Spasmonal

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Spasmonal

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Medically reviewed

Laura Arias

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.

Overview of Spasmonal

What is Spasmonal? Defining the Antispasmodic

Property Description
Active ingredient Alverine (as Alverine citrate)
Form Capsule (Oral dosage form)
Pharmacological class Direct-acting smooth muscle relaxant
General Purpose Relief from visceral discomfort/spasms
Origin Synthetic propylamine derivative

What Type of Medicine is Spasmonal? (Definition and Class)

Spasmonal is a synthetic, single-ingredient medicinal preparation classified as a direct-acting smooth muscle relaxant. Its identity is centered on the active ingredient, Alverine, which is commonly formulated as the salt Alverine citrate. This compound is part of the broader pharmacological group known as antispasmodic drugs, which are designed to address abnormal muscle contractions. Alverine is characterized by its musculotropic action, meaning it acts directly on muscle fibers. This specific chemical structure, classified as a propylamine derivative, is a distinctive feature of the compound.


Composition, Form, and General Purpose

The formulation is an oral dosage form, supplied as a capsule, which ensures effective systemic delivery of the active component. Spasmonal is a monopreparation, containing only the Alverine substance. The primary objective of this formulation is to achieve smooth muscle relaxation throughout the gastrointestinal organs. The active component, Alverine, is a musculotropic agent used for conditions involving smooth muscle spasm. Consequently, the medication's overall purpose is to provide relief by acting on the source of the involuntary muscle tension. By interrupting the abnormal contraction cycle, the medication generally helps to ease visceral discomfort and restore the proper function of affected organs.

What side effects are possible with Spasmonal?

Possible Side Effects and Safety Information

The safety profile of Spasmonal (alverine citrate) is characterized by official data collected through post-marketing surveillance. This results in the majority of documented adverse reactions being classified with a frequency of Not known, meaning their occurrence rate cannot be estimated from the available data.

Officially Documented Adverse Reactions

Adverse effects listed in regulatory documents are grouped across several systems:

  • Immune System Disorders: These include allergic reactions and, less frequently, the serious reaction anaphylaxis.
  • Hepatobiliary Disorders: Effects such as jaundice due to hepatitis and abnormal liver function tests have been documented. The hepatitis is typically reported to resolve upon cessation of alverine.
  • Nervous System Disorders: Reactions include headache and dizziness.
  • Skin and Subcutaneous Tissue Disorders: Possible effects include rash and itching.
  • Gastrointestinal Disorders: Nausea is a documented adverse effect.

Safety Restrictions and Contraindications

Formal regulatory documentation outlines specific situations where the use of alverine citrate is contraindicated, which defines key safety boundaries for the medicine:

  • Gastrointestinal Conditions: Use is restricted in patients diagnosed with paralytic ileus or any form of intestinal obstruction.
  • Hypersensitivity: It must not be used by individuals with a known hypersensitivity to alverine citrate or any related components.
  • Specific Populations: The use of alverine is not recommended during pregnancy or lactation. Furthermore, it is not recommended for use in children below the age of 12 years.

Overdose and Emergency Response

Overdose and when to seek help

Overdose scope: Official Regulatory Information

Feature Official Regulatory Statement
Documented overdose presentations Overdose can produce hypotension (low blood pressure) and atropine-like toxic effects. These effects may include a fast heart rate, dizziness, dry mouth, blurred vision, confusion, and hallucinations.
Physiological systems affected The official label documents effects on the Cardiovascular system (hypotension) and the Central Nervous System (atropine-like effects).
Dose-related or exposure-related factors Fatality has occurred following an overdose with very high doses of the active substance.
Population-specific overdose notes No specific or differentiated overdose considerations for populations (e.g., pediatric, elderly) are explicitly detailed in the regulatory overdose management sections.
Emergency-response statements Management is as for atropine poisoning, focusing on supportive therapy for hypotension. No specific antidote is known for this overdose.
When immediate medical help is required Contact your doctor or nearest hospital emergency department immediately if an overdose is suspected or has occurred. The remaining capsules and product box should be taken for assessment.

Resulting Overdose Structure

Official overdose statements:

  • Overdose may present with a dangerous decrease in blood pressure (hypotension) and central nervous system effects known as atropine-like toxic effects.
  • The most severe outcome documented is fatality following ingestion of very high doses.
  • It is explicitly stated that no specific antidote is known for this overdose.
  • The required action is to seek immediate medical attention and transport the individual to an emergency department for supportive management.

Connection to the overall overdose profile:

Regulatory documents define the overdose profile by listing severe cardiovascular and neurological manifestations, notably hypotension and atropine-like effects, which pose a risk of fatality following massive ingestion. This severity classification strictly mandates that patients seek medical attention immediately at a hospital emergency department. Official guidance dictates that treatment must be supportive since a specific antidote is not known to exist.

Therapeutic Uses of Spasmonal

What Spasmonal Treats: Main Uses and Benefits

Spasmonal (alverine citrate) is applied across domains where additional symptomatic support is needed to address discomfort. The use of alverine citrate is relevant for easing symptoms associated with Irritable Bowel Syndrome, painful diverticular disease of the colon, and primary dysmenorrhoea (period pain). It is commonly used when short-term symptomatic assistance is needed to address symptoms associated with acute or episodic changes.


Managing Cramping and Pain in Key Areas

This medication plays a role in managing symptom clusters that may become intense or disruptive, particularly those related to physical discomfort in the digestive and pelvic areas. It is applied during phases of increased distress or discomfort, and generally contributes to easing the overall symptom load.

“It helps address symptoms associated with acute or episodic changes, which is relevant when symptomatic management is appropriate.”

It is commonly used across conditions presenting with acute episodes of pronounced cramping and pain. The medication may assist with maintaining functional stability and supports patients during difficult episodes, which helps ease distress.

Quick Fact: Support for Symptoms Related to Spasm Spasmonal is relevant for easing symptoms linked to organ-specific functional stress.

Regulatory References

  1. HPRA Summary of Product Characteristics for Alverine Citrate

Eligibility and Restrictions for Use

The eligibility for using Spasmonal (Alverine citrate) is strictly determined by regulatory documents, which define absolute prohibitions and specific conditions that require professional medical advice.

Contraindicated Populations

Use is absolutely prohibited (contraindicated) for the following populations and conditions, as stated in the official regulatory labeling:

Category Contraindicated Status
Allergy Known hypersensitivity to Alverine citrate or any excipients.
Gastrointestinal Comorbidity Patients with Intestinal obstruction or Paralytic ileus.
Reproductive Status Women who are pregnant or breastfeeding (lactation).

Age-Group and Conditional Restrictions

Category Regulatory Status
Children under 12 Not recommended for use.
Adults and Older Adults Eligible for use under standard labeled conditions.

Mandatory Consultation Restrictions

Use is restricted and must not begin until a medical professional is consulted if the patient is aged 40 years or over with new symptoms, or presents with specific warning signs such as passing blood from the bowel, unexplained vomiting, unexplained weight loss, or fever. These limitations are listed in the official prescribing information to guide appropriate treatment decisions.

What should I know about interactions with other medicines?

The official regulatory profile for Spasmonal (Alverine citrate) indicates a generally low risk for specific drug-drug interactions. The dedicated interaction section in the Summary of Product Characteristics (SmPC) from various national health agencies often reports no interactions stated.

Interaction Constraint Official Regulatory Information
Contraindicated Combinations No medicinal products or classes are explicitly listed as a contraindicated combination due to interaction risk in the official label.
Pharmacokinetic (PK) Basis No interactions involving major metabolic pathways, such as CYP enzymes or drug transporters, are officially documented. The drug exhibits high renal clearance of its metabolites.
Food, Alcohol, or Supplements No specific restrictions or interactions with food, alcohol, or herbal products are documented in the regulatory prescribing information.

The most relevant interaction considerations stem from the product's primary effect on the body:

  • Pharmacodynamic Influence on Absorption: As a smooth muscle relaxant, Alverine citrate affects gastric motility. This pharmacodynamic action may alter the rate and extent of absorption and resulting exposure of other concurrently administered oral medicines.
  • Timing Requirement: To mitigate the potential for altered absorption, regulatory-aligned guidance advises a separation of administration between Alverine citrate and certain other oral products.
  • Population-Specific Note: Caution is noted for administration to hypotensive patients due to the possibility of the drug contributing to additive effects on blood pressure.

The overall interaction structure is defined by its low systemic interaction risk, placing the emphasis on administration timing rather than on chemical incompatibility.

Mechanism of Action

The mechanism of action for Spasmonal (Alverine) is defined by its dual influence on the smooth muscle and the visceral afferent signaling pathways. The drug acts within two distinct mechanistic domains that converge to influence physiological processes in the gut and uterus.


Direct Regulation of Visceral Muscle Tone

This domain covers the drug's effect directly on the smooth muscle cells by inhibiting the flow of calcium ions ( Ca^2+) through their membrane channels and reducing the muscle's sensitivity to available Ca^2+ . By modifying these fundamental molecular steps of excitation-contraction coupling, the mechanism leads to the reduction of muscle cell contractility and smooth muscle tone.


Modulation of Peripheral Nociceptive Signals

This second domain involves the drug's interaction with the nervous system of the gut, where it acts as an antagonist at the 5-HT1A receptor. This action modifies the way the gut processes and transmits visceral afferent signaling, altering the signaling dynamics associated with peripheral neural activity.

Dosage and Administration Information

Administration Scope

Spasmonal (Alverine citrate) is a medication for oral use, supplied in the form of a hard capsule. Available strengths are typically 60 mg and 120 mg per capsule.

The standardized adult dosing regimen, which also applies to older adults, is 60 mg to 120 mg per administration. This dose is taken up to three times a day, establishing the maximum daily intake at 360 mg of Alverine citrate. This frequency pattern defines the standard parameters of consumption.

Preparation and Procedural Rules

For proper administration, the capsules must be swallowed whole with a drink of water and should not be altered. Intake timing is independent of food, providing flexibility in the daily schedule.

Procedural guidelines also address adherence: if a dose is forgotten for more than four hours, the user is instructed to skip the missed dose and resume the normal schedule, rather than compensating with a double quantity.

Population Constraints and Duration

Regarding patient populations, the medication is not recommended for use in children below the age of 12 years. The treatment is intended for symptomatic use and is subject to a review constraint: if symptoms show no improvement after a period of two weeks, a consultation with a healthcare professional is advised to assess continuation of the regimen. These constraints define the established context and duration of the medication's use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Spasmonal


Evidence for Use in Irritable Bowel Syndrome (IBS)

The research landscape for Alverine citrate (Spasmonal) in the context of Irritable Bowel Syndrome includes Randomized Controlled Trials (RCTs). These short-term trials utilized double-blind, placebo-controlled designs, which are relevant in trials assessing short-term or episodic symptom patterns in adults diagnosed with IBS. Studies examined patient-reported outcomes describing perceived discomfort, such as abdominal pain and bloating, and monitored scores reflecting daily functioning. Findings were mixed when Alverine monotherapy was evaluated against an inactive substance (placebo). Research describes changes measured during the study period, particularly when Alverine was evaluated as part of a combination product with other agents. Long-term effects are not fully established, as follow-up durations were limited, often to a few weeks.


Evidence for Use in Painful Diverticular Disease

The evidence base for Alverine citrate in painful diverticular disease of the colon includes studies observing responses over defined time intervals. Research explored outcomes related to physical discomfort and systemic or functional imbalance. The evidence base includes older controlled trials and a larger body of uncontrolled studies. Studies monitored certain physiological measures, with some tracking changes in internal gut pressure. This area of research has significant limitations, and the evidence quality varies across studies, meaning certainty remains low. The results apply only to the populations studied.


Evidence for Use in Primary Dysmenorrhoea

The research exploring Alverine citrate for primary dysmenorrhoea (menstrual pain) was evaluated in research exploring short-term symptom changes associated with acute or disruptive episodes. The use was studied for outcomes related to physical discomfort and outcomes capturing phases of heightened symptom activity. The regulatory inclusion of this indication is acknowledged, and studies monitored outcomes related to physical discomfort. For this specific indication, the evidence is limited and certainty remains low. The research primarily provides insight into short-term changes, and the follow-up durations were limited.


Research Gaps and Uncertainty

Research describes what is known — and what is still uncertain — about Alverine citrate. One key gap is the inconsistency observed in findings from older trials of Alverine used alone (monotherapy). Comparative evidence is lacking against other modern standard therapies. Across all indications, follow-up durations were limited, and there is limited information for long-term outcomes. Data for certain groups remain insufficient, and research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Spasmonal (FAQ)


Q: Can Spasmonal be used for stomach cramps not related to IBS?

A: The medicine is approved for the relief of smooth muscle spasms related to Irritable Bowel Syndrome, painful diverticular disease, and painful periods (primary dysmenorrhoea).

It is classified as a spasmolytic, meaning it works by relaxing the smooth muscles in the gut and uterus. Use for other specific types of stomach cramps is not addressed in the official indications.


Q: Can I drink alcohol while taking Spasmonal?

A: According to official product information, no specific interactions with alcohol are explicitly documented.

However, because this medicine may have effects on the nervous system, general caution is noted regarding substances that may affect the central nervous system.


Q: Does Spasmonal interact with pain medications like Paracetamol or Ibuprofen?

A: Official regulatory documents generally state that no specific medicinal interactions with common oral painkillers are explicitly documented.

The medicine is a smooth muscle relaxant, and its effect on gut movement may change how quickly or how much of other oral medicines are absorbed. To mitigate potential alteration of absorption, regulatory guidance advises considering a separation of administration.


Q: Can I take Spasmonal if I am already taking another antispasmodic?

A: Official regulatory documents do not list any specific antispasmodic medicinal products as prohibited combinations. The drug is classified as a spasmolytic that specifically targets the smooth muscle of the digestive system.


Q: How quickly should a patient expect to feel relief after taking a capsule of Spasmonal?

A: According to some official product information, the onset of action is generally described as occurring within 30 to 60 minutes after taking the capsule.

The concentration of the active substance in the body typically peaks around 1 to 1.5 hours after oral administration.


Q: What should I do if my symptoms do not improve after starting Spasmonal?

A: Official regulatory guidance advises a medical consultation if symptoms worsen or do not show any improvement after a period of two weeks of treatment. This review is intended to assess the continuation of use.


Q: What is the main difference between Spasmonal and a generic Alverine citrate capsule?

A: Generic Alverine citrate capsules contain the identical active ingredient in the same strength as the Spasmonal brand. Generic medicines are generally expected to be bioequivalent to the branded product under regulatory standards.

The typical differences are related to cost, packaging, and the type of inactive ingredients (excipients) used in the formulation.


Q: Does Spasmonal affect all muscles in the body, or only certain ones?

A: Official regulatory information indicates the medicine has a specific action on the smooth muscle of the gut and the uterus.

It is stated not to affect other muscle tissues such as the heart, blood vessels, or tracheal muscle when taken at approved therapeutic doses.


Q: Are there any known interactions with herbal supplements?

A: Official regulatory documents state no specific interactions with herbal supplements are documented in the prescribing information. This lack of documentation is consistent for food and non-medicinal products.


Q: Are there different brand names for Alverine citrate?

A: Yes, the active ingredient, Alverine citrate, is marketed under different brand names in various countries around the world. Spasmonal is one of several brand names for this medicine.


Q: What is the difference between an antispasmodic and a muscle relaxant?

A: Spasmonal is formally classified as an antispasmodic medicine, which is a class of drugs used to treat muscle spasms.

It is also described as a direct-acting smooth muscle relaxant because of its specific action on the muscle fibers of the alimentary tract and uterus. The terms are used in official texts to describe the drug's classification and its direct action on muscle fibers.


Q: What is the main active metabolite of Alverine citrate?

A: Pharmacokinetic information describes the process by which the body changes the active ingredient. The primary active component created during this metabolic process is stated to be a substance called 4-hydroxyalverine.


Q: Does Spasmonal cause drowsiness or make you tired?

A: Official safety information lists dizziness as a possible adverse effect on the nervous system.

Due to this possibility, users are advised not to drive or operate machinery if they find themselves affected.


Q: Can people with severe constipation use Spasmonal?

A: Constipation is a common symptom of Irritable Bowel Syndrome, which is an approved use of this medicine.

However, official safety documentation states that the medicine is contraindicated in patients with intestinal obstruction or paralytic ileus.


Q: How long does the effect of one dose of Spasmonal typically last?

A: The intended effect of a single dose is reported in some official sources to continue for approximately 3 to 4 hours.

The way the body processes the medicine is reflected in the half-life of the active substance, which averages around 5.7 hours.

How should Spasmonal be stored and disposed of?

How to Store and Dispose of Spasmonal (Alverine Citrate)

The storage and disposal of Spasmonal capsules must comply strictly with the requirements set out in official regulatory labeling to ensure product stability and safety.

Storage Requirement Official Condition
Temperature Do not store above 25 C.
Protection Store in the original container to protect from light and keep in a dry place.
Child Safety Keep all medicines out of the sight and reach of children.
Shelf-Life Do not use after the expiry date (EXP) stated on the packaging.

For disposal, the medicine must not be thrown away via wastewater or household waste. You are required to ask a pharmacist for instructions on how to properly discard unused or expired capsules. This measure helps protect the environment by ensuring appropriate pharmaceutical waste handling.

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

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