Spasmine SR

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Spasmine SR

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.

Overview of Spasmine SR

What is Spasmine SR?

Spasmine SR is an antispasmodic medication formulated to manage functional gastrointestinal disorders. It is a sustained-release (SR) oral treatment designed to provide a steady release of its active ingredient over an extended period, which helps maintain consistent levels of the medication in the body.

Active Ingredient and Classification

The primary active component of Spasmine SR is alverine citrate. Alverine is classified as a musculotropic antispasmodic agent. Unlike some other medications used for digestive issues, it works directly on the smooth muscles of the gastrointestinal tract and the uterus rather than acting through the central nervous system.

Mechanism of Action

Spasmine SR functions by reducing muscle spasms in the digestive system. It achieves this through several physiological pathways:

  • Smooth Muscle Relaxation: It acts directly on the muscle fibers of the gut wall to reduce excessive contractions and tension.
  • Calcium Channel Regulation: It helps modulate the movement of calcium ions into muscle cells, which is a key step in the process of muscle contraction.
  • Sensitivity Reduction: It may help decrease the sensitivity of the pain receptors in the gut to stretching and movement, which are often heightened in functional bowel disorders.

Therapeutic Intent

The medication is primarily used to address symptoms associated with irritable bowel syndrome (IBS) and other functional digestive disturbances. It is intended to alleviate abdominal pain, bloating, and discomfort caused by intestinal spasms. Due to its effect on smooth muscle, it is also sometimes utilized for the symptomatic relief of spasmodic pain associated with menstrual cycles (dysmenorrhea).

What side effects are possible with Spasmine SR?

Possible Side Effects and Safety Information

The information in this section is derived strictly from government regulatory documentation, such as the Summary of Product Characteristics (SmPC) and official prescribing labels for mebeverine-containing products.


Documented Adverse Reactions

The most commonly documented adverse reactions are linked to hypersensitivity and allergic responses. Because these reactions are typically identified through voluntary post-marketing reports, a precise frequency cannot be estimated, and they are generally classified as Not Known.

System-Organ Class (SOC) Adverse Reactions
Immune System Disorders Hypersensitivity, Anaphylactic reactions
Skin and Subcutaneous Tissue Disorders Urticaria (hives), Angioedema (swelling), Face oedema, Exanthema (rash)

Serious adverse events relate to severe manifestations of allergy, including Anaphylactic reactions and Angioedema, which involves swelling of the face, lips, or throat.


Safety Constraints and Special Populations

Official regulatory documents include specific safety constraints and limitations on use:

  • Contraindications: The medicine is restricted for use in individuals with known allergy to Mebeverine hydrochloride or any of its specific excipients, such as lactose or sucrose, where a hereditary intolerance is present.
  • Pregnancy and Breast-feeding: Use is not recommended during pregnancy or while breast-feeding due to insufficient safety data in these populations.
  • Pediatric Use: The medication is not recommended for use in children and adolescents below 18 years due to a lack of adequate data on safety and efficacy in this age group.

Mebeverine is noted in regulatory texts as lacking the systemic anticholinergic side effects often seen with other classes of antispasmodics.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation describes the overdose profile of Mebeverine hydrochloride based on observed clinical experience and mandated emergency actions.

Overdose symptoms are characterized as typically absent or mild and generally rapidly reversible. The observed clinical manifestations in overdose cases primarily involve the neurological and cardiovascular systems. In rare instances, theoretical Central Nervous System (CNS) excitability may occur.

Required Emergency Actions

If an overdose of Spasmine SR is taken or suspected, the explicit guidance from regulatory patient information is to talk to a doctor or go to a hospital straight away. This action is mandated because no specific antidote is known for Mebeverine hydrochloride.

Management Protocols

Treatment for overdose should be symptomatic treatment, which is officially recommended to manage the clinical manifestations. Procedural interventions, such as gastric lavage, should only be considered under the specific constraints of multiple intoxication or if the discovery of the overdose occurs within approximately one hour of ingestion. Routine absorption reducing measures are otherwise not necessary. No specific increased risk or management adjustments for overdose are documented for populations such as the elderly or those with hepatic or renal impairment.

Therapeutic Uses of Spasmine SR

What Spasmine SR Treats: Main Uses and Benefits

This medicine is commonly used in situations involving certain distressing symptoms related to heightened physiological activity, primarily addressing painful visceral spasms and cramps in the digestive and urinary systems. It is considered relevant for managing symptoms associated with disorders of the GI tract and the class of medicines typically used for these conditions.

The medication is applied when appropriate for conditions characterized by periods of heightened symptoms, such as those seen in Irritable Bowel Syndrome (IBS), biliary or renal colic, and painful menstruation. The overall therapeutic benefit supports the patient during difficult episodes, contributing to easing the overall symptom load during periods of increased distress. For certain traditional formulations, it is commonly used to help with nervous tension, agitation, and minor sleep disturbances.

“It helps manage symptoms that interfere with daily comfort and assists with functional stability during episodes of increased distress.”


Quick Fact: Relief for Spasmodic Pain

This medicine is commonly used to provide support that helps ease symptoms related to heightened physiological activity. The relief provided is primarily for symptoms of increased muscular activity.

Regulatory References

  1. NIH MedlinePlus overview of antispasmodic uses

Eligibility and Restrictions for Use

Who Can and Cannot Use Spasmine SR?

This information is based strictly on official regulatory labeling, outlining specific populations and conditions that determine eligibility for Spasmine SR use.

Contraindicated Populations and Conditions

Spasmine SR must not be used (is contraindicated) in the following situations:

  • Hypersensitivity: Individuals with a known allergy or hypersensitivity to the active substance or any other component (excipients) of the medicine.
  • Age Restriction: Children under 6 years of age. Use is reserved for adults and children aged 6 years and older.
  • Metabolic Disorders: Patients diagnosed with specific conditions related to sugar absorption, such as congenital galactosemia, glucose and galactose malabsorption syndrome, or lactase deficiency. This is due to the presence of excipients (lactose and sucrose).

Use Limitations and Special Populations

  • Pregnancy: Use of Spasmine SR is not recommended during pregnancy as a precautionary measure. Regulatory authorities note that there is insufficient clinical follow-up data to fully exclude all potential risk.
  • Breastfeeding: Official regulatory status for use while breastfeeding is not definitively stated as a prohibition or contraindication in standard labeling documents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Spasmine SR (Mebeverine hydrochloride) is characterized by a notable absence of known clinically significant interactions with other co-administered medicinal products. This information is based on comprehensive assessments found in government-approved prescribing documents.

Interaction Category Official Regulatory Status
Documented Drug-Drug Interactions None known. Regulatory labels report no known interactions with other medicinal products.
Pharmacokinetic/Metabolic Effects None documented. There are no official label statements regarding Mebeverine’s effect on CYP enzymes, drug transporters, or the exposure levels of co-administered medicines.
Timing-based Administration Rules None documented. Official labeling does not require mandatory separation or spacing of doses when co-administered with other medicines.

Substance and Population-Specific Considerations

The official documentation addresses the compound's status regarding specific non-medicinal substances and contains one mandated population-specific restriction:

  • Alcohol (Ethanol): The regulatory profile documents the absence of interaction between mebeverine hydrochloride and ethanol.
  • Food and Herbal Products: Official sources do not list specific interactions with food or common herbal products.

The principal constraint documented in the interaction context is tied to the non-active ingredients. Certain formulations contain lactose or sucrose. This mandates a formal restriction for use in patient populations with documented hereditary sugar intolerances, such as total lactase deficiency, glucose-galactose malabsorption, or specific forms of fructose intolerance.

This structure defines the product's official interaction profile, which is primarily set by the finding of no known interactions with other medicines and a specific required caution related to excipient content.

Mechanism of Action

Mechanism of Action: Smooth Muscle Dynamics

Spasmine SR operates as a musculotropic antispasmodic, exerting its action directly on the smooth muscle cells of the visceral organs. Its primary mechanistic targets are the Phosphodiesterase (PDE) enzymes, which it acts on as an inhibitor, and Voltage-dependent Calcium Channels ( VDCCs), which it functions to modulate.

Inhibition of PDE results in an increase in intracellular cyclic nucleotides ( cAMP and cGMP). This pathway, combined with the reduction of Ca^2+ ion influx via VDCC modulation, prevents the activation of Myosin Light Chain Kinase (MLCK). This molecular cascade stops the necessary steps for fiber shortening, leading to relaxation (spasmolysis) of the hyperactive smooth muscle tissue. The physiological consequence of this selective action is a reduction of excessive muscle tone in the gastrointestinal, biliary, or urogenital tracts, leading to the cessation of the mechanical stimulus that induces visceral nociception.

Dosage and Administration Information

How to Use Spasmine SR: Official Administration Guidelines

Spasmine SR (Mebeverine hydrochloride 200 mg) is administered following a structured protocol.

Official Dosing and Frequency

The standard approach involves oral administration of the modified-release capsule.

Instruction Domain Official Guideline
Standard Adult Dose One 200 mg capsule per dose.
Frequency Taken twice daily (b.i.d.).
Duration The duration of use is generally not limited; the dose may be gradually reduced once the desired effect is sustained over several weeks.

Administration Requirements and Precautions

The medicine is subject to specific handling instructions to preserve the integrity of its sustained-release (SR) formulation.

  • Timing: The capsule should be taken approximately 20 minutes before a meal.
  • Capsule Integrity: The capsule must be swallowed whole with an adequate amount of water and must not be chewed, crushed, or broken. Altering the capsule integrity disrupts the controlled release of the active ingredient.
  • Missed Dose: If a scheduled dose is missed, the user must continue with the next scheduled dose at the usual time; compensation for a missed dose by taking a double quantity is not permitted.

Population Rules

For the 200 mg modified-release capsule, the medicine is not recommended for use in children and adolescents below 18 years of age. No specific dosage adjustment is typically required for older adults or individuals with mild to moderate renal or hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Spasmine SR

Evidence for use in Irritable Bowel Syndrome (IBS) and Functional Spasms

Research into mebeverine hydrochloride, the active ingredient in Spasmine SR, was studied for its role in conditions characterized by fluctuating or episodic manifestations, including Irritable Bowel Syndrome (IBS) and related functional spasms. The main evidence comes from short-term Randomized Controlled Trials (RCTs) and comprehensive systematic reviews that have pooled these results. These studies used in research exploring how symptoms change over time to focus primarily on patient-reported outcomes describing perceived discomfort, such as the frequency and intensity of abdominal pain, and overall symptom relief.

The studies report how symptoms changed in the observed populations during the trial period. While individual trials describe patterns observed in studies evaluating patient-reported outcomes for abdominal pain, scientific reviews have noted inconsistency or variability across studies and that findings were mixed when assessing global symptom relief compared to placebo. This evidence contributes to understanding symptom patterns but reflects the inherent difficulty in assessing conditions characterized by functional limitations like IBS, where symptoms may vary in intensity.

Long-Term Evidence and Study Follow-up Duration

The majority of the research for Spasmine SR research examined treatment effects over defined time intervals that are generally short-term, typically extending up to 12 weeks. Because of this focus on short-term data, there is limited information for long-term outcomes that may arise from continuous use. Long-term effects are not fully established, and research provides context but not individual predictions regarding the durability of any observed changes over many months or years.

Research in Special Populations

Specific trials research examined its use in adolescent and pediatric groups with Functional Abdominal Pain-Not Otherwise Specified (FAP-NOS). Conversely, data for certain groups remain insufficient. For instance, high-level evidence systematically evaluating mebeverine for older adults with IBS is generally lacking. Similarly, this research has not included pregnant populations or patients with certain complex comorbidities, meaning results apply only to the populations studied in the major RCTs.

What is Still Uncertain in the Research Record

Scientific reviews have noted several areas where certainty remains low. A primary concern is the inconsistency or variability across studies, contributing to the noted heterogeneity in findings when comparing the overall reported relief against placebo. The available evidence is limited for fully determining the overall scientific context of mebeverine, given the observed variability in trial results.

Key Studies & References

  1. Effect of antispasmodic agents, alone or in combination, in the treatment of Irritable Bowel Syndrome: systematic review and meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Spasmine SR (FAQ)


Q: How is Spasmine SR different from the immediate-release form of the same medication?

Spasmine SR is a sustained-release (SR) formulation, which means the active ingredient is released slowly and steadily over a longer period of time. This controlled-release design supports a less frequent dosing schedule. Immediate-release formulations require more frequent daily administration to achieve comparable drug delivery.


Q: What are the most commonly reported side effects of Spasmine SR?

Official documents list a variety of adverse reactions that have been reported, including reported reactions such as headache, tiredness, indigestion, and dizziness. However, due to the way this information is collected from post-marketing reports, a precise frequency for most reactions cannot be definitively estimated. For this reason, many side effects are officially classified as having a 'Not Known' frequency.


Q: Are there specific foods or dietary supplements that interact with Spasmine SR?

Regulatory documents state that Spasmine SR should be taken approximately 20 minutes before a meal. This specific timing is noted in the guidelines to align with the period when symptoms are frequently reported to increase after eating. Official sources do not list specific interactions with common foods or herbal products.


Q: What are the general safety considerations for older adults using Spasmine SR?

According to official prescribing information, a specific dosage change is generally not required for older adults. However, patient safety materials note that elderly individuals may be more likely to experience certain adverse effects, such as dizziness or drowsiness.


Q: Is Spasmine SR intended for short-term use or long-term management?

The duration of use for Spasmine SR is generally described in regulatory guidelines as being not limited. The dose may be gradually reduced once the desired effect is sustained over several weeks, as described in the official documents. However, studies primarily focus on short-term periods, meaning long-term outcomes are not fully established.


Q: Can people with pre-existing kidney conditions use Spasmine SR?

Official product information notes that use requires caution for individuals with advanced renal disease (severe kidney problems) due to the way the medicine is eliminated from the body. However, specific dosage adjustments are typically not required for those with mild to moderate kidney impairment.


Q: Can people with existing liver conditions use Spasmine SR?

Use requires caution for people with advanced liver disease, such as cirrhosis, because the medicine is processed (metabolized) through the liver. For individuals with mild to moderate liver impairment, a specific dosage adjustment is usually not required.


Q: What does regulatory information say about stopping treatment with Spasmine SR?

Regulatory documents state that cessation of the medicine should not be done abruptly. The official prescribing information notes that the dose may be gradually reduced over time, based on professional assessment.


Q: What information is available regarding taking Spasmine SR with fruit juices like grapefruit juice?

The official regulatory profile for Spasmine SR is noted for an absence of known clinically significant interactions with medicines, food, or other products. Because of this, specific warnings about common items like grapefruit juice are not mandated in the official labeling documents.


Q: How quickly does Spasmine SR typically begin to take effect?

Patient information materials indicate that the medicine's effect is typically observed approximately one hour after administration. Because Spasmine SR is a sustained-release capsule, the active ingredient continues to be released over an extended period after this initial onset.


Q: Is it normal to experience mild dizziness when first starting Spasmine SR?

Official documents list dizziness as a reported adverse reaction. Adverse effects such as this are generally described as being mild and of short duration.


Q: Does Spasmine SR have the potential to cause weight gain or weight loss?

Medical information summaries generally describe Spasmine SR as a product that does not typically cause weight gain or weight loss. Questions about significant changes in weight should be directed to a healthcare professional.


Q: Does Spasmine SR affect a person's ability to drive or operate heavy machinery?

According to the official product information, the regulatory profile and post-marketing experience do not suggest any harmful effect on a person’s ability to drive or operate heavy machinery. While formal studies on this specific topic have not been performed, the risk is not flagged by authorities.


Q: How do official documents describe the side effect of dry mouth with Spasmine SR?

Dry mouth is listed in official documents as a reported adverse reaction associated with the use of Spasmine SR.


Q: Is there any information about Spasmine SR causing changes in a person's appetite?

Anorexia (loss of appetite) is listed in official documents as a reported adverse reaction. This means it has been reported by users but does not imply a known frequency.


Q: Does Spasmine SR have any known effect on a person's blood pressure or heart rate?

A decreased pulse rate (bradycardia) is listed in official documents as a reported adverse reaction. Significant effects on blood pressure are generally not noted in reports for the oral formulation of Spasmine SR.


Q: What non-drug therapies are sometimes used together with Spasmine SR?

Patient information often notes the inclusion of non-drug therapies in the overall management plan. Diet and lifestyle adjustments, such as increasing dietary fiber or utilizing relaxation techniques, are sometimes mentioned as complementary measures.


Q: How is the clearance (elimination) of Spasmine SR from the body described?

According to pharmacokinetic information, the active ingredient in Spasmine SR is primarily broken down in the body by a process called hydrolysis. The major route of elimination for the resulting substances is via the urine. Nearly all of the byproducts are recovered in the urine within 24 hours of administration.


Q: Is Spasmine SR known to cause insomnia or difficulty sleeping?

Insomnia (difficulty sleeping) is listed in official documents as a reported adverse reaction associated with the use of Spasmine SR.


Q: Are there any special monitoring requirements described for people taking Spasmine SR?

Official guidelines state that liver function tests may be indicated if a patient develops certain symptoms, such as jaundice, which could suggest hepatic sensitivity (a reaction in the liver). This monitoring is conditional upon the presentation of these specific symptoms.

How should Spasmine SR be stored and disposed of?

How to Store and Dispose of Spasmine SR

Official regulatory documents define strict conditions for the storage and disposal of mebeverine modified-release capsules.

Storage Conditions

The medicine must be stored at a temperature below 30 C and protected from moisture. To maintain product integrity, the capsules must be kept in the original package. It is a mandatory safety instruction to keep this medicine out of the sight and reach of children.

The capsules must not be used after the expiry date printed on the packaging, and storage environments that include freezing or refrigeration are prohibited.

Disposal Instructions

When disposing of unused or expired Spasmine SR, the product must not be thrown away via wastewater or household waste. All unused or unwanted capsules must be returned to a pharmacist for proper pharmaceutical waste management to help protect the environment.

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

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