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Espass Compuesto

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Espass 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 Espass Compuesto

Quick Facts

Property Description
Active ingredients Paracetamol (Acetaminophen), Scopolamine (Hyoscine)
Form Oral Solid Formulation (Tablet or Capsule)
Pharmacological Class Analgesic-Antispasmodic
General Purpose Mitigation of Painful Spasmodic Conditions
Origin Combination of Synthetic and Natural Alkaloid

What is Espass Compuesto?

Espass Compuesto is defined as a fixed-dose combination (FDC) medicinal product, which is fundamentally an analgesic-antispasmodic agent. This structure is engineered for oral administration, typically as a tablet or capsule, and is designed to provide comprehensive relief from pain that is associated with smooth muscle spasm. The specific combination of Paracetamol and Scopolamine is often regionally recognized for the targeted relief of acute, cramping abdominal discomfort.

Defining Composition and Class: A Dual-Action Agent

The medication's dual classification stems from its two distinct active ingredients: Paracetamol (Acetaminophen) and Scopolamine (Hyoscine). The Paracetamol component is utilized for its established non-opioid pain relief and fever-reducing properties. The Scopolamine component, conversely, is classified as a potent anticholinergic agent, primarily functioning as a nonselective muscarinic antagonist to relax smooth muscle. Scopolamine is a tropane alkaloid, an entity naturally derived from certain plants, while Paracetamol is a synthetic compound. This combination is commonly found in formulations internationally, underscoring its established presence in the therapeutic area.

General Purpose and Verified Action

The primary function of Espass Compuesto is the efficient mitigation of acute discomfort that arises in visceral organs due to involuntary muscle contractions. The combination offers a therapeutic synergy: the Paracetamol component diminishes the overall feeling of discomfort, while the Scopolamine component directly resolves the underlying muscular spasm. This mechanism is clinically recognized for providing relief in cases where simple non-steroidal anti-inflammatory drugs (NSAIDs) may not adequately address the spasmodic component of the pain.

Regulatory References

  1. NIH MedlinePlus
  2. NIH StatPearls
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What side effects are possible with Espass Compuesto?

Possible Side Effects and Safety Information

The safety profile of Espass Compuesto, as defined by government regulatory agencies, details the documented adverse reactions and safety restrictions associated with its use. Side effects are officially categorized by their frequency and the affected body system.

Adverse Reaction Classification

Adverse reactions are classified according to standard regulatory definitions based on the likelihood of occurrence:

  • Common: Reactions expected to occur in 1% to less than 10% of patients.
  • Uncommon / Rare: Reactions occurring in less than 1% of patients, with Very Rare events occurring in less than 0.01% of patients.
  • Not Known: Reactions where the frequency cannot be reliably estimated from available data.

Officially documented side effects are grouped by the System Organ Class (SOC) they affect, including the Gastrointestinal System, Nervous System, Immune System, and Skin.

Key Documented Adverse Reactions

Commonly reported non-serious adverse events often relate to the medicine's components and may include anticholinergic effects like dry mouth, constipation, and blurred vision.

Serious Adverse Reactions

The official labeling highlights specific serious adverse reactions that are typically rare but clinically significant:

  • Agranulocytosis: A severe blood disorder officially documented, which may occur at any time during treatment and requires immediate discontinuation and monitoring.
  • Anaphylactic Reactions: Severe, potentially life-threatening hypersensitivity reactions.
  • Severe Cutaneous Adverse Reactions (SCARs): Including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Safety Restrictions and Monitoring

The medicine is subject to official restrictions and specific safety considerations. It is contraindicated (must not be used) in patients with known severe conditions, such as bone marrow depression or known hypersensitivity to the drug's components. Special warnings mandate caution in patients with conditions like glaucoma or prostatic hypertrophy. Furthermore, regulatory documents require monitoring, particularly blood cell counts, to detect the potential onset of serious hematologic side effects.

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Overdose and Emergency Response

Espass Compuesto overdose involves a dual risk profile due to its active ingredients, requiring urgent medical assessment based strictly on documented regulatory guidance. Overdose manifestations include symptoms of early Paracetamol toxicity, such as pallor, nausea, and vomiting, alongside the acute anticholinergic syndrome caused by Scopolamine, which presents with agitated delirium, dilated pupils (mydriasis), tachycardia, confusion, and urinary retention.

The regulatory profile documents the potential for severe, life-threatening outcomes, including acute liver failure, acute renal failure, seizures, and cardiovascular collapse. Because severe liver damage from the Paracetamol component can have a delayed onset, immediate medical attention must be sought in all cases of suspected overdose, even if the patient appears well.

Management procedures officially described include the administration of the documented antidote, N-acetylcysteine, for Paracetamol toxicity, and specialized care for the anticholinergic component, such as using Physostigmine for severe symptoms. Required monitoring includes continuous observation, specifically continuous cardiac monitoring and measurement of plasma Paracetamol concentration. Special considerations are noted for patients with hepatic or renal impairment, who face an increased risk of severe toxicity.

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Therapeutic Uses of Espass Compuesto

Main Uses of Espass Compuesto

Espass Compuesto is a combination medication primarily used to manage symptoms associated with gastrointestinal and biliary spasms. It addresses conditions characterized by involuntary muscle contractions in the digestive tract and associated pain.

Relief of Smooth Muscle Spasms

The medication is frequently utilized for the symptomatic treatment of colics and cramps. It works by relaxing the smooth muscles found in the walls of internal organs, which helps to alleviate the following conditions:

  • Gastrointestinal Spasms: Relief of painful contractions in the stomach or intestines.
  • Biliary Colic: Management of pain resulting from spasms in the bile ducts.
  • Renal Colic: Addressing acute pain caused by spasms in the urinary tract.

Pain Management

In addition to its antispasmodic properties, Espass Compuesto contains an analgesic component. This combination is specifically designed to provide dual action: reducing the underlying muscle spasm while simultaneously dampening the pain signals associated with the condition. This makes it effective for acute episodes where pain and cramping occur together.

Therapeutic Benefits

The primary benefit of this medication is the restoration of comfort by addressing both the physical contraction of the muscle and the resulting pain sensation. By targeting these two distinct pathways, the medication helps to:

  • Decrease the intensity and frequency of abdominal cramps.
  • Improve functional comfort during digestive disturbances.
  • Provide rapid relief from acute spasmodic pain episodes.

Because it addresses the involuntary movement of internal muscles, it is specifically indicated for visceral pain rather than musculoskeletal or surface-level pain.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Espass Compuesto?

This section outlines the population eligibility and non-eligibility criteria for Espass Compuesto (a combination of Paracetamol and Hyoscine Butylbromide) as defined by authoritative regulatory documents.


Absolute Contraindications

The medicine is contraindicated and must not be used by individuals presenting with the following conditions:

  • Hypersensitivity to Paracetamol, Hyoscine Butylbromide, or any excipients.
  • Severe Hepatocellular Insufficiency or Severe Active Liver Disease.
  • Untreated Narrow-Angle Glaucoma or Myasthenia Gravis.
  • Obstructive Diseases such as mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon, or obstructive uropathy with urinary retention.

Eligibility Restrictions

Age-Related Rules: The product is not suitable or not recommended for children under 10 years of age. Caution is advised when administering to older adults due to increased sensitivity to anticholinergic effects.

Organ Function: Use is contraindicated in severe liver impairment. Caution is required when administering to patients with non-severe impaired kidney or liver function or certain cardiovascular conditions.

Reproductive Status: Use is not recommended during pregnancy and lactation and should be avoided as a precautionary measure due to insufficient safety data.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Espass Compuesto, containing Paracetamol (Acetaminophen) and Scopolamine (Hyoscine), outlines specific pharmacokinetic and pharmacodynamic interactions documented in governmental prescribing information.

Documented Interaction Patterns

Classification Interacting Agents and Official Description
Exposure-Altering Interactions Metoclopramide may increase the absorption rate of Paracetamol, while Cholestyramine reduces its absorption. Probenecid is documented to reduce Paracetamol clearance, potentially altering plasma concentrations.
Additive Pharmacodynamic Effects Co-administration with other anticholinergic agents (e.g., tricyclic antidepressants) may result in an additive intensification of anticholinergic effects. CNS depressants, including alcohol, may enhance effects like drowsiness.
Hepatotoxicity Risk Formal prohibition exists against using this medicine with other Paracetamol-containing products to prevent exceeding the daily maximum dose and the risk of severe liver damage. Chronic consumption of alcohol is also documented to enhance this specific risk.
Anticoagulant Modulation Prolonged use of maximum daily doses of Paracetamol (4 g/day for at least 4 days) may formally increase the effect of oral anticoagulants like Warfarin, necessitating monitoring.

Administration Constraints

To mitigate reduced absorption, Paracetamol should be administered at least one hour apart from Cholestyramine. Caution is advised for the use of the Scopolamine component in elderly patients and those with impaired renal or hepatic function due to the increased likelihood of CNS adverse reactions.

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Mechanism of Action

Peripheral Muscarinic Receptor Blockade and Spasmolysis

This mechanism, driven by Scopolamine (Hyoscine), involves the non-selective competitive antagonism of muscarinic acetylcholine receptors ( M receptors) on visceral smooth muscle. By blocking acetylcholine binding, the drug interrupts the parasympathetic nerve signal that stimulates muscle contraction. This action modulates the initial molecular steps of excitation, resulting in spasmolysis—a physiological reduction in the baseline tone and contractility of the smooth muscle fibers. This action modulates dysregulated parasympathetic tone, which contributes to an overall physiological state characterized by reduced visceral smooth muscle contractility.

Central Modulation of Nociceptive and Thermoregulatory Pathways

The analgesic component, Paracetamol, acts by preferentially inhibiting Cyclooxygenase (COX) enzymes within the Central Nervous System. This enzyme inhibition reduces the synthesis of key prostaglandins ( PGE2) in the spinal cord and hypothalamus. This modification of mediator levels elevates the central nociceptive threshold and resets the hypothalamic thermoregulatory center, thereby altering the body's response to pyrogenic signals and nociceptive input.

Complementary Two-Pronged Pathway Engagement

Espass Compuesto engages two mechanistically distinct systems simultaneously: receptor antagonism at the periphery and enzyme inhibition/neuromodulation in the CNS. This strategy supports the modulation of two different physiological consequences: peripheral smooth muscle contractility and central nociceptive transmission. The combined action utilizes mechanisms that influence the spasm-nociception feedback loop by modulating two distinct physiological systems.

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Dosage and Administration Information

Espass Compuesto is a fixed-dose combination product containing Hyoscine Butylbromide 10 mg and Paracetamol 500 mg per tablet. The drug is intended for oral use only.

Official Administration Guidelines

Instruction Detail
Route of Administration Oral administration only.
Standard Dosing Regimen Adults and adolescents over 10 years: 1 to 2 tablets per dose, taken up to three times daily.
Maximum Daily Dose The total daily dose must not exceed 6 tablets in 24 hours (equivalent to 60 mg Hyoscine Butylbromide / 3000 mg Paracetamol).
Administration Method The tablets must be swallowed whole with an adequate amount of water. They should not be chewed or crushed.
Duration Constraint The product is restricted to short-term use only. It should not be taken for more than 3 days without consulting a healthcare professional.
Age Restriction Not suitable for use in children under 10 years of age.

Procedural Context

This medication is dosed on a multiple-times-daily basis, with doses typically spaced out evenly. The instructions defining the maximum daily intake and the short-term duration constraint establish a protocol for the standardized use of the product. Due to the Paracetamol component, patients with hepatic or renal impairment may require dose adjustments, though specific guidance is determined by a clinician.

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Recent Clinical Evidence

Espass Compuesto: Recent Clinical Evidence

This section summarizes the published research and clinical evaluations conducted for the fixed-dose combination of an antispasmodic (Scopolamine/Hyoscine) and an analgesic (Paracetamol/Acetaminophen). The findings describe group patterns observed in studies and help contextualize how patients reported their experiences.


Evidence for Main Therapeutic Uses

The combination was studied for use in recurrent crampy abdominal pain through Randomized Controlled Trials (RCTs). These trials often compared the combination against placebo and its individual components, with some studies reporting that the measured change in pain intensity was similar to outcomes seen with the analgesic or antispasmodic used separately. Research also explored the combination in settings of acute, colicky abdominal pain, where data showed patterns related to measured changes that were associated with the measured effect of the single components. For primary dysmenorrhea (menstrual cramps), studies explored outcomes related to pain intensity and functional limitations over short, five-day periods, though the evidence is limited by the modest number of dedicated placebo-controlled trials on the fixed combination.


Evidence Gaps and Scientific Uncertainty

Across multiple indications, research is still needed to clarify whether the combination is associated with a demonstrable advantage over monotherapy, as data show patterns related to the measured effect of its individual components. The majority of clinical trials focused on short-term or acute symptom patterns. Consequently, long-term effects are not fully established, and follow-up durations were limited, making it difficult to contextualize outcomes beyond the trial periods. Furthermore, data for certain groups remain insufficient, including evidence for children, older adults, or pregnant individuals.

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Frequently Asked Questions (FAQ)

Common questions about Espass Compuesto (FAQ)


Q: How long does it typically take to feel the effects after taking Espass Compuesto?

Official information suggests that the antispasmodic component may begin to affect painful cramps within 15 minutes. The rate at which the analgesic component is absorbed can sometimes be affected if the stomach empties more slowly.

Q: What are the most common mild side effects reported for Espass Compuesto?

According to the medicine's official profile, commonly reported non-serious adverse events often relate to the anticholinergic component. These may include mild effects such as dry mouth, constipation, and blurred vision.

Q: Can Espass Compuesto cause drowsiness or affect my ability to drive?

Official documents indicate that the hyoscine component may cause drowsiness or temporary vision problems. Official documents indicate the need for caution regarding driving or operating machinery until patients are aware of how this medicine affects their individual response.

Q: What happens if I forget a dose of Espass Compuesto?

Regulatory guidance suggests that a missed dose is typically skipped if it is nearly time for the next scheduled dose. Two doses are not taken together, but the specific protocol should follow the guidance of a healthcare professional.

Q: What is the intended duration of use for Espass Compuesto as described by the manufacturer?

The product is generally restricted to use for no more than three consecutive days. The official administration guidelines state that use beyond this duration requires consultation with a healthcare professional.

Q: Is there official information available regarding the use of Espass Compuesto during pregnancy?

Regulatory documents indicate that use during pregnancy is not recommended and is avoided as a precautionary measure due to insufficient specific safety data. Data on the paracetamol component, however, has not shown an increased risk of malformations.

Q: Does Espass Compuesto help with symptoms of irritable bowel syndrome (IBS)?

The antispasmodic ingredient, hyoscine butylbromide, is specifically indicated in some regions for the relief of gastro-intestinal spasm, which is a common symptom in medically confirmed Irritable Bowel Syndrome (IBS). The combination is used to modulate the painful spasmodic component of abdominal discomfort.

Q: Why is Espass Compuesto sometimes prescribed for kidney stone pain?

The antispasmodic component is documented for use in conditions of acute spasm. This mechanism is relevant for conditions such as renal or biliary colic, which involve painful smooth muscle contractions in the urinary or bile duct systems.

Q: Can Espass Compuesto be taken on an empty stomach?

The official administration guidelines state that the tablets are to be swallowed unchewed with sufficient liquid. The documents do not provide specific regulatory guidance on whether the medicine must be taken with or without food.

Q: Are there different forms of Espass Compuesto, like tablets versus solution?

The fixed-dose combination product is generally available as an oral solid formulation, such as a film-coated tablet or capsule. Injectable forms (solutions) typically contain only the antispasmodic ingredient and are not the combination product.

Q: Can elderly patients use Espass Compuesto safely according to official guidelines?

Official guidelines advise caution when this medicine is administered to older adults. This is due to their increased sensitivity to the anticholinergic effects, which may increase the potential for central nervous system reactions.

Q: Does taking Espass Compuesto affect birth control pills?

Current authoritative guidelines suggest there are no documented interactions between the antispasmodic component and Oral Contraceptive Pills (OCPs) that would compromise their effectiveness. Any concern is typically limited to the potential for significant vomiting shortly after taking an OCP.

Q: What types of drug-drug interactions are listed in the official documents for Espass Compuesto?

The official prescribing information classifies documented interaction patterns into several regulatory types. These include Exposure-Altering Interactions, Hepatotoxicity Risk, Additive Pharmacodynamic Effects, and Anticoagulant Modulation.

Q: Is Espass Compuesto used to treat muscular cramps or only cramps in internal organs?

The medicine's primary mechanism of action involves blocking receptors on visceral smooth muscle, which refers to the muscles of internal organs, such as the gastrointestinal tract. The product is not typically documented for treating skeletal muscular cramps.

Q: Is the medicine known to have 'rebound' effects when stopped suddenly?

Official information indicates that abrupt discontinuation of the analgesic component after prolonged use at high doses may be associated with certain withdrawal symptoms. These can include headache, tiredness, or nervousness, which are typically temporary.

Q: Do people sometimes use Espass Compuesto for stomach aches that aren't spasms?

While the official purpose of the combination product is centered on managing painful spasmodic conditions, the medicine is also indicated for general pain in diseases of the stomach or intestine. The paracetamol component contributes to general pain relief.

Q: What should I do if I experience a severe, rare side effect?

Regulatory labeling indicates that discontinuation is necessary at the first sign of a hypersensitivity reaction or the onset of severe cutaneous adverse reactions (SCARs). Immediate medical advice should be sought if symptoms are severe or new symptoms occur.

Q: What is the regulatory status of Espass Compuesto in the US or Europe?

The single antispasmodic component is available without a prescription for certain indications in some regions. However, the regulatory classification and availability of the fixed-dose combination product can vary significantly between countries and jurisdictions.

Q: Does Espass Compuesto interact with alcohol?

Official warnings state that alcohol consumption may increase the chance of certain side effects, such as drowsiness. Chronic alcohol consumption is also documented to enhance the specific risk of severe liver damage associated with the Paracetamol component.

Q: Does the efficacy of Espass Compuesto diminish over time with repeated use?

A clinical study that examined the combination over three weeks indicated that measured efficacy remained stable across the assessment periods. Regulatory context generally advises short-term use.

Q: Where can I find the most authoritative information about Espass Compuesto?

The most authoritative and official drug information is consistently published by national regulatory agencies. These include government bodies such as the FDA, the European Medicines Agency (EMA), Health Canada, or the MHRA.

Q: Are there any studies that have examined the long-term safety of Espass Compuesto?

Regulatory context indicates that long-term effects are not fully established, and follow-up durations in most clinical trials have been limited. Regulatory guidelines include advisories for monitoring blood cell counts and organ function if the product is used for a prolonged period.

Q: What kind of research has been done on Espass Compuesto in different patient groups?

Clinical research primarily focused on general adult populations experiencing crampy abdominal pain. Regulatory documents note that evidence is currently considered insufficient for certain specific patient groups, including children, older adults, and pregnant individuals.

Q: What is the general patient expectation for symptom relief with Espass Compuesto?

Based on information for the single antispasmodic component, symptom relief is often associated with the easing of cramps within 15 minutes. The product is intended to modulate the acute discomfort caused by visceral spasms.

Q: Are there any warnings about using Espass Compuesto before a surgical procedure?

The official labeling does not specifically list broad pre-operative warnings for the oral tablet form. Caution is generally advised for patients with certain pre-existing cardiac conditions due to the potential for the antispasmodic ingredient to cause temporary tachycardia (increased heart rate).

Q: Is Espass Compuesto available without a prescription in some countries?

While the single antispasmodic component (Hyoscine butylbromide) is available without a prescription for certain indications in some countries, the regulatory classification and availability of the fixed-dose combination product can vary significantly by country and jurisdiction.

Q: Is there official information available regarding the use of Espass Compuesto during lactation?

According to official regulatory documents, the use of this medicine is not recommended during lactation. Use is avoided as a precautionary measure due to insufficient safety data.

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How should Espass Compuesto be stored and disposed of?

How to Store and Dispose of Espass Compuesto?

The storage and disposal of Espass Compuesto must strictly follow regulatory labeling to maintain product stability and ensure safety.

Official Storage Requirements

Condition Requirement (Official Labeling)
Temperature No special temperature conditions are required.
Container Conserve in its original packaging to protect from humidity.
Child Safety Must be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired medication must not be disposed of through wastewater or household waste. Instead, the product and its packaging must be taken to a designated pharmaceutical waste collection point in accordance with local regulations.

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

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