Espasmovet Compuesto

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Espasmovet Compuesto

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Overview of Espasmovet Compuesto

Quick Facts

Property Description
Active Ingredients Hyoscine Butylbromide, Ibuprofen
Form Tablet (Fixed-dose combination)
Pharmacological Class Antispasmodic / Nonsteroidal Anti-inflammatory Drug (NSAID)
Route of Administration Oral
Origin Synthetic Compounds

What Type of Medicine is Espasmovet Compuesto?

Espasmovet Compuesto is defined as a fixed-dose combination product, which is a specific type of combination analgesic containing two distinct active ingredients in a single unit, typically supplied as tablets for oral administration. This unique formulation simultaneously classifies the medicine as an antispasmodic agent (Hyoscine Butylbromide) and a Nonsteroidal Anti-inflammatory Drug (NSAID) (Ibuprofen). This dual-component approach addresses the multifaceted nature of visceral discomfort, providing relief compared to single-agent treatments. The formulation is intended to manage a comprehensive set of symptoms associated with visceral pain by targeting both muscle spasm and pain signals.


Active Ingredients and Composition

The composition is centred on the combined mechanisms of the two synthetic active ingredients: Hyoscine Butylbromide and Ibuprofen. Hyoscine Butylbromide acts as an anticholinergic to promote targeted smooth muscle relaxation in the gastrointestinal, biliary, or genito-urinary tracts, directly easing the cramping (spasm). Ibuprofen provides the systemic analgesic and anti-inflammatory components by limiting the synthesis of prostaglandins. These combined actions provide symptomatic relief from pain and inflammation within the formulation. This means the preparation is positioned as a dual-acting solution for managing acute discomfort, such as the pain associated with an episode of intestinal spasm.


General Purpose and Dual Action

The general purpose of this preparation is to deliver a synergistic effect through its dual action, which is a key differentiating feature. This mechanism is intended to provide symptomatic relief of spasmodic pain by easing muscle tension while simultaneously mitigating accompanying pain and inflammation. The product thus addresses the two main facets of acute visceral tension within a single, orally administered tablet.

Regulatory References

  1. EMA's mission and activities
  2. National Library of Medicine (NLM)
  3. MedlinePlus, "Ibuprofen"
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What side effects are possible with Espasmovet Compuesto?

Possible side effects and safety information

The safety profile of this fixed-dose combination reflects the adverse reactions officially documented for its two active components, Hyoscine Butylbromide (anticholinergic) and Ibuprofen (NSAID). Adverse effects are classified by frequency and the body systems they affect.

Adverse Reaction Classification

Frequency Category Representative Effects
Common (officially listed) Tachycardia (increased heart rate), Dry mouth, Constipation, Dizziness, Accommodation disorders (blurred vision), Nausea, Headache
Not Known (post-marketing) Anaphylactic Shock, Urinary retention, Flushing, Increased intraocular pressure, Serious Skin Reactions (e.g., SJS)

Serious Adverse Reactions and Systemic Risks

The official labeling for the Ibuprofen (NSAID) component carries warnings regarding serious and potentially fatal systemic risks. These include an increased risk of Cardiovascular Thrombotic Events (such as Myocardial Infarction and Stroke) and serious Gastrointestinal Events (including bleeding, ulceration, and perforation).

Other serious adverse reactions documented in regulatory sources include Anaphylactic Shock, severe Hepatotoxicity (liver injury), and rare but severe Skin Reactions.

Safety Considerations for Specific Populations and Exposure

Safety statements address specific patient groups and duration of use. Older adults are noted in regulatory documents as having a greater risk for serious gastrointestinal events from the NSAID component and increased susceptibility to anticholinergic effects like urinary retention. The risk of serious cardiovascular events may increase with the duration of use of the Ibuprofen component. Additionally, the medicine is used with caution in patients with conditions predisposing to urinary retention (such as prostate hypertrophy) or narrow-angle glaucoma.

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Overdose and Emergency Response

The official regulatory profile for an overdose of Espasmovet Compuesto is defined by the combined effects of its two active components, Hyoscine Butylbromide and Ibuprofen, impacting the CNS, cardiovascular, GI, and renal systems. Overdose manifestations may present as a dual-component toxidrome combining anticholinergic symptoms such as tachycardia, dry mouth, urinary retention, and flushing, with signs of systemic NSAID toxicity, including gastrointestinal distress, severe headache, incoherence, and confusion.


Documented Severe Outcomes and Required Actions

Outcome/Action Official Regulatory Statement
Severe Outcomes Overdose is associated with severe or life-threatening events, specifically including coma, convulsions (seizures), shock (severe low blood pressure), acute kidney injury, respiratory paralysis, and severe gastrointestinal bleeding.
Emergency Action Seek immediate medical attention or contact a Poison Control Center right away if overdose is suspected. Urgent medical help is mandated for signs of severe allergic reaction, or clear signs of severe internal bleeding (e.g., vomiting blood, black stools).
Specific Treatment Note Management is primarily symptomatic and supportive. For the Hyoscine component, anticholinergic symptoms are officially documented to respond to parasympathomimetics; however, no specific antidote is known for Ibuprofen, and intensive monitoring may be required.
Population Risk Patients age 60 or older have an increased risk of severe GI bleeding. Adverse effects may be more serious in patients with underlying cardiac conditions due to the Hyoscine component.
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Therapeutic Uses of Espasmovet Compuesto

Espasmovet Compuesto is commonly used when short-term symptomatic assistance is needed, applied across domains where additional symptomatic support is required. This medication provides support that helps ease the overall symptom burden in conditions marked by increased discomfort or tension. Fixed-dose combinations of this nature are utilized for managing symptoms related to physical discomfort and heightened physiological activity.

Common scenarios of use include symptoms associated with gastrointestinal, biliary, or genitourinary spasms, as well as other conditions where symptoms intensify temporarily. The formulation is intended to address symptom clusters that become intense or disruptive, and assists with maintaining functional stability when symptoms interfere with daily comfort.

“The goal is to provide supportive relief that helps patients cope more steadily during difficult episodes.”

This approach is relevant in conditions characterized by periods of heightened symptoms, often used when manifestations escalate temporarily and supportive relief is needed.

Quick Fact: Key Focus: Symptomatic Support During Pronounced Discomfort

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Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Espasmovet Compuesto

This section describes the officially documented eligibility and non-eligibility for using Espasmovet Compuesto, strictly based on government regulatory documentation (such as product labeling and SmPC equivalents).

Eligible Population (Conditional Use):

Use is allowed only for adults and children older than 12 years of age who are free from all contraindicating conditions, sensitivities, and physiological states listed below.

Populations for Whom Use is Strictly Contraindicated:

The medicine must not be used by the following groups or in the presence of these conditions:

  • Hypersensitivity: Patients with known allergy to any component, or a history of bronchospasm, angioedema, or urticaria caused by aspirin or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs).
  • Age and Physiological Status: Children under 12 years of age, and women who are pregnant or breastfeeding.
  • Existing Comorbidities: Individuals with active peptic ulcer or gastroduodenal hemorrhage, severe renal insufficiency, glaucoma, hematopoietic disorders, myasthenia gravis, prostatic hypertrophy (or tendency toward urinary retention), or specific intestinal conditions like paralytic ileus or ulcerative colitis.

These official eligibility constraints define the safe use profile, ensuring that only individuals outside of these high-risk categories may receive the medicine.

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What should I know about interactions with other medicines?

The official regulatory profile for Espasmovet Compuesto, a fixed-dose combination of an NSAID (Ibuprofen) and an anticholinergic (Hyoscine Butylbromide), establishes strict constraints for co-administration based on documented pharmacokinetic and pharmacodynamic interactions.

Classification Interacting Substances/Contexts Official Interaction Outcome
Contraindicated Other NSAIDs (including aspirin), CABG surgery setting High risk of serious gastrointestinal bleeding or cardiovascular events.
Exposure Alteration Lithium, Digoxin, Methotrexate Documented increase in serum concentration or plasma levels.

The Ibuprofen component elevates the risk of severe bleeding when co-administered with Anticoagulants (e.g., Warfarin), Corticosteroids, and SSRIs. It also officially reduces the effectiveness of Antihypertensive Agents and Diuretics. The Hyoscine component's effects are officially intensified by other Anticholinergic agents (e.g., tricyclic antidepressants, antihistamines), leading to an additive pharmacodynamic response. This action may be diminished by Dopamine Antagonists. Furthermore, consumption of Alcohol (three or more drinks daily) is documented to increase the risk of GI bleeding, and certain Antacids require time separation to maintain drug absorption. The interaction structure is defined by these documented prohibitions and constraints.

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Mechanism of Action

The mechanism of action for Espasmovet Compuesto involves two distinct components acting upon smooth muscle cells. The primary active component selectively binds to muscarinic M3 receptors, thereby antagonizing acetylcholine binding. This molecular interaction decreases the downstream signal transduction cascade in the smooth muscle cells, which typically mediates cellular contraction.

The secondary compound, a derivative of papaverine, acts on L-type calcium channels. It non-selectively inhibits phosphodiesterase and functions as an antagonist at these channels, reducing calcium influx across the cell membrane. The combined effect of muscarinic receptor antagonism and calcium channel modulation results in a significant reduction of intracellular Ca^2+ concentration in the targeted smooth muscle, decreasing sustained contractile force.

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Dosage and Administration Information

Espasmovet Compuesto is a fixed-dose combination tablet administered exclusively by the oral route. The medicine is designed for use on an as-required (PRN) basis for acute, symptomatic episodes, and is not intended for chronic, continuous scheduled administration.


Administration Method and Dosing

The tablet must be swallowed whole with an adequate amount of water; it should not be chewed, crushed, or broken to ensure the fixed components are administered as intended.

Dosing follows the principle of using the lowest effective dose for the shortest possible duration. Doses are typically administered up to three to four times daily (divided doses), corresponding to the scheduling of the antispasmodic component. A minimum interval (e.g., typically 6 hours) between doses is observed to manage systemic exposure and prevent exceeding the maximum daily limits for both active ingredients.


Duration and Population Constraints

Administration of this medicine is limited to short-term treatment. Standard guidelines specify discontinuing administration once acute symptoms have resolved, as the product is not intended for long-term continuous use without medical investigation.

Regarding specific populations, the product is generally not recommended for administration to children below a specified age (often under 6 years), reflecting established limitations for the antispasmodic component.

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Recent Clinical Evidence

Espasmovet Compuesto: Recent Clinical Evidence

Espasmovet Compuesto is a combination medication containing the active ingredients Dipyrone (an analgesic/antipyretic) and Hyoscine Butylbromide (an antispasmodic agent). Research efforts have focused on evaluating how this combination addresses pain associated with spasms, particularly in the gastrointestinal and genitourinary tracts.


Efficacy in Pain and Spasm

Clinical trials and related systematic reviews have explored the use of the component drugs, both individually and combined, for treating various forms of colicky pain (pain characterized by cramping and spasms). Research indicates that the combination is investigated for its potential to leverage the different actions of its components: Dipyrone to influence pain signals, and Hyoscine Butylbromide to help relax the smooth muscles responsible for spasms.

Evidence for the individual components shows:

  • Hyoscine Butylbromide: Studies support its role as a spasmolytic (muscle relaxant) in conditions like irritable bowel syndrome (IBS), acute gastroenteritis-related abdominal pain, and spasms in the genitourinary system.
  • Dipyrone: Research has evaluated its efficacy as a non-opioid pain reliever in acute conditions, including renal colic.

Comparative studies on fixed-dose combinations suggest that combining an analgesic with a spasmolytic may be a strategy to address insufficient response from a single therapy. This combined approach is evaluated for potential additive or synergistic effects on the complex symptom of spasmodic pain.


Safety and Tolerability

As with all combined medications, safety profiles must consider each active ingredient. Research and regulatory reviews emphasize the importance of using these components under careful medical supervision due to potential adverse effects associated with each drug.

Specific safety considerations documented in trials and reviews relate to:

  • Dipyrone: Risk of hematological reactions, which requires careful patient monitoring.
  • Hyoscine Butylbromide: Its anticholinergic nature may lead to common side effects such as dry mouth or increased heart rate (tachycardia).

Clinical trials are continuously being conducted to further evaluate the safety and efficacy of these agents in diverse patient populations and for specific indications.

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Frequently Asked Questions (FAQ)

Common questions about Espasmovet Compuesto (FAQ)

Q: Why is the drug called 'Compuesto'?

The term 'Compuesto' in the medicine's name refers to its composition. According to regulatory documents, this medicine is a fixed-dose combination product. This means it contains two distinct active ingredients—an antispasmodic and an NSAID (Nonsteroidal Anti-inflammatory Drug)—combined into a single tablet.


Q: How quickly should I expect Espasmovet Compuesto to start working?

Studies and official information indicate that the onset of pain relief is generally related to the NSAID component. The time it takes for this ingredient to reach its maximum concentration in the body is typically observed within 30 to 60 minutes. This suggests that effects may start to be noticeable within this timeframe.


Q: How long does the effect of a dose of Espasmovet Compuesto typically last?

The duration of the therapeutic effect is often linked to the half-life of the active components. For the NSAID component, this typically suggests pain relief effects lasting around 4 to 6 hours. Official documents define the maximum recommended daily use based on the drug's duration profile.


Q: Does Espasmovet Compuesto cause drowsiness or make you sleepy?

Official safety profiles do not typically list drowsiness as a common side effect. However, the anticholinergic component may cause central nervous system effects such as dizziness and blurred vision. Official documents include warnings that the medicine may impair the ability to drive or operate machinery for patients who experience these effects.


Q: Can Espasmovet Compuesto be taken at the same time as cold or flu medicine?

Official interaction warnings indicate that the risk of adverse effects is increased if the cold or flu medicine contains other NSAIDs or certain anticholinergic agents. Regulatory information stresses the need to check components, as co-administration with these classes is often strictly contraindicated.


Q: What does 'research evidence' mean for this medicine?

The term 'research evidence' refers to the scientific data that supports the medicine's use. This data is generated from controlled clinical trials and studies that evaluate the product's efficacy and safety profile. Regulatory authorities use this evidence to approve the medicine for specific indications (uses).


Q: What happens if I miss a dose of Espasmovet Compuesto?

Official regulatory documents address the procedure for missed doses. This guidance generally states that if a dose is missed, it should be skipped if the next scheduled dose is imminent, and that double dosing is prohibited to make up for the missed one.


Q: Is Espasmovet Compuesto known to be addictive?

The medicine's active ingredients, Ibuprofen (NSAID) and Hyoscine Butylbromide (anticholinergic), are not officially designated as controlled substances under national or international drug control acts. Official safety profiles do not identify this medicine as having a known risk of addiction.


Q: Are there any warning signs I should look for before taking this medicine?

Official regulatory documents list specific contraindications that must be considered prior to use. These include known allergic reactions to NSAIDs, existing GI bleeding or ulcers, and conditions such as glaucoma or a tendency toward urinary retention. The official eligibility constraints define the safe use profile.


Q: What is the shelf life or expiration date structure of Espasmovet Compuesto?

Based on official stability data provided to regulatory bodies, the medicine is assigned a specific shelf life upon manufacture. The expiration date, which defines the final use date, is printed on the product's packaging, and official constraints prohibit use of the medicine after this date.


Q: Why do official documents list so many potential side effects?

Regulatory agencies require that product documentation provides the most complete safety profile possible. Official documents list side effects based on all adverse events reported during clinical trials and continuous post-marketing surveillance, including very rare effects. This practice ensures that patients and healthcare providers have full knowledge of potential reactions.


Q: Is Espasmovet Compuesto considered a controlled substance?

Official regulatory schedules, such as those governing narcotics, confirm that the active ingredients in this medicine are not classified as controlled substances. This means the medicine is not subject to special storage, prescribing, or dispensing restrictions for narcotics or opioid medications.


Q: Does Espasmovet Compuesto help with headaches or migraines?

Official regulatory documents indicate that this medicine is approved specifically for the symptomatic relief of pain associated with spasms, typically in the gastrointestinal or genitourinary tracts. It is not specifically indicated for the treatment of typical tension headache or migraine pain.


Q: Are there specific instructions for what to do if an allergic reaction occurs?

Official labeling provides guidance for managing serious reactions, such as swelling, hives, or difficulty breathing. The instructions state that the medication must be discontinued immediately, and emergency medical attention is necessary if these signs occur.


Q: What should be done if Espasmovet Compuesto is taken by mistake?

In cases of accidental overdose or ingestion by a person for whom the medicine is not intended, users are instructed to immediately contact a doctor or poison control center for guidance, according to official labeling.


Q: Does Espasmovet Compuesto contain caffeine?

The official regulatory composition sections list only Ibuprofen and Hyoscine Butylbromide as the active ingredients. Caffeine is not listed as an active component in the medicine's formulation.


Q: Why might a doctor switch a patient from a different antispasmodic to Espasmovet Compuesto?

A switch may be clinically considered because this product offers a fixed dual-action approach, which addresses two different aspects of visceral discomfort. This dual action combines the spasm-relieving effect of the anticholinergic component with the pain and inflammation relief of the NSAID component in one medication.

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How should Espasmovet Compuesto be stored and disposed of?

How to Store and Dispose of Espasmovet Compuesto?

Official regulatory guidance requires that Espasmovet Compuesto tablets be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The medicine must be kept in its original container, which should be tightly closed to protect the contents from excessive heat and moisture.

A mandatory storage requirement is to keep the product out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired medicine should follow official pharmaceutical waste procedures. The preferred method is returning the medicine to a secure drug take-back location. If a take-back option is unavailable, the tablets may be mixed with an undesirable substance (such as dirt or used coffee grounds) and placed in a sealed bag before being discarded in the household trash. The medicine should not be flushed down a toilet or sink.

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

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