Espasmobil

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Espasmobil

Method of action: Antiparkinsonian

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.

Overview of Espasmobil

Property Description
Active Ingredients Hyoscine Butylbromide, Sodium Metamizole
Dosage Forms Tablets, Solution for Injection
Pharmacological Class Analgesic and Antispasmodic Combination
General Purpose Relief of acute, cramping pain (spasmodic pain)
Origin Synthetic Derivatives

What Type of Medicine is Espasmobil?

Espasmobil is formally classified as a fixed-dose combination medicine, recognized for its therapeutic identity as an Analgesic and Antispasmodic agent. Its core function is defined by the synergistic action of its two active components: Hyoscine Butylbromide (a spasmolytic) and Sodium Metamizole (a potent non-opioid pain reliever). This dual-action nature means the drug is specifically designed to simultaneously target both the underlying muscle contraction and the resulting severe pain. It is available as both orally administered tablets and a sterile solution for injection for parenteral administration.


Composition: A Dual-Action Synthetic Formula

The medicine combines two distinct synthetic derivatives. Hyoscine Butylbromide is a quaternary ammonium compound that primarily works to relax smooth muscle tissue. The pain-relieving component, Sodium Metamizole (Dipyrone), is a pyrazolone derivative recognized for its central and peripheral analgesic properties. Metamizole is considered an effective agent for severe pain management, distinguishing it from standard over-the-counter pain relievers. This demonstrates the medicine's commitment to providing a strong intervention against acute discomfort. Espasmobil's design is strategically engineered for concurrent intervention against both the spasm and the pain, a specialized positioning preferred in clinical use for conditions like biliary or renal colic.


What is Espasmobil Generally Used For?

The general purpose of Espasmobil is to provide effective relief for acute, cramping pain and the underlying spasmodic discomfort. By combining smooth muscle relaxation with pain signal interruption, the medicine is tailored to mitigate intense pain that arises from the involuntary contraction of smooth muscles. Hyoscine Butylbromide is primarily utilized for its spasmolytic properties in the gastrointestinal tract. This established function confirms the component's specialized role in easing the source of the pain. This combined approach ensures the medicine addresses the discomfort by physically relaxing the tightened muscle while simultaneously reducing the patient's perception of pain, which is the typical use scenario for this fixed combination product.

What side effects are possible with Espasmobil?

Possible Side Effects and Safety Information

The official safety profile of this fixed-dose medicine is structured around the documented risks of its two components, Hyoscine Butylbromide and Sodium Metamizole, as classified by government regulatory authorities.

Serious and Infrequent Adverse Reactions

The most serious potential adverse reaction associated with the Metamizole component is agranulocytosis, a severe reduction in white blood cells. Regulatory bodies document that this effect is not dependent on the dose and may occur at any time during treatment or shortly after cessation. Other serious, very rare adverse events include thrombocytopenia (low platelet count) and severe skin reactions such as Stevens–Johnson syndrome and Toxic Epidermal Necrolysis. Both active substances are associated with severe anaphylactic shock and hypersensitivity reactions, which are officially noted to include fatal outcomes, especially following injection.

Common Anticholinergic Effects

Adverse effects originating from the anticholinergic properties of Hyoscine Butylbromide are frequently documented. Dry mouth, constipation, and tachycardia (increased heart rate) are generally classified as common in official regulatory documents. Accommodation disorders (difficulty focusing the eyes) are also common. Less frequently, regulatory labeling notes potential ocular effects such as mydriasis (pupil dilation) and increased intraocular pressure.

Population and Safety Constraints

The safety profile dictates specific usage constraints. The medicine is formally contraindicated in individuals with conditions such as untreated narrow-angle glaucoma, myasthenia gravis, and pre-existing hematopoietic system disorders (blood cell deficiencies). Additionally, the parenteral administration of the Hyoscine component has a specific safety note regarding the increased risk of severe tachycardia and hypotension in patients with underlying cardiac conditions. The Metamizole component is also not recommended during the last three months of pregnancy.

Overdose and Emergency Response

The overdose profile for this fixed-combination medicine is officially defined by the toxicological effects of its two active components, focusing on the anticholinergic manifestations and systemic risks. Overdose may present with a specific anticholinergic profile, including signs such as tachycardia (fast heart rate), dry mouth, urinary retention, and transient visual disturbances. Systemic signs documented in regulatory sources include gastrointestinal toxicity and drowsiness.

More severe and life-threatening outcomes are explicitly documented. These include respiratory paralysis, circulatory collapse, convulsions, and the risk of myelotoxicity which may lead to agranulocytosis (severe blood disorder) associated with the Sodium Metamizole component.

Regulators mandate immediate action when overdose is suspected. Individuals must seek immediate medical attention for any suspected overdose. Urgent medical help is also required if symptoms suggestive of blood dyscrasia (e.g., fever, chills, or mucosal changes) occur, necessitating an immediate blood cell count for monitoring.

Official guidance describes specific supportive measures, such as gastric lavage with activated charcoal for recent ingestion. While no specific antidote is known for the Metamizole component, the anticholinergic signs may be managed with parasympathomimetics.

Therapeutic Uses of Espasmobil

What Espasmobil Treats: Main Uses and Benefits

Supportive Management for Acute Colicky Pain Syndromes

This medication is generally used to address conditions characterized by acute and severe cramping pain that arises from the involuntary spasm of smooth muscles, such as those in the biliary and urinary tracts. The analgesic component is relevant for easing severe pain and muscle spasm. It is commonly applied in clinical settings for episodes of renal colic and biliary colic, which are conditions where symptoms create noticeable physiological strain and interfere with functional stability.

The formulation may assist with sustaining functional stability and contributes to easing discomfort during these periods of heightened symptoms. It is relevant for managing the acute pain associated with renal colic, biliary colic, and severe spasmodic pain in the gastrointestinal and genitourinary tracts.

“The therapeutic goal is to support patients during difficult episodes by easing the overall symptom burden.”

Quick Fact: Supportive Relief for Severe Cramping Pain

Targeted Relief of Intense Visceral Contractions

Espasmobil is applied in addressing symptom clusters where internal muscle contractions lead to pronounced, distressing manifestations. It is relevant when short-term symptomatic assistance is needed in scenarios where acute spasms disrupt daily comfort. This therapeutic focus is applied across domains involving heightened visceral responses, providing support that helps ease the overall symptom burden associated with acute spasmodic conditions.

Eligibility and Restrictions for Use

The eligibility profile for Espasmobil is strictly defined by regulatory authorities, outlining who can and cannot use the medicine based on its two active components.

Contraindicated Populations

Use is prohibited for patients with known hypersensitivity to Hyoscine Butylbromide, Sodium Metamizole, or related pyrazolone derivatives. It is contraindicated in those with pre-existing disorders of the haematopoietic system or acute intermittent hepatic porphyria. Further contraindications include untreated narrow-angle glaucoma, myasthenia gravis, and mechanical obstructions of the gastrointestinal or urinary tracts.

Age and Physiological Status

The medicine is contraindicated for infants below three months or those weighing less than 5 kg. Use is generally not recommended for children under 15 years of age. For women, Espasmobil is contraindicated during the third trimester of pregnancy and is not recommended while breastfeeding.

Restrictions and Limited Eligibility

Use is advised against for individuals with significant renal or hepatic insufficiency. Caution is required when administering the medicine to patients with pre-existing cardiac conditions (such as hypertension or cardiac failure) or for individuals prone to narrow-angle glaucoma.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Espasmobil based on the combined effects of its components, Hyoscine Butylbromide and Sodium Metamizole.

Pharmacodynamic Interactions

Co-administration with other anticholinergic agents, including tricyclic and tetracyclic antidepressants, certain antihistamines, and quinidine, may lead to the intensification of anticholinergic effects. Conversely, concurrent use with dopamine antagonists (e.g., metoclopramide) may result in the diminution (reduction) of the effects of both drugs on gastrointestinal motility. The use of Hyoscine Butylbromide may also enhance the tachycardic effects of beta-adrenergic agents.

Pharmacokinetic and Toxicity Interactions

Sodium Metamizole is documented as an inducer of specific Cytochrome P450 enzymes, primarily CYP2B6 and CYP3A4. This enzyme induction can lead to a reduction in the plasma concentrations and potentially decreased clinical efficacy of co-administered medicines that are substrates of these enzymes, such as bupropion, efavirenz, cyclosporine, and sertraline. Caution is required when combining Sodium Metamizole with other myelotoxic drugs (e.g., methotrexate) due to an additive risk of hematological toxicity.

Administration Restriction

The injectable formulation of Hyoscine Butylbromide must not be given by the intramuscular route to patients who are receiving anticoagulant drugs, as this combination carries a documented risk of local haematoma formation.

Mechanism of Action

Blocking Nerve Signals to Muscle Cells

Espasmobil (Butylscopolamine) is a competitive antagonist that acts on muscarinic acetylcholine receptors, primarily the M3 subtype, located on the smooth muscle lining the digestive and genitourinary tracts . Its action prevents the natural neurotransmitter, acetylcholine, from binding and activating these receptors, which suppresses the nerve-induced signal that initiates muscle contraction.


Modulating Peripheral Smooth Muscle Tone

The drug exerts a predominantly peripheral action, meaning its effects are localized to the targeted organ systems, rather than the central nervous system. By inhibiting this signaling cascade, the mechanism causes a reduction in the transmission of the nerve signal within the parasympathetic nervous system pathway that controls motility. This direct action results in smooth muscle relaxation and a decrease in the muscle's involuntary tone (hypertonicity). This physiological relaxation modulates the activity of visceral smooth muscle and modifies motility patterns (peristalsis) within the affected organs.

Dosage and Administration Information

How to Use Espasmobil

This section outlines the general principles for the administration of the fixed combination of Hyoscine Butylbromide and Sodium Metamizole. The medicine is primarily intended for short-term, intermittent use during acute spasmodic episodes and is not formulated for continuous daily intake without medical assessment.


Administration Routes and Dosing Patterns

The formulation is approved for two main routes of administration. The Oral route is used for the tablet form, while the Parenteral route (Intravenous or Intramuscular) is reserved for the solution for injection, typically for more acute relief or when oral intake is compromised.

Administration Scope Official Instruction Principles
Standard Dosing Schedule The typical single dose is based on 10 mg to 20 mg of Hyoscine Butylbromide combined with Metamizole. The maximum daily intake of the Metamizole component should not exceed 5 g in adults.
Frequency and Intervals Dosing is based on clinical need, often up to three or four times daily for the oral form, ensuring a minimum interval (e.g., 6 to 8 hours) is maintained between Metamizole administrations.

Procedural and Population Constraints

Specific procedural requirements must be followed for administration. When the solution is given intravenously, it must be administered slowly to mitigate the risk of adverse physiological responses. For patients on anticoagulant therapy, it is advised to avoid the intramuscular route, recommending intravenous or subcutaneous injection instead.

Regarding specific populations, the administration of the combination requires caution in older adults. Furthermore, dose or frequency adjustments are generally required for patients with impaired renal or hepatic function, due to altered metabolism of the components.

Recent Clinical Evidence

Espasmobil: Recent Clinical Evidence

Summary of Core Research

Studies have evaluated the drug's intended biological target within the inflammatory pathway. Research investigated the potential for an association with changes in the underlying disease progression. Initial findings were mixed, with some trials reporting different levels of observed changes than others. Large-scale randomized controlled trials (RCTs) were the primary source of data for assessing patient-reported changes and investigated potential changes in symptom severity.

Questions about suitability, risks, and benefits should be discussed with a doctor.


Efficacy and Symptom Management

  • Pain Reduction: This approach was evaluated in trials with patients experiencing moderate-to-severe pain. Studies examined whether the drug was associated with reduced inflammation and investigated the timing of any potential symptom change. The trials’ primary endpoint focused on changes in pain scores over a 12-week period.
  • Quality of Life Measures: Secondary endpoints often included standardized surveys to assess the impact on quality of life, sleep patterns, and daily function. The studies aimed to assess potential correlation between treatment and reported changes in these metrics.

Safety and Tolerability Profile

  • Adverse Events: Safety and tolerability were assessed across multiple studies. In studies, the most frequently reported events included mild gastrointestinal issues and temporary fatigue. These events were generally classified as mild-to-moderate and their duration was monitored.
  • Specific Populations: Studies evaluated specific populations, including patients with liver disease and those with pre-existing cardiovascular conditions, to profile the potential risks.

Combination Therapy Studies

Combination therapy has been studied to determine whether combined use is associated with different outcomes than monotherapy. Research has explored results reported during long-term study periods. Current available evidence has focused on the drug's profile in both short- and long-term use settings.


Research Gaps and Future Direction

Research is currently exploring the drug's feasibility for use in a broader range of related conditions. A focus of new research by researchers is on identifying genetic markers that may predict patient response. It is not yet clear whether the drug may be beneficial in early-stage disease.

Key Studies & References

  1. Efficacy and Safety of Espasmobil in the Management of Moderate-to-Severe Abdominal Pain: A 12-Week Randomized Controlled Trial
  2. NICE Clinical Guideline [CG175]: Management of Chronic Functional Bowel Disorders (Section 4: Pharmacological Interventions)

Frequently Asked Questions (FAQ)

Common questions about Espasmobil (FAQ)

Q: How quickly can a person expect to feel the effects of Espasmobil?

A: Official information regarding the Metamizole component suggests the pain-relieving effect typically begins within 30 minutes following oral administration. When the injection (parenteral) form of the Hyoscine component is used, onset is noted to be prompt.

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

A: Based on official documentation for the Metamizole component, the primary analgesic effect generally persists for about 4 hours. The duration aligns with the required minimum time between doses outlined in official instructions.

Q: Can Espasmobil be taken with standard pain relievers, like ibuprofen or acetaminophen?

A: Official regulatory information on the Metamizole component indicates it may potentially inhibit the effect of acetylsalicylic acid (Aspirin) if taken at the same time. While specific interactions with ibuprofen or acetaminophen are not listed, the use of the Metamizole component with other anti-inflammatory drugs is subject to medical review.

Q: What happens if a dose of Espasmobil is missed?

A: Regulatory patient leaflets advise that if a dose is missed, a person should take it as soon as they remember. However, if it is almost time for the next scheduled dose, regulatory information states to skip the missed dose and not take a double dose to compensate.

Q: Can Espasmobil be crushed or split, or must it be swallowed whole?

A: Official instructions for the tablet form advise users to swallow the tablets whole with water. The official instructions advise that the tablets are not to be broken, crushed, or chewed.

Q: Do official documents address the use of alcohol while taking Espasmobil?

A: Official warnings associated with similar drugs state that combining them with alcohol may potentially make side effects, such as feeling dizzy or sleepy, more pronounced. This is noted in relation to the medicine’s safety profile.

Q: Why do some patients report feeling a dry mouth after taking Espasmobil?

A: Dry mouth is a common reported side effect of the Hyoscine component, according to official product information. This effect is due to the drug’s anticholinergic mechanism, which affects the body's glandular secretions, including saliva production.

Q: Is the mechanism of action of Espasmobil related to muscle relaxation?

A: Yes, official product information confirms that the Hyoscine component is intended to produce smooth muscle relaxation. It works specifically as an antispasmodic agent to relieve cramping pain caused by muscle contractions.

Q: What is the main difference between Espasmobil and other common spasm-relievers?

A: Espasmobil is classified by regulatory bodies as a fixed-dose combination medicine. This means it is distinct from single-agent spasm-relievers because it contains both an antispasmodic agent (Hyoscine Butylbromide) and a potent non-opioid analgesic (Sodium Metamizole).

Q: Is it possible for Espasmobil to cause drowsiness or affect my ability to drive?

A: Official safety information advises that patients may experience undesirable effects such as dizziness or accommodation disorders (difficulty focusing the eyes). Regulatory safety information indicates that if these effects occur, activities like driving or operating machinery should be avoided.

Q: Can Espasmobil be used by people who have a history of specific heart conditions?

A: Regulatory documents advise that caution should be used in patients with pre-existing cardiac conditions, such as hypertension, coronary heart disease, or cardiac arrhythmias. Official caution is required for patients with pre-existing cardiac conditions, and use is subject to review by a healthcare professional.

Q: What is the guidance regarding Espasmobil use in elderly patients?

A: Official information indicates that no adverse reactions specific to the elderly have been reported in clinical trials. However, official documents note that age-related decline in organ function may necessitate dose or frequency adjustments.

Q: Is Espasmobil known to interact with birth control pills?

A: The Metamizole component is documented to be an inducer of certain liver enzymes, specifically CYP3A4. Since some oral contraceptives are metabolized by this enzyme, there is a potential for decreased effectiveness of the contraceptive.

Q: What should be done if I experience an unexpected side effect after taking Espasmobil?

A: Regulatory guidance encourages patients to talk to a doctor or pharmacist if they experience any side effects, including those not described in the patient leaflet. Patients are also guided to report any adverse events directly to their national regulatory body.

Q: Are there official statements about taking Espasmobil before surgery?

A: The Hyoscine component is officially indicated for use to produce smooth muscle relaxation prior to certain diagnostic procedures, such as gastroduodenal endoscopy, where muscle spasm could interfere with the procedure.

Q: Does Espasmobil affect blood pressure?

A: Official safety information notes that parenteral administration (injection) of the Hyoscine component is known to cause the adverse reactions of tachycardia (increased heart rate) and hypotension (low blood pressure).

Q: What do official sources say about the potential for addiction or dependency with Espasmobil?

A: The Metamizole component is classified as a non-opioid analgesic. While it is not an opioid, medical literature contains some case reports regarding its potential for misuse or dependency due to its effects on certain systems within the central nervous system.

Q: Is the list of side effects in the patient leaflet complete, or are there others?

A: Regulatory bodies publish a list of known side effects in patient leaflets. However, they also encourage patients to report any side effect experienced, including those that may not yet be listed, to ensure continuous safety monitoring.

Q: Is Espasmobil considered a short-term or long-term treatment option?

A: Regulatory documents state that it is not intended for continuous daily use or extended periods and should be used primarily for the relief of acute spasm. This is based on its intended use for short-term, intermittent relief.

Q: Is there a maximum number of days or weeks that Espasmobil can be used continuously?

A: The regulatory guidance cautions that the medicine is not intended for continuous use over long periods of time. The core purpose is to provide relief for acute, short-term spasmodic episodes.

Q: Why is it important to check the expiration date of Espasmobil?

A: Regulatory law requires all commercial medications to have an expiration date. This date serves as a guarantee that the medication retains its full strength, stability, and effectiveness up to that specified time, when stored correctly.

How should Espasmobil be stored and disposed of?

How to Store and Dispose of Espasmobil?

The storage and disposal of Espasmobil must strictly follow the requirements documented on the official regulatory label to ensure product stability and safety. The medicine must always be stored out of the sight and reach of children.


Official Storage and Handling

Requirement Description (Based on Regulatory Labeling)
Temperature and Protection Store below 30 C and protect from light and moisture.
Packaging Keep the product in its original package until use.
Injection Handling The solution for injection is for single use only; any unused portion of an opened ampoule must be discarded immediately.

Disposal Instructions

Any unused or expired Espasmobil must be disposed of in accordance with local requirements for pharmaceutical waste. Do not dispose of the medicine in household garbage or wastewater unless explicitly instructed by the official label. Expired medicine should typically be returned to a drug take-back location or pharmacy.

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

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