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Spasmomen (ANXIOLYTIC)

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Spasmomen (ANXIOLYTIC)

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Method of action: Anxiolytic

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Spasmomen (ANXIOLYTIC)

Quick Facts

Property Description
Active Ingredients Diazepam and Otilonium Bromide
Form Film-coated tablets (Solid oral dose)
Pharmacological Class Anxiolytic and Antispasmodic
Origin Synthetic (Chemically synthesized)

What Type of Medicine is Spasmomen (ANXIOLYTIC)?

Spasmomen (ANXIOLYTIC) is a prescription-only combination product that integrates two distinct pharmacological actions into a single drug entity. It is supplied as a solid oral dose form (film-coated tablets) for oral administration. It is classified as an antispasmodic in combination with a psycholeptic, reflecting its design to address both the physical symptoms of muscle spasm and the associated nervous tension. This integrated therapeutic approach is designed to address the complex requirements of treating functional disorders.


Dual Composition: Diazepam and Otilonium Bromide

The medication's effectiveness stems from its two synthetic active ingredients [INN]: Otilonium Bromide and Diazepam. Otilonium Bromide is classified as a synthetic anticholinergic, quaternary ammonium compound (WHO ATC Code A03AB06) and functions as the peripheral agent, primarily targeting the gastrointestinal tract. The Benzodiazepine derivative, Diazepam, is known for its ability to reduce central nerve activity by enhancing the effects of the inhibitory neurotransmitter GABA. As an intestinal antispasmodic, the compound works to regulate the muscle contractions in the gut. This suggests the medication helps ease physical cramping by directly acting on the intestinal muscles.


What is the General Purpose of This Combination?

The general purpose of this combination medicine is to provide dual therapeutic relief by simultaneously reducing intestinal muscle spasms and managing the accompanying nervous tension. The Otilonium Bromide component helps alleviate the cramping and abdominal pain caused by involuntary smooth muscle contractility, while the Diazepam component exerts a calming influence on the Central Nervous System (CNS). The integrated action of the combination formulation is intended for relieving the painful symptoms associated with functional gut disorders. This means the combined medicine is recognized for its ability to address both the physical pain and the nervous distress experienced by the patient. This synergistic action offers a strategic advantage in managing conditions where the brain-gut axis is highly sensitized.

Regulatory References

  1. Diazepam - MedlinePlus Drug Information
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What side effects are possible with Spasmomen (ANXIOLYTIC)?

Possible Side Effects and Safety Information

Spasmomen (Otilonium Bromide) is generally well-tolerated, with a low incidence of adverse effects observed in clinical trials, often comparable to placebo. The drug has very low systemic absorption, meaning its primary action is localized to the gastrointestinal tract.

Adverse Reactions

The frequency of adverse reactions is classified using standard regulatory frameworks:

Classification Adverse Reactions
Uncommon (up to 1 in 100 people) Dry mouth, Nausea, Upper abdominal pain, Headache, Vertigo, Pruritus (itching), Erythema (skin redness), Fatigue, Asthenia (weakness).
Not Known (Post-marketing) Skin hypersensitivity reactions (e.g., Urticaria, Angioedema).

Serious adverse reactions are rare; however, isolated reports of skin hypersensitivity reactions (such as swelling of the face, lips, or throat, and rash) have been reported during post-marketing surveillance.

Safety Restrictions and Contraindications

The drug is contraindicated in patients with known hypersensitivity (allergy) to otilonium bromide or any of its excipients. The product contains lactose and should not be used by patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

Special Caution is required for use in patients with pre-existing conditions such as glaucoma (increased eye pressure), prostatic hypertrophy (enlarged prostate gland), or pyloric stenosis (narrowing of the passage from the stomach to the intestine).

Use in children and adolescents below 18 years of age is not recommended as safety and efficacy have not been established in this population. Data on use during pregnancy and lactation are limited; therefore, use should be avoided unless strictly necessary and under close medical supervision.

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Overdose and Emergency Response

Overdose and When to Seek Help

The following information is derived from official regulatory documentation regarding overdose with Spasmomen (Otilonium bromide).


Overdose Profile Summary

Official regulatory labeling indicates that no specific toxic signs or symptoms are currently documented for an overdose of Otilonium bromide. The compound has a low systemic absorption, meaning that the quantity entering the bloodstream is typically limited.

Since no specific symptoms are listed, an overdose could potentially lead to an exaggeration of the known pharmacological effects of the drug. However, this is not confirmed in the official overdose statements.

Overdose Component Regulatory Statement
Documented Symptoms No specific symptoms are documented.
Dose-Related Factors No specific toxic dose levels are detailed.
Systems Affected No specific physiological systems are listed as affected in the overdose section.

Required Emergency Actions

It is essential to seek medical advice immediately in the event of a suspected or confirmed overdose. This applies even if the person appears to feel well or is asymptomatic. Immediate medical assessment is necessary because the official labeling does not provide specific guidance on how to manage or monitor an overdose situation at home.

When seeking help, patients are instructed to take the product with them to the medical facility, as this information is crucial for the healthcare professional to provide appropriate management.

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Therapeutic Uses of Spasmomen (ANXIOLYTIC)

The therapeutic context of this combination is relevant in contexts marked by increased discomfort and tension, focusing on both the physical symptoms of gastrointestinal spasm and the associated emotional distress.

What Spasmomen (ANXIOLYTIC) Treats: Main Uses and Benefits

This medication is commonly used across conditions presenting with recurrent or episodic manifestations, primarily targeting Irritable Bowel Syndrome (IBS) and related painful, spastic states of the intestinal tract. It is applied across domains where additional symptomatic support is needed, assisting with symptoms that interfere with daily functioning. The anxiolytic component is generally applied in situations where patients experience anxiety or apprehension linked to their gastrointestinal condition. This category of medication is traditionally used to assist with managing anxiety and related physiological activity.

The primary therapeutic goals include offering supportive relief for symptoms of IBS, addressing spastic states of the intestinal tract, and easing the nervous tension that often accompanies these painful episodes. This dual approach is commonly used to help with managing symptoms that create noticeable physiological strain during periods of heightened symptoms.

“This medication is considered relevant for managing symptom clusters that may become intense or disruptive, especially those linked to organ-specific functional stress.”

This support is relevant in situations where additional symptomatic assistance is considered appropriate, particularly when symptoms become temporarily overwhelming, and may assist with maintaining comfort and coping steadily with symptom fluctuations.


Quick Fact: Relief for Pain and Anxiety in IBS

Feature Description
Primary Symptom Target Abdominal cramping, painful spasms, and intestinal hypermotility.
Associated Symptom Target Nervous tension, anxiety, and apprehension linked to gut distress.
Use Context Symptomatic management of functional colonic diseases (IBS) and procedural premedication.

Regulatory References

  1. NIH StatPearls overview of Diazepam
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Eligibility and Restrictions for Use

Who can and cannot use Spasmomen (Otilonium Bromide)

Spasmomen is specifically indicated for use in adults (patients 18 years of age and older). The medicine must not be used by any patient with a known hypersensitivity (allergy) to the active substance, otilonium bromide, or any other component in the tablet.

Use is not recommended for the paediatric population (children and adolescents under 18 years) because the safety and efficacy of the medicine have not been established in this age group. Additionally, patients with rare hereditary problems such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should avoid this medicine due to its excipient content.

Use requires special caution and medical consultation for individuals with pre-existing conditions such as glaucoma (increased eye pressure), prostatic hypertrophy (enlarged prostate gland), or pyloric stenosis (narrowing of the passage from the stomach to the intestine).

For pregnancy and breastfeeding, the use of Spasmomen is generally preferred to be avoided. It should only be administered if absolutely necessary and under direct, close medical supervision.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes documented interaction patterns for this combination medicine, as defined in regulatory sources. Due to its dual composition, interaction information relates primarily to the Diazepam component. The Otilonium Bromide component has been officially assessed as having a negligible effect on the absorption of other orally administered medicinal products.


Interaction Type Interacting Substances/Conditions Official Interaction Outcome
Contraindicated Combination Opioids Risk of profound sedation, respiratory depression, coma, and death.
Pharmacokinetic (Exposure) CYP2C19 & CYP3A4 Inhibitors Decreased Diazepam elimination, leading to increased drug exposure.
Pharmacodynamic Reinforcement Alcohol and other CNS Depressants Additive CNS depressant effects; simultaneous ingestion is advised against.
Absorption Alteration Moderate Fat Meal Absorption of Diazepam is delayed and decreased, altering the pharmacokinetics.
Plasma Protein Binding Valproate (Valproic Acid) Increases the free fraction of Diazepam by displacing it from plasma proteins.

Population-Specific Considerations

The use of the medicine is restricted in cases of severe hepatic insufficiency, reflecting a heightened risk due to impaired metabolism and clearance. Care is also required for elderly or very ill patients when co-administered with other CNS depressants due to increased sensitivity to additive effects.

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Mechanism of Action

How Spasmomen (Otilonium Bromide) Works

Otilonium bromide's mechanism of action is initiated by its selective binding to muscarinic receptors, particularly the M2 and M3 subtypes, located on the smooth muscle of the gastrointestinal tract. This interaction consequently influences the regulation of peristaltic contractions.

Furthermore, its action involves the modulation of L-type calcium channels on the smooth muscle cell membrane. This dual effect results in the modulation of ion fluxes and membrane potential, which collectively contributes to inducing relaxation of the smooth muscle and thereby decreasing its contraction frequency and force. The overall action is confined to the cellular and tissue level.

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Dosage and Administration Information

The administration of Spasmomen (ANXIOLYTIC) is restricted to the oral route, delivered as a film-coated tablet containing the active components, including Otilonium Bromide. The standard adult dosage regimen specifies the intake of one tablet per dose, which translates to a total daily intake of 80 mg to 120 mg of the antispasmodic component. This standard dose is typically administered two to three times a day in divided doses, following the prescribed frequency pattern.

A critical instruction related to proper administration is the timing relative to meals. The tablet must be swallowed whole with a glass of water, and the standard protocol involves taking the dose approximately 20 minutes before meals. The tablets must not be broken, crushed, or chewed, a procedural condition that preserves the intended release characteristics of the dosage form. If a dose is missed, it is standard procedure that a double dose should not be taken to compensate for the omission.

Treatment with this combination product is defined by a strict duration constraint. Due to the presence of a psycholeptic (Diazepam), the course of therapy is designed to be kept as short as possible, generally not exceeding 8 to 12 weeks in total, which includes any necessary gradual tapering period. For older adults, the established approach involves beginning treatment with the lowest effective dose to account for potential sensitivity to the components. The overall use protocol is non-cyclical and is focused entirely on providing time-limited, intermittent symptomatic support.

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Recent Clinical Evidence

Research Evidence: Overview of Studies

Evidence for Use in Irritable Bowel Syndrome (IBS)

The clinical evaluation of Spasmomen (ANXIOLYTIC) was studied for its use in Irritable Bowel Syndrome (IBS) and other functional conditions characterized by fluctuating or episodic manifestations. The primary research available includes Randomized Controlled Trials (RCTs) and controlled comparative studies that researched the combination product against the component monotherapy. These studies were applied in research contexts involving fluctuating or unstable symptoms in adult patients and were used in research exploring how symptoms change over time. The research examined outcomes related to physical discomfort, such as changes in abdominal pain, discomfort, and bloating, which are common patient-reported outcomes describing perceived discomfort associated with IBS.

Evaluation of Dual Symptom Relief

Research has specifically examined the combination in studies designed to evaluate dual outcomes related to both physical spasm symptoms and accompanying nervous tension. Studies were conducted during periods of increased symptom activity and focused on episodes where symptoms become more noticeable. Researchers measured two distinct sets of outcomes: those related to physical discomfort (spasm and pain) and those related to the central nervous system (anxiety or nervous tension).

The combination product was evaluated in studies that monitored physiological strain or stress alongside the physical symptoms. The trials reported how symptoms evolved in the observed populations, with research describing measurements related to the anxiogenic situation. This research describes the measured outcomes linked to both physical discomfort and systemic or functional imbalance.

Observation Periods and Long-Term Follow-up

The observation periods used in the core clinical trials for the combination product were limited to short-term and intermediate-term durations, typically ranging from a few weeks up to approximately eight weeks. Research exploring short-term symptom changes provides insight into temporary physiological imbalance.

However, there is limited information for long-term outcomes regarding the use of the combination beyond these initial time intervals. Consequently, the long-term effects are not fully established, and follow-up durations were limited in the key studies. Data are still emerging to help characterize the durability of any observed patterns or the impact on symptoms over extended use.

What Remains to be Fully Characterized

The current evidence base, while including controlled trials, has certain limitations. The sample sizes were modest in some combination-specific trials, which can limit the overall certainty of the findings. The evidence quality remains variable based on the findings available, and comparative evidence against other treatment classes is limited.

In summary, the research helps show what has been observed so far under specific conditions of the study, and evidence highlights what is known—and what is still uncertain. Findings describe group patterns, not personal outcomes, and the research does not determine whether an individual will respond similarly.

Key Studies & References

  1. [Otilonium bromide-diazepam in the treatment of the irritable colon. A controlled study versus otilonium bromide]
  2. Meta-analysis: the treatment of irritable bowel syndrome (on antispasmodics and IBS)
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Frequently Asked Questions (FAQ)

Common questions about Spasmomen (ANXIOLYTIC) (FAQ)


Q: Why is Spasmomen sometimes referred to as an 'ANXIOLYTIC' when it is an antispasmodic?

Official product information describes Spasmomen as a combination medicine that acts as both an antispasmodic and a psycholeptic, which is another term for an anxiolytic. This is because it contains two synthetic active ingredients: Otilonium Bromide to treat physical spasms and Diazepam, which is the component that addresses nervous tension.


Q: Is Spasmomen used for conditions other than Irritable Bowel Syndrome (IBS)?

Regulatory documents state that Spasmomen was studied for its use in Irritable Bowel Syndrome (IBS). Research evidence also included its study for other functional conditions characterized by symptoms that fluctuate or appear episodically.


Q: How does Spasmomen relate to other antispasmodic medications?

The mechanism of action for the antispasmodic component involves specific action on the smooth muscle of the gut. It works by binding to certain receptors and regulating calcium channels in the muscle cells to induce relaxation. Official sources indicate that comparative evidence against other treatment classes is limited.


Q: What does 'spasmolytic' mean in the context of this medicine?

Spasmolytic is another name for an antispasmodic. In the context of this medicine, it refers to how the Otilonium Bromide component helps relieve painful cramping. It is understood to act on the smooth muscle of the gastrointestinal tract to induce relaxation and decrease the frequency and force of muscle contractions.


Q: Is Spasmomen expected to work for all types of IBS?

The clinical research evidence available relates to the product's use for Irritable Bowel Syndrome (IBS) in general. However, official information does not provide specific findings or conclusions regarding its application or effectiveness across the various officially recognized subtypes of IBS.


Q: Does Spasmomen cause drowsiness or affect alertness?

Because the medicine contains the psycholeptic component Diazepam, it can affect the Central Nervous System (CNS). Uncommon side effects like Fatigue and Asthenia (weakness) have been reported. For this reason, official labels state that caution is necessary if the medicine is used alongside other CNS depressants, as this may increase sensitivity to additive effects.


Q: Are there any side effects that are considered very uncommon but serious with Spasmomen?

Official safety information indicates that serious adverse reactions are rare. However, isolated reports of skin hypersensitivity reactions have been observed during post-marketing surveillance. These reports, classified as having a Not Known frequency, include reactions such as Urticaria, Angioedema, or swelling of the face, lips, or throat.


Q: Does Spasmomen affect the ability to drive or operate machinery?

The medicine contains Diazepam, which is a component that acts on the Central Nervous System (CNS). Regulatory classification lists the product as a psycholeptic, which is associated with effects on the central nervous system. Due to this potential, caution is advised when considering tasks that require full alertness.


Q: Is the active ingredient in Spasmomen, otilonium bromide, absorbed into the bloodstream?

The primary action of the antispasmodic component, Otilonium Bromide, is localized to the muscle cells of the gastrointestinal tract. Regulatory data indicates that the product has very low systemic absorption, meaning only a minimal amount enters the general bloodstream.


Q: What is the general conclusion of research evidence regarding Spasmomen's effectiveness?

Studies related to the combination formulation indicate that the product's integrated action is beneficial for relieving the painful symptoms associated with functional gut disorders. This research describes the measured outcomes linked to both physical discomfort and accompanying nervous tension.


Q: Can Spasmomen affect the function of the kidneys or liver?

Official product information indicates a restriction for use in cases of severe hepatic insufficiency (severe liver impairment). This is due to the potential for impaired metabolism and clearance of the drug components. The labeling does not specify restrictions related to kidney function.


Q: What is the difference between an antispasmodic and a traditional ANXIOLYTIC medication?

An antispasmodic and an anxiolytic work on different parts of the body. The antispasmodic component, Otilonium Bromide, acts locally to alleviate muscle spasms in the gut. In contrast, the anxiolytic component, Diazepam, works centrally by reducing nerve activity to manage nervous tension.


Q: Are there different forms or strengths of Spasmomen available?

According to official product descriptions, Spasmomen is supplied as a film-coated tablet for oral administration. The official dosage regimen defines the daily intake and the dose per tablet.


Q: How quickly can a person expect to feel the effects of Spasmomen after taking it?

Clinical information indicates the antispasmodic component may have an observable effect, with relief often reported within 30 minutes to an hour. Achieving the full pattern of therapeutic benefits, especially for chronic conditions, may take a few days to a week. The anxiolytic component also has a rapid oral onset.


Q: What is the typical duration of action for one dose of Spasmomen?

The duration of action is influenced by the product's components. The Diazepam component, which addresses nervous tension, is classified as a long-acting substance. This component is associated with a duration of action reported to be more than 12 hours.


Q: What should be expected if a person stops taking Spasmomen suddenly?

Official instructions for the product emphasize that the therapeutic course must be kept short, particularly due to the psycholeptic component. The duration constraint includes any necessary gradual tapering period. This information indicates that a sudden cessation procedure is a factor that must be considered.


Q: Can Spasmomen cause or worsen constipation in some people?

The antispasmodic component, Otilonium Bromide, acts on gut motility, and its effect has been studied in research. Clinical trials for this component have included constipation as one of the single endpoints studied for change.


Q: What is the significance of Spasmomen being a 'quaternary ammonium compound'?

The antispasmodic component, Otilonium Bromide, is classified chemically as a quaternary ammonium compound. This classification is consistent with its profile, which includes very low systemic absorption and its action being primarily localized to the gastrointestinal tract.


Q: What should be done if a person accidentally takes more Spasmomen than recommended?

Regulatory documents, such as the SmPC, provide information on the symptoms and description of the management for potential overdose situations. Clinical studies for the antispasmodic component showed no particular effects when taken in overdose, but regulatory documents state that symptomatic or supportive treatment may be needed.


Q: Is Spasmomen associated with weight gain or loss?

Research related to the Diazepam component (the anxiolytic) suggests that body weight may be affected by its use in certain patient groups. Some studies have described an association between the reduction or discontinuation of the component and weight loss, and its restoration and weight gain.


Q: Is the active ingredient otilonium bromide widely approved by global health authorities?

The active ingredient, Otilonium Bromide, holds a World Health Organization (WHO) Recommended International Nonproprietary Name (Rec.INN). Furthermore, Periodic Safety Update Reports (PSURs) are used to estimate worldwide usage, which indicates that the product has been used by millions of adult patients per month.


Q: Is Spasmomen a brand name, and what is its generic name?

Spasmomen is the recognized brand name for this medicine. It is a combination product whose generic names are the synthetic active ingredients contained within it: Otilonium Bromide and Diazepam.

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How should Spasmomen (ANXIOLYTIC) be stored and disposed of?

Storage and Disposal Requirements

Official labeling requires Spasmomen tablets to be stored at controlled room temperature, typically between 20 C and 25 C. The medicine must be kept in its original container with the lid tightly closed to protect it from moisture and maintain product stability until the printed expiration date.

Storage Restriction Requirement
Temperature Controlled room temperature (20 C to 25 C)
Packaging Keep in original, tightly closed container
Protection Keep out of the sight and reach of children

Due to the presence of the controlled substance Diazepam, Spasmomen must be stored in a safe, secure place away from children and pets. The preferred method for disposal of unused or expired medicine is a drug take-back program or an authorized collection site. The product should not be disposed of by flushing down the sink or toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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