Scopex

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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 Scopex

Property Description
Active Ingredient Hyoscine Butylbromide (INN)
Forms Oral Tablets, Solution for Injection, Syrup
Pharmacological Class Anticholinergic, Antispasmodic
Common Action Smooth muscle relaxation (spasmolysis)
Origin Semisynthetic derivative

What is Scopex and its Core Identity?

Scopex is a trade name for the medicine containing the single active ingredient Hyoscine Butylbromide (INN). This drug is formally classified within the anticholinergic class, primarily functioning as an antispasmodic agent. Hyoscine Butylbromide is a semisynthetic derivative of scopolamine, a naturally occurring tropane alkaloid. Its structure is that of a quaternary ammonium compound, which is chemically designed to limit its passage across the blood-brain barrier. This structural characteristic ensures that the drug's therapeutic effects remain highly concentrated on the peripheral nervous system.


What Type of Relief Does Scopex Provide?

The primary function of this medicine is to provide relief from discomfort by easing painful, involuntary contractions of internal organs, a process medically known as spasmolysis. Scopex achieves this via a direct spasmolytic action that relaxes the smooth muscle tissue. The drug's mechanism involves blocking muscarinic receptors on smooth muscle cells, thereby inhibiting the action of the neurotransmitter acetylcholine, which typically causes these muscles to contract. This focused action is intended for alleviating cramping pain and spasms associated with conditions affecting the gastrointestinal tract and the genitourinary tract.


Available Forms: Oral and Injectable Preparations

Hyoscine Butylbromide is supplied in multiple pharmaceutical forms to allow for flexible therapeutic intervention. It is commonly available as oral tablets (often film-coated) for routine management. A solution for injection is also provided for parenteral administration in clinical settings, used when relief from severe acute spasms is necessary. The World Health Organization (WHO) includes the compound on its Essential Medicines List for specific uses related to pain and spasms. This inclusion reflects the compound's use in targeted therapeutic contexts.

Regulatory References

  1. WHO Model List of Essential Medicines
  2. WHO eEML Entry for Hyoscine Butylbromide

What side effects are possible with Scopex?

Possible Side Effects and Safety Information

The safety profile of Scopex (Hyoscine Butylbromide) is documented in regulatory labeling based on its peripheral anticholinergic properties. Adverse reactions are classified by frequency and system-organ class.

Classification Examples of Documented Adverse Reactions (SOC)
Common Tachycardia (Cardiac), Dry mouth (Gastrointestinal), Accommodation disorders (Eye)
Uncommon Dizziness (Vascular), Hypotension (Vascular), Skin reactions (Skin), Dyshidrosis (Skin)
Rare Urinary retention (Renal and urinary)
Not Known Anaphylactic shock, Angioedema (Immune system), Increased intraocular pressure (Eye)

Serious Adverse Reactions and Safety Constraints

Official prescribing information lists Anaphylactic shock and Anaphylactic reactions, including cases with fatal outcomes, as serious adverse reactions, especially following injection. The drug can cause Tachycardia and Hypotension, which may be severe in patients with pre-existing cardiac conditions like heart failure or coronary heart disease.

Key safety limitations, or contraindications, mean the medicine must not be used in patients with conditions such as myasthenia gravis, megacolon, tachycardia, or untreated narrow-angle glaucoma. Caution is also required in individuals susceptible to urinary retention due to prostatic enlargement.

Due to the possibility of accommodation disorders (blurred vision) or dizziness, patients are officially advised to avoid driving or operating machinery if affected. Safety labeling also advises that oral forms should not be taken on a continuous daily basis or for extended periods without appropriate medical investigation of the underlying abdominal pain.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Scopex, a buprenorphine analogue, is a serious medical emergency that primarily affects the central nervous system and respiratory function, as documented in official regulatory labeling.


Documented Overdose Manifestations

System Manifestations
Respiratory Decreased rate and depth of breathing (respiratory depression).
CNS Extreme sedation, stupor, loss of consciousness, and coma.
Physical Sign Pinpoint (miotic) pupils.

When to Seek Immediate Medical Help

Immediate emergency medical attention must be sought if any signs of overdose are observed. Calling emergency services (e.g., 911) is required if the patient exhibits slow, shallow breathing, extreme sleepiness, or cannot be awakened. Accidental ingestion by a child is considered a medical emergency requiring immediate hospitalization.

Management and Antidote

The most severe outcome is life-threatening respiratory depression, which can lead to death, especially when Scopex is misused or combined with other central nervous system depressants, such as alcohol or benzodiazepines. An opioid antagonist, such as naloxone, is the primary treatment. Due to the high affinity and long duration of action of Scopex, regulatory guidelines note that higher or repeated doses of the antagonist may be necessary, and the patient must be held under continuous observation for recurrence of symptoms.

Therapeutic Uses of Scopex

What Scopex treats: Main Uses and Benefits

Scopex (scopolamine/hyoscine) is primarily applied in areas where additional symptomatic support is needed due to its antiemetic and anticholinergic therapeutic action, which is applied in addressing specific types of nausea and vomiting. The transdermal formulation is applied in two main therapeutic areas: easing symptoms associated with motion sickness and assisting with the symptomatic management of post-operative nausea and vomiting (PONV).

This medication helps address symptoms related to heightened physiological activity that interfere with daily functioning, such as acute or episodic nausea and vomiting associated with travel. Scopex is also applied in clinical settings that involve acute or unstable symptom patterns and may assist with managing the symptomatic burden of PONV, which can occur following anesthesia, opiate analgesia, and surgery.

This supportive relief, commonly used when short-term symptomatic assistance is needed, contributes to easing the overall symptom load and supports patients during episodes of heightened discomfort.

“The therapeutic action of hyoscine supports patients during difficult episodes by easing distress and may help them cope more steadily with symptom fluctuations.”

In other forms, scopolamine (hyoscine butylbromide) may assist with symptoms related to inflammatory or irritative states, such as gastrointestinal spasms.


Quick Fact: May provide supportive relief for Nausea and Vomiting

Eligibility and Restrictions for Use

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

Eligibility Scope

Populations for whom use is allowed (as stated in label): Adults and children typically over 6 years of age for the oral tablet formulation, provided no contraindicating conditions are present.

Populations for whom use is not recommended (if applicable): Use is not recommended during pregnancy and lactation due to limited safety data. Oral tablets are not recommended for children under 6 years.

Populations for whom use is contraindicated: Patients with hypersensitivity, myasthenia gravis, megacolon, paralytic or obstructive ileus, mechanical stenosis of the GI tract, untreated narrow-angle glaucoma, prostatic hypertrophy with urinary retention, tachycardia, and cardiac failure must not use Scopex.

Age-related eligibility rules:

The oral tablet is not recommended for children under 6 years.

Condition-specific eligibility rules:

Caution is required for patients prone to narrow-angle glaucoma and intestinal/urinary outlet obstructions. Intramuscular injection is contraindicated in patients on anticoagulants.

Pregnancy and lactation eligibility status (if explicitly documented):

Not Recommended.


Eligibility Classifications (high-level)

Eligibility severity classification (as defined in official documents): Contraindicated (Absolute Ban), Not Recommended (Avoid use), Caution (Conditional Use).

Regulatory basis (EMA / FDA / etc.): Summary of Product Characteristics (SmPC) / Prescribing Information (PI).

Eligibility-context constraints (as defined in official documents): Anticholinergic properties defining exclusion for conditions worsened by smooth muscle paralysis.


Resulting eligibility structure

Official eligibility statements: Scopex is contraindicated for use in myasthenia gravis, megacolon, mechanical obstructions, untreated glaucoma, and existing cardiac failure or tachycardia. Use is not recommended for children under 6 years and during pregnancy or lactation, as per regulatory documentation.

Connection to the overall eligibility profile (2–4 sentences): Regulatory documents strictly define who can and cannot use Scopex through numerous absolute contraindications that exclude patients whose underlying conditions could be aggravated by the drug's anticholinergic actions. Eligibility is further restricted for the pediatric population and designated not recommended for pregnant and lactating individuals due to established regulatory caution.

What should I know about interactions with other medicines?

Scopex (hyoscine butylbromide) may interact with various other medicinal products due to its primary action as an antimuscarinic agent, which impacts smooth muscle motility.

Documented Pharmacodynamic Interactions

  • Other Anticholinergics: The effects of Scopex may be intensified by the concomitant administration of other medicines with antimuscarinic properties. This category includes specific products like amantadine, certain antihistamines, phenothiazines, butyrophenones, tricyclic antidepressants, quinidine, disopyramide, and other anticholinergics such as tiotropium and ipratropium. This combination increases the risk of enhanced peripheral anticholinergic side effects.
  • Dopamine Antagonists: Co-treatment with dopamine antagonists, such as metoclopramide, may result in a diminution of the effects of both medicines on the movement of the gastrointestinal tract, as their actions are opposing.
  • Beta-Adrenergic Agents: The tachycardic effects (increased heart rate) of beta-adrenergic agents may be enhanced by hyoscine butylbromide.

Other Relevant Interaction Information

  • Absorption of Other Medicines: The absorption rate of other orally administered medicines may be affected or delayed due to the reduction in gastric motility caused by Scopex.
  • Central Nervous System (CNS) Depressants: Simultaneous intake of alcohol or other central nervous system depressants may aggravate effects such as drowsiness and impaired concentration.

Mechanism of Action

Scopex, which is hyoscine butylbromide, functions as a non-selective muscarinic acetylcholine receptor (mAChR) antagonist. Its primary biological targets are the post-ganglionic muscarinic receptors, particularly the M3 subtype, located on the smooth muscle cells and exocrine glands of the gastrointestinal, biliary, and urinary tracts. Due to its quaternary ammonium structure, the compound exhibits limited lipophilicity and does not readily cross the blood-brain barrier, resulting in predominantly peripheral activity.

At the cellular level, hyoscine butylbromide competitively binds to the mAChRs, preventing the endogenous neurotransmitter acetylcholine from initiating signal transduction. In the case of the M3 receptor, this antagonism blocks the Gq protein-coupled pathway, which normally leads to the activation of phospholipase C and subsequent elevation of intracellular calcium ion concentrations. This disruption in the signaling cascade results in the inhibition of smooth muscle contraction.

The system-level physiological consequence of this localized peripheral antagonism is a reduction in visceral smooth muscle tone and motility throughout the targeted organs, and a decrease in glandular secretions in the peripheral exocrine glands.

Dosage and Administration Information

How Scopex is Used

Scopex (Hyoscine Butylbromide) administration follows a standardized protocol, which establishes guidelines for dosage, route, and duration of use. This medicine is utilized for two main patterns of administration: routine use via the oral route and immediate use via parenteral routes (injection) for acute episodes.


Administration Routes and Dosing

The choice of route is determined by the speed of effect required, with specific dose maximums established for safety and effectiveness.

Administration Route Standard Adult Dose Frequency and Schedule
Oral (Tablets 10 mg) 10 mg to 20 mg per dose Up to four times daily
Parenteral (IV/IM/SC) 20 mg (single dose) May be repeated after 30 minutes (Max 100 mg/day)

Specific Instructions and Constraints

The oral tablets are intended to be swallowed whole with adequate water and are not to be crushed or chewed. For parenteral administration (IV, IM, SC), the injectable solution may be diluted with glucose or 0.9% sodium chloride solution for injection. Intravenous injection is procedurally administered slowly.

Duration: This medicine is intended for short-term use only. Guidelines suggest avoiding continuous daily use for extended periods unless the underlying cause of symptoms has been medically investigated.

Pediatric Use: For children aged 6 to 12 years, the oral dose is typically 10 mg three times daily. Parenteral administration in infants and young children is guided by weight (0.3–0.6 mg/kg).

Recent Clinical Evidence

The research for Hyoscine Butylbromide involves studies that explore the investigation of symptoms related to painful internal cramping. The evidence base consists primarily of Randomized Controlled Trials (RCTs) and systematic reviews that examine changes measured in symptoms.


Evidence for Acute Abdominal Cramping and Pain

Research has explored the medicine's use in patients experiencing acute, non-specific abdominal cramps. Studies include short-term RCTs comparing the medicine against a placebo and against active comparators, such as non-narcotic pain relievers. The research monitored differences in pain intensity scores over short time frames. Some comparative studies noted patterns where the measured change in pain intensity score was not significantly different from certain non-narcotic analgesic agents.

Evidence for Irritable Bowel Syndrome (IBS)-Related Spasm

The medicine was evaluated in studies for managing cramping and pain associated with medically confirmed IBS, a condition marked by functional limitations. Findings for this indication are summarized in meta-analyses, which pool data from multiple RCTs. Studies report that symptom patterns evolved over short treatment courses (a few weeks). However, the evidence is subject to heterogeneity (variability) across studies, meaning certainty remains low when drawing broad, definitive conclusions.

Acute Colic, Procedures, and Research Gaps

The injectable form has been evaluated in acute clinical settings for severe spasms like renal or biliary colic, as well as in diagnostic procedures to explore muscle movement reduction (peristalsis). Research describes that a pattern of change was observed shortly after administration in acute colic settings.

A key limitation across the entire research landscape is the duration of follow-up. The large majority of evidence focuses on short-term or episodic symptom patterns, and long-term effects are not fully established. Additionally, data for special populations, such as specific subgroups of older adults and patients with co-occurring conditions, remains limited in the primary research literature.

Key Studies & References

  1. Hyoscine butylbromide administered at the cecum increases polyp detection: a randomized double-blind placebo-controlled trial
  2. A Comprehensive Review of the Effects of Hyoscine Butylbromide in Childhood
  3. Hyoscine butylbromide: a review of its use in the treatment of abdominal cramping and pain
  4. Canadian Association of Gastroenterology (CAG) Position Statement on the Use of Hyoscine-n-butylbromide (Buscopan)

Frequently Asked Questions (FAQ)

Common questions about Scopex (FAQ)

Q: How quickly does Scopex typically start working?

A: The dosing frequency of Scopex is based on its established duration of action, which is approximately four to six hours. Official product information indicates that the onset of the medicine's therapeutic effects is considered relatively rapid.

Q: Is it normal to feel general, non-severe sensations when starting Scopex?

A: Regulatory labeling confirms that common temporary effects include having a dry mouth and a faster than normal heart rate (tachycardia). Blurred vision (accommodation disorders) is also a commonly documented side effect when starting the medicine.

Q: What happens if I forget a dose of Scopex?

A: If a dose is forgotten, the official guidance often states the medicine may be taken as soon as remembered, provided it is not almost time for the next scheduled dose. Regulatory instructions strictly advise against taking two doses together to make up for a missed one.

Q: How is Scopex generally processed by the body?

A: Official prescribing information states that after being taken orally, Scopex is quickly absorbed into the bloodstream. It is then primarily distributed, in higher concentrations, to the gastrointestinal tract, liver, and kidneys, which aligns with its targeted action.

Q: What should I do if I accidentally take two doses of Scopex close together?

A: Signs of potentially taking too much medicine may include a very dry mouth, fast heart rate, difficulty passing urine, or changes in vision. Official guidance advises that immediate medical attention is necessary if an overdose is suspected.

Q: What is the purpose of the black box warning on Scopex (if applicable)?

A: Official prescribing documents do not state the existence of a Black Box Warning for Scopex. However, safety alerts have been issued by regulatory bodies to highlight the risk of serious adverse effects following injection, especially for patients with pre-existing heart conditions.

Q: What should I do if my symptoms don't improve on Scopex?

A: Regulatory guidance states that if abdominal pain continues, worsens, or does not show improvement within a short timeframe (such as 48 hours), this is a condition where further medical investigation is necessary. This step is advised to ensure the underlying cause of the symptoms is properly diagnosed.

Q: Why does Scopex need to be taken [once a day/twice a day/specific timing pattern]?

A: The recommended dosing frequency is based on the drug's established duration of action, meaning how long the effects last in the body. According to official product characteristics, Scopex is typically dosed every four to six hours as needed for acute symptoms.

Q: Are there long-term side effects associated with Scopex use?

A: Official regulatory documents state the medicine is only intended for short-term use. The regulatory warning indicates that continuous daily use for extended periods should be avoided without a proper medical investigation, as safety evidence is primarily focused on episodic use.

Q: What is the evidence level (e.g., Phase 3 trials) supporting Scopex's use?

A: Studies supporting the medicine's indications include Randomized Controlled Trials (RCTs) and systematic meta-analyses that pool data from multiple clinical studies. The compound has been used in clinical practice and is included in essential medicine lists for many years.

Q: Is Scopex available over the counter in some countries?

A: The regulatory status of Scopex varies significantly across different countries. In some regions, the oral formulation is approved as a General Sales List (GSL) medicine, which can be purchased over the counter. In other major markets, it remains classified as a Prescription Only Medicine.

Q: Does Scopex affect birth control pills?

A: Current official guidelines do not document a direct interaction between Scopex and oral contraceptive pills. A rare theoretical risk exists only if the drug causes significant vomiting that occurs shortly after taking a birth control pill.

Q: Does Scopex interact with herbal supplements?

A: Official patient information states there is currently not enough information to definitively confirm the safety of combining Scopex with all herbal remedies or complementary medicines. This is because these products are generally not subject to the same rigorous testing requirements as licensed pharmaceutical products.

Q: Is Scopex considered a 'first-line' treatment for a main condition?

A: While its primary therapeutic indication is for spasms, official guidelines acknowledge its use in specialized clinical contexts. For instance, in palliative care, the injectable form is often designated as a first-line agent for managing excessive respiratory secretions.

Q: Is there a link between Scopex and vision problems?

A: Yes, the medicine can cause accommodation disorders, which manifest as blurred vision. Furthermore, it can increase the pressure inside the eye, meaning it is officially contraindicated (must not be used) in patients who have untreated narrow-angle glaucoma.

Q: How does the non-active ingredients list in Scopex affect patients?

A: Regulatory documents require that all non-active ingredients (excipients) used in the formulation of Scopex be clearly listed. Official guidance includes a warning that the medicine is not recommended if a patient has a known hypersensitivity or allergy to any of these components.

Q: Can Scopex cause dry mouth or changes in taste?

A: Dry mouth is classified as a common and expected side effect, as the medicine works by reducing glandular secretions. While less frequent, regulatory documents note that some anticholinergic drugs have been associated with reporting of taste disorders.

Q: Does Scopex cause changes in mood or anxiety levels?

A: Official prescribing information reports rare instances of central nervous system (CNS) effects, particularly when the drug is given by injection. These rare effects have included reports of confusion, agitation, drowsiness, and hallucinations.

Q: How long can a person safely stay on Scopex?

A: Regulatory guidance is clear that Scopex is intended for short-term use only for acute symptoms. Official instructions state that if symptoms persist or if there is a need to use the drug for longer than a short, defined period (such as two weeks), this warrants seeking medical advice.

Q: Are there certain medical tests that are necessary before starting Scopex?

A: Since the medicine is officially contraindicated for conditions like untreated narrow-angle glaucoma and certain heart conditions (tachycardia), the use of Scopex requires a screening process. This implies a healthcare provider's review of these high-risk conditions before treatment can be initiated.

How should Scopex be stored and disposed of?

Official Storage and Disposal Requirements

Scopex (Hyoscine Butylbromide) Injection must be stored under specific conditions to maintain product integrity. The unopened ampoules must be stored at a temperature below 30°C and must be protected from light. Regulatory documents specify the need to keep the medicine in its original container to ensure light protection.

The product is for single use only. Once the ampoule is opened, any unused contents must be discarded immediately. Diluted solutions have a defined in-use stability of 24 hours at 25°C.

For safety, all medicinal products must be stored out of the sight and reach of children.

Disposal of unused or expired product must follow local requirements for pharmaceutical waste. The medicine should be returned to a pharmacist or a drug take-back program; it is not recommended for flushing.

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

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