Spasverine

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Spasverine

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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 Spasverine

Quick Facts

Property Description
Active ingredient Alverine citrate
Form Hard capsules
Pharmacological class Antispasmodic agent (Spasmolytic)
General purpose Relief of painful muscle spasms (cramping)
Origin Synthetic

Spasverine: Definition, Class, and Composition

Spasverine is a pharmaceutical preparation classified as an antispasmodic agent, or spasmolytic, whose sole active ingredient is Alverine citrate. This synthetic compound belongs to the Propylamine tertiary amine group and is manufactured in the form of hard capsules intended for oral administration. As a class, antispasmodic agents are well-recognized in medical practice for their ability to selectively reduce the involuntary muscle activity that causes pain. Unlike many combination products, Spasverine is specifically positioned to deliver the focused action of Alverine citrate for muscle relaxation.


How Does Spasverine Act to Relieve Spasm?

Spasverine functions by exerting a direct action on smooth muscle, which is the involuntary muscle tissue found primarily in the walls of the gut. The active substance, Alverine, achieves this by modulating the flow of calcium ions into the muscle cells, which is the necessary trigger for contraction and subsequent spasm. This effect is clinically recognized for providing relief in scenarios where patients experience acute abdominal pain or cramping due to spasmodic gut activity. This selective action directly addresses the muscle hyperactivity, which is a key symptom of functional gastrointestinal disorders, offering a general benefit of reduced muscle tension.


Is Spasverine a Single-Ingredient Product?

Yes, Spasverine is formulated as a single-ingredient product in a hard capsule, containing only Alverine citrate alongside necessary pharmaceutical excipients. This composition ensures the focus of the treatment is entirely on the properties of Alverine itself, specifically its effectiveness in promoting smooth muscle relaxation. This single-agent status is a differentiating factor when compared to some alternative spasmolytics which are often presented as combination products, featuring additional active ingredients to address secondary issues like excess intestinal gas. The use of the capsule form is the standard for delivering this type of spasmolytic for internal action.

What side effects are possible with Spasverine?

Possible Side Effects and Safety Information

The safety profile for Spasverine (Alverine citrate) is based on official regulatory classifications, which organize potential adverse events by the affected body system and reported frequency. The majority of listed effects are classified as Frequency Not Known, meaning their rate of occurrence cannot be reliably estimated from available data, according to governmental safety documentation.


Official Adverse Reaction Groupings

Adverse reactions that have been officially documented and reported primarily involve several System-Organ Classes (SOC):

  • Immune System Disorders: Includes general hypersensitivity reactions and the potential for a severe, systemic reaction known as anaphylaxis.
  • Hepatobiliary Disorders: Documented reports include the potential for jaundice due to hepatitis, a serious reaction typically reversible upon discontinuation of the medicine.
  • Nervous System Disorders: Officially listed effects include headache and dizziness.
  • Gastrointestinal Disorders and Skin and Subcutaneous Tissue Disorders: These systems may exhibit reactions such as nausea, rash, and pruritus (itching).

Regulatory Safety Constraints

Official labeling defines specific safety constraints and limitations on the use of Spasverine. The medicine is contraindicated in cases of known hypersensitivity to Alverine citrate and in patients with established or suspected intestinal obstruction or paralytic ileus. Furthermore, use is not recommended in children below the age of 12 years due to insufficient data on safety in this specific population. The possibility of experiencing dizziness is noted in official documents as a factor that may affect the ability to drive or operate machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the potential clinical effects of an overdose of Spasverine (Alverine Citrate), drawing on information from official regulatory documents. In the event of an overdose, it is essential to seek immediate professional medical attention.


Documented Overdose Presentations

Regulatory information indicates that an overdose of this substance may lead to two primary clinical presentations:

  • Hypotension: A significant drop in blood pressure.
  • Atropine-like Toxic Effects: Systemic manifestations resembling poisoning by atropine, which can affect the nervous and cardiovascular systems.

These effects signify a potentially serious medical event requiring prompt evaluation.


Emergency Action Required

In a case of suspected or confirmed Spasverine overdose, immediate professional medical assistance must be sought. Official regulatory guidelines state that the management should follow the protocol for atropine poisoning.

This management includes providing supportive therapy for hypotension to help stabilize the patient’s blood pressure. Due to the risk of serious cardiovascular and systemic toxicity, an overdose of Spasverine is defined by regulatory bodies as a condition requiring urgent and specialized clinical care. Do not attempt to manage a suspected overdose at home.

Therapeutic Uses of Spasverine

Quick Facts: Spasverine

  • May offer relief from smooth muscle spasms.
  • Used for conditions involving the gastro-intestinal tract, biliary tract, and urogenital system.
  • Intended to help manage symptoms like abdominal pain and discomfort associated with irritable bowel syndrome (IBS).

Spasverine (which contains Alverine citrate) is an agent used to address symptoms associated with smooth muscle spasm. Its therapeutic domains primarily involve conditions of the digestive system and urogenital system. It may be used to provide symptomatic relief in disorders of the gastro-intestinal tract and the biliary tract.

The use of this type of antispasmodic agent may help manage abdominal pain and discomfort, which are key symptoms experienced by patients with irritable bowel syndrome (IBS). Furthermore, it is prescribed for spasmodic pains linked to the urogenital system.

For a comprehensive understanding of the approved uses and related safety data, healthcare professionals and patients should refer to official labeling and resources.

Regulatory References

  1. NIH MedlinePlus guidance

Eligibility and Restrictions for Use

Who can and cannot use Spasverine?

This section outlines the officially documented population eligibility and non-eligibility rules for Spasverine (Alverine citrate), based strictly on regulatory prescribing information.


Eligibility and Exclusion Rules

Classification Eligibility Rules as per Regulatory Documents
Allowed Populations Generally indicated for use in Adults and Adolescents aged 12 years and over. Use in the elderly follows standard adult guidelines.
Contraindicated Populations (Must Not Use) Pregnant or Breastfeeding women, due to limited safety data. Individuals with a known hypersensitivity or allergy to Alverine citrate or its components. Patients diagnosed with Intestinal Obstruction or Paralytic Ileus.
Use Not Recommended Children below the age of 12 years, as safety and efficacy have not been established in this age group.

Important Restrictions

Patients are advised to consult a doctor before taking Spasverine if they develop new, severe, or concerning symptoms, such as vomiting, blood from the bowel, severe constipation, or if they are aged 40 or over with a new onset of symptoms. These are official label warnings intended to rule out serious underlying conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Spasverine (Alverine) is primarily characterized by the risk of enhanced effects when co-administered with other medicines that possess Central Nervous System (CNS) depressant properties. This documented risk arises from the potential for additive pharmacodynamic effects.

Documented Pharmacodynamic Interactions

Co-administration with numerous medicinal products is officially stated to increase the risk or severity of adverse effects, specifically including CNS depression. Patients should be aware of this potential for additive effects when taking the following categories of medicines:

  • Opioids and Sedatives: Medicines used for pain relief or to promote sleep.
  • Antihistamines: Certain medicines used to treat allergies that may cause drowsiness.
  • Antidepressants and Anxiolytics: Specific medicines used for mood disorders or anxiety (e.g., Benzodiazepines, Tricyclic Antidepressants).
  • Other CNS Depressants: This includes general CNS depressants and specific muscle relaxants.

This broad interaction structure means that a patient taking Spasverine alongside any of these agents must be monitored closely. The official documentation notes that both Spasverine and the concomitant agent may mutually increase their CNS depressant activities, requiring careful assessment of the combined risk. Specific agents such as Acenocoumarol have also been identified in regulatory documents as increasing the risk or severity of adverse effects when co-administered with Spasverine.

Mechanism of Action

Spasverine (Alverine) modulates intestinal smooth muscle activity through a multifaceted pharmacodynamic mechanism. The compound and its active metabolite accumulate in the gastrointestinal tract, acting as a non-selective musculotropic agent. At the cellular level, Spasverine exerts a direct effect on smooth muscle fibers, reducing the sensitivity of the contractile apparatus to intracellular calcium (Ca^2+) signals. It also functions as a 5-HT1A receptor antagonist, preventing the binding of serotonin (5-HT) to these receptors on afferent sensory neurons. This receptor-level interaction modulates neural signaling pathways involved in gut activity. Furthermore, Spasverine inhibits the influx of Ca^2+ ions into the smooth muscle cell cytoplasm, likely through interaction with membrane channels. The collective molecular actions of reduced Ca^2+ sensitivity, Ca^2+ influx inhibition, and 5-HT1A antagonism result in a net reduction of smooth muscle tone and a normalization of peristaltic rhythm within the enteric system.

Dosage and Administration Information

The administration of Spasverine (Alverine citrate) focuses on the mechanics of ingestion and dosing patterns. The medicine is provided as hard capsules in strengths of 60 mg and 120 mg.

Administration Parameters

Field Instruction
Route of Administration Oral (swallowed by mouth).
Preparation Requirements The capsule must be swallowed whole with a drink of water; it should not be opened or crushed.
Timing Relative to Meals Administration may occur before or after consuming food.

Dosing and Regimen

The regimen for adults and older adults involves administering a single dose ranging from 60 mg to 120 mg of Alverine citrate. This dose corresponds to taking one or two 60 mg capsules, or one 120 mg capsule, per single instance of use. The maximum administration frequency is three times per day. The use of this medicine is generally intended to be short-term, covering periods when relief is required.

Population Use Constraints

The standard adult regimen applies to older adults, as specific dose adjustments for this population are not specified in the prescribing information. The use of Spasverine is not recommended for pediatric patients under 12 years of age.

This protocol ensures the administration of the drug adheres to the standardized dosage and frequency.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Safety and Efficacy Profile

Studies have evaluated the safety and efficacy of the drug for treating the target condition across a range of adult populations. These investigations included both short-term (up to 12 weeks) and long-term (up to one year) randomized controlled trials (RCTs).

Research has explored whether the drug is associated with a reduction in chronic pain and the time course of any observed effects on discomfort. Some observational studies have provided insight into patient-reported outcomes beyond the clinical trial setting.

Combination vs. Monotherapy

Comparative studies evaluated whether a combination treatment regimen differed in outcome compared to monotherapy in patients with a specific subtype of the condition. Primary endpoints for these analyses included markers used to track the condition and health-related quality of life assessments.

Studies examined the effects of the combination treatment, including the maintenance of any observed reduction in symptoms over time. Findings from initial analyses suggest variable responses, with some patient subgroups showing a differential effect. Research has explored the effects associated with the use of the lowest possible dose investigated in clinical trials.

Mechanism of Action (MoA)

Clinical trials evaluated whether the drug acts by suppressing the underlying mechanism proposed to drive the condition's progression. In vitro data support this proposed action by showing a measurable effect on target biomarkers. Further exploratory research has examined whether this proposed mechanism of action is consistent across all patient demographics.

Use in Specific Populations

Studies have examined the use of the drug in individuals with mild to moderate kidney impairment to assess any necessary dose adjustments or altered pharmacokinetics. Conversely, research has explored the effects associated with this treatment in individuals with severe liver disease.

Long-term Outcomes

Evidence from several prospective cohort studies examined whether the drug was associated with a reduction in the frequency of acute episodes over a period exceeding two years. In summary, evidence evaluated the drug's potential as an initial treatment option.

Frequently Asked Questions (FAQ)

Common questions about Spasverine (FAQ)

Q: What is Spasverine mainly used for in different countries?

Official product documents indicate that the medicine is indicated for the relief of smooth muscle spasm. This includes spasms associated with conditions such as Irritable Bowel Syndrome (IBS), painful diverticular disease of the colon, and primary dysmenorrhoea (painful periods).

Q: Can Spasverine be taken on an as-needed basis?

The recommended dosing schedule in regulatory documents suggests a set frequency, typically one to three times daily. This is intended to cover periods when relief of symptoms is required. A healthcare professional can be consulted regarding the appropriate frequency based on individual circumstances.

Q: Do most people who take Spasverine experience side effects?

The official regulatory information for many side effects, such as nausea and dizziness, lists their frequency as 'Not known'. This means that the rate of occurrence cannot be reliably estimated from the available data. It is known that a majority of the reported adverse events fall into this classification.

Q: Can taking Spasverine cause dizziness or drowsiness?

Dizziness is listed in the official documents as a possible undesirable effect. Product labeling advises that the ability to drive or operate machinery may be impaired if dizziness occurs. Drowsiness itself is not explicitly listed as a common side effect.

Q: What are the common signs of a serious allergic reaction to Spasverine?

Regulatory documents mention the potential for serious reactions, including anaphylaxis (a severe, whole-body allergic reaction) and general hypersensitivity. Documented signs include skin rash, itching, wheezing, and difficulty breathing.

Q: Is it normal to feel a bit nauseous when first starting treatment with Spasverine?

Nausea is noted in official sources as a possible undesirable effect, but its frequency is classified as 'Not known'. Regulatory information does not specifically indicate whether this effect is more common during the initial days of treatment.

Q: Can people with pre-existing kidney or liver problems use Spasverine?

Official product documents note that undesirable effects can include abnormal liver function tests and jaundice (yellowing of the skin) due to hepatitis. These effects are generally reported to be reversible upon discontinuation of the medication. Specific constraints on use in patients with pre-existing kidney or liver impairment are best addressed by a healthcare professional.

Q: Is Spasverine sometimes used to treat conditions outside of its main purpose?

The official product characteristics outline specific approved therapeutic indications, such as Irritable Bowel Syndrome and primary dysmenorrhoea. Information on using the medicine for any other conditions is not included in the official regulatory documents.

Q: How do the official sources describe the expected efficacy of Spasverine?

The drug is described as a spasmolytic (antispasmodic) agent. Its action is directed at the smooth muscle found in the gut and uterus, which is intended to relieve painful muscle spasms.

Q: Is Spasverine available to purchase over the counter?

Patient information leaflets indicate that the medicine is typically provided through a prescription from a healthcare professional. Official guidance states that the medicine is prescribed only for the individual patient for whom it is intended.

Q: How long does it usually take for Spasverine to start working?

Pharmacokinetic data from official sources indicate how quickly the medicine is absorbed. The peak level of the most active substance in the blood is observed approximately 1 to 1.5 hours after an oral dose.

Q: How long does the effect of a single dose of Spasverine last?

The duration of a drug's presence in the body is often measured by its plasma half-life. Official data reports that the half-life of the active primary metabolite averages 5.7 hours.

Q: Does Spasverine have any known effects on blood pressure?

While the medicine is generally reported not to affect blood vessels at normal doses, regulatory documents mention an effect on blood pressure in extreme circumstances. Specifically, overdose situations are documented as being associated with hypotension (low blood pressure).

Q: Can Spasverine be taken at the same time as Tylenol (acetaminophen)?

The official product characteristics, which summarize potential drug interactions, state 'None stated' for interactions with other medicinal products.

Q: Are there known interactions between Spasverine and caffeine?

The regulatory section covering drug interactions states 'None stated' for other medicinal products. This official statement covers common non-drug substances like caffeine.

Q: Does Spasverine have any documented interaction with hormonal birth control pills?

The official documentation that lists possible drug-to-drug interactions states 'None stated' for interactions with other medicinal products, including hormonal contraceptives.

Q: Can Spasverine be taken simultaneously with other stomach or indigestion medicines?

The regulatory section detailing interactions with other medicinal products states 'None stated.' This means no specific interaction with common stomach or indigestion medicines has been officially listed.

Q: What common vitamins or herbal supplements might interact with Spasverine?

The official product characteristics document for Spasverine states 'None stated' for interactions with other medicinal products, which covers common vitamins and herbal supplements.

Q: Where can a patient find the official patient information leaflet for Spasverine?

The official patient information leaflet (PIL) or similar regulatory documents are generally made available online by national regulatory authorities. They can often be found on public databases under the drug’s generic name, Alverine citrate.

Q: Are there different brand names used for the drug Spasverine?

Spasverine is the brand name for the active ingredient, Alverine citrate. This active substance may be marketed under several other brand names in different regions around the world.

Q: Does Spasverine contain any ingredients that are not gluten-free?

The official document lists all non-active ingredients, or excipients, used in the capsule, such as Maize Starch, Pregelatinised Starch, and Magnesium Stearate. A formal 'gluten-free' certification is not typically included in the official regulatory documentation itself.

Q: Does Spasverine interact with common headache medications?

The section of the official product characteristics that details drug interactions states 'None stated.' This official statement covers potential co-administration with most common over-the-counter headache medications.

Q: What should be done if Spasverine has been stored improperly?

The official guidance specifies that the medicine should be kept in its original packaging. Storage temperature should not exceed 25 C or 30 C, depending on the formulation. The best guide for proper storage is always the instructions printed on the carton.

How should Spasverine be stored and disposed of?

How to Store and Dispose of Spasverine (Alverine Citrate)

The storage and disposal of Spasverine hard capsules must adhere strictly to regulatory requirements to ensure product stability and safety. The medicine must be kept out of the sight and reach of children (official regulatory formulation).

Storage Requirement Official Condition
Temperature Store below 25 C or 30 C (varies by formulation).
Protection Keep in the original container/outer carton to protect from light and moisture.

Storage within the specified temperature and environmental conditions is required to maintain the stability and integrity of the product until its expiration date. Unused or expired Spasverine must not be thrown away with household waste or wastewater. Disposal is required to follow local pharmaceutical waste handling instructions, often involving return to a pharmacy or designated collection point (official regulatory formulation).

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

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