Duspatalin

Quick links to important sections

Duspatalin

Selected form

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Duspatalin

What is Duspatalin?

Duspatalin is a medication primarily used to treat symptoms associated with functional gastrointestinal disorders, most notably irritable bowel syndrome (IBS). It belongs to a group of medicines known as antispasmodics, which work directly on the muscles of the digestive system.

Mechanism of Action

The active ingredient in Duspatalin is mebeverine hydrochloride. Unlike some other treatments that affect the entire nervous system, mebeverine acts as a musculotropic antispasmodic. This means it works directly on the smooth muscles of the intestinal wall to relieve spasms and cramps. It helps to normalize intestinal movement without interfering with the normal motility of the gut.

Primary Uses

Duspatalin is utilized to manage a variety of abdominal symptoms, including:

  • Abdominal pain and cramps
  • Persistent diarrhea or alternating constipation
  • Flatulence and bloating
  • Discomfort related to spasms of the colon

By relaxing the intestinal muscles, the medication helps reduce the physical discomfort associated with an overactive or sensitive digestive tract. It is designed to provide symptomatic relief during flare-ups of chronic intestinal conditions.

Regulatory References

  1. Medsafe Data Sheet

What side effects are possible with Duspatalin?

Official Safety Profile and Adverse Reactions

This section summarizes the officially documented adverse reactions and safety information for Duspatalin (mebeverine), strictly based on authoritative government regulatory documents.

Frequency-Classified Side Effects

Adverse reactions are classified by frequency as documented in regulatory sources:

Frequency Classification Side Effects (System-Organ Class)
Rare (1 in 1,000 to 1 in 10,000 users) Urticaria (hives), Angioedema (swelling beneath the skin), Facial oedema (swelling of the face), Exanthema (rash/skin eruption).
Not Known (Cannot be estimated from available data) Hypersensitivity, Anaphylactic reactions (severe, systemic allergic response).

These effects fall primarily under the Immune System Disorders and Skin and Subcutaneous Tissue Disorders categories.

Serious Adverse Reactions

Regulatory documents highlight the possibility of Anaphylactic reactions, which are a potentially life-threatening form of hypersensitivity. Angioedema is also documented as a rare event that can be medically significant.

Population-Specific Safety Considerations

  • Pregnancy and Lactation: Use of Duspatalin is not recommended during pregnancy or breastfeeding, as there is insufficient safety data from human studies.
  • Pediatric Use: The modified-release (retard) formulation of Duspatalin is not recommended for use in children and adolescents below 18 years of age due to a lack of sufficient clinical safety and efficacy data in this population.

Safety-Related Restrictions

Duspatalin is contraindicated (must not be used) in individuals with known hypersensitivity to the active substance (mebeverine hydrochloride) or any of the product's inactive ingredients. Certain formulations are also restricted in patients with rare hereditary issues related to sugar intolerance (e.g., lactose, sucrose). The overall safety documentation indicates that the medicine is not expected to impair the ability to drive or operate machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents describe the profile of Mebeverine Hydrochloride overdose primarily around the nature of the reported clinical manifestations and the mandated emergency actions.

Documented Manifestations and Risk

Reports indicate that symptoms of mebeverine overdose are frequently absent or mild and are rapidly reversible. When manifestations do occur, they have been observed to involve the neurological and cardiovascular systems. Regulators also address the potential for serious outcomes by noting the theoretical risk of Central Nervous System (CNS) excitability. Pre-clinical studies reference the occurrence of tremor and convulsions at high doses.

The official labeling confirms that no specific antidote is known.

Mandated Emergency Action

If an overdose is taken, the official patient guidance instructs you to talk to a doctor or go to a hospital straight away. Management is restricted to symptomatic treatment. Absorption reducing measures are not necessary. Gastric lavage should only be considered in cases of suspected multiple intoxication or if discovered within approximately one hour of ingestion. Furthermore, post-marketing data has identified no specific increased risk of overdose or unique considerations for elderly or patients with hepatic or renal impairment.

Therapeutic Uses of Duspatalin

What Duspatalin Treats: Main Uses and Benefits

Duspatalin (mebeverine) is considered relevant for symptomatic management in the distressing symptom patterns associated with Functional Gastrointestinal Disorders, primarily Irritable Bowel Syndrome (IBS). Its therapeutic role is relevant when supportive symptom management is appropriate in clinical contexts marked by heightened patient discomfort and irregularity. It is an antispasmodic and is commonly used to help with painful stomach cramps associated with irritable bowel syndrome or similar conditions like chronic irritable colon.

The medication is commonly used to address symptoms that create noticeable interference with daily stability, including abdominal pain, colicky cramping, and associated distress such as bloating and abdominal distension. It is applied across conditions characterized by episodic or fluctuating symptom patterns, assisting with maintaining functional stability when discomfort becomes more noticeable.

“Mebeverine helps address groups of symptoms that may become intense or disruptive, supporting the patient during difficult episodes by easing distress.”

Quick Fact: Primary Symptomatic Domains
Supports patients during episodes of heightened discomfort caused by abdominal spasm and pain.

Eligibility and Restrictions for Use

Who Can and Cannot Use Duspatalin?

This section outlines the official population eligibility and non-eligibility rules for Duspatalin (mebeverine hydrochloride), as defined strictly by governmental regulatory documentation.


Approved Population and Limitations

Adults, including the elderly, are the standard approved population for Duspatalin. Regulatory sources indicate that no specific dosage adjustment is generally deemed necessary for patients with renal (kidney) or hepatic (liver) impairment, based on available post-marketing data.

Absolute Contraindications

Duspatalin is contraindicated (must not be used) in the following populations:

  • Patients with a known hypersensitivity (allergy) to mebeverine hydrochloride or any of the product's excipients.
  • Individuals with specific hereditary metabolic disorders, such as total lactase deficiency, galactose intolerance, or glucose-galactose malabsorption, due to excipients in the formulation.

️ Age and Reproductive Restrictions

  • Pediatric Use: The main formulations (135 mg tablets and 200 mg capsules) are not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy in this age group.
  • Pregnancy and Lactation: Use is not recommended during pregnancy and should not occur while breast-feeding, as data on human safety and excretion into breast milk is limited or unknown.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Duspatalin (mebeverine hydrochloride) indicates a very limited known interaction profile with other medicinal products. The drug is generally considered safe to take alongside most prescription and non-prescription medicines, including common pain relievers such as paracetamol and ibuprofen.

Documented Interaction Information

Interaction Type Status in Regulatory Documents
Interacting Medicinal Products No interactions with other medicinal products are known or reported.
Interaction Studies Performed No formal interaction studies have been conducted, with the exception of alcohol (ethanol).
Ethanol (Alcohol) Interaction In vitro and in vivo studies in animals have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol.

It is important for patients to inform their healthcare provider or pharmacist about all other medicines, vitamins, herbal remedies, and supplements they are currently taking. While the established regulatory data indicates no known interactions with other medicines, caution is generally advised against combining mebeverine with other remedies specifically intended for Irritable Bowel Syndrome (IBS), as these may possess similar mechanisms of action. Combining such remedies may not yield extra symptom relief and could potentially increase the likelihood of side effects.

Mechanism of Action

Duspatalin, containing the active substance mebeverine, is a musculotropic antispasmodic primarily targeting the smooth muscle cells of the gastrointestinal tract. Its pharmacodynamic action is multifaceted, leading to direct muscle relaxation.

One central mechanism is the inhibition of ion channel permeabilities in the smooth muscle cell membrane. This includes a blockade of L-type voltage-gated calcium channels (L-VGCCs), which reduces the influx of extracellular Ca^2+ ions required for the excitation-contraction coupling process. The reduction in intracellular calcium concentration leads to a decrease in the phosphorylation of the myosin light chain, resulting in the cessation of sustained smooth muscle contraction.

Additionally, mebeverine exhibits a local anesthetic-like effect on the gut wall, which may modulate nerve signal transduction involved in motility. There is also evidence suggesting potential involvement in noradrenaline reuptake blockade and mild phosphodiesterase (PDE) inhibition. Collectively, these intracellular and membrane-level interactions modulate the excitability of the smooth muscle, leading to a reduction in smooth muscle tone and decreased frequency of contractility in the intestinal wall without systemic anticholinergic consequences.

Dosage and Administration Information

How to Use Duspatalin (Mebeverine)

The administration of Duspatalin (mebeverine hydrochloride) is intended for oral use only.


Dosage and Scheduling

The standard dosing regimen varies based on the specific dosage form and strength:

  • 135 mg Tablets: The usual dose for adults, including the elderly, is one tablet taken three times a day (three tablets daily maximum). After symptoms improve, the dosage may be gradually reduced.
  • 200 mg Prolonged-Release Capsules: The standard dose for adults, including the elderly, is one capsule taken twice daily, typically once in the morning and once in the evening.

Administration Conditions

The following steps are generally observed:

  • Timing: The medicine should ideally be taken 20 minutes before a meal.
  • Preparation: Tablets and prolonged-release capsules must be swallowed whole with a sufficient amount of water (e.g., at least 100 mL of water). The capsules and tablets must not be crushed, chewed, or divided.
  • Missed Dose: If a dose is missed, skip the forgotten dose and take the next dose at the usual scheduled time. Do not take a double dose to compensate for a missed one.
  • Pediatric Use: Duspatalin is not recommended for use in children and adolescents below the age of 18 due to insufficient data on safety and efficacy. No specific dose adjustment is generally required for the elderly or patients with kidney or liver impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Duspatalin

Evidence for Use in Irritable Bowel Syndrome (IBS) and Related Functional Bowel Disorders

The research into mebeverine was studied for its use in conditions characterized by symptoms associated with Irritable Bowel Syndrome and other similar functional bowel conditions. The evidence base includes structured Randomized Controlled Trials (RCTs), as well as several Systematic Reviews and Meta-Analyses. These studies were conducted during periods of increased symptom activity, and research examined symptoms related to gut function and smooth muscle activity, specifically for conditions characterized by fluctuating or episodic manifestations.

In these research settings, studies explored outcomes related to physical discomfort and outcomes describing episodic or acute changes. The core focus of the trials was to see how symptoms changed in the observed populations, with outcomes related to overall symptom change and patient-reported perceived discomfort being the primary axes examined. While many individual studies reported measured changes during the study period, a synthesis of the evidence indicates that findings were mixed across different meta-analyses regarding the consistency of overall clinical change, meaning certainty remains low regarding highly predictable results.

Focus of Research: Outcomes Examined in Clinical Trials

The research examined mebeverine's use through patient-reported outcomes describing perceived discomfort. Researchers monitored changes in core symptoms of IBS, including how the frequency and intensity of abdominal pain was studied for during the study intervals. Studies also explored outcomes related to systemic or functional imbalance, such as abdominal distension and bloating.

Beyond outcomes related to physical discomfort, research also examined outcomes reflecting daily functioning, such as Quality of Life (QoL) scores. These patient-reported outcomes were evaluated in studies examining the overall impact of IBS on a person's daily functioning. Findings help contextualize how patients reported their experience when using mebeverine.

Evidence Gaps and Duration of Study Follow-up

The majority of mebeverine research explored short-term symptom changes over defined time intervals, typically ranging from two to twelve weeks. While these studies provide context for managing episodic or acute changes, long-term effects are not fully established. There is limited information for long-term outcomes, as follow-up durations were limited in many of the key studies. Data for certain groups remain insufficient, and overall, findings were mixed or uncertain for some non-adult populations compared to the data for adults, indicating that research is ongoing.

Frequently Asked Questions (FAQ)

Common questions about Duspatalin (FAQ)


Q: How is Duspatalin different from other common medications for gut problems?

A: Official information describes Duspatalin (mebeverine) as a musculotropic antispasmodic. This means it works by acting directly on the smooth muscle cells of the gut to relieve spasms. The medicine is described as targeting these spasms with the intention of relieving them, generally without causing systemic effects on normal gut motility.

Q: If I miss a dose of Duspatalin, what is the general guidance?

A: Regulatory documents provide clear guidance for a missed dose. If a dose is forgotten, the recommendation is to skip the forgotten dose entirely. The guidance is to then take the next dose at the usual scheduled time and to avoid taking a double dose to compensate.

Q: Is it common to feel tired when taking Duspatalin?

A: Tiredness, often described as fatigue, is listed in regulatory documents as a less common side effect. It is typically described as mild and short-lived. Other officially recognized less common effects include headache and dizziness.

Q: Are there any known side effects on the liver from Duspatalin?

A: Official information does not specifically list liver damage as a common or rare side effect. Regulatory documents also state that no specific adjustment to the standard dose is generally deemed necessary for patients with existing liver impairment. Any patient with liver problems is generally advised to consult a doctor or pharmacist before taking the medicine.

Q: Is it described in official information that Duspatalin can be taken during pregnancy?

A: The use of Duspatalin is not recommended during pregnancy. This is because official documents indicate there is limited or insufficient information available about its safety when used by pregnant women.

Q: Can Duspatalin affect driving ability, according to official documents?

A: According to the official product information, Duspatalin is not likely to impair the ability to drive or use tools or machines. However, regulatory documents note that if side effects occur, they could potentially impact the ability to perform skilled tasks.

Q: Can Duspatalin be taken with common acid-reducing medications?

A: Official regulatory documents indicate that there are no known or reported interactions with other medicinal products. It is standard practice to inform a doctor or pharmacist about all prescription and non-prescription medicines being taken.

Q: Why is Duspatalin sometimes prescribed for bowel spasms?

A: Duspatalin is prescribed because it is a musculotropic antispasmodic. Its function is to directly relax the excessive, painful squeezing of the smooth muscles in the gut. By targeting these spasms, it is intended to relieve abdominal pain and intestinal discomfort.

Q: What is the key difference between Duspatalin and certain antispasmodic drugs?

A: The key distinction noted in pharmacology information is that Duspatalin is a direct-acting musculotropic antispasmodic. This means it works directly on the muscle cells and is noted for having no systemic anticholinergic consequences, which are sometimes seen with other types of antispasmodic drugs.

Q: What is the duration of action for a single dose of Duspatalin?

A: The 200 mg version is described as a modified-release formulation. This design controls the rate at which the medication is released into the body, which provides a prolonged action over a longer time period, aligning with its typical twice-daily administration.

Q: Is there an official statement on Duspatalin's potential for overdose?

A: Official sources note that in cases where an overdose has occurred, central nervous system excitability has been reported. No specific antidote is known, and a suspected overdose would be managed by symptomatic treatment, according to regulatory notes.

Q: Do people typically take Duspatalin for a long time?

A: Some official documents state that the duration of use is not limited. The dosage is intended to be individualized, and regulatory information notes that it may be gradually reduced by a doctor once the desired effect on symptoms has been achieved.

Q: Does Duspatalin address the cause of symptoms or just manage them?

A: Official therapeutic indications state that Duspatalin is indicated for the symptomatic treatment of abdominal pain, cramps, and intestinal discomfort. Its action is to relieve these symptoms rather than addressing the underlying cause of the condition.

Q: What kind of digestive issues is Duspatalin typically used for?

A: Duspatalin is indicated for the symptomatic treatment of discomfort related to functional bowel conditions. This includes symptoms associated with Irritable Bowel Syndrome (IBS), as well as chronic irritable colon, spastic constipation, and similar functional bowel issues characterized by pain and discomfort.

Q: Is there a certain age group that cannot use Duspatalin?

A: Yes, official documentation specifies that Duspatalin is not recommended for use in children and adolescents below 18 years of age. This restriction is due to insufficient data regarding its safety and effectiveness in this specific age group.

Q: Can Duspatalin be used by people with a history of heart conditions?

A: While heart conditions are not listed as an absolute restriction, official product information notes that patients with a history of heart conditions are generally advised to consult with a doctor or pharmacist before taking the medicine.

Q: Are there any specific food or drinks that might interact with Duspatalin?

A: Official studies have specifically looked at the interaction between mebeverine and ethanol (alcohol) and demonstrated the absence of any interaction. No specific food or non-alcoholic drinks are listed in the regulatory documents as interacting with the medicine.

Q: How long does it typically take for Duspatalin to start working?

A: Based on how the medicine is absorbed, peak concentrations in the body are typically reached within one to three hours after administration. This pharmacokinetic data helps explain the expected time frame for the body’s processing of the medicine.

Q: If someone stops taking Duspatalin, do the original symptoms usually come back?

A: Official documentation notes that the decision to stop taking the medicine, even if symptoms improve, typically involves medical guidance. Patients whose symptoms return or change should consult their prescribing physician.

Q: What happens if Duspatalin is taken along with common over-the-counter pain relievers?

A: Official documents state that no interactions with other medicinal products are known or reported. The drug is generally considered safe to be taken alongside common pain relievers, but it is standard practice to inform a healthcare provider about all medications being used.

Q: Is Duspatalin approved by regulatory bodies in countries like the US or UK?

A: Duspatalin (mebeverine) is a fully authorized medicine in many countries, including the UK under the jurisdiction of regulatory bodies like the MHRA and EMA. However, the drug is not currently available in the United States as a branded or generic product.

Q: Are there research findings about Duspatalin use in people with kidney issues?

A: The regulatory documents state that no specific dosage adjustment is generally deemed necessary for people with renal (kidney) impairment, based on available post-marketing data. Formal studies in this group are noted as limited.

Q: Are there reported interactions between Duspatalin and herbal supplements?

A: While no specific adverse interactions with herbal supplements are known or reported, official documentation indicates that patients should inform their doctor or pharmacist about all medicines, vitamins, and herbal remedies they are currently taking.

Q: Is Duspatalin generally described as safe for older adults?

A: Yes, adults, including the elderly, are the standard approved population for this medicine. Regulatory information indicates that no specific dosage adjustment is generally deemed necessary for older patients.

Q: Is it unusual for someone to feel dizzy after starting Duspatalin?

A: Official adverse reaction reports list dizziness as a less common side effect. If this symptom occurs, it is usually described as mild and short-lived. Patients should be aware of this possibility.

Q: Is there any information on Duspatalin's use in children?

A: The medicine is explicitly not recommended for use in children and adolescents below 18 years of age. This is due to a lack of sufficient clinical safety and efficacy data specific to this younger age group.

Q: Are there reports of Duspatalin causing skin reactions?

A: Yes, regulatory documents report rare skin and allergic reactions. These can include generalized skin eruptions, hives (urticaria), and swelling beneath the skin or face (angioedema). Severe, systemic allergic reactions are also possible.

Q: What research is available on Duspatalin for conditions beyond its primary use?

A: The medicine’s official guidance relates to its use only for the conditions listed in its therapeutic indications. It is generally not intended to be taken for other complaints, ensuring use is aligned with the documented regulatory scope.

Q: Is Duspatalin generally taken before, during, or after a meal?

A: The standard method of administration, according to official documents, is to take the medicine 20 minutes before a meal. The tablets or capsules should be swallowed whole with water.

Q: Does official prescribing information discuss how Duspatalin is eliminated from the body?

A: Yes, pharmacology documents discuss how the body handles the medicine. Mebeverine is completely broken down by the body into two main compounds, which are then almost completely excreted into the urine.

How should Duspatalin be stored and disposed of?

How to Store and Dispose of Duspatalin (Mebeverine Hydrochloride)

Duspatalin must be stored according to specific regulatory conditions to maintain product stability and safety. The medicine must be kept at a temperature not greater than 30°C and should be stored in a dry place and protected from light.

Storage Requirements

Condition Requirement
Temperature Not above 30°C
Protection Store in a dry place; Protect from light
Packaging Rule Store 200 mg capsules in the original package (to protect from moisture)
Child Safety Keep out of the sight and reach of children

Disposal

Official labeling for the 135 mg tablets states there are no special requirements for disposal of the product. Unused or expired medication should be discarded following local regulations, often by using general non-flush disposal methods.

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

Available in countries:

Equivalent of Duspatalin found in:

A-Z Index: