Spasmolit

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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 Spasmolit

Property Description
Active ingredient Hyoscine Butylbromide (Butylscopolamine)
Forms Tablet, Solution for injection, Suppository
Pharmacological class Antispasmodic, Anticholinergic agent
Common purpose Relief from visceral smooth muscle spasms
Origin Semi-synthetic derivative

What is Spasmolit and What Class of Drug is it?

Spasmolit is a single-ingredient medicinal product categorized as an antispasmodic and an anticholinergic agent. Its core active compound is Hyoscine Butylbromide, a name sometimes substituted with Butylscopolamine.

This medicine is classified as a semi-synthetic derivative because its structure is chemically modified from the naturally occurring plant alkaloid, scopolamine. Hyoscine Butylbromide is a quaternary ammonium compound. This specific chemical structure is significant as it prevents the compound from readily crossing the blood-brain barrier, ensuring its primary therapeutic action is focused on the peripheral nervous system. This peripheral selectivity is a key differentiating feature from older anticholinergics.


Composition, Forms, and General Purpose

The active compound, Hyoscine Butylbromide, is made available in several distinct pharmaceutical formulations, including tablets for oral administration, solutions for injection (parenteral administration), and suppositories for rectal administration.

The availability of these multiple routes of administration allows the medicine to be delivered based on clinical need. The drug is used for easing the pain associated with smooth muscle spasms in conditions affecting the lower urinary tract and gastrointestinal tract. By relaxing the involuntary smooth muscles lining internal passages—such as those in the gastrointestinal tract, biliary tract, or urinary tract—Spasmolit addresses the physical cause of cramping. Its overall general purpose is to alleviate the intense discomfort and pain specifically associated with these visceral spasms, helping to restore normal muscular activity within the affected organs.

Regulatory References

  1. MedlinePlus

What side effects are possible with Spasmolit?

Possible Side Effects and Safety Information

The official documentation for Hyoscine Butylbromide (Spasmolit) details a safety profile consistent with its function as a peripheral anticholinergic agent. Potential adverse reactions are classified by frequency as published in regulatory documents, with most common effects relating to the drug's action outside the central nervous system.


Officially Classified Adverse Reactions

Adverse reactions are grouped by the affected System-Organ Class (SOC) and documented frequency:

  • Common Reactions (may affect up to 1 in 10 people):

    • Eye Disorders: Accommodation disorders (difficulty focusing).
    • Cardiac Disorders: Tachycardia (increased heart rate).
    • Gastrointestinal Disorders: Dry mouth, Constipation.
  • Uncommon Reactions (may affect up to 1 in 100 people):

    • Skin Disorders: Skin reactions (e.g., urticaria, pruritus), Dyshidrosis (abnormal sweating).
  • Frequency Not Known (Post-marketing experience):

    • Serious Reactions: Anaphylactic shock (including fatal cases), Anaphylactic reactions, Hypotension, and Urinary retention.

Special Safety Considerations

Serious Adverse Reactions such as anaphylactic shock and severe hypotension have been documented, particularly following the injectable form. Due to the risk of anticholinergic complications, the medicine is contraindicated in conditions like untreated narrow-angle glaucoma, Myasthenia Gravis, and Megacolon as listed in regulatory labeling.

Official prescribing information notes that use is not recommended during pregnancy and lactation due to limited data. Furthermore, continuous daily use of tablets is not advised without investigation into the cause of the abdominal pain, and patients experiencing visual disturbances or dizziness should avoid operating machinery.

Overdose and Emergency Response

Overdose and when to seek help

Overdose of Spasmolit (Hyoscine Butylbromide) is officially documented in regulatory labeling as presenting with characteristic anticholinergic symptoms. These manifestations include tachycardia (fast heart rate), urinary retention, dry mouth, reddening of the skin, inhibition of gastrointestinal motility, and transient visual disturbances. Very rare transient central nervous system effects, such as confusion or hallucinations, have also been reported following parenteral administration.

Severe Outcomes and Emergency Response

The official profile highlights the risk of severe outcomes, including Cheyne-Stokes respiration and the rare occurrence of anaphylactic shock or severe cardiac adverse reactions following injection. Immediate medical attention must be sought if severe, unexplained abdominal pain persists or worsens or occurs with symptoms such as fever, nausea, vomiting, decreased blood pressure, fainting, or blood in stool. Additionally, urgent ophthalmological advice is required if a painful, red eye with loss of vision develops.

Official Management and Monitoring

Regulatory guidance states that overdose symptoms respond to parasympathomimetics. Officially described supportive measures include considering gastric lavage for oral poisoning, catheterisation for urinary retention, and the use of intubation and artificial respiration in case of respiratory paralysis. Monitoring is specifically advised for patients with pre-existing cardiac conditions.

Therapeutic Uses of Spasmolit

What Spasmolit Treats: Main Uses and Benefits

Spasmolit is a prescription medication utilized to provide relief from spasms and associated symptoms affecting the smooth muscles within internal organs. Its primary applications focus on the gastrointestinal and genitourinary tracts.


Main Therapeutic Uses

Spasmolit is indicated for the management of conditions characterized by excessive or painful muscle contractions. Key uses include the treatment of abdominal pain and cramping related to Irritable Bowel Syndrome (IBS). By promoting smooth muscle relaxation, the medication helps to lessen the frequency and intensity of these distressing gastrointestinal symptoms.

The medication is also used in other circumstances involving visceral smooth muscle spasm, such as those that affect the urinary tract or biliary tract.

Therapeutic Benefits

The benefit of using Spasmolit is the targeted symptom relief it provides for discomfort caused by muscle spasms. For individuals with functional bowel disorders, this relief from pain and cramping can lead to an improvement in daily functioning and overall quality of life. The medication is part of a broader strategy for IBS treatment, often used in conjunction with other therapies.


Quick Facts: Spasmolit Treatments

Condition Treated Primary Symptom Relief
Irritable Bowel Syndrome (IBS) Abdominal pain and cramping
Gastrointestinal Spasm Discomfort and muscle contraction
Genitourinary/Biliary Spasm Pain and functional symptom relief

Eligibility and Restrictions for Use

Eligibility for Spasmolit (Hyoscine Butylbromide) is strictly defined by regulatory guidelines that outline populations permitted for use and those who are formally contraindicated. The medicine is absolutely contraindicated for patients with a known hypersensitivity to the drug, as well as those diagnosed with conditions such as myasthenia gravis, narrow-angle glaucoma, or megacolon. Use is also prohibited in cases of mechanical stenosis or paralytic/obstructive ileus in the gastrointestinal tract, and for individuals with prostatic hypertrophy leading to urinary retention.

Age and Life Stage

  • Pediatric Use: The oral formulation is not recommended for children under 6 years of age.
  • Pregnancy/Lactation: Use during pregnancy and breastfeeding is not recommended by regulators as a precautionary measure due to insufficient human data.

Conditional Restrictions

  • The injection form is contraindicated in patients with certain cardiac conditions like tachycardia or cardiac failure.
  • The intramuscular route is prohibited for patients on anticoagulant drugs.
  • Conditional use is required for patients with pyrexia (fever) and those susceptible to developing intestinal or urinary tract obstructions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The officially documented interaction profile for Spasmolit (Hyoscine Butylbromide) is based on its pharmacological class, and the constraints are governed by regulatory authority documentation.

Property Official Regulatory Information
Medicinal product categories with documented interactions: Agents with anticholinergic properties, Dopamine antagonists, Beta-adrenergic agents, Anticoagulant drugs, Antacids, Adsorbent anti-diarrheals.
Specific interacting medicines (if explicitly listed): Metoclopramide, Domperidone, Quinidine, Amantadine, Disopyramide.
Timing-based interaction rules: Oral formulations must be administered at least one hour before antacids or adsorbent anti-diarrheals to prevent reduced absorption.
Interaction-related restrictions: The intramuscular injection route is restricted in patients receiving anticoagulant drugs due to the risk of intramuscular hematoma [Source 2.3, 4.1].

Official Interaction Statements

  • Co-administration with other medicines possessing anticholinergic properties (e.g., tricyclic antidepressants, antihistamines, specific antipsychotics) may result in an intensification of the anticholinergic effects.
  • Treatment involving dopamine antagonists (e.g., metoclopramide or domperidone) may lead to a diminution of the effects of both drugs on the gastrointestinal tract.
  • The tachycardic effects of beta-adrenergic agents may be enhanced.
  • There are no specific CYP enzyme-mediated or P-glycoprotein transporter-based interactions documented in the official regulatory prescribing information.

The regulatory documentation defines the product’s interaction structure primarily through pharmacodynamic reinforcement with similar agents and counteraction with agents that affect gastrointestinal motility. The profile further establishes a specific procedural constraint by prohibiting the intramuscular route when anticoagulants are co-administered.

Mechanism of Action

Spasmolit: Understanding the Mechanism of Action

The action of Spasmolit involves the specific modulation of key neurotransmitter signaling pathways that govern smooth muscle activity. The primary function is centered on inhibiting the mechanism that triggers muscle contraction, resulting in smooth muscle relaxation.

Antagonizing Cholinergic Signaling

Spasmolit acts as a competitive blocker of muscarinic acetylcholine receptors ( M3 subtype) expressed on smooth muscle cells. By occupying the receptor site, the drug prevents the binding of the endogenous neurotransmitter, acetylcholine. This action suppresses the primary signal for contraction, leading to a reduction of smooth muscle tone in the target systems.

Modulating Intracellular Calcium Dynamics

The receptor blockade initiates a downstream cascade that influences cellular processes. Specifically, blocking M3 receptors effectively dampens the release of intracellular calcium ( Ca^2+) stores required for muscle contraction. This modification of the early molecular steps influences the effect of mediator activity and modifies the physiological processes governing the contractile state of the tissue.

Dosage and Administration Information

How to Use Hyoscine Butylbromide (Spasmolit)

Hyoscine Butylbromide is available in distinct pharmaceutical forms that define its method of administration. The medicine is used as an oral tablet (typically 10 mg or 20 mg) for routine management or as a solution for injection (20 mg/mL) for situations requiring rapid onset. The injectable solution may be administered via intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes, with the IV route requiring a slow injection rate.

The standard dosing regimen for oral use in adults and children over 12 years is 10 mg to 20 mg per dose, up to four times daily. The tablets must be swallowed whole with water and should not be broken, crushed, or chewed. For acute use scenarios, the standard parenteral dose is 20 mg, which may be repeated after 30 minutes, not to exceed a total maximum of 100 mg in one day.

Usage is subject to a constraint: the medicine should not be taken on a continuous daily basis or for extended periods without professional investigation of the underlying cause of the symptoms. For children aged 6 to 12 years, a lower 10 mg dose three times a day is generally observed, and oral tablets are not recommended for children under 6 years. Furthermore, a procedural instruction exists for the injectable form, prohibiting the IM route in patients on anticoagulant therapy; the SC or IV routes must be utilized in these instances. If an oral dose is missed, the procedure is to skip the forgotten dose and take the next dose at the scheduled time, without doubling the amount.

Recent Clinical Evidence

Evidence for Use in Gastrointestinal Cramping and Spasm

Research has examined measures of pain intensity and symptom change in short-term Randomized Controlled Trials (RCTs) involving adults with functional abdominal cramping and Irritable Bowel Syndrome (IBS). These studies monitored patient-reported outcomes describing perceived discomfort when compared against a placebo or other study agents. Findings describe patterns observed in the studies related to outcomes describing episodic or acute changes in pain following short-term use. However, for conditions characterized by fluctuating manifestations like IBS, evidence for overall management of global IBS symptoms across intermediate-term use scenarios was observed to be inconsistent across different systematic reviews.

Evidence for Colic and Medical Procedures

The injectable form has been explored in acute intervention studies focusing on adults presenting with renal colic or biliary colic, tracking outcomes like the time elapsed until pain reduction was reported. These studies focused on outcomes linked to inflammatory or irritative states. Separately, research has explored the drug's role in endoscopic and radiological procedures to measure quality of visualization and reduction of muscle movement. Studies documented observed changes in image clarity when Spasmolit was administered, though outcomes relating to overall procedural duration have varied across different types of routine endoscopy.

Duration, Special Populations, and Research Gaps

Research exploring short-term symptom changes is primarily relevant in trials assessing short-term or episodic symptom patterns over limited follow-up durations. Long-term effects are not fully established, and there is limited information regarding durability of response for chronic pain conditions. Studies have explored the use in children and adolescents, but research has not fully explored the populations of older adults or patients with complex comorbidities. The overall quality of evidence varies across studies, and comparative evidence against other agents remains limited, highlighting areas where research is ongoing.

Frequently Asked Questions (FAQ)

Common questions about Spasmolit (FAQ)


Q: What is the main difference between Spasmolit and other common medications used for spasms?

According to official product information, Spasmolit is a quaternary ammonium compound. Official documentation describes that this specific structure contributes to the drug acting primarily on the peripheral nervous system—the nerves and muscles outside the brain and spinal cord, such as those in the digestive tract. This focused action is what differentiates it from some other types of spasm medications.


Q: Can Spasmolit affect my ability to drive or operate machinery?

Regulatory documents note that the experience of side effects such as dizziness or accommodation disorders (difficulty focusing the eyes) may occur. If these effects are present, it is noted that caution should be used when driving or operating machinery.


Q: What should I know about the safety classification of Spasmolit for pregnant or breastfeeding individuals?

Use of the drug during pregnancy and breastfeeding is not recommended by regulatory bodies. Official product information notes this precautionary measure is due to limited human data and insufficient animal studies.


Q: What does official data say about the frequency of rare side effects of Spasmolit?

Serious adverse reactions have been observed following the drug's use, particularly the injectable form, including severe hypotension (decreased blood pressure) and anaphylactic shock. Official data classifies the frequency of these serious events as 'Not Known,' meaning their incidence cannot be reliably estimated from available clinical trial data.


Q: Why do some people report feeling tired when they take Spasmolit?

Tiredness or fatigue is not listed as a common reaction in official drug information. However, a common effect is dizziness. It is possible that this dizziness is related to a perceived feeling of tiredness.


Q: How long after stopping Spasmolit will it be fully out of my system?

Information on how the drug is cleared from the body is available in the official pharmacokinetics section. The terminal elimination half-life—the time it takes for half the drug to be eliminated—is described as ranging from approximately 6 to 11 hours.


Q: Can other medications make Spasmolit more effective, as described in drug labels?

Regulatory documents indicate that co-administration with other medicines that also possess anticholinergic properties may lead to an intensification of the drug's effects. Such medicines include certain tricyclic antidepressants or antihistamines.


Q: What happens to the body when the drug takes effect?

The drug is an antispasmodic that works by blocking muscarinic receptors in the body, primarily in the digestive and urinary tracts. This action leads to the relaxation of smooth muscle, which is intended to relieve painful spasms and cramping.


Q: Why do doctors prescribe Spasmolit for issues that don't seem like muscle spasms?

While the main use is to relieve visceral smooth muscle spasms, the injection form is also indicated for use in diagnostic procedures, such as endoscopy and radiology. In these settings, it is used to reduce muscle movement and aid in the visualization of internal organs.


Q: Does Spasmolit work right away, or does it take time to feel the effects?

The official product information indicates that the onset of action is generally considered to be relatively rapid. The quickest effects are typically achieved when the medicine is administered via the intravenous (IV) route.


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

The duration of the clinical effect for a single dose of the drug is noted to be approximately 4 to 6 hours.


Q: What are some very common or expected feelings people have when starting Spasmolit?

Official documentation lists common effects, which may affect up to 1 in 10 people. These include dry mouth, experiencing an increased heart rate (tachycardia), and noticing accommodation disorders (difficulty focusing).


Q: Is there a maximum time someone is advised to take Spasmolit according to official guidelines?

Regulatory warnings state that the oral tablets should not be taken on a continuous daily basis or for extended periods without a medical professional first investigating the underlying cause of the symptoms.


Q: Is Spasmolit safe for use in older adults (seniors)?

Regulatory documents state that no specific safety information for use in the elderly is available in the dedicated product sections. Clinical trials have included patients over 65 years, but no adverse reactions specific to this age group have been separately reported.


Q: How is Spasmolit eliminated from the body?

Based on official pharmacokinetic data, the majority of the substance is eliminated from the body via the faeces, with a small amount excreted in the urine.


Q: Are there specific age restrictions for using Spasmolit mentioned in regulatory documents?

Yes, official patient information leaflets state that the oral formulation of the drug is not recommended for use in children under 6 years of age.


Q: Does Spasmolit work on all types of muscle spasms?

The drug's action is described as relaxing the visceral smooth muscles. These are the involuntary muscles found in internal organs like the gastrointestinal tract, the biliary tract, and the genito-urinary tract.


Q: Is Spasmolit used to treat chronic conditions or only acute episodes?

The drug is indicated for symptomatic relief of conditions like Irritable Bowel Syndrome, which is a long-term condition. However, a specific warning notes that continuous daily use is not recommended without investigating the underlying cause of the pain.


Q: How does Spasmolit potentially affect blood pressure?

The drug can affect blood pressure; hypotension (decreased blood pressure) is listed as an adverse reaction of unknown frequency, particularly noted in connection with the injectable form. Additionally, tachycardia (increased heart rate) is a common side effect.


Q: Can I take other spasm-relieving medications while using Spasmolit?

Official documentation notes caution regarding concomitant use with other medications that have anticholinergic properties (which may include other spasm-relieving drugs). Combining such drugs can lead to an intensification of the anticholinergic effects of Spasmolit.

How should Spasmolit be stored and disposed of?

How to Store and Dispose of Spasmolit

Official regulatory documents define strict conditions for the storage and disposal of Spasmolit (Hyoscine Butylbromide).


Storage Requirements

Spasmolit tablets must be stored at a temperature not exceeding 30°C. The medicine must be protected from light and moisture; therefore, keep the blister in the outer carton. Like all medicines, it is mandatory to store Spasmolit out of the sight and reach of children.

Disposal Instructions

Unused or expired medicine must not be disposed of via wastewater (such as flushing down a toilet) or standard household waste. The official instruction is to return any unused medicine to a pharmacist for safe, environmentally compliant disposal.

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

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