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Spasmoliv

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Spasmoliv

Spasmoliv_EN

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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 Spasmoliv

Spasmoliv is a specific type of medication used to relieve sudden, painful tightening of internal smooth muscles. It is fundamentally an antispasmodic agent and belongs to the anticholinergic pharmacological class. The product is defined by its single active ingredient, which is engineered for targeted action on the body's peripheral nervous system, a property clinically recognized for minimizing central nervous system effects.

Quick Facts

Property Description
Active Ingredient Hyoscine Butylbromide (Hyoscine-N-butylbromide)
Forms Tablets, Injection Solution, Suppositories
Pharmacological Class Antispasmodic, Anticholinergic
Common Use Alleviation of visceral cramps
Origin Semi-synthetic derivative

Defining the Medicine and Its Pharmacological Class

Spasmoliv is a medication primarily classified as a spasmolytic, designed for the targeted relaxation of involuntary smooth muscle contractions. As an anticholinergic agent, its function is to block specific nerve signals that cause muscles in internal organs—such as the gastrointestinal, biliary, and urinary tracts—to contract excessively. The product is available globally under various trade names, reflecting the widespread use of this formulation.

The product's classification confirms its general therapeutic purpose: the direct and rapid relief of the pain caused by visceral cramps. Based on its core pharmacological identity, the drug is consistently classified as an antispasmodic agent across global drug databases.

Composition, Origin, and Therapeutic Purpose

The single active component in Spasmoliv is Hyoscine Butylbromide, a semi-synthetic derivative of the natural alkaloid scopolamine. It is chemically known as a quaternary ammonium compound. This structure is a design feature that prevents the molecule from easily crossing the blood-brain barrier, thereby focusing its antispasmodic effect primarily on the periphery.

This mechanism results in the drug's core benefit: selective smooth muscle relaxation to resolve painful cramping. Hyoscine Butylbromide is effective for relieving spasm in smooth muscle. This means the medicine is specifically helpful in easing the acute discomfort that accompanies a visceral event, such as an episode of sharp abdominal cramping. The medicine is available as film-coated tablets for oral intake and as injection solutions for rapid parenteral administration, offering flexibility in patient care pathways.

Regulatory References

  1. antispasmodic agent
  2. anticholinergic
  3. scopolamine

What side effects are possible with Spasmoliv?

Possible Side Effects and Safety Information

The safety profile for Spasmoliv (Hyoscine Butylbromide) is formally organized by regulatory authorities, focusing on potential adverse reactions and specific risks tied to its anticholinergic properties. All information is derived from official governmental regulatory documents.

Frequency-Classified Adverse Reactions

The most common adverse reactions reported are generally related to the medicine's primary action.

Classification Adverse Reaction
Uncommon (>1/1,000 to <1/100) Dry mouth, Increased heart rate (tachycardia), Dyshidrosis (abnormal sweating), Skin reactions (e.g., rash, pruritus)
Rare (>1/10,000 to <1/1,000) Urinary retention
Not Known (Frequency cannot be estimated) Anaphylactic shock, Anaphylactic reactions, Dyspnoea (shortness of breath)

Serious Adverse Reactions and Safety Restrictions

Serious adverse events include anaphylactic shock and other severe hypersensitivity reactions. The medicine is contraindicated (must not be used) in patients with specific pre-existing conditions where the drug's action could cause harm. These contraindications include:

  • Myasthenia gravis
  • Narrow-angle glaucoma
  • Mechanical stenosis or obstructive ileus in the gastrointestinal tract
  • Megacolon

Population and Duration Considerations

Use is not recommended during pregnancy or breastfeeding due to a lack of sufficient safety data in these populations. The medication is not intended for continuous daily use or for extended periods without a medical investigation to determine the cause of the underlying abdominal symptoms.

Overdose and Emergency Response

Overdose and When to Seek Help

The official documentation for Spasmoliv (Hyoscine Butylbromide) overdose describes clinical manifestations related to anticholinergic toxicity. Documented signs and symptoms include tachycardia (fast heart rate), dry mouth, reddening of the skin, urinary retention, and transient visual disturbances (accommodation disorders). In cases of severe or toxic doses, central nervous system effects such as restlessness, confusion, or hallucinations may be observed.

Immediate Emergency Actions

Regulatory authorities mandate that immediate medical attention be sought or that individuals go to a hospital straight away in the event of suspected overdosage. The need for urgent medical advice is also required if unexplained pain persists, worsens, or occurs alongside severe symptoms like fever, vomiting, or blood in stool. Severe intoxication carries the risk of life-threatening outcomes, including respiratory paralysis and circulatory failure.

Management and Specific Measures

The treatment approach for Spasmoliv overdose is officially defined as symptomatic and supportive. The regulatory information notes that overdosage symptoms are known to respond to parasympathomimetics (such as Neostigmine). Specific interventions may include gastric lavage and the use of activated charcoal for oral poisoning. Hospital monitoring is required, and specialized procedures like intubation for respiratory complications or catheterisation for urinary retention may be necessary.

Therapeutic Uses of Spasmoliv

What Spasmoliv Treats: Main Uses and Benefits

Spasmoliv is applied across therapeutic areas where additional symptomatic support is needed in situations involving certain distressing symptoms. The medication's role is in managing symptoms related to heightened physiological activity, and it is commonly used to help with such symptoms in several key domains.

This medication is generally used to address symptom clusters that may become intense or disruptive, specifically cramping and painful spasms originating in the stomach and intestines. It is relevant in conditions characterized by periods of heightened symptoms, such as Irritable Bowel Syndrome (IBS), where it contributes to easing the overall symptom load of functional GI disorders. These applications are also relevant in conditions involving episodic or fluctuating manifestations, such as renal colic and biliary colic.

The therapeutic benefit focuses on managing symptoms that become acutely disruptive. It supports patients during difficult episodes by easing the associated discomfort. It is commonly used to help with symptoms related to muscle tension, such as relieving menstrual cramps or when short-term assistance is needed during certain diagnostic procedures (like endoscopy).

“The primary benefit is offering supportive relief that helps ease the overall symptom burden.”

Quick Fact: Relief for Symptoms of Physical Discomfort The medication is generally used to help with symptoms related to physical discomfort associated with conditions affecting the gastrointestinal, genito-urinary, and biliary tracts.

Regulatory References

  1. Health Canada Product Monograph

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Spasmoliv? — Official Regulatory Information

The following information is strictly based on governmental regulatory documents regarding population eligibility.

Populations for Whom Use is Prohibited (Contraindicated)

Spasmoliv must not be used by patients who have documented hypersensitivity to its active substance (Hyoscine Butylbromide) or any excipients. Use is also formally prohibited in patients with certain pre-existing conditions:

  • Myasthenia gravis (a muscle weakness disorder)
  • Narrow-angle glaucoma
  • Megacolon
  • Paralytic or obstructive ileus (bowel obstruction)
  • Mechanical stenosis in the gastrointestinal tract
  • Rare hereditary problems of galactose/fructose intolerance, total lactase deficiency, or glucose-galactose malabsorption (due to excipients).

Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory)
Children under 6 years Not recommended (safety not established)
Pregnancy Use is not recommended (limited human data)
Breastfeeding Use is not recommended (insufficient data)

Restricted Use and Special Consideration

Use requires special caution and medical review in patients with conditions predisposing them to tachycardia (rapid heart rate) or those at risk of intestinal and/or urinary tract obstructions.

What should I know about interactions with other medicines?

Spasmoliv Interactions with other medicines and products

Official regulatory information regarding Spasmoliv (Hyoscine Butylbromide) interactions is primarily focused on pharmacodynamic reinforcement of its anticholinergic properties and certain administration-related constraints.

Documented Pharmacodynamic Interactions

Several medicine classes are documented in regulatory labels as potentially intensifying the anticholinergic effects of Spasmoliv. These combinations may lead to additive effects and include:

  • Antidepressants: Specifically tri- and tetracyclic agents.
  • Antihistamines: Certain H-1 antagonists.
  • Antipsychotics: Such as phenothiazines and butyrophenones.
  • Antiarrhythmics: Including quinidine and disopyramide.
  • Other Anticholinergics: Compounds like ipratropium or tiotropium.

Additionally, combining Spasmoliv with beta-adrenergic agents may enhance the tachycardic effects. Dopamine antagonists, such as metoclopramide, may result in a diminution of the effects of both medicines on the gastrointestinal tract due to opposing actions on motility.

Administration and Absorption Constraints

Regulatory documents establish the following restrictions:

  • Route-Specific Contraindication: The intramuscular (IM) injection of Spasmoliv is contraindicated in patients receiving concurrent anticoagulant drugs due to the officially documented risk of intramuscular haematoma formation.
  • Timing Requirement: Substances that interfere with absorption, such as antacids or adsorbent antidiarrheals, should be administered at least one hour before Spasmoliv to avoid a reduction in its absorption.

Interactions with food or herbal products are generally not formally established in official prescribing information. Regulatory text advises that alcohol should be avoided as it may increase the chance of side effects such as drowsiness.

Mechanism of Action

Blocking Muscarinic Receptors in the Viscera

Spasmoliv, containing Hyoscine N-Butylbromide, functions as a competitive antagonist at the muscarinic acetylcholine receptors ( M1, M2, M3) located on the smooth muscle cells and nerve ganglia of the gastrointestinal and genito-urinary tracts. This molecular interaction directly blocks the excitatory signals propagated by the neurotransmitter acetylcholine within the parasympathetic nervous system.

Peripheral Regulation and Cascade

The drug is a quaternary ammonium compound, restricting its activity to the peripheral nervous system without crossing the blood-brain barrier. This ensures its action is focused on the visceral tissues. The receptor blockade interrupts the excitation-contraction coupling process within the muscle fibers. This suppression of uncoordinated electrical activity results in a predictable decrease in smooth muscle tone and motility throughout the viscera, leading to a localized spasmolytic physiological effect. This process limits the impact of dysregulated acetylcholine signaling, resulting in a reduction in muscular hypermotility.

Dosage and Administration Information

How to Use Spasmoliv: Official Administration Guidelines

This section outlines the procedures for administering Spasmoliv (Hyoscine Butylbromide), excluding all information regarding mechanism or therapeutic effects.

Administration Scope

Category Official Instruction
Route of administration Oral (tablets), Intravenous (IV), Intramuscular (IM), and Subcutaneous (SC) (injection solution).
Dosing schedule (Adults) Oral Dose: 10 mg to 20 mg per administration. Parenteral Starting Dose: 20 mg. Maximum Parenteral Daily Dose: 100 mg.
Timing in relation to meals Oral tablets can generally be taken with or without food.
Preparation requirements Tablets must be swallowed whole with water. The injection solution may be diluted with standard solutions like Sodium Chloride 0.9% or Glucose solutions.
Age-group administration rules Oral: Generally not recommended for children under 6 years of age. Injection: Generally not recommended for those under 12 years.
Missed-dose rules Information on handling missed doses is not consistently available and is therefore excluded.
Special procedural conditions IV Administration: Must be performed slowly. IM Administration: Must be avoided (contraindicated) in patients receiving anticoagulant therapy; IV or SC routes must be used instead.

Instruction Classifications (High-Level)

Category Classification
Administration method type Oral, Parenteral (IV, IM, SC)
Frequency pattern As-needed (injection), Multiple times per day (oral, up to 4 times daily)
Use-context constraints Strictly limited to short-term, symptomatic use; not authorized for continuous daily or extended periods without medical investigation.

Resulting Procedural Structure

Official step sequence:

  • Select the appropriate route and form (oral tablet or parenteral injection solution) based on the requirement for general management versus acute intervention.
  • Administer the specified dose (10 mg to 20 mg orally, 20 mg parenterally) at the defined frequency, ensuring the parenteral maximum daily dose is not exceeded.
  • For oral intake, the tablet must be swallowed whole. For intravenous use, the injection must be given slowly to comply with administration standards.

Connection to the overall use protocol: The official instructions define a clear protocol for administration, establishing approved routes, dose limits, and frequency patterns to ensure consistent delivery. The strict limits on continuous daily use and age-based restrictions frame the medicine as a short-term, acute intervention, rather than a general, long-term medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Spasmoliv (Hyoscine Butylbromide)

Evidence for Use in Acute Visceral Cramping and Abdominal Pain

Research has evaluated Spasmoliv in studies conducted during periods of increased symptom activity, specifically focusing on sudden, painful cramping in the abdomen. The primary evidence base includes Randomized Controlled Trials (RCTs), where the drug was studied against a placebo (an inactive substance) or against other active agents. These trials included adults experiencing pain from functional digestive issues and some studies also included children with non-specific colicky abdominal pain.

In these acute settings, researchers examined outcomes related to physical discomfort, often monitoring patient-reported experiences using pain intensity scales. Findings describe patterns observed in the studies over short time intervals, such as minutes to an hour, specifically noting the time that was measured for patient reports. The certainty of the evidence for this indication appears to be Moderate, as categorized in official research summaries.

Evidence for Use in Functional Gastrointestinal Conditions (e.g., IBS)

Research into Spasmoliv for conditions characterized by fluctuating or episodic manifestations, such as Irritable Bowel Syndrome (IBS), primarily consists of high-level reviews and Meta-analyses that pool data from multiple smaller trials. These reviews explore the medicine in adult patients diagnosed with IBS, examining outcomes related to daily functioning and patient-reported discomfort.

Follow-up durations were limited, typically focused on acute episodes. For this indication, the certainty remains low in some major clinical guidelines. This is often due to the heterogeneity (inconsistency) across the individual studies reviewed, meaning long-term effects are not fully established regarding the management of chronic IBS symptoms.

Research Gaps and Areas of Uncertainty

The evidence base for Spasmoliv contributes to the broader evidence landscape regarding symptom patterns in acute settings, but official research summaries note several areas where certainty remains low or where data are still emerging. The research limitations include the fact that follow-up durations were limited in many key trials. Furthermore, comparative evidence is lacking for many possible alternatives, and research provides context but not individual predictions about how any single person will respond.

Key Studies & References

  1. A Comprehensive Review of the Effects of Hyoscine Butylbromide in Childhood
  2. Summary of Product Characteristics (Hyoscine Butylbromide 10 mg film-coated tablets) – HPRA (Regulatory Document)

Frequently Asked Questions (FAQ)

Common questions about Spasmoliv (FAQ)

Q: How long does it take for Spasmoliv to start working after taking a tablet?

Studies and official product information indicate that the oral tablet formulation has a rapid onset. Effects observed in clinical studies have been noted starting as early as 15 minutes after administration. This rapid action is consistent with its intended use for the acute relief of sudden, painful cramps.

Q: What do I do if I accidentally miss a dose of my Spasmoliv tablets?

Official product information advises that if a dose is missed, the patient may take it as soon as they remember. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped, and the normal dosing schedule should be resumed. A double dose is advised against to compensate for a missed dose.

Q: Can I drink alcohol while I am taking Spasmoliv?

Regulatory documents state that patients should avoid drinking alcohol while taking this medicine. Avoiding alcohol may help to minimize the chance of experiencing certain anticholinergic side effects, such as drowsiness.

Q: Is Spasmoliv the same as buscopan?

Spasmoliv contains the active ingredient Hyoscine Butylbromide. Since both products contain the same active ingredient, they are categorized as having the same mechanism of action and intended use. This substance is the same active ingredient found in numerous products marketed globally under different trade names, including Buscopan.

Q: Where can I get the Spasmoliv injection from—do I need a prescription, or can I buy it over the counter?

The injection form of Spasmoliv is classified as a prescription-only medicine (POM) in many regions. This classification means its use and administration are restricted to a healthcare setting and it is not available for over-the-counter purchase.

How should Spasmoliv be stored and disposed of?

How to Store and Dispose of Spasmoliv (Hyoscine Butylbromide)

The storage and disposal of Spasmoliv must strictly follow official regulatory guidelines to maintain its stability and ensure safety.

Official Storage Requirements

  • Temperature and Protection: Store the medication below 30 C or 25 C, depending on the formulation. It must be kept in its original outer carton to protect it from light and moisture.
  • Prohibited Areas: Do not store the medicine in damp environments like the bathroom or near sinks, or in locations exposed to direct heat or sunlight.
  • Child Safety: It is mandatory to keep Spasmoliv out of the sight and reach of children at all times.

Disposal Instructions

  • Expiration: Do not use the product after the expiry date printed on the package.
  • Unused Product: The medicine must not be disposed of via household waste or wastewater.
  • Procedure: Dispose of the unused or expired product and waste material in accordance with local pharmaceutical waste requirements.

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

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