholine receptors in the gastrointestinal tract. By blocking these receptors, it reduces the influx of calcium ions into smooth muscle cells, leading to relaxation of the muscles and a decrease in spasmodic activity.

Pharmacodynamics

The drug exhibits antispasmodic effects through its action on the muscarinic receptors, particularly M3, which are primarily involved in smooth muscle contraction. Otilonium's anticholinergic properties help to decrease gastrointestinal motility and relieve pain associated with spasms.

Pharmacokinetics

Otilonium is poorly absorbed from the gastrointestinal tract, resulting in minimal systemic levels. Its effects are localized primarily within the bowel. The drug undergoes hepatic metabolism and is excreted predominantly in the feces. The half-life of otilonium is not well characterized due to its limited absorption.

Pregnancy

There is insufficient data on the safety of otilonium during pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Otilonium is not recommended during breastfeeding due to lack of data on excretion in human milk.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: otilonium

PubChem CID 72093

Molecular formula: C29H43N2O4+

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.