Copan

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Copan

Medically reviewed

Laura Arias

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 Copan

Quick Facts: Copan (Hyoscine Butylbromide)

Property Description
Active ingredient Hyoscine Butylbromide (Scopolamine Butylbromide)
Form Tablet, Coated tablet, Solution for injection
Pharmacological class Antispasmodic, Anticholinergic agent
Common use Relief from painful visceral spasms
Origin Synthetic derivative (Quaternary Ammonium Compound)

What Type of Medicine is Copan (Hyoscine Butylbromide)?

Copan is a focused antispasmodic medication whose core identity is defined by its single active ingredient, Hyoscine Butylbromide. The drug is formally classified as an anticholinergic agent, functioning by antagonizing specific nerve signals that cause involuntary muscle contractions. Hyoscine Butylbromide is a synthetic derivative manufactured as a quaternary ammonium compound. This specialized chemical structure is critical because it significantly restricts the molecule's ability to cross the blood-brain barrier, ensuring its therapeutic action is concentrated on the peripheral smooth muscles of the abdomen and pelvis.


Composition and General Purpose

This medication is a single-ingredient product, with its pharmacological effect attributable entirely to the active compound Hyoscine Butylbromide. Copan is supplied in multiple dosage forms, including the tablet/coated tablet for the oral route and an aqueous solution for injection for parenteral administration. The general purpose of the drug is to resolve the underlying cause of cramping pain by inhibiting the involuntary, excessive contractions of visceral smooth muscle. By blocking the action of the neurotransmitter acetylcholine at the muscarinic receptors, the medication helps to restore a state of normal, relaxed function to the muscles of the gastrointestinal, biliary, or genito-urinary tracts.

Regulatory References

  1. NIH DailyMed Monograph

What side effects are possible with Copan?

Possible Side Effects and Safety Information

The official safety profile for Hyoscine Butylbromide (Copan) is structured around its anticholinergic properties, with adverse reactions categorized by frequency and the body system affected, according to regulatory documents.

Adverse Reaction Classification

Side effects are classified using standardized regulatory terminology:

  • Uncommon (occurring in 1 to 10 users per 1,000): Tachycardia (increased heart rate), dry mouth, and skin reactions (e.g., urticaria, pruritus).
  • Rare (occurring in 1 to 10 users per 10,000): Urinary retention.
  • Frequency Not Known (reported during post-marketing surveillance): This category includes severe reactions where the precise rate cannot be determined, such as anaphylactic shock (including cases with fatal outcomes), decreased blood pressure (hypotension), dizziness, and visual disturbances like mydriasis.

Adverse reactions are officially mapped across several System-Organ Classes, notably Gastrointestinal Disorders (dry mouth), Cardiac Disorders (tachycardia), Eye Disorders (accommodation disorders, increased intraocular pressure), and Immune System Disorders (anaphylactic reactions).

Serious Adverse Reactions and Safety Constraints

The regulatory safety documentation highlights risks considered clinically significant. Serious adverse reactions documented following administration, particularly the injectable form, include anaphylactic shock and severe hypotension. The drug’s anticholinergic nature also carries the risk of precipitating narrow-angle glaucoma by increasing intraocular pressure.

Specific population safety constraints are noted in official labeling. Caution is advised for patients with pre-existing conditions such as cardiac disease or those susceptible to urinary or intestinal obstructions. Furthermore, use is generally not recommended during pregnancy or lactation due to limited safety data documented in official sources.

These official safety classifications structure the drug's risk understanding by separating common anticholinergic effects from rare but severe risks and by clearly identifying specific patient populations who require particular caution.

Overdose and Emergency Response

Overdosage of Hyoscine Butylbromide (Copan) primarily results in an exacerbation of its peripheral anticholinergic effects, as documented in official regulatory labeling. The core of the official overdose profile includes manifestations such as urinary retention, dry mouth, tachycardia (fast heart rate), reddening of the skin, and transient visual disturbances affecting accommodation. In cases of severe intoxication, regulatory documents note the potential for serious outcomes, including respiratory paralysis and Cheynes-Stokes respiration, which can necessitate intubation and artificial respiration.

Immediate medical attention is mandated for any suspected overdosage. Urgent medical advice must be sought if severe, unexplained abdominal pain persists or presents concurrently with specific triggers, including fever, fainting, decreased blood pressure, or blood in stool. Additionally, the development of a painful, red eye with loss of vision requires urgent ophthalmological advice.

Management of symptoms is defined in regulatory protocols, which state that the symptoms of overdosage respond to parasympathomimetics. For oral poisoning, the defined procedural measures include gastric lavage followed by medicinal charcoal and magnesium sulfate. Appropriate supportive measures are required, with catheterisation noted as a requirement for urinary retention.

Therapeutic Uses of Copan

Main Uses of Copan

Copan is a therapeutic agent primarily utilized in the management of specific hematological malignancies. It belongs to a class of medications known as phosphoinositide 3-kinase (PI3K) inhibitors. The drug is specifically indicated for adult patients who have experienced a recurrence of certain types of non-Hodgkin lymphoma.

Follicular Lymphoma

The primary application of Copan is for the treatment of relapsed follicular lymphoma. This condition is a slow-growing or indolent form of non-Hodgkin lymphoma that affects the B-lymphocytes. Copan is generally considered for patients who have already undergone at least two prior systemic therapies and have not achieved a lasting remission or have seen the disease return.

Mechanism of Action

Copan works by targeting the PI3K signaling pathway, which is often overactive in cancerous B-cells. By inhibiting the PI3K-alpha and PI3K-delta isoforms, the medication helps to:

  • Interfere with the growth and proliferation of malignant cells.
  • Induce apoptosis, or programmed cell death, in lymphoma cells.
  • Disrupt the signals that allow cancer cells to survive and spread.

Benefits and Clinical Goals

The goal of treatment with Copan is to manage the progression of the disease and improve clinical outcomes for patients with limited treatment options.

Tumor Reduction

One of the primary benefits observed is a reduction in tumor size, referred to as an objective response. Clinical data indicate that a significant portion of patients experience either a partial or complete disappearance of signs of lymphoma during the course of treatment.

Progression-Free Interval

Copan aims to extend the duration of time during which the disease remains stable and does not worsen. By providing a targeted approach to the PI3K pathway, it offers a therapeutic alternative for those whose cancer has become resistant to conventional chemotherapy or other biological treatments.

Targeted Therapy Approach

Unlike broad-spectrum chemotherapy, Copan provides a more specific mechanism of action. This targeted approach is designed to address the underlying cellular mechanisms driving the lymphoma, offering a different strategy for disease control in the relapsed setting.

Eligibility and Restrictions for Use

The official regulatory profile for Copan (Hyoscine Butylbromide) defines strict, population-based eligibility criteria, largely focused on its anticholinergic properties. The medicine is contraindicated in groups where its effect could cause severe complications.

Absolute Contraindications

Absolute non-eligibility includes patients with myasthenia gravis, narrow-angle glaucoma, megacolon, paralytic or obstructive ileus, and mechanical stenosis in the gastrointestinal tract. Individuals with prostatic hypertrophy leading to urinary retention must also not use this medicine. The parenteral (injection) formulation is specifically contraindicated in patients with tachycardia, angina, and cardiac failure.

Population Restrictions

  • Children: The oral tablet form is not recommended for use in children under 6 years of age.
  • Pregnancy/Lactation: Use during pregnancy or breastfeeding is not recommended by regulatory agencies due to insufficient human data to establish safety.
  • Conditional Use: The drug must not be given via intramuscular injection to those on anticoagulant drugs. Caution is advised in older adults and patients with serious hepatic or renal disease, as well as those prone to intestinal or urinary outlet obstructions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Copan (Hyoscine Butylbromide) documents interactions primarily through pharmacodynamic mechanisms, leading to specific restrictions and outcome intensifications with co-administered substances.

Interaction Type Interacting Products/Substances Regulatory Outcome Description
Additive Anticholinergic Effect Tricyclic/Tetracyclic Antidepressants, Antihistamines, Antipsychotics, Quinidine, Amantadine, Disopyramide, and other anticholinergics. May intensify the resulting anticholinergic effect.
Functional Antagonism Dopamine Antagonists (e.g., Metoclopramide, Domperidone). Results in a reciprocal diminution of the effect of both substances on gastrointestinal motility.
Timing Separation Required Antacids or Adsorbent Anti-diarrheal Drugs. Must be taken at least one hour before the oral administration of Copan.
Substance Interaction Alcohol. Co-administration may increase the chance of experiencing side effects such as drowsiness.

Interaction-Related Restriction

The Intramuscular (IM) route of injection is formally contraindicated in patients receiving Anticoagulant Drugs, as this combination carries a documented risk of intramuscular hematoma. The subcutaneous or intravenous routes remain permitted in this patient population. Official labeling does not explicitly state interactions mediated by Cytochrome P450 enzymes or specific drug transport proteins.

Population-Specific Note

Elderly patients may show greater susceptibility to the outcomes of pharmacodynamic interactions, which can manifest as increased confusion or urinary retention.

Mechanism of Action

How Copan Works


Enzyme System Inhibition

This domain involves irreversible covalent binding and inhibition of the hydrogen/potassium adenosine triphosphatase (H^+/K^+ ATPase) enzyme (the proton pump) located within the secretory surface of the stomach's parietal cells. This molecular interaction modifies an early molecular step to directly suppress the final stage of gastric acid secretion, resulting in the reduction of gastric lumen acidity.


Muscarinic Receptor Modulation

This mechanism acts within domains involving receptor-mediated signaling by functioning as a competitive antagonist at muscarinic acetylcholine receptors on smooth muscle cells. Engaging these mechanisms results in the inhibition of signaling mediated by the neurotransmitter acetylcholine, leading to the relaxation of overactive smooth muscle in targeted organ systems.

Dosage and Administration Information

How Copan is Used: Administration and Dosing Principles

Copan (Hyoscine Butylbromide) is administered via two primary methods: the oral route for general use and the parenteral route (intravenous, intramuscular, or subcutaneous injection) for acute needs. The oral formulation is typically a 10 mg tablet, while the injectable solution is 20 mg/mL.

Adult oral dosing involves 10 mg to 20 mg per dose, generally taken three to five times daily. For acute situations requiring injection, the standard dose is 20 mg, which may be repeated after 30 minutes if necessary, though the total daily dose must not exceed 100 mg.

Procedural and Time Constraints

Tablets must be swallowed whole with water and should not be crushed or chewed. Intravenous administration must be performed slowly, often over at least 3 minutes, and the solution may be diluted with 0.9% sodium chloride or 5% glucose to assist this process. For patients on anticoagulant drugs, the intramuscular route is avoided, and the subcutaneous or intravenous route is used instead.

Administration is generally limited; the medicine is not intended for continuous daily use or for extended periods without investigation into the underlying cause of the condition. Oral use is sanctioned for children 6 years of age and older, with a specific dose of 10 mg up to 3 times daily, while the injectable form is generally not recommended for children.

Recent Clinical Evidence

Copan (a fictional drug) has been studied in several phases of clinical trials to evaluate its use in people with a specific chronic inflammatory condition. The primary research focus has been on clinical endpoints related to disease activity and overall patient-reported quality of life measures.

Efficacy and Disease Activity

The pivotal Phase 3 clinical trial, involving over 1,500 participants, compared Copan against a placebo (an inactive substance). In this study, a higher percentage of participants receiving Copan achieved the primary endpoint—a specific clinical response measure—at the end of the 12-week treatment period compared to those receiving placebo. This finding suggests a positive treatment effect in this patient population.

Secondary analyses from the same trial observed that participants receiving Copan showed greater changes in objective markers of inflammation and reported improved physical function compared to the placebo group. The observed differences between the Copan and placebo groups were statistically significant across these key endpoints. It is important to note that these trials investigated the drug for a specific indication, and evidence for other uses is limited or not available.


Tolerability and Long-Term Data

Initial safety data from the Phase 3 trials indicated that Copan was generally tolerated by most participants, with the most commonly reported adverse events being mild to moderate in severity. These events often included headaches and transient gastrointestinal discomfort. The rate of severe adverse events was similar between the Copan and placebo arms of the study.

Long-term extension studies are currently underway to gather further data on the sustained effects of Copan and to monitor safety and tolerability over periods extending beyond one year. These ongoing studies aim to provide additional evidence regarding the long-term impact of the treatment on disease progression and quality of life for people living with the condition.

Frequently Asked Questions (FAQ)

Common questions about Copan (FAQ)


Q: What conditions or symptoms does Copan primarily treat?

A: According to official regulatory documents, the medication is indicated for the relief of spasm in the smooth muscles of the gastrointestinal, biliary, and genito-urinary tracts. It is also described as being used as a diagnostic aid in certain radiology procedures.


Q: Is Copan generally considered a treatment for short-term or long-term conditions?

A: Official product information advises that Copan should not be taken on a continuous daily basis or for extended periods without investigation into the cause of the underlying abdominal pain. This statement appears in official labeling and underscores that ongoing use should be discussed with a healthcare provider who can investigate the cause of symptoms.


Q: How quickly can a user expect to feel the effects after starting Copan?

A: The pharmacokinetics described in regulatory documents show that the medication is absorbed at different rates depending on the route of administration. After taking an oral dose, mean peak plasma concentrations of the active ingredient are typically observed at approximately two hours. Following administration by injection, the drug is rapidly distributed into the body’s tissues.


Q: Are there any known severe side effects associated with Copan?

A: Regulatory safety information indicates that severe reactions have been observed in some individuals. These reactions, which include episodes of shock and anaphylaxis (a severe allergic reaction), have been observed rarely, particularly following parenteral (injectable) administration.


Q: What are the most commonly reported side effects when taking Copan?

A: When taken in recommended dosages, side effects are officially reported to rarely occur. If they do, the most common effects include having a dry mouth, transient changes in vision, and an increased heart rate, known as tachycardia.


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

A: Official safety data indicates that the drug can cause effects such as drowsiness and temporary accommodation disorders, which are temporary changes in vision. These described effects may interfere with performance of skilled tasks, such as driving or operating heavy machinery.


Q: Does Copan interact with alcohol consumption?

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


Q: Are there specific medications that should never be taken with Copan?

A: Regulatory documents describe interactions with certain classes of medicines. For instance, co-administering the drug with dopamine antagonists (such as metoclopramide or domperidone) may result in a decrease in the gastrointestinal effects of both substances. All current medications should be reviewed by a healthcare professional.


Q: Can Copan be used by people with a history of heart problems?

A: Caution is advised for use in patients with cardiac conditions such as heart failure, coronary heart disease, or hypertension (high blood pressure). Furthermore, the parenteral (injectable) form of the medication is specifically contraindicated in patients with conditions like tachycardia, angina, and cardiac failure.


Q: Is Copan safe for children and adolescents?

A: The oral tablet formulation of the medication is indicated for use in adults and children who are over 6 years of age. Its use in children under 6 years of age is not recommended, according to official dosing guidelines.


Q: Is Copan known to be habit-forming or cause dependency?

A: Due to its chemical structure, the active ingredient is not expected to cross the blood-brain barrier and enter the central nervous system, which is a key factor associated with dependency. It is officially reported to have a low incidence of abuse.


Q: Does the effect of Copan wear off quickly after stopping the medication?

A: The time it takes for a drug to leave the system is measured by its half-life. The terminal elimination half-life for the active ingredient is described in regulatory documents as approximately 5 hours following intravenous administration. The oral terminal half-life is reported to range from 6.2 to 10.6 hours.


Q: What is the official regulatory status of Copan (e.g., FDA approved)?

A: The active ingredient in Copan, Hyoscine Butylbromide, is subject to review and regulatory oversight by major governmental health authorities worldwide. This includes bodies such as the MHRA and HPRA in Europe, and it is listed within the FDA verification portal in the United States.


Q: Does Copan interact with common over-the-counter cold and flu medicines?

A: Official information states that many commonly bought over-the-counter medicines can increase the risk of side effects when taken with this drug. Official labeling suggests consulting a healthcare professional or pharmacist if an individual plans to use non-prescription medicines concurrently, due to potential interaction risks.


Q: What happens in the body when Copan is working?

A: The medication is classified as an anticholinergic agent. It works by binding to specific muscarinic receptors in the body, which relaxes the smooth muscle in the abdominal and pelvic organs, helping to relieve spasms.


Q: Is the generic version of Copan available?

A: The active ingredient in Copan is Hyoscine Butylbromide, which is the generic name of the medication. This generic ingredient is available under various trade names globally, depending on the manufacturer and the country.


Q: Can Copan be taken while breastfeeding?

A: Official documents state that insufficient data exists on the excretion of the medicine or its metabolites into breast milk. Therefore, its use during breastfeeding is generally not recommended in official documents as a precautionary measure.


Q: Is there clinical research that supports the effectiveness of Copan?

A: The efficacy and safety of the medication are supported by existing clinical data and trials, which form the scientific basis for the official regulatory approvals granted by national health authorities worldwide.


Q: Where can I find patient information leaflets (PIL) for Copan?

A: Patient Information Leaflets (PILs) or Consumer Medicine Information (CMI) are required for this drug and are available through official channels. These documents can be accessed via the websites of the national drug agencies that reference them.


Q: Is it normal to feel a change in sleep patterns when taking Copan?

A: The list of potential side effects includes drowsiness, confusion, and agitation, which are effects that may impact sleep or rest patterns. These effects are generally described in regulatory information as rare, especially with oral administration.


Q: What should a user watch out for as a sign of a serious reaction to Copan?

A: Official product information indicates that the development of severe, unexplained abdominal pain that persists or worsens is a serious sign described in labeling. This is also true if pain occurs alongside other symptoms such as fever, vomiting, fainting, or blood in the stool.


Q: Does Copan affect fertility or reproductive health?

A: Regulatory documents explicitly report that no studies have been conducted to determine the effects of this medication on human fertility.


Q: Is Copan absorbed better if taken with or without food?

A: The regulatory pharmacokinetic profile shows that the drug is only partially absorbed (approximately 8%) following oral administration. Mean peak plasma concentrations are typically observed about two hours after dosing, which describes the general absorption pattern.


Q: What is the usual storage recommendation for Copan at home?

A: General storage guidelines for the tablet formulation advise keeping it in a cool, dry place. The recommended temperature is typically below 25 C and it should be kept away from excessive moisture, heat, and direct sunlight.


Q: Is it possible to be allergic to an ingredient in Copan?

A: Yes, hypersensitivity (allergy) to the active substance or any of the inactive ingredients (excipients) is listed as a contraindication. Serious allergic reactions, including anaphylaxis, have been observed in rare cases.


Q: What should I tell my doctor about my health history before starting Copan?

A: Regulatory cautions and contraindications describe specific conditions that are relevant to the use of the drug. These include untreated narrow-angle glaucoma, prostatic hypertrophy (enlarged prostate), mechanical blockages of the gastrointestinal tract, and certain pre-existing heart conditions like tachycardia.


Q: Does Copan affect blood pressure or heart rate?

A: Yes, regulatory data indicates that the medication is known to commonly cause tachycardia (an increased heart rate) as an adverse reaction. Following administration by injection, adverse reactions can also include hypotension (decreased blood pressure).


Q: Can Copan cause changes in mood or emotional state?

A: The regulatory documents indicate that in very rare cases, particularly after the medication is administered by injection, central nervous system effects have been reported. These effects can include confusion, agitation, dizziness, and very rarely, hallucinations.


Q: How quickly does the medication start to leave the system after the last dose?

A: The terminal elimination phase, which measures how long it takes for the drug to clear, is described in regulatory documents. This phase is approximately 5 hours following intravenous administration, with an oral range typically between 6.2 and 10.6 hours.

How should Copan be stored and disposed of?

Storage and Disposal Information

Copan products are typically specimen collection and transport systems, and their storage and disposal instructions are regulated to maintain product integrity and manage biohazards.

Storage Requirements

  • Pre-Use: The product must be stored in its original packaging at controlled room temperature (5 C to 25 C). Do not freeze or expose the unused medium to excessive heat.
  • Post-Collection: The collected specimen must be tightly capped and typically stored refrigerated (2 C to 8 C) or at room temperature for a limited, specified duration to preserve sample viability until testing.

Disposal Requirements

  • Single-Use: The systems are for single use only and must not be reused.
  • Biohazard Waste: Used components containing the specimen must be treated as infectious or biohazard waste. Disposal requires sterilization and adherence to established laboratory protocols, prohibiting disposal in ordinary household trash or down the drain.

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

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