Hyospasmol

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Hyospasmol

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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 Hyospasmol

What is Hyospasmol and its Classification?

The medicine known commercially as Hyospasmol is defined by its active ingredient, Hyoscine Butylbromide (INN), which is classified as a peripherally acting antispasmodic drug. Mechanistically, it functions as an anticholinergic or antimuscarinic agent. Its core purpose is to alleviate the pain and discomfort resulting from the involuntary, often painful muscular spasms of internal organs, particularly within the gastrointestinal, biliary, and urinary tracts. This therapeutic effect is applied for the acute relief of abdominal cramping.

Composition, Forms, and Origin of Hyoscine Butylbromide

Hyoscine Butylbromide is a single-ingredient product, containing only the active substance and necessary excipients. This compound is characterized as a semisynthetic derivative, chemically produced by modifying the structure of scopolamine, a naturally occurring belladonna alkaloid. The medication is prepared in multiple dosage form(s), including oral tablets and liquid solutions for parenteral administration (injection). As an antispasmodic, its use is specifically for relaxing smooth muscle spasms.

How does the Anticholinergic Mechanism Define Hyospasmol?

The function of Hyoscine Butylbromide as an anticholinergic agent is key to its identity: it defines its action as blocking the nerve impulses, specifically those carried by the neurotransmitter acetylcholine, which trigger the contraction of smooth muscle. This action results in smooth muscle relaxation. This compound is a quaternary ammonium compound, a structural feature that makes it intentionally peripherally acting, which means its therapeutic effects are focused on the muscles of the internal organs while minimizing potential central nervous system impact.

Regulatory References

  1. NIH MedlinePlus on Hyoscine Butylbromide

What side effects are possible with Hyospasmol?

Possible Side Effects and Safety Information

The official safety profile for Hyospasmol (Hyoscine Butylbromide) is primarily defined by the anticholinergic properties of the medication and established regulatory classifications of adverse reactions.


Documented Adverse Reactions

The majority of documented effects are related to the medicine's mechanism and are categorized by frequency in regulatory documents. These are often classified under specific System-Organ Classes (SOC):

Classification Examples of Effects (SOC)
Uncommon Tachycardia (Cardiac), Dry mouth (Gastrointestinal), Dyshidrosis and Urticaria (Skin)
Rare Urinary retention (Renal and urinary disorders)
Not Known Anaphylaxis/Anaphylactic shock, Angioedema (Immune system disorders)

Serious adverse reactions, while rare and often classified as frequency Not Known (based on post-marketing reports), are officially documented. These include severe hypersensitivity reactions such as anaphylactic shock and angioedema. Following parenteral (injection) administration, there are specific regulatory warnings regarding the risk of serious events, including hypotension, particularly in patients with pre-existing cardiac disease.


Safety Restrictions and Limitations

The regulatory label mandates specific restrictions on use (contraindications) due to the potential to aggravate certain medical conditions:

  • Untreated narrow-angle glaucoma
  • Prostatic hypertrophy with urinary retention
  • Myasthenia gravis
  • Paralytic or obstructive ileus

The label also contains a specific duration-related safety note, advising that the medicine is not recommended for continuous daily use without a medical assessment to identify the cause of abdominal pain. Furthermore, patients may experience visual accommodation disturbances and should exercise caution when driving or operating machinery if affected.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the overdose profile for Hyoscine Butylbromide (Hyospasmol) based primarily on its known anticholinergic activity. Serious signs of poisoning have generally not been observed in humans; however, overdosage may present with the expected anticholinergic symptom cluster.

Documented Manifestations and Severe Outcomes

Classification Aspect Official Regulatory Statement
Documented Manifestations Symptoms include tachycardia (fast heart rate), urinary retention, dry mouth, reddening of the skin (flushing), and transient visual disturbances.
Severe Outcomes The most serious documented effects include respiratory paralysis and Cheynes-Stokes respiration. Severe neurological effects, such as coma or hallucinations, have also been reported.
Population Note Geriatric patients may exhibit an increased susceptibility to anticholinergic side effects like confusion and urinary retention.

Regulator-Mandated Emergency Actions

Seek immediate medical attention for any suspected overdose or if severe, unexplained abdominal pain persists, particularly when accompanied by fever, vomiting, or fainting.

Regulatory documentation describes management procedures for overdosage, including the use of parasympathomimetics to treat symptoms. For oral poisoning, gastric lavage with activated charcoal and follow-up with magnesium sulfate is described. Intubation and artificial respiration are official considerations in cases of respiratory paralysis.

Therapeutic Uses of Hyospasmol

What Hyospasmol Treats: Main Uses and Benefits

Hyospasmol, the brand name for hyoscine butylbromide, is generally categorized as an antispasmodic medication. Its primary therapeutic domains are used in areas where short-term symptom management is appropriate and are considered relevant for easing symptoms related to physical discomfort and symptoms that create noticeable physiological strain.

The medication is commonly used to help with stomach cramps and to relieve symptom clusters that may become intense or disruptive, such as those linked to Irritable Bowel Syndrome (IBS). This therapeutic area is relevant for managing symptoms that become more disruptive during flare-ups and is commonly used to help with symptoms linked to organ-specific functional stress. It is applied in scenarios where additional management of discomfort is required in areas presenting with systemic or localized discomfort, focusing on episodic manifestations that create physiological strain.

It provides support that helps ease the overall symptom burden, particularly during conditions characterized by periods of heightened symptoms or episodic or fluctuating manifestations of discomfort. Hyospasmol may assist with maintaining functional stability and contributes to improved comfort when groups of symptoms appear suddenly or fluctuate.

“The support offered may help patients cope more steadily with symptom fluctuations.”

Quick Fact: Relevant for easing symptoms associated with acute or episodic changes

Eligibility and Restrictions for Use

The eligibility for using Hyospasmol (Hyoscine Butylbromide) is strictly defined by regulatory documents, particularly concerning existing medical conditions and age. Use is generally permitted for adults and children aged 6 years and older.

Contraindications: Who Must Not Use Hyospasmol

Official regulatory labeling classifies several conditions as absolute contraindications, meaning the medicine must not be used:

  • Obstructive Conditions: Patients with paralytic or obstructive ileus, mechanical stenosis of the gastrointestinal tract, megacolon, or prostatic hypertrophy with urinary retention.
  • Neuromuscular/Ocular: Individuals with myasthenia gravis or untreated narrow angle glaucoma.
  • Allergy: Known hypersensitivity to the active ingredient or excipients.

Use Restrictions and Special Populations

Population/Condition Regulatory Status
Children Under 6 Years Not recommended (safety/efficacy not established).
Pregnancy and Lactation Not recommended (precautionary measure due to limited data).
Tachycardia Use with caution (potential to increase heart rate).
Excipient Intolerance Contraindicated in patients with certain rare metabolic disorders, such as hereditary fructose intolerance (oral tablets only).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Hyospasmol (hyoscine butylbromide) can interact with other medicines, primarily due to its anticholinergic or antimuscarinic properties. These interactions can enhance the effects of Hyospasmol, potentially leading to increased side effects, or can alter the absorption of other medicines.

Key Interaction Categories:

Category Mechanism and Affected Medicines
Anticholinergic Agents Concurrent use with other antimuscarinic medicines enhances the overall effect, increasing the risk of side effects like dry mouth, blurred vision, and urinary retention. This includes certain tricyclic antidepressants, antihistamines, amantadine (used for Parkinson’s disease), phenothiazines, and butyrophenones.
Gastrointestinal Motility Agents Hyospasmol reduces the movement (motility) of the stomach and intestines. This may alter the rate and extent of absorption of other orally administered medicines (a pharmacokinetic interaction).
Central Nervous System Depressants The sedative effect of Hyospasmol may be enhanced by the use of alcohol or other central nervous system depressants.

Patients should inform a healthcare professional of all medicines, supplements, and herbal products currently being taken before starting treatment with Hyospasmol.

Mechanism of Action

Hyospasmol, containing hyoscine butylbromide, is a peripheral anticholinergic agent. Its principal biological targets are the muscarinic acetylcholine receptors ( mAChR), primarily the M3 subtype, located on the smooth muscle cells within the walls of the gastrointestinal (GI) tract and the intramural parasympathetic ganglia.

At the molecular level, hyoscine butylbromide functions as a competitive antagonist, binding to mAChRs. This interaction prevents the endogenous neurotransmitter acetylcholine ( ACh) from binding to and activating the receptor.

Downstream, the antagonism of mAChRs on smooth muscle cells inhibits the intracellular signaling cascade that normally leads to calcium release and subsequent muscle fiber contraction.

System-level physiological consequences involve a reduction in smooth muscle tone and peristaltic activity throughout the GI tract, specifically mitigating the excessive visceral contractility that characterizes spasm.

Dosage and Administration Information

Official Administration Guidelines for Hyospasmol

Hyospasmol, containing hyoscine butylbromide, is provided in two main dosage forms, each with distinct routes of administration and dosing patterns.


Administration Scope Oral Tablets (10 mg) Parenteral Solution (20 mg/mL)
Route of Administration Swallowed whole (Oral) Intravenous (slow IV), Intramuscular (IM), or Subcutaneous (SC)
Standard Adult Dose 10 mg to 20 mg per dose. 20 mg per dose (one ampoule).
Frequency/Timing Up to 3 to 5 times daily as needed. May be repeated after 30 minutes.
Maximum Daily Limit Up to 80 mg (for some indications). Strictly limited to 100 mg per day.
Contextual Rule May be taken regardless of food intake. IV injection must be performed slowly; solution may be diluted with glucose or 0.9% sodium chloride.
Duration Constraint Intended for short-term use and should not be taken continuously for extended periods (e.g., more than two weeks) without investigating the cause of symptoms.

Age-Group Administration Rules: The oral 10 mg tablet is generally used for children aged 6 to 11 years at a dose of 10 mg, three times daily. The injectable form is typically not recommended for the general pediatric population. No specific dose adjustment information for older adults is established.

Special Procedural Conditions: For patients receiving anticoagulant drugs, the intramuscular route is generally avoided, with preference given to the intravenous or subcutaneous routes, due to the risk of localized haematoma.

This framework describes the administration guidelines intended for proper use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Hyospasmol


Evidence for Functional Abdominal Cramping and Irritable Bowel Syndrome (IBS)

Research has explored measured outcomes for conditions characterized by fluctuating or episodic manifestations, such as functional abdominal cramping and Irritable Bowel Syndrome (IBS). These investigations primarily relied on Randomized Controlled Trials (RCTs) and supporting Systematic Reviews and Meta-analyses. The research explored outcomes related to physical discomfort, particularly examining how symptoms evolved in the observed populations, such as abdominal pain intensity and the frequency of cramping.

Research conducted during periods of increased symptom activity reported patterns involving short-term measurements of symptom change compared to a placebo. Findings describe patterns observed in the studies over intermediate durations of a few weeks. Regulatory documentation describes that the low systemic bioavailability following oral use is a structural constraint on the research base.

Evidence for Acute Spasm (Colic) in the Gastrointestinal, Biliary, and Renal Tracts

The evidence base for acute conditions associated with acute or disruptive episodes, such as renal colic and biliary colic, includes regulatory documentation summaries and controlled trials, often utilizing the injectable formulation. Studies monitored outcomes related to physical discomfort, including the use of rescue pain medication, within defined time intervals, such as 30 to 60 minutes after administration.

Research highlights the measurements of pain scores recorded during the short study period. However, findings were mixed when the treatment was evaluated in studies for specific acute clinical situations, such as pain related to acute gastroenteritis. Some trials observed no statistically significant difference in pain reduction compared to placebo in those specific populations.


Key Research Gaps and Uncertainties

Evidence exploring long-term symptom changes is limited, meaning long-term effects are not fully established. Data for certain groups, such as specific severity levels of IBS, remain insufficient, and results apply only to the populations studied. Furthermore, the low systemic bioavailability of the oral formulation is a notable limitation in the research profile. Subgroup findings for patients with specific clinical characteristics are uncertain, and the quality of evidence varies across studies.

Key Studies & References

  1. Buscopan 10 mg Coated Tablets - Summary of Product Characteristics (Oral Bioavailability/Absorption)
  2. BUSCOPAN Product Monograph (Injectable Acute Spasm Indications)

Frequently Asked Questions (FAQ)

Common questions about Hyospasmol (FAQ)


Q: How quickly can I expect Hyospasmol to start working?

Studies on the oral tablet formulation of Hyospasmol indicate that the highest concentrations of the active ingredient in the bloodstream are typically reached at approximately 2 hours after administration. This measurement reflects the time required for the concentration of the active ingredient to peak in the plasma.


Q: What are the most common side effects listed for Hyospasmol?

According to the official product information, Common side effects can include dry mouth, constipation, dizziness, and tachycardia (increased heart rate). A complete list of documented effects is available in the official regulatory safety information.


Q: Does Hyospasmol cause drowsiness or make you sleepy?

Because the medicine is designed to act peripherally, significant drowsiness is not a commonly reported central nervous system side effect. However, official information notes that common effects like dizziness and temporary visual issues are possible.


Q: Can older adults typically use Hyospasmol?

Clinical trials have included patients over 65 years old, and no specific adverse reactions unique to this age group have been reported. However, regulatory documents indicate that caution is advised for use in older adults, due to the general risks associated with anticholinergic medications.


Q: Are there any specific foods or drinks to avoid while taking Hyospasmol?

Official regulatory documents specifically state that the sedative effects of Hyospasmol may be enhanced by alcohol consumption. No specific restrictions are listed for avoiding any particular foods while taking the medication.


Q: Is Hyospasmol known to interact with herbal supplements?

Regulatory documents contain a general advisory note stating that the use of all medicines, supplements, and herbal products should be disclosed to a healthcare professional. This is a precaution due to the potential for additive anticholinergic effects or altered absorption.


Q: Are there different strengths of Hyospasmol tablets?

The active ingredient, hyoscine butylbromide, is commercially available as both 10 mg and 20 mg film-coated tablets for oral use. The active ingredient is available in these different strengths for oral use.


Q: Is there a generic version of Hyospasmol available?

The active ingredient is hyoscine butylbromide, which is registered under several generic trade names globally. This means that versions of the medicine may be sold under a different commercial name.


Q: Why do official prescribing documents list so many precautions for Hyospasmol?

Precautions are listed because the medicine's mechanism of action is as an anticholinergic agent. This mechanism can cause specific side effects, such as increasing heart rate or potentially causing difficulty passing urine, in susceptible patients.


Q: Does Hyospasmol cause constipation or diarrhea?

Official documentation lists constipation as a Common side effect associated with Hyospasmol. Diarrhea is not listed among the commonly reported adverse reactions in the official safety profile.


Q: Is it normal to feel a bit dizzy after taking Hyospasmol?

Dizziness is listed in official regulatory documents as a Common side effect. Patients are advised to exercise caution when engaging in activities like driving or operating machinery if they experience this effect.


Q: Why would a person need to use Hyospasmol before a medical procedure?

The injectable form of the medicine is officially indicated for use as a diagnostic aid in radiology. Its purpose in this context is to temporarily relax the smooth muscles of internal tracts (like the gastrointestinal or urinary tracts) to help achieve clearer images during a procedure.

How should Hyospasmol be stored and disposed of?

How to Store and Dispose of Hyospasmol?

This information is based on official government regulatory documents detailing the storage, handling, and disposal requirements for Hyoscine Butylbromide.

Storage Conditions

Formulation Temperature Requirement Additional Requirements
Tablets No special conditions required. Keep out of the sight and reach of children.
Syrup Store at or below 25 °C. Must be protected from light.
Injection (Unopened) No special conditions required. Shelf-life is typically 5 years.

Handling and Stability

Solution for Injection must be used immediately after opening the ampoule, and any unused portion must be discarded. Diluted solutions are typically chemically and physically stable for 24 hours at 25 C or 2-8 C. The Injection should be visually inspected before use, and only clear, particle-free solutions should be administered.

Disposal Instructions

Any unused or expired medicine, including tablets, must not be thrown away via wastewater or household waste. Disposal must be done in accordance with local requirements to protect the environment.

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

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