Scopolan

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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 Scopolan

The section below provides a comprehensive overview of the pharmaceutical identity and core function of Scopolan, also known by its active substance, Hyoscine Butylbromide.


Quick Facts: Scopolan (Hyoscine Butylbromide)

Property Description
Active Ingredient Hyoscine Butylbromide (INN)
Pharmacological Class Antispasmodic Drug, Anticholinergic Agent
Forms Tablet, Injectable Solution, Rectal Suppository
Common Use Relief of cramping and smooth muscle spasms
Origin Semisynthetic derivative of the Tropane Alkaloid Scopolamine

What is Scopolan (Hyoscine Butylbromide) and What Class of Medicine is it?

Scopolan is a pharmaceutical preparation primarily containing the single active ingredient Hyoscine Butylbromide, and it is formally classified as an Antispasmodic Drug. This medicine belongs to the broader class of Anticholinergic Agents, specifically functioning as a muscarinic antagonist. The clinical benefit of this action is widely clinically recognized for providing relief when the hollow organs of the abdomen contract involuntarily.

Chemically, Hyoscine Butylbromide is synthesized as a semisynthetic derivative of the naturally occurring tropane alkaloid Scopolamine. However, it features a distinct chemical structure known as a quaternary ammonium compound. This specific molecular design is crucial because it makes the compound highly polar, intentionally preventing it from significantly crossing the Blood-Brain Barrier, which limits its activity primarily to the peripheral nervous system.


Forms and General Purpose of Scopolan

Scopolan is available for patient use in several common dosage form(s), including the tablet for oral administration, as well as an injectable solution for acute situations, and rectal suppository preparations. The general purpose of this medicine is to provide relief from cramping and colicky pain that originates from the tightening of smooth muscles in the abdominal, urinary, or biliary tracts.

The drug acts to relax the muscles of the gastrointestinal and genito-urinary tracts. The medicine provides relief from discomfort by effectively utilizing a powerful spasmolytic effect—its ability to relax these involuntary muscle walls, thereby alleviating the painful pressure they create. A typical use scenario involves sudden, severe abdominal pain resulting from an internal muscle spasm, where the drug works by directly blocking the signals that cause the contraction.

What side effects are possible with Scopolan?

Possible Side Effects and Safety Information: Scopolan (Hyoscine Butylbromide)

The safety profile of Hyoscine Butylbromide is primarily characterized by effects related to its anticholinergic pharmacological class, as documented in government regulatory labeling (e.g., SmPC, FDA). Adverse reactions are formally classified by frequency and grouped into specific System-Organ Classes.


Adverse Reaction Scope

Classification Frequency (Regulatory Terminology) System-Organ Class Involved
Expected Effects Common (up to 1 in 10) Eye Disorders (accommodation disorders), Cardiac Disorders (tachycardia), Gastrointestinal Disorders (dry mouth, constipation).
Less Common Effects Uncommon (up to 1 in 100) Skin and Subcutaneous Tissue Disorders (urticaria, pruritus), Renal and Urinary Disorders (urinary retention).
Serious Adverse Reactions Not Known (Post-Marketing) Immune System Disorders (anaphylactic shock, anaphylactic reactions), Vascular Disorders (hypotension).

Serious adverse reactions documented in regulatory sources include anaphylactic shock and severe hypotension, particularly following injection. Transient disturbances of accommodation (difficulty focusing) have been reported following parenteral administration.


Regulatory Safety Considerations

Population-Specific Safety Considerations: The medicine is contraindicated in conditions where its anticholinergic effect could pose a severe risk, including untreated narrow-angle glaucoma, prostatic hypertrophy with urinary retention, myasthenia gravis, and mechanical stenosis of the gastrointestinal tract. Use during pregnancy and lactation is generally not recommended due to limited data.

Safety-Related Restrictions or Limitations: Continuous daily use for extended periods is not recommended without investigating the underlying cause of abdominal pain. The injectable form should not be given intramuscularly to patients receiving anticoagulant drugs due to the risk of hematoma formation.

Context-of-Use Safety Notes: Patients predisposed to tachyarrhythmia or urinary outlet obstructions require caution due to the risk of exacerbating these conditions, as explicitly noted in the prescribing information.

Connection to the Overall Safety Profile

These safety classifications and restrictions formally define the boundaries of the medicine's risk profile, establishing which known adverse effects are likely and under what conditions the drug must be avoided. The structure ensures that users are informed about the spectrum of effects, from routine anticholinergic manifestations to life-threatening hypersensitivity events, based strictly on government-verified data.

Overdose and Emergency Response

The official regulatory description of a Scopolan (Hyoscine Butylbromide) overdose details an extreme exaggeration of the medicine's intended anticholinergic effects. The documented clinical presentation typically includes symptoms such as tachycardia (fast heart rate), pronounced dry mouth, urinary retention, and transient visual disturbances, including mydriasis. Other common manifestations include reddening of the skin and severe inhibition of gastrointestinal motility. Isolated post-marketing reports have also documented rare central nervous system effects such as confusion, agitation, and hallucinations following parenteral administration.

Overdosage can lead to severe or life-threatening outcomes, including respiratory paralysis and serious cardiovascular complications, sometimes presenting with Cheyne-Stokes respiration. Due to the potential for these severe issues, regulatory bodies mandate that patients must seek urgent medical attention and immediately inform medical staff in the event of suspected overdosage.

Officially documented initial supportive measures may include gastric lavage with activated charcoal. Severe systemic symptoms are known to respond to the administration of parasympathomimetics, such as Neostigmine, as documented in the label. Procedures such as intubation and artificial respiration may be necessary for managing respiratory paralysis, and catheterisation may be required to resolve urinary retention.

Therapeutic Uses of Scopolan

What Scopolan Treats: Main Uses and Benefits

Scopolan is primarily applied across therapeutic domains involving symptoms related to heightened physiological activity and smooth muscle tension. The medication is commonly used to help with spasmodic discomfort in conditions such as Irritable Bowel Syndrome (IBS), colic episodes (like renal and biliary colic), and painful menstrual cramps (primary dysmenorrhea). The medication may assist with supportive relief when symptoms interfere with routine activities.

The supportive role of this medication is relevant in clinical settings that involve acute or unstable symptom patterns, including those related to the genitourinary tract (bladder and ureters) and adjunctively during certain diagnostic imaging procedures. It helps address symptom clusters that may become intense or disruptive.

“The therapy plays a role in managing acute or disruptive episodes of visceral cramping.”

A key benefit is that it contributes to easing discomfort during periods of heightened symptoms, supporting patients during difficult episodes by easing distress.

Quick Fact: Relief for Smooth Muscle Spasms

Category Typical Use
Symptom Type Cramping and Colicky Pain
Primary Domains Gastrointestinal, Biliary, Genitourinary
Clinical Context Acute episodes and chronic flare-ups
Patient Benefit Supports a sense of stability and easing discomfort

Eligibility and Restrictions for Use

Official Regulatory Eligibility Profile for Scopolamine (Scopolan)

This section details the official eligibility and non-eligibility information as documented in government regulatory sources (e.g., FDA, EMA, Medsafe).


Contraindicated Populations (Must Not Use)

Scopolamine is strictly contraindicated and must not be used by individuals with the following conditions:

  • Angle-Closure Glaucoma (or a known predisposition).
  • Known Hypersensitivity or allergy to scopolamine, other belladonna alkaloids, or any component of the formulation.
  • Obstructive Gastrointestinal Diseases (e.g., paralytic ileus, pyloric obstruction).
  • Obstructive Uropathy (e.g., urinary bladder neck obstruction).

Populations Requiring Conditional Use (Caution)

Use of scopolamine requires caution and monitoring in the following groups due to increased risks or susceptibility to side effects:

  • Elderly Patients: Used with caution due to increased risk of Central Nervous System (CNS) side effects (e.g., confusion, hallucinations).
  • Patients with Hepatic or Renal Impairment: Caution is advised due to the potential for increased CNS effects.
  • Patients with Open-Angle Glaucoma: Requires caution and pressure monitoring.
  • Patients with Tachyarrhythmias or other cardiovascular conditions.
  • Pregnancy and Lactation: Use should be avoided in severe preeclampsia. Caution is necessary during breastfeeding, as the drug distributes into breast milk.

Age-Group Eligibility

  • Pediatric Population: The transdermal system is generally not recommended by major authorities as a safe and effective dose has not been established.

What should I know about interactions with other medicines?

Interactions with other medicines and products — Official Regulatory Information for Scopolan (Hyoscine Butylbromide)

This section summarizes information concerning interactions strictly based on official government regulatory documents.


Pharmacodynamic Interactions

The primary interaction profile of Hyoscine Butylbromide is rooted in its anticholinergic properties and is defined by pharmacodynamic effects.

  • Additive Anticholinergic Effects: Co-administration with other medicines possessing anticholinergic properties, such as tricyclic and tetracyclic antidepressants, certain antihistamines, quinidine, amantadine, and disopyramide, may lead to a potentiated overall anticholinergic burden.
  • Antagonism of Motility Agents: The therapeutic effects of dopamine antagonists (e.g., metoclopramide or domperidone) on gastrointestinal motility may be reduced by Hyoscine Butylbromide.
  • Cardiac Effects: The tachycardic effects (increased heart rate) associated with beta-adrenergic agents may be enhanced when combined with Hyoscine Butylbromide.

Procedural Interaction Constraints

Official labeling contains a specific constraint regarding the route of administration in certain patient groups:

Patient Condition Interaction-Related Constraint
Patients on Anticoagulant Drugs Intramuscular (IM) injection of Hyoscine Butylbromide is not to be used due to the risk of intramuscular hematoma. Subcutaneous (SC) or intravenous (IV) administration may be appropriate alternatives.

Pharmacokinetic and Other Interactions

Regulatory documents do not typically list specific interactions related to CYP450 enzymes, drug transporter systems (P-gp, OATP, BCRP), or required dose-timing separation with meals, alcohol, or herbal products for Hyoscine Butylbromide.

Mechanism of Action

The mechanism of action for Scopolan (Hyoscine butylbromide) centers on disrupting excessive cholinergic nerve signaling, resulting in the inhibition of smooth muscle contraction.

Primary Mechanism: Blocking Cholinergic Transmission

Scopolan's primary biological target is the muscarinic acetylcholine receptor (mAChR) located on peripheral smooth muscle cells. The drug acts as a competitive antagonist, binding to these receptors and blocking the action of the neurotransmitter acetylcholine (ACh). This action directly modulates the parasympathetic nervous system pathway, limiting the magnitude of signaling on visceral organs.

Pathway Modulation and Cellular Cascade

By inhibiting ACh interaction, Scopolan interrupts the molecular cascade that normally initiates contraction. This targeted pathway interference prevents the necessary intracellular calcium influx required for the muscle fibers to tighten. This modification of the signaling sequence results in the limitation of excessive physiological activation, thereby interrupting the biochemical sequence that drives contraction.

Targeted Peripheral Action

The mechanism is primarily relevant in the gastrointestinal and genitourinary tracts. Due to its quaternary ammonium compound structure, Scopolan predominantly acts within the peripheral nervous system, focusing its mechanistic activity on the smooth muscle of visceral organs where excessive motility often occurs.

Dosage and Administration Information

How Scopolan (Hyoscine Butylbromide) is Used: Administration Guidelines

Administration Routes and Dosage

Hyoscine Butylbromide is administered via two primary routes: oral (tablet form) and parenteral (injection). The parenteral route includes intravenous (IV), intramuscular (IM), and subcutaneous (SC) injection, typically reserved for acute needs. The oral dose for adults and children 12 years and older generally ranges from 10 mg to 20 mg per dose. The maximum recommended daily dose for parenteral administration is 100 mg. The dose for children aged 6 to 12 years is 10 mg per dose.


Frequency and Duration

The medicine is generally intended for symptomatic relief and is used as needed. For continuous symptoms, oral doses are typically taken up to 3 or 4 times daily. Hyoscine Butylbromide should not be taken on a continuous daily basis. For unsupervised use, the duration should generally not exceed two weeks without a full review of the underlying cause of the symptoms.


Administration Conditions and Constraints

Oral tablets must be swallowed whole and should not be crushed, chewed, or broken. They can be taken with or without food. When administered intravenously, the injection must be performed slowly. An important procedural constraint restricts the use of the IM route in patients receiving anticoagulant drugs, requiring the SC or IV route instead due to procedural risks.

Recent Clinical Evidence

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


Evidence for Managing General Abdominal Cramping and Spasms

The research explored how Scopolan (Hyoscine Butylbromide) is used in conditions characterized by fluctuating or episodic manifestations of physical discomfort, such as general cramping. This research was primarily conducted using placebo-controlled Randomized Controlled Trials (RCTs) and Systematic Reviews to explore how symptoms change over time in the gastrointestinal tract. Studies typically focused on patient-reported outcomes describing perceived discomfort, measuring changes in pain intensity and the frequency of spasms over short periods.

Findings describe patterns observed in the studies where participants reported short-term changes in pain intensity measurements when Hyoscine Butylbromide was compared to a placebo. This body of evidence contributes to understanding the medicine's effect on outcomes related to physical discomfort during periods of heightened symptom activity. However, many of the foundational studies are older clinical reports and trials, some conducted prior to the establishment of modern, standardized criteria for diagnosing functional conditions like Irritable Bowel Syndrome (IBS).


Evidence for Acute Visceral Colic (Renal and Biliary)

Research has examined the use of Scopolan, particularly its injectable form, in research contexts involving fluctuating or unstable symptoms, such as renal (ureteral) colic. These studies involved RCTs and Systematic Reviews where the medicine was observed in patients presenting with acute, severe pain. Research explored outcomes related to episodic or acute changes, specifically measuring the change in pain scores and the patient's rate of requiring additional pain medication.

Findings were mixed when evaluating the drug as a single agent for these conditions. Some trials described patterns where the outcomes measured for Hyoscine Butylbromide did not differ substantially from those measured for a placebo, and where some trials described minimal or no differentiation from conventional agents. Consequently, certainty remains low regarding its intended role as a consistent monotherapy in these acute, severe pain episodes.

Frequently Asked Questions (FAQ)

Common questions about Scopolan (FAQ)


Q: How quickly can I expect Scopolan to start working for abdominal cramps?

A: According to regulatory documents and clinical information, the effect of this medicine begins quickly. Information indicates that the spasmolytic effect is typically observed within 15 minutes of administration, based on clinical reports.

Q: Can Scopolan be used to relieve painful periods (menstrual cramps)?

A: Yes, Scopolan is classified as an antispasmodic, which helps to relax smooth muscle. Official drug information notes that due to its action on the genito-urinary tract, it is often used to help ease the symptoms of painful periods or menstrual cramps.

Q: Can Scopolan be used to help with symptoms of Irritable Bowel Syndrome (IBS) cramps?

A: Official guidance and patient information indicate that this medicine can be taken to help relieve the spasm-type pain and cramping that is associated with Irritable Bowel Syndrome (IBS). Regulatory guidance notes that use for symptoms such as those associated with IBS is typically following a diagnosis from a healthcare provider.

Q: Is Scopolan available in forms other than tablets, like suppositories or injections?

A: Yes, the active ingredient in Scopolan, Hyoscine Butylbromide, is available in several forms. In addition to the oral tablet form, it is also prepared as an injectable solution and as a rectal suppository preparation.

Q: What is the safety information regarding Scopolan use during pregnancy?

A: Official regulatory documents state that the safety of Scopolan during pregnancy has not been established due to limited data. Official documents describe its use as generally not recommended unless a healthcare provider assesses the risk and benefit.

Q: Is Scopolan considered safe to use while breastfeeding?

A: The safety of this medicine during the breastfeeding period has not been established. Regulatory information advises that caution is necessary because the drug may pass into breast milk.

Q: What is the difference between regular Scopolan and Scopolan Compositum?

A: The term 'Compositum' or 'Plus' typically indicates a combination product. These formulations include the spasm-relieving ingredient Hyoscine Butylbromide along with a secondary active ingredient, which is usually a pain reliever such as paracetamol (acetaminophen).

Q: Is Scopolan used for motion sickness, or is it only for spasms/cramps?

A: Scopolan (Hyoscine Butylbromide) is for the treatment of internal spasms and cramps. It is chemically distinct from the related drug (hyoscine hydrobromide) that is typically used for preventing or treating motion sickness.

Q: What is the difference between Scopolan and Buscopan?

A: The medicine Buscopan is one of the common brand names used globally for the active ingredient Hyoscine Butylbromide. This is the same active substance found in Scopolan.

Q: Is Scopolan the same drug as the scopolamine patch used for travel?

A: No, they are not the same drug. While Scopolan is a derivative of scopolamine, its chemical structure is modified. This design prevents the drug from significantly crossing the blood-brain barrier, which limits its effects primarily to the peripheral nervous system, unlike the scopolamine patch used for travel sickness.

Q: Does Scopolan have any effect on blood pressure?

A: Yes, a decrease in blood pressure, known as hypotension, is listed as an adverse reaction in regulatory documents. Regulatory documents state that this effect is particularly noted following the injectable administration of the medicine.

Q: Are there specific food or drink interactions with Scopolan I should know about?

A: Official patient information advises against drinking alcohol while using this medicine. This is because alcohol consumption may increase the chance of experiencing side effects such as drowsiness.

Q: Does Scopolan cause sleepiness or drowsiness in most people?

A: Drowsiness is noted as a possible side effect of the medicine. It is classified as an uncommon effect, but the risk of feeling sleepy is increased if the medicine is taken with alcohol or other sedating drugs.

Q: Can Scopolan affect mental alertness for driving or operating machinery?

A: Due to the potential for side effects, official documents carry a warning that patients should refrain from driving or operating machinery if they experience blurred vision or dizziness.

Q: What should I do if the side effects I experience feel severe or concerning?

A: If severe or concerning side effects, such as signs of a serious allergic reaction (like swelling or difficulty breathing), or worsening pain are experienced, official guidance states that immediate medical attention is necessary.

Q: What are the main symptoms of an accidental overdose of Scopolan?

A: Symptoms noted following an accidental high dose are related to the drug's action and may include a fast heart rate (tachycardia), redness of the skin, severe dry mouth, and disturbances in vision.

Q: Is Scopolan a controlled substance?

A: The drug's regulatory classifications globally show it is generally available either over-the-counter or by prescription. Its chemical structure prevents it from significantly affecting the brain, giving it a low incidence of abuse potential.

Q: Why is Scopolan Compositum only indicated for short-term, severe pain?

A: Combination products like Scopolan Compositum often contain an additional active pain-relieving ingredient, such as paracetamol. The requirement for short-term use is usually due to the specific safety profile and maximum daily dose limitations of this secondary component.

Q: Is there evidence that Scopolan is used in medical procedures like MRI or colonoscopies?

A: Yes, the medicine is used in certain medical procedures. Due to its smooth-muscle relaxing properties, it is commonly employed in diagnostic imaging, such as CT scans and MRIs, to reduce bowel movement and improve image clarity.

Q: Does taking Scopolan affect my stomach's ability to digest food?

A: The medicine works by relaxing the smooth muscles of the digestive tract, which slows down the movement (peristalsis) of the intestines. This effect can lead to side effects like constipation.

Q: Are severe allergic reactions to Scopolan commonly reported?

A: Severe allergic reactions, including anaphylactic shock, are listed in official documents as possible serious adverse reactions. However, these are classified as very rare or of 'not known' frequency based on post-marketing reports.

Q: What should I know about taking Scopolan if I have pre-existing heart conditions?

A: Caution is advised for individuals with pre-existing heart conditions. The medicine is generally unsuitable for use in patients with certain conditions like tachyarrhythmia (a fast, irregular heart rhythm) because it may worsen these symptoms.

Q: Can Scopolan make existing acid reflux (GERD) symptoms worse?

A: Clinical literature suggests that because the medicine relaxes smooth muscles throughout the digestive tract, it may potentially worsen symptoms of Gastroesophageal Reflux Disease (GERD).

Q: Is there a risk of hallucinations or severe confusion with Scopolan?

A: Hallucinations and confusion are noted in regulatory documents as very rare, isolated reports. The drug's chemical design is intended to limit these central nervous system effects, though they are still possible, particularly with the injected form.

Q: Are there any long-term side effects noted for Scopolan use?

A: The medicine is generally intended for short-term use. Regulatory safety warnings indicate that in cases of prolonged or continuous use, monitoring of organ functions, such as blood count, kidney, and liver function, is advised.

How should Scopolan be stored and disposed of?

How to Store and Dispose of Scopolan

Official regulatory documents define strict storage and disposal requirements for Scopolan (Hyoscine Butylbromide) to maintain product stability and ensure safety.


Storage Requirements

Requirement Official Rule
Temperature Store at a temperature not exceeding 25 C (77 F).
Protection Keep protected from light and moisture. The product must not be frozen.
Packaging Must be stored in its original blister or carton.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Expired or unused product must not be disposed of in wastewater or ordinary household refuse. The product should be returned to a local pharmaceutical take-back program or pharmacist for proper disposal as pharmaceutical waste. Do not use the medication after the expiry date printed on the package.

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

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