Spasmopan

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Medically reviewed

Rosario Oropesa

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 Spasmopan

Property Description
Active Ingredient Hyoscine Butylbromide (Scopolamine Butylbromide)
Pharmacological Class Antispasmodic; Anticholinergic (Antimuscarinic)
Forms Film-coated tablets, Solution for injection, Suppositories
Common Use Relief from acute visceral spasms/cramps
Origin Semisynthetic derivative (of Hyoscine)

1. Defining Spasmopan: A Focused Antispasmodic Agent

Spasmopan is a recognized medicinal product centered on the active ingredient Hyoscine Butylbromide. Pharmacologically, it is classified as an anticholinergic drug and a powerful, peripherally acting antispasmodic agent. The compound is a semisynthetic derivative, chemically tailored from the naturally occurring belladonna alkaloid Hyoscine (Scopolamine). This specific chemical modification creates a highly polar structure that prevents the drug from easily crossing the blood-brain barrier, ensuring its therapeutic effect is concentrated locally on the smooth muscle of the abdominal and pelvic organs, a mechanism clinically recognized for its high specificity.

2. Composition and Forms: Delivery of the Single Active Ingredient

Spasmopan is a product dedicated to the delivery of the single active ingredient, Hyoscine Butylbromide, via several routes. The medicine is commonly available as film-coated tablets for oral ingestion, and as a sterile solution for injection in an aqueous vehicle. Its importance in medical settings is underscored by its inclusion in the WHO Model List of Essential Medicines. This global recognition confirms its established effectiveness and public health relevance in managing spasms, particularly in patients presenting with acute episodes of intestinal or renal colic. While Spasmopan is a common brand, other formulations containing the same active ingredient include Buscopan.

3. General Purpose: Targeted Relief from Visceral Spasms

The primary purpose of Spasmopan is to alleviate the discomfort and pain resulting from involuntary, hyperactive muscle contractions, such as acute cramps or colic. This effect is achieved because the agent works by blocking the nerve signals responsible for these spasms, leading to the relaxation of the smooth muscle tissue found in the gastrointestinal, biliary, and genito-urinary tracts. This targeted nerve signal interruption causes the walls of the internal organs to relax. Consequently, the general therapeutic contribution of Spasmopan is to restore normal muscle tone to the viscera, effectively addressing the underlying cause of spasmodic abdominal pain.

What side effects are possible with Spasmopan?

Possible side effects and safety information

Spasmopan (Hyoscine Butylbromide) has an official safety profile primarily defined by its anticholinergic properties, with adverse reactions categorized by frequency according to regulatory standards.

Documented Adverse Reactions

The most frequently classified adverse reactions are generally uncommon (may affect up to 1 in 100 people) and align with the drug’s effects on involuntary systems, encompassing the following System-Organ Classes:

  • Gastrointestinal Disorders: Dry mouth.
  • Cardiac Disorders: Tachycardia (increased heart rate).
  • Skin and Subcutaneous Tissue Disorders: Urticaria (hives), pruritus (itching), and dyshidrosis (abnormal sweating).
  • Renal and Urinary Disorders: Urinary retention (rarely documented, affecting up to 1 in 1,000 people).

Serious Safety Considerations

Serious adverse reactions are officially documented, though their frequency is classified as Not Known (cannot be estimated from available data). These include severe systemic reactions such as anaphylactic shock and other severe hypersensitivity reactions. The injectable formulation carries documented safety considerations, with reports of serious cardiac events (including cardiac arrest) noted, particularly in patients with pre-existing heart conditions.

Population-Specific Safety Notes

Official regulatory documents advise caution in specific patient groups. Use during pregnancy and lactation is generally not recommended due to limited safety data. The injectable form requires careful monitoring for patients with underlying cardiac disease due to the heightened risk of serious adverse effects. The oral form should not be used continuously or long-term without investigating the cause of the underlying abdominal pain.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Hyoscine Butylbromide (Spasmopan) is officially documented in regulatory sources as an intensification of its anticholinergic effects. The documented clinical manifestations generally include tachycardia (fast heart rate), dry mouth, difficulty passing urine (urinary retention), transient visual disturbances, and reddening of the skin (flushing).

Required Emergency Actions

The regulatory guidance mandates that patients seek immediate medical attention for any suspected overdose or if severe, unexplained abdominal pain persists or worsens, especially if accompanied by systemic symptoms like fever, vomiting, hypotension, or blood in stool.

Severe Outcomes and Management

Life-threatening outcomes cited in regulatory labeling include respiratory paralysis and reports of Cheynes-Stokes respiration. For the injectable form, there is a documented risk of serious adverse effects, including a fatal outcome in patients with underlying cardiac disease.

Overdose symptoms are known to respond to parasympathomimetics. Officially described supportive measures for management may include gastric lavage and activated charcoal for oral poisoning, and procedures like intubation for respiratory paralysis or catheterization for urinary retention, as required by the clinical presentation.

Therapeutic Uses of Spasmopan

Main Uses and Benefits of Spasmopan

Spasmopan is a combination medication designed to address various types of functional gastrointestinal and biliary disorders. Its primary purpose is to alleviate discomfort caused by muscle spasms in the internal organs.

Smooth Muscle Spasms

The medication is most frequently used to treat spasms of the smooth muscles in the digestive tract. These involuntary contractions can lead to significant discomfort, and Spasmopan works by helping these muscles relax. This makes it a common option for conditions involving:

  • Stomach and Intestinal Cramps: Relieving the localized pain associated with hypermotility in the digestive system.
  • Irritable Bowel Syndrome (IBS): Managing the spasmodic abdominal pain often associated with functional bowel disturbances.
  • Biliary Colic: Addressing spasms in the bile ducts which can cause intense pain in the upper abdomen.

Urinary and Renal System Relief

Beyond the digestive system, Spasmopan is utilized to treat spasms within the urinary tract. This includes:

  • Renal Colic: Alleviating the acute, severe pain caused by spasms in the ureters, often associated with the movement of kidney stones.
  • Tenesmus: Reducing the frequent, painful urge to urinate or defecate when caused by muscular spasms of the bladder or rectum.

Gynecological Applications

In certain clinical contexts, Spasmopan may be used to manage spasmodic pain related to the female reproductive system, specifically for relieving painful menstruation (dysmenorrhea) caused by uterine contractions.

Core Benefits

The primary benefit of this medication is its dual-action approach. By combining an antispasmodic agent with a mild analgesic, it targets both the underlying cause of the pain (the muscle contraction) and the perception of the pain itself. This integrated approach helps to restore normal functional movement to the affected organs and provides relief from acute cramping and colicky sensations.

Regulatory References

  1. FDA verification portal documentation

Eligibility and Restrictions for Use

Population Eligibility Rules for Spasmopan

Official regulatory documents define strict criteria for the use of Spasmopan (Hyoscine Butylbromide), centered on absolute prohibitions, age, and physiological status. The medicine is generally approved for use in adults and in children aged 6 years and over for oral tablet formulations.

Absolute Contraindications

Spasmopan is strictly contraindicated in patients with a diagnosis of Myasthenia Gravis and in those with mechanical obstructions of the gastrointestinal tract, such as Paralytic or Obstructive Ileus, or Megacolon. Use is also prohibited for patients with untreated narrow-angle glaucoma or urinary retention caused by conditions like prostatic hypertrophy. The injectable form is further contraindicated in patients with severe tachycardia or cardiac failure.

Age and Life Stage Restrictions

The medicine is not recommended for children under 6 years of age (oral tablets). Furthermore, use during pregnancy and lactation is officially not recommended due to insufficient data to exclude potential risk. Special caution is advised when the medicine is used in the elderly due to their increased susceptibility to anticholinergic effects.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Spasmopan (Hyoscine Butylbromide) based primarily on its core pharmacological class as a peripheral anticholinergic agent.


Pharmacodynamic and Exposure Interactions

Spasmopan must not be administered via intramuscular injection to patients receiving anticoagulant drugs, as this specific combination is classified as contraindicated due to the documented risk of intramuscular haematoma.

Co-administration with other anticholinergic agents—including certain tri- and tetracyclic antidepressants, antihistamines, and antipsychotics (e.g., phenothiazines)—may lead to an intensification of the anticholinergic effect. Conversely, combining the medicine with dopamine antagonists (such as metoclopramide) may result in the diminution of the effects of both drugs on the gastrointestinal tract. The tachycardic effects may also be enhanced when combined with beta-adrenergic agents.

As Spasmopan reduces gastrointestinal motility, the systemic absorption and pharmacologic effects of other oral medications may be delayed, a formally documented exposure-modifying interaction.

Substance and Population Notes

Alcohol may increase the chance of side effects such as drowsiness. Population-specific interaction notes indicate that the adverse reactions of tachycardia and hypotension associated with the parenteral form may be more severe in patients with underlying cardiac conditions.

Mechanism of Action

Spasmopan's active ingredient, hyoscine butylbromide, is classified as an antimuscarinic and anticholinergic agent. Its primary mechanism involves high-affinity binding as a competitive antagonist to muscarinic acetylcholine receptors, specifically those located on the smooth muscle cells within the gastrointestinal (GI) tract and the genitourinary system.

Acetylcholine is the key neurotransmitter of the parasympathetic nervous system that activates these receptors, leading to an influx of calcium and subsequent smooth muscle contraction. By blocking the binding site of acetylcholine, hyoscine butylbromide interrupts this signal transmission cascade.

This blockade prevents the acetylcholine-induced depolarization and activation of the smooth muscle cells. The intracellular consequence is a reduction in the resting muscle tone and amplitude of contraction. At a system level, this pharmacodynamic effect results in the relaxation of the visceral smooth muscle, which reduces hypermotility and spastic activity in the GI and urogenital tracts. Due to its quaternary ammonium structure, the drug is minimally absorbed systemically, localizing its antimuscarinic action primarily at the target tissues.

Dosage and Administration Information

How to Use Spasmopan (Hyoscine Butylbromide) — Administration Guidelines

Spasmopan (Hyoscine Butylbromide) is used according to specific administration protocols to manage acute spasms. Its usage is categorized by route, standardized dose ranges, and duration constraints.


Administration and Dosing Protocols

The medicine is administered through oral and parenteral routes. Oral use is typically for non-acute scenarios, while the parenteral form (Intramuscular, Slow Intravenous, or Subcutaneous injection) is primarily reserved for severe, acute episodes, often in a supervised setting.

Administration Scope Instruction
Route of Administration Oral (tablets), Intramuscular (IM), Slow Intravenous (IV), or Subcutaneous (SC) injection.
Standard Adult Dose Oral: 10 mg to 20 mg per dose. Parenteral: 20 mg to 40 mg per dose.
Maximum Daily Dose (Parenteral) Should not exceed 100 mg.
Frequency Pattern Oral: Up to three to four times daily. Parenteral: May be repeated after 30 minutes in acute settings.
Duration Constraint Intended for short-term use only and is not recommended for continuous daily use or prolonged treatment.

Procedural and Age-Group Rules

Oral Administration: Tablets must be swallowed whole with water. Specific timing in relation to meals is generally not a mandated condition.

Parenteral Administration: If administered intravenously, the injection must be given slowly. The solution may be diluted with standard solutions such as sodium chloride 0.9% or dextrose. The IM route may be constrained in certain patient groups, directing use toward the IV or SC routes.

Pediatric Dosing: For children (6–12 years), the oral dose is typically 10 mg up to three times daily. Specific weight-based parenteral dosing (0.3 mg/kg to 0.6 mg/kg) is utilized for severe cases. The overall use protocol is structured by these dose limits, repetition intervals, and short-term duration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Spasmopan


Evidence for Use in Abdominal and Gastrointestinal Spasms

Research has examined Spasmopan in studies of conditions characterized by fluctuating or episodic manifestations in the digestive tract, such as Irritable Bowel Syndrome (IBS). The types of studies was evaluated in include randomized controlled trials and applied in research contexts involving fluctuating or unstable symptoms in daily life.

These studies examined outcomes related to physical discomfort, particularly changes in abdominal cramping and pain intensity. While findings describe patterns observed in the studies that suggest an association, study results reflect the specific conditions under which they were conducted.


Evidence for Use in Genitourinary Spasms

Spasmopan was studied for conditions involving periods of heightened symptoms in the urinary and genital systems, often relevant in trials assessing short-term or episodic symptom patterns. Research in this area typically monitored patient-reported outcomes describing perceived discomfort related to spasms and cramps. The available research describes patterns related to outcomes describing episodic or acute changes in these spasms.


Evidence for Use in Painful Menstruation (Dysmenorrhea)

Studies evaluated Spasmopan in painful menstruation, a condition marked by functional limitations. Research explored changes in the intensity of menstrual cramping, which are considered outcomes capturing phases of heightened symptom activity. Research has shown patterns related to these outcomes, but sample sizes were modest in some key studies, which means results apply only to the populations studied.


Long-term Studies and Follow-up

Research has explored the effects of Spasmopan beyond short-term use, but follow-up durations were limited in many cases. The long-term effects are not fully established, and there is limited information for long-term outcomes that fully established research on the durability of effects. Research is ongoing to provide a more complete picture of the long-term context.


Evidence in Special Populations

Spasmopan was evaluated in some studies that included people outside the general adult population. Evidence regarding children and older adults has been observed in some studies, but subgroup findings are uncertain, and data for certain groups remain insufficient.


What is Still Uncertain About Spasmopan

While Spasmopan was studied for various acute spasms, findings were mixed in certain study populations. The evidence highlights what is known — and what is still uncertain, particularly regarding the precise differences in response across various underlying spasm-related conditions. Comparative evidence is lacking for many alternative approaches, making it difficult to fully contextualize the current data.

Frequently Asked Questions (FAQ)

Common questions about Spasmopan (FAQ)


Q: Is Spasmopan considered an over-the-counter (OTC) or prescription-only medicine?

The availability of the medicine may vary across different regions. Regulatory summaries indicate that the medicine is sold globally as both a prescription drug and, in many countries, as an over-the-counter product, often available from behind the pharmacy counter.


Q: What specific type of pain is Spasmopan designed to relieve?

According to official product information, Spasmopan is indicated to provide relief from acute pain and involuntary muscle contractions, commonly known as visceral spasms or colic. This includes relief for spasms associated with the gastrointestinal, biliary, and genito-urinary tracts.


Q: How quickly should Spasmopan start working?

Official information suggests a relatively rapid onset of action after administration. For the oral tablet form, the therapeutic effects typically last for approximately four to six hours, which informs the recommended frequency for repeating a dose.


Q: Can you take Spasmopan for several days in a row?

Regulatory documents explicitly state that the medicine is intended for short-term use only. It also states that the medicine should not be used on a continuous daily basis or for extended periods without first investigating the cause of the underlying abdominal pain.


Q: Is feeling dizzy or drowsy a reported side effect of Spasmopan?

Official safety documents list dizziness as a common side effect of the medicine. Drowsiness is also a reported potential side effect, and this can be made more likely when the medicine is combined with certain other substances, such as alcohol.


Q: Can Spasmopan be taken with food or on an empty stomach?

Regulatory instructions state that the tablets should be swallowed whole with water. Official documents do not typically specify that the medicine must be taken at a particular time relative to meals, meaning specific timing relative to meals is generally not a required condition in the label.


Q: Can people with a history of cardiac conditions use Spasmopan?

Regulatory warnings indicate that the injectable form of Spasmopan should be used with caution and monitoring in patients with certain underlying cardiac diseases, such as cardiac failure or coronary heart disease. This is based on documented risks for serious adverse reactions in this population.


Q: Is Spasmopan the same as Buscopan or other antispasmodics?

The medicine Spasmopan contains the active ingredient hyoscine butylbromide. Official product information confirms that this same active ingredient is sold under various different brand names globally, including Buscopan.


Q: Does Spasmopan have known interactions with common herbal supplements?

While specific interactions are not widely documented for all products, consultation with a healthcare professional regarding the use of herbal remedies and supplements is suggested. This is especially important for supplements that may also cause side effects like drowsiness or dry mouth, as combining them may intensify these effects.


Q: Can Spasmopan affect the effectiveness of oral contraceptive pills?

According to official interaction databases and contraceptive guidelines, no interactions between the active ingredient (hyoscine butylbromide) and oral contraceptive pills are documented. Therefore, the drug is not described as interfering with the effectiveness of these contraceptives.


Q: Is Spasmopan safe for children?

Official regulatory information defines the approved patient population. The oral tablet form of the medicine is officially approved for use in children aged 6 years and over.


Q: Does Spasmopan affect the central nervous system (CNS)?

The chemical structure of Spasmopan is designed to minimally cross the blood-brain barrier. Because of this property, the medicine has a reduced occurrence of centrally mediated side effects.


Q: Can Spasmopan be taken with antacid products and if so, how far apart?

General regulatory principles indicate that the administration of antacids is typically separated from film-coated tablets. This is because antacids may affect the coating and consequently alter the drug's intended absorption.


Q: Does Spasmopan interfere with the absorption of other necessary medications?

Due to the reduction in gastrointestinal motility (movement), official documents describe that the systemic absorption and pharmacologic effects of other oral medications may be delayed.


Q: Do regulatory agencies provide a Medication Guide for Spasmopan?

Yes, regulatory agencies like the FDA, EMA, and Health Canada require and provide comprehensive documents for the medicine. These documents are known as the Summary of Product Characteristics (SmPC) or Product Monograph, which outline the drug's approved use, safety, and administration details.


Q: Is there a maximum number of days or weeks Spasmopan is typically recommended for continuous use?

While regulatory documents state the medicine is not recommended for continuous daily use and is intended for short-term use, they typically do not specify a fixed maximum duration in terms of days or weeks.


Q: Does Spasmopan carry a risk of blurred vision in older patients?

Official notes advise caution for older adults when using the medicine. This is because the elderly may be more sensitive to anticholinergic side effects such as dizziness and eye problems (including blurred vision) compared to the general adult population.

How should Spasmopan be stored and disposed of?

The storage and disposal instructions for Spasmopan (Hyoscine Butylbromide) are strictly defined by regulatory documents to ensure product stability.

Storage Requirements

Formulation Temperature and Protection Handling/Container Rule
Tablets Store at or below 30 C; keep in the original package to protect from moisture. Keep out of the sight and reach of children.
Injection Store below 30 C; keep in the outer carton to protect from light. Do not refrigerate or freeze. For single use only; discard any unused solution immediately.

All forms of Spasmopan must be stored out of the sight and reach of children.

Disposal Requirements

Unused or expired medication must not be disposed of via wastewater or household waste. Disposal must follow local regulations, often requiring return to a pharmacy. Used needles and syringes from the injection must be placed immediately in an FDA-cleared sharps disposal container.

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

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