Registered Tanzania · TMDA

Spasmomen

Otilium Bromide 40 mg,Otilonium Bromide 40 mg

TZ 14 H 0323 Tablets 40

What it does

Otilium is a medication used to help relieve stomach and intestinal cramps.

Commonly used for: stomach cramps, intestinal 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.
TZ 14 H 0323
Registration date
2024-11-29
Expiry date
2029-11-28
Status
Registered/Compliant
Active ingredient
Otilium Bromide 40 mg,Otilonium Bromide 40 mg
Dosage form
Tablets
Strength
40
Pack size
-
Therapeutic class
-
Manufacturer / MAH
A. Menarini
Country of origin
ITALY
Manufacturer location
Via Rosolino Pilo, 4, 50131 Firenze FI, Italy

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:47:19 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About otilium

Otilium is a medication used to help relieve stomach and intestinal cramps.

What it treats

  • stomach cramps
  • intestinal cramps
  • irritable bowel syndrome (IBS)

How it works

Otilium works by relaxing the muscles in the gut, which helps to reduce pain and discomfort.

Who it's for

Otilium is for adults and children experiencing abdominal pain and discomfort due to cramping.

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

About otilonium

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: otilium

Otilium bromide is an antispasmodic agent primarily used for the treatment of gastrointestinal disorders characterized by spasms. It is a selective muscarinic antagonist that helps relieve smooth muscle contractions in the gastrointestinal tract, thus alleviating symptoms associated with conditions such as irritable bowel syndrome and other spastic conditions.

Indications

  • Irritable bowel syndrome
  • Functional gastrointestinal disorders
  • Abdominal pain associated with spastic conditions

Dosage

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

Adults: Refer to the BNF for appropriate dosing information, as specific doses vary based on the condition being treated.

Mechanism of action

Otilium bromide works by selectively blocking M1 muscarinic receptors in the smooth muscle of the gastrointestinal tract. This blockade leads to a reduction in the contractility of smooth muscle, thereby decreasing spasms and associated pain. The drug also has a mild local anesthetic effect, which may contribute to its efficacy in treating abdominal discomfort.

Pharmacodynamics

The antispasmodic effects of otilium bromide manifest through its action on muscarinic receptors, which are part of the parasympathetic nervous system. By inhibiting these receptors, otilium reduces the activity of the smooth muscle, leading to relaxation and relief from spasm-induced pain. This mechanism is particularly relevant in conditions like irritable bowel syndrome, where abnormal contractions can lead to significant discomfort.

Pharmacokinetics

Otilium bromide is absorbed relatively quickly following oral administration, with peak plasma concentrations typically occurring within 1 to 2 hours. The drug undergoes hepatic metabolism and is eliminated primarily via the kidneys. Its half-life ranges from 4 to 6 hours, allowing for dosing that can effectively manage symptoms without excessive accumulation in the body.

Contra-indications

  • Hypersensitivity to otilonium bromide or any of its components
  • Severe ulcerative colitis
  • Acute glomerulonephritis
  • Myasthenia gravis

Adverse effects

  • Dry mouth
  • Constipation
  • Nausea
  • Dizziness
  • Headache
  • Skin rash

Interactions

  • May enhance the effects of other anticholinergic drugs
  • Caution with concomitant use of drugs that affect gastrointestinal motility

Precautions

  • Use with caution in patients with a history of urinary retention
  • Caution in the elderly due to the increased risk of anticholinergic effects
  • Monitor for signs of dehydration in patients with significant gastrointestinal disturbances

Pregnancy

Otilium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult healthcare professionals for advice.

Breast-feeding

It is not known whether otilium is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Otilonium bromide 40 mg film-coated tablets
  • Otilonium bromide 20 mg oral solution

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

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.