Эреспал

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Эреспал

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Medically reviewed

Marina Burgos

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 Эреспал

Identifying Эреспал: An Overview

Property Description
Active Ingredient Fenspiride Hydrochloride
Primary Forms Oral Tablets and Syrup/Solution
Pharmacological Class Selective Mediator Antagonist
General Purpose Symptomatic relief for inflammatory respiratory diseases
Origin Synthetic

Эреспал is a brand name for the medicine containing the active ingredient fenspiride hydrochloride, which is a synthetic compound. It is classified under the Anatomical Therapeutic Chemical (ATC) system as R03DX03, within the group of Other systemic drugs for obstructive airway diseases. The medication is formulated for oral administration and has historically been available as film-coated tablets for adults and an oral solution or syrup, often used for children.


General Therapeutic Purpose of Fenspiride

Fenspiride is used for the symptomatic treatment of acute and chronic inflammatory diseases affecting the respiratory tract and ENT (ear, nose, and throat) organs. Its general therapeutic purpose is to alleviate the disruptive symptoms associated with airway inflammation, such as chronic cough and increased expectoration. It is often employed as an adjunct treatment to complement primary medications in cases of conditions like bronchitis or laryngitis.


Composition and Pharmacological Class

The key component is the active ingredient, fenspiride hydrochloride, which defines its pharmacological class as a selective mediator antagonist. This classification distinguishes it from conventional treatments like steroids or traditional NSAIDs. Its mechanism involves blocking specific receptors, including H1-histamine and alpha-adrenergic receptors, thus interfering with the production and action of pro-inflammatory substances. This targeted action provides the medicine with its recognized anti-inflammatory properties. The final products contain this active drug along with various inactive ingredients (excipients) necessary for manufacturing and palatability, particularly in the syrup formulation.

What side effects are possible with Эреспал?

Possible side effects and safety information

The safety profile of Fenspiride (Эреспал) is officially characterized by a range of common reactions and a critical cardiac safety concern documented by regulatory authorities, which led to the suspension of its marketing authorization in several regions.


Documented Adverse Reactions

Adverse reactions are officially categorized according to the affected physiological systems and frequency:

  • Gastrointestinal Disorders (Common): Reactions such as nausea, vomiting, diarrhea, and stomach pain are frequently listed in regulatory documents.
  • General Disorders (Common): General fatigue or asthenia has been noted.
  • Skin and Subcutaneous Tissue Disorders (Rare): Reactions include skin rash, hives (urticaria), and angioedema.
  • Cardiac Disorders (Uncommon to Rare): Less frequent effects include sinus tachycardia and palpitations.

Critical Cardiac Safety Concern

Regulatory safety analyses identified a serious adverse reaction associated with fenspiride use: QT interval prolongation. This is a change in the heart’s electrical cycle, documented through ECG observation, which carries a potential risk of developing Torsade de Pointes—a life-threatening ventricular arrhythmia. This risk is the defining constraint of the drug's safety profile.

Safety-Related Restrictions

Due to the cardiac risk, official regulatory documents define strict limitations on use. Fenspiride is formally contraindicated in individuals with pre-existing conditions that affect the QT interval, such as a history of Torsade de Pointes, or those with uncorrected electrolyte imbalances. It is also absolutely restricted from co-administration with other medicines known to prolong the QT interval.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Fenspiride is defined by the risk of severe, life-threatening cardiovascular effects in cases of overdose, mandating immediate emergency action due to the potential for fatal outcomes.

Documented Overdose Presentations

Overdose is characterized by a range of symptoms and clinical signs. These include tachycardia (elevated heart rate), agitation, drowsiness, nausea and vomiting, and orthostatic hypotension. The primary system affected is the cardiovascular system, which can manifest as Electrocardiogram QT prolongation and the risk of Torsades de pointes and sudden death.

Regulator-Mandated Emergency Actions

Due to the established life-threatening risks, immediate medical attention is required, and emergency services must be contacted upon any suspicion of overdose. Continuous cardiac monitoring is a mandated management procedure to detect and address the specific cardiovascular abnormalities. No specific antidote is known, therefore symptomatic and supportive treatment are the officially described measures. Procedures such as gastric lavage or activated charcoal may be considered following massive ingestion.

Therapeutic Uses of Эреспал

What Эреспал Treats: Main Uses and Benefits

The primary therapeutic role of Fenspiride (Эреспал) is to provide symptomatic relief for symptoms related to heightened physiological activity or irritative states. The medication is applied in clinical settings that involve acute or unstable symptom patterns. The authorised uses for fenspiride were for the symptomatic treatment of generally benign conditions, specifically to relieve cough resulting from lung diseases.

This medicine is considered relevant for a range of symptoms associated with conditions involving inflammatory or irritative processes of the airways and ENT organs. The medication is considered relevant for addressing symptoms associated with conditions such as bronchitis, laryngitis, sinusitis, and rhinopharyngitis. Fenspiride is relevant for managing symptom clusters that may become intense or disruptive, including a disruptive cough and excessive sputum production (increased expectoration).

It provides support that helps ease the overall symptom burden, particularly in conditions characterized by periods of heightened symptoms. The medication may also be part of symptomatic management for more complex long-term conditions, including Chronic Obstructive Pulmonary Disease (COPD) and Bronchial Asthma, where it is applied as a supportive, adjunct therapy.


“Fenspiride is commonly used in settings where short-term symptomatic assistance is needed for acute respiratory discomfort.”

Quick Fact: Focus on Symptom Management

The primary benefit is symptomatic relief for disruptive cough patterns and symptoms of increased physiological activity associated with irritative states.

Eligibility and Restrictions for Use

The official eligibility profile for Эреспал (Fenspiride) is primarily defined by the regulatory action taken by the European Medicines Agency (EMA), which recommended the revocation of marketing authorizations (MA) in the EU and affiliated jurisdictions. This action, based on the established, unpredictable risk of serious cardiac arrhythmias, constitutes the most severe restriction on use.


Eligibility scope

Scope Element Official Regulatory Status
Populations for whom use is allowed NO POPULATION in regions with MA revocation is currently authorized for use.
Populations for whom use is contraindicated All patients in regions with MA revocation; patients with known hypersensitivity to Fenspiride; children below 2 years of age.
Condition-specific eligibility rules Prohibited for patients with conditions that predispose to QT prolongation or Torsades de pointes (serious heart rhythm problems).
Pregnancy and lactation eligibility status Not Recommended due to a lack of officially established safety data.

Eligibility classifications (high-level)

Classification Element Official Regulatory Terminology/Description
Eligibility severity classification Revocation of Marketing Authorisation / Contraindicated
Regulatory basis European Medicines Agency (EMA) / PRAC / CMDh

Resulting eligibility structure

Official eligibility statements:

  • Use of Fenspiride is prohibited for all patients in regions where marketing authorizations have been revoked due to confirmed cardiac risk.
  • The medicine is formally contraindicated in children below 2 years of age and in patients with known hypersensitivity to the active substance.

Connection to the overall eligibility profile:

Official regulatory documents define who can and cannot use the medicine primarily through severe exclusionary rules, centered on the market revocation by the EMA due to cardiac risk. Eligibility is further restricted by formal contraindications based on age, hypersensitivity, and specific cardiovascular conditions, while use is officially stated as not recommended for pregnant or breastfeeding women.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for fenspiride (Эреспал) is defined by pharmacodynamic and pharmacokinetic constraints outlined in regulatory documentation. The most critical interaction involves additive risks to cardiac function.


Contraindicated Combinations

Co-administration is strictly contraindicated with medicinal products known to prolong the QT interval or those known to cause bradycardia (slow heart rate). This restriction is a mandatory measure to prevent additive pharmacodynamic effects that could increase the risk of serious ventricular arrhythmias, such as Torsades de Pointes.


Interactions Affecting the Nervous System

Fenspiride carries an additive pharmacodynamic risk when combined with substances that affect the central nervous system (CNS):

  • Other CNS Depressants: Concurrent use with medicines like sedating H1 antihistamines or opioid analgesics may result in the potentiation of sedative effects.
  • Alcohol (Ethanol): Ingestion of alcohol is documented to exacerbate the sedative effects of fenspiride, reinforcing the risk of CNS depression.

Pharmacokinetic Caution

Caution is noted for co-administration with potent Cytochrome P450 (CYP) inhibitors. These substances carry a risk of inhibiting fenspiride’s metabolic clearance, potentially leading to increased systemic exposure and higher plasma concentrations. This elevated exposure may enhance the risk of dose-dependent adverse effects.

Mechanism of Action

The mechanism of fenspiride is pleiotropic, meaning the single molecule operates through multiple, complementary pathways to modulate pathways regulating physiological responses in the respiratory system.


Dual Receptor Antagonism and Spasmolysis

This primary domain involves the competitive antagonism of the H1 Histamine Receptor and the Alpha-1 (alpha1) Adrenergic Receptor. This dual blockade interrupts signaling that mediates pathways that increase edema and bronchoconstriction, contributing to the modulation of airway smooth muscle tone and limitation of histamine-mediated vascular permeability in the mucosa.


️ Inhibition of Inflammatory Mediator Synthesis

The drug engages the inflammatory cascade by acting as an inhibitor of the synthesis of key downstream mediators like Leukotrienes and the cytokine Tumor Necrosis Factor-alpha ( TNF-alpha). By suppressing the formation of these pro-inflammatory molecules, the mechanism limits inflammatory cell infiltration and the subsequent downstream physiological alterations regulated by chronic airway inflammation.

Dosage and Administration Information

How to Use Эреспал: Official Administration Guidelines

The use of fenspiride (Эреспал) is strictly governed by the product’s official prescribing information, which outlines the required route, dose, and administration schedule. The medicine is formulated for oral administration and is available as film-coated tablets and an oral solution (syrup). All instructions must be followed to maintain the authorized use profile.


Standard Dosing and Frequency

Population Daily Dose Range Frequency Pattern
Adults 80 to 160 mg (tablets) or 45 to 90 ml (syrup). Total daily dose is administered in divided doses.
Pediatric (Syrup) 4 mg/kg body weight/day. Administered in divided doses.

Procedural Administration Rules

A key requirement for administration is timing in relation to food: the medicine must be taken directly before meals. This ensures adherence to the specific intake conditions detailed in the regulatory label.

For pediatric patients, the syrup form is the standard and its use is not recommended for children below two years of age. Dosage for children over this age is strictly calculated based on the child’s body weight, utilizing the 4 mg/kg/day ratio. When administering the syrup, a measuring spoon or oral syringe must be used for precise volumetric dosing, as stated in the product characteristics. The duration of use is determined solely by the persistence of the symptomatic condition.

Recent Clinical Evidence

Research Evidence Overview for Fenspiride (Эреспал)

This section was studied for summarizes the official research base for fenspiride, drawing on clinical trial data and systematic reviews to describe what was observed in the studies and the type of evidence available. The findings describe patterns observed in the studies but research does not determine whether an individual will respond similarly.


Evidence for Symptomatic Relief in Acute Respiratory Tract Conditions

Research was evaluated in settings involving acute or disruptive episodes, where symptoms may vary in intensity. Studies explored the use of fenspiride during periods of increased symptom activity. The main body of research for these conditions consisted of Randomized Controlled Trials (RCTs) and open-label studies. These trials included adults and children and focused on outcomes linked to inflammatory or irritative states such as cough and increased phlegm (expectoration).

The studies report how symptoms evolved in the observed populations over the course of treatment, typically a few weeks. Some trials described patterns related to patient-reported symptom scores for cough and sputum. When compared to a placebo, studies monitored outcomes describing episodic or acute changes in patient-reported experiences. A later regulatory review examined the balance between the symptomatic findings that describe patterns observed in the studies and potential risks identified during subsequent evaluations.

Evidence for Use in Chronic Obstructive Pulmonary Disease (COPD)

Research examined patients with conditions marked by functional limitations, specifically adults with stable Chronic Obstructive Pulmonary Disease (COPD). The research was studied for use as an adjunct therapy to address symptoms associated with this long-term condition. Studies monitored both patient-reported outcomes describing perceived discomfort and changes in physiological measures like lung function tests (such as FEV1).

Some studies reported measurements related to lung function indices in populations where fenspiride was studied alongside standard maintenance therapy in some cohorts. The results apply only to the populations studied, and the overall evidence certainty remains low regarding its role in long-term disease management.

Long-Term Studies and Follow-Up Duration

Most studies researching short-term symptom changes had follow-up durations that were limited to a few weeks, which provides limited information for long-term outcomes or the durability of any observed symptomatic changes. For chronic conditions like COPD, studies were conducted with intermediate follow-up spanning several months. Overall, long-term effects are not fully established across the entire range of former uses.

Frequently Asked Questions (FAQ)

Common questions about Эреспал (FAQ)

Q: Can Эреспал be taken with blood pressure medication?

Regulatory documents advise caution regarding co-administration with other medicines. Specifically, use is strictly contraindicated with any medicine known to prolong the QT interval or those that cause a slow heart rate (bradycardia). These restrictions are in place due to the potential for an increased risk of serious heart rhythm problems.

Q: Does Эреспал cause drowsiness or affect driving?

The official product information notes the potential for sedative effects, especially when combined with alcohol or other medicines that affect the central nervous system (CNS depressants). This potential requires awareness that the ability to drive or operate machinery may be affected, as stated in regulatory documents.

Q: What is the difference between the syrup and tablet forms of Эреспал?

Эреспал is available as two primary forms: film-coated tablets and an oral solution (syrup). The syrup form is primarily indicated for use in children. The forms have different administration requirements and different dose units (milligrams versus milliliters).

Q: What are the signs of an allergic reaction to Эреспал?

Hypersensitivity to the active substance is listed as a contraindication in official documents. Documented allergic-type reactions include a skin rash, hives (urticaria), and angioedema. Angioedema is characterized by swelling of the deeper layers of the skin.

Q: Can I take other cough suppressants while using Эреспал?

Regulatory warnings focus on the pharmacological class of the interacting medicine. Co-administration with other medicines that may cause CNS depression or that contain sedating H1 antihistamines is noted as potentially resulting in an additive sedative effect.

Q: Can Эреспал be mixed with juice or food for children?

The official product information states that the medicine must be taken before meals. Official guidelines sometimes include instructions stating that the oral solution can be added to a small amount of food or liquid, such as water or fruit juice, to facilitate administration.

Q: Are there any specific dietary restrictions while taking Эреспал?

The only specific restriction universally highlighted in regulatory warnings concerns alcohol (ethanol). The ingestion of alcohol is documented to exacerbate the sedative effects of the medicine. No other specific food or beverage restrictions are explicitly noted in official regulatory documents.

Q: Can I stop taking Эреспал as soon as my symptoms improve?

According to the official product information, the duration of use is determined solely by the persistence of the symptomatic condition being addressed. This principle means the duration is dictated by the continued presence of the condition's symptoms.

Q: How quickly should I expect to see an effect from Эреспал?

Pharmacokinetic data, which describes how the body processes the drug, indicates that the maximum plasma concentration (Cmax) is reached in approximately six hours following administration. This measurement describes the point at which the highest levels of the active substance are circulating in the body, based on population data.

Q: How long does the effect of Эреспал typically last after taking it?

The half-life for the elimination of the active ingredient is documented in pharmacokinetic data to be approximately twelve hours. The half-life is the time required for the concentration of the medicine in the body to reduce by half.

Q: Do older adults require special consideration when using Эреспал?

Regulatory documentation generally states that no specific dose adjustment is considered necessary for use in the elderly population. This indicates that official guidance does not distinguish the dosing requirements for older adults compared to other adult patients.

Q: What should I do if I forget to take a dose of Эреспал?

Official instructions for a forgotten dose typically state to skip the missed dose entirely. The instruction is to continue with the next scheduled dose at the usual time, without taking a double dose.

Q: What happens if Эреспал is taken for longer than recommended?

Regulatory safety information primarily focuses on the risks associated with overdose, which may include serious cardiac effects like QT interval prolongation. Official documents do not explicitly detail the specific outcomes of prolonged use that does not involve exceeding the recommended dose.

Q: Is there a generic version of Эреспал available?

The active ingredient in Эреспал is fenspiride hydrochloride. This substance serves as the basis for generic formulations in regions where the medicine is authorized for use.

Q: Can people with liver or kidney issues use Эреспал?

Regulatory documentation advises caution for patients who have renal (kidney) impairment. This is due to the potential for reduced clearance of the drug from the body. In such cases, regulatory information indicates that specific dose adjustments or careful monitoring may be required.

Q: Can Эреспал be used alongside painkillers like paracetamol?

Regulatory documentation does not list paracetamol (acetaminophen) as a medicine that has a specific, documented contraindication. There is no known pharmacodynamic interaction with the active substance noted in official sources.

Q: Is Эреспал addictive?

Official regulatory documentation does not classify the active ingredient as having a known potential for dependence, tolerance, or addiction. The medicine is not typically scheduled as a controlled substance.

Q: What is the shelf life of Эреспал once the bottle is opened?

For the oral solution (syrup), the official labeling includes an "in-use" period which defines how long the product can be safely used once the bottle has been opened. This period is specifically defined on the product label and determines how long the solution maintains its stability after the seal is broken.

Q: Is there a risk of interaction with herbal supplements when taking Эреспал?

Official documentation notes a need for caution when co-administering with substances identified as potent Cytochrome P450 (CYP) inhibitors. Certain herbal supplements can fall into this category, potentially leading to increased exposure to the drug in the body.

How should Эреспал be stored and disposed of?

How to Store and Dispose of Érespal (Fenspiride)

Storage Requirements

Érespal must be stored under specific temperature control as documented in official labeling, with the mandate to keep the product below 30 C. To maintain its stability and integrity, the medicine should be kept in its original container.

Child-Safety and Protection

For safety, the product must be stored in a location that is securely out of the sight and reach of children.

Disposal Instructions

Disposal must adhere to environmental regulations. The medicine should not be discarded via wastewater or placed into household waste. Unused or expired medication must be disposed of through approved channels; individuals are instructed to consult a pharmacist for the correct procedure.

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

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