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Espacil Compuesto

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Espacil Compuesto

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Treatment option:

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.

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Overview of Espacil Compuesto

Quick Facts

Property Description
Active ingredient Clonixin, Hyoscine Butylbromide
Form Tablet, Solution for injection
Pharmacological class NSAID and Anticholinergic Spasmolytic
General purpose Relief of pain associated with spasms
Origin Synthetic compound

What Type of Medicine is Espacil Compuesto?

Espacil Compuesto is a fixed-dose combination synthetic preparation characterized by its dual functionality in the management of discomfort. It is primarily categorized by its two distinct pharmacological classes: an Analgesic agent and an Anticholinergic Spasmolytic agent. This approach is intended for addressing discomfort where both pain signals and involuntary muscle contractions are present. This dual mechanism is the distinguishing feature of the combination, offering a therapeutic strategy against acute visceral discomfort.

Composition and Available Forms

The preparation combines two specific active ingredients to achieve its therapeutic goals: Clonixin (functioning as the Nonsteroidal Anti-inflammatory Drug component) and Hyoscine Butylbromide (Scopolamine Butylbromide), which is responsible for the peripheral muscle-relaxing effect. The combination of these two established pharmacological agents provides a profile for treating spasm-related pain. The drug is produced as tablets for oral intake and as a solution for injection for parenteral administration, providing flexibility based on therapeutic need.

General Purpose of the Dual-Action Formula

The general therapeutic purpose of Espacil Compuesto is the targeted mitigation of acute, intense visceral discomfort and associated cramping. The formula's design addresses both the pain signals (analgesic action) and the underlying involuntary muscle contraction (spasmolytic action) that characterize this type of pain. This strategy ensures the relief is specific to pain that originates from internal organ spasms, providing a more complete therapeutic outcome than either ingredient could offer alone.

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What side effects are possible with Espacil Compuesto?

Possible Side Effects and Safety Information

The safety profile of Espacil Compuesto reflects the combined effects of its components: Clonixin (an NSAID) and Hyoscine Butylbromide (an anticholinergic).

Adverse reactions are formally organized by regulatory authorities into System Organ Classes (SOC) and classified by official frequency categories (e.g., Common, Uncommon, Rare, Not Known).

Common and Systemic Adverse Reactions

Adverse reactions classified as Common typically include those related to the anticholinergic action, such as dry mouth and tachycardia (increased heart rate). Side effects involving the Gastrointestinal System, such as stomach pain and indigestion, are frequently associated with the NSAID component.

Serious Adverse Reactions (SARs) and Limitations

The official label documents Serious Adverse Reactions which, though rare, are critical safety concerns. These include Anaphylactic Shock and severe Hypotension, especially following injection, and the potential for Gastrointestinal Bleeding or Ulceration associated with the NSAID component. Serious cardiac events have been reported in vulnerable patient populations.

Safety is considered in patients predisposed to conditions such as narrow-angle glaucoma or obstructions in the intestinal and urinary tracts. The injection form is specifically constrained for patients with pre-existing rapid heart rate conditions.

Special Population Safety Notes

Older adults may show increased susceptibility to both anticholinergic effects and the general risks of NSAIDs. Specific caution is noted in regulatory documents for patients with pre-existing impaired renal or hepatic function and those with underlying cardiac disease. Furthermore, the risk of cardiovascular events is noted to increase for the NSAID component with long-term exposure.

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Overdose and Emergency Response

An overdose of Espacil Compuesto is formally described in regulatory documents as presenting a distinct anticholinergic toxicity syndrome due to one of its active components. The documented clinical manifestations involve peripheral signs, including tachycardia (fast heart rate), urinary retention, dry mouth, flushing (reddening of the skin), and the presence of transient visual disturbances, such as accommodation disorders and mydriasis. Central Nervous System effects, including confusion, agitation, and hallucinations, have also been reported, particularly following injection.

Overdose is classified by the potential for severe, life-threatening outcomes, notably respiratory paralysis and abnormal breathing patterns like Cheynes-Stokes respiration. Regulator-mandated instructions stress that individuals must seek immediate medical attention for suspected overdose or if severe, unexplained abdominal pain occurs alongside systemic symptoms such as fever, vomiting, or fainting.

Official management procedures listed in regulatory information specify the use of parasympathomimetics as an antidote. Supportive care includes treating urinary retention with catheterisation and applying intubation and artificial respiration for respiratory paralysis. Furthermore, regulatory guidelines indicate that medical observation for at least 48 hours is required, as symptoms may have a delayed onset due to the drug’s components.

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Therapeutic Uses of Espacil Compuesto

What Espacil Compuesto Treats: Main Uses and Benefits

Espacil Compuesto is primarily indicated for the management of symptoms associated with painful spasms in the gastrointestinal and genitourinary tracts. It is commonly used to help manage spasmodic pain and related discomfort, which may present as intestinal colic, biliary colic, and renal colic. The benefit to the patient is the provision of symptomatic relief from these painful episodes.

This medication is used in the supportive care for various conditions, including spastic irritable bowel syndrome, certain types of enterocolitis, cholecystitis, and nephropathies associated with severe spasm.

Quick Fact: Relief for Spasmodic Pain

Regulatory References

  1. MedlinePlus drug guidance on antispasmodics
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Eligibility and Restrictions for Use

Who can and cannot use Espacil Compuesto?

This section outlines the official population eligibility for Espacil Compuesto (Clonixinato de Lisina / Butilbromuro de Hioscina) as defined by regulatory documents, focusing strictly on contraindications and limitations.


Populations with Absolute Contraindications

Use of this medicine is strictly prohibited in several populations. It is formally contraindicated in patients with known hypersensitivity to its components, as well as those with Active peptic ulcer, Megacolon, Acute abdomen, or Prostatic hypertrophy with urinary retention. Furthermore, use is Contraindicated during both pregnancy and lactation.


Age and Condition-Based Restrictions

The medicine is approved for adults and adolescents aged 12 years and older. Its effects are unknown in children under 12 years of age. Use with caution is advised for patients with severe liver disease or severe kidney disease. Caution is also required for those with pre-existing cardiovascular diseases or a history of gastrointestinal disorders, as specified in the official labeling.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Espacil Compuesto (Clonixin and Hyoscine Butylbromide) documents specific interaction patterns concerning its dual components.

Pharmacodynamic and Contraindicated Combinations

Co-administration with Anticoagulant Drugs is formally prohibited when the Hyoscine Butylbromide component is administered via intramuscular injection. The anticholinergic effect may be intensified by co-administration with other anticholinergic agents, including tricyclic antidepressants, antihistamines, and certain antipsychotics. Conversely, Dopamine Antagonists like Metoclopramide may result in a diminution of the product’s gastrointestinal effects.

Exposure Modification and Timing Rules

Co-administration with the NSAID component (Clonixin) may lead to an increase in the plasma concentration of Lithium and Methotrexate. The effects of Diuretics and ACE Inhibitors may be reduced. Antacids and Adsorbent Antidiarrheals may reduce the absorption of the medicine and therefore must be administered at least one hour before Espacil Compuesto. Official labeling also documents an increased risk of gastrointestinal bleeding when the NSAID component is co-administered with Alcohol.

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Mechanism of Action

How Espacil Compuesto Works

Muscarinic Receptor Modulation

This domain involves the action of Butylscopolamine (Hyoscine Butylbromide), which acts as an anticholinergic agent. It blocks muscarinic receptors on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts, inhibiting the effects of the neurotransmitter acetylcholine. This results in the inhibition of smooth muscle motility and reduction of basal muscle tone.

Prostaglandin Synthesis Inhibition

This second domain is mediated by Lysine Clonixinate, which acts by inhibiting the enzyme prostaglandinsynthetase (cyclooxygenase). This action modifies early molecular steps in the arachidonic acid cascade, reducing the synthesis of inflammatory mediators, specifically prostaglandins (PGE and PGF2alpha). This mechanism decreases the generation of key signals associated with inflammation and heightened tissue signaling.

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Dosage and Administration Information

How to Use Espacil Compuesto

This section describes the high-level, standardized usage principles for Espacil Compuesto. The administration is guided by the dual-action formula and its available dosage forms.

Administration Scope Official Guidelines
Route of Administration The drug is available for oral intake (tablets/capsules) and for parenteral administration, specifically via intramuscular (I.M.) or slow intravenous (I.V.) injection.
Dosing Schedule The standard parenteral dose for the spasmolytic component is 20 mg per single injection. The maximum total daily dose for the injectable component should not exceed 100 mg.
Frequency & Schedule Oral administration is generally used up to four times daily. The injectable dose may be repeated after 30 minutes if required for acute relief, while observing the daily maximum limit.

Procedural and Usage Constraints

Constraint Instruction
Administration Method Oral forms must be swallowed whole with water and must not be crushed, broken, or chewed. Intravenous injection must be administered slowly.
Age-Group Rules The medication is generally not recommended for use in children under 12 years of age.
Course Duration The medicine is designated for short-term use for acute episodes and should not be taken on a continuous daily basis or for extended periods.

These instructions establish a protocol where the oral form supports symptomatic management with a clear daily frequency, while the injectable form is reserved for rapid, acute intervention under controlled procedural conditions.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Espacil Compuesto

Evidence for Acute Visceral Pain and Colic

Research has examined this dual-action strategy, which combines an analgesic with a spasm-relieving component, in settings where patients experience sudden, severe abdominal discomfort. Studies primarily consist of short-term Randomized Controlled Trials (RCTs) and comparative trials, which were used in research exploring how symptoms change over time in patients presenting to urgent care. Researchers monitored outcomes related to patient-reported outcomes describing perceived discomfort, such as changes on standard pain intensity scales.

Findings indicate that the research documented variations in pain measurements in the initial hours following administration of this type of combined treatment. Comparative studies researching outcomes related to physical discomfort have reported how symptom intensity evolved in the observed groups when compared against placebo or single-agent treatments.

Research on Renal and Biliary Colic

Specific research has evaluated the use of spasm-relieving and pain-reducing combinations in acute episodes of renal colic and biliary colic. These are conditions involving periods of heightened symptoms due to issues in the urinary or biliary tracts. The trials reported measurements related to the speed with which pain intensity changed in patients with these acute conditions. Research also examined outcomes related to managing the acute event, such as the documentation of subsequent intervention or rates of hospital admission.

Unanswered Questions and Research Gaps

The evidence highlights what is known — and what is still uncertain — about this specific dual formulation. A primary gap is that many high-quality, comparative trials focused on combination therapies used similar but not identical analgesic components. As a result, comparative evidence is lacking specifically for the Clonixin and Hyoscine Butylbromide pairing across all indications. Additionally, research is predominantly designed around studies conducted during periods of increased symptom activity and short-term use, meaning long-term effects are not fully established.

Key Studies & References

  1. Hyoscine N-Butylbromide (Regulatory Document - General Safety and Use)
  2. Hyoscine Butylbromide – Application in Therapy and Current Clinical Research (Review on Antispasmodic component)
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Frequently Asked Questions (FAQ)

Common questions about Espacil Compuesto (FAQ)


Q: What factors might increase the risk of experiencing side effects with Espacil Compuesto?

A: According to official product information, the risk of experiencing side effects may be greater in older adults or in patients who have pre-existing conditions like heart, liver, or kidney disease. The risk can also increase if the medicine is taken with certain other drugs, such as those that have anticholinergic properties or central nervous system (CNS) depressants.


Q: Is it normal to feel slightly drowsy after taking Espacil Compuesto?

A: Official documents list dizziness as a common undesirable effect of the medicine. While drowsiness is not listed as common, official documents advise caution when performing tasks that require mental alertness after taking the medicine.


Q: Are there any warnings about driving or operating machinery after taking this medicine?

A: Yes, official labeling advises that caution should be observed when driving or operating machinery. This warning is in place because the medicine may cause undesirable effects such as dizziness or temporary vision changes (accommodation disorders).


Q: Can Espacil Compuesto be used if a person has pre-existing glaucoma?

A: Official regulatory documents indicate that the medicine is contraindicated (must not be used) in patients with untreated narrow-angle glaucoma. If a patient experiences a painful, red eye with loss of vision while taking the medication, official documents note that these symptoms require urgent medical assessment.


Q: What is stated in the official literature about use in patients with prostatic enlargement?

A: The medicine is formally contraindicated in patients with prostatic hypertrophy (enlargement) that leads to urinary retention. General caution is advised in official documents for use in patients with prostatic enlargement.


Q: Does taking Espacil Compuesto affect a person's ability to sweat or regulate body temperature?

A: Due to the anticholinergic component, the medicine may reduce sweating. Because of this, official product information advises caution when the medicine is administered to patients who already have a fever.


Q: Are there any serious side effects associated with Espacil Compuesto that are listed in the product information?

A: Yes, official regulatory labels document Serious Adverse Reactions (SARs), though these are rare. These serious concerns include the possibility of anaphylactic shock (a severe allergic reaction), severe hypotension (very low blood pressure), and the potential for gastrointestinal bleeding or ulceration.


Q: Does Espacil Compuesto affect the effectiveness of oral contraceptives?

A: Regulatory-aligned guidance indicates there are no documented clinical interactions between the antispasmodic component and hormonal contraceptives. However, official information notes that if vomiting occurs as a side effect, the absorption of other orally taken medications may be affected.


Q: What is the difference between an antispasmodic and an antispastic medication?

A: Authoritative medical literature provides a conceptual distinction between these drug classes. Antispasmodics are described as agents that treat acute muscle spasms, such as those that occur in the gut. Antispastics are generally agents used to treat continuous muscle spasticity resulting from neurological conditions.


Q: Is the combined use of the two active ingredients considered a common therapeutic strategy?

A: The product is defined in official literature as a fixed-dose combination, and this dual-action strategy is a comprehensive therapeutic approach. It is designed to address discomfort where both pain signals (analgesic) and involuntary muscle contractions (spasmolytic) are present.


Q: Is there any information regarding the effects of Espacil Compuesto on blood pressure?

A: Official labeling documents that the medicine can cause a decrease in blood pressure (hypotension) and an increase in heart rate (tachycardia), particularly when administered by injection. Caution is noted in official documents for patients with pre-existing heart conditions.


Q: How does Espacil Compuesto relate to other antimuscarinic drugs, if at all?

A: Espacil Compuesto contains Hyoscine Butylbromide, which is pharmacologically classified as an anticholinergic agent. This means the compound works by blocking muscarinic receptors to achieve its smooth muscle-relaxing effect.


Q: What should be done if an adverse reaction to the medicine occurs, based on official guidance?

A: Official guidance indicates that a severe, unexplained abdominal pain or other concerning symptoms like fever, vomiting, or blood in stool require immediate medical assessment. Patients are also advised to officially report suspected adverse reactions to the relevant regulatory authority.


Q: Does official documentation specify how to dispose of unused Espacil Compuesto?

A: Official documentation requires that the product be discarded in accordance with local environmental and pharmaceutical waste regulations. Disposal via household waste or wastewater is generally advised against to protect the environment.


Q: What official warnings exist about using Espacil Compuesto with other prescription medications?

A: Official warnings document that the medicine may intensify the effects of other anticholinergic drugs, such as certain antidepressants. Additionally, the medicine can increase the blood concentration of certain drugs, including Lithium and Methotrexate.

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How should Espacil Compuesto be stored and disposed of?

Official Storage Requirements

Espacil Compuesto must be stored according to regulatory requirements to ensure its stability. The medication must be kept at room temperature, specifically at a temperature not exceeding 30 C. To prevent product degradation, it is required to store the drug in a dry place and away from light. The medication does not require refrigeration and must not be stored in freezing conditions.

Handling and Disposal

As mandated by official labeling, the medication must be stored out of the sight and reach of children for safety. No specific instructions are provided for environmental handling or disposal beyond the requirement to discard unused or expired product in accordance with local environmental and pharmaceutical waste regulations.

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

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