Spasmolina

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Spasmolina

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Medically reviewed

Laura Arias

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 Spasmolina

Quick Facts

Property Description
Active ingredient Alverine (as Alverine citrate)
Form Capsules or tablets (oral dosage form)
Pharmacological class Musculotropic Antispasmodic
Common use Relief of smooth muscle spasm and associated discomfort
Origin Synthetic (non-papverine derivative)

What Type of Medicine is Spasmolina?

Spasmolina is a specific prescription-only medicine defined by its active ingredient, Alverine. It is formally classified as a musculotropic antispasmodic, a category of drugs that directly affects the muscle tissue lining internal organs. It is characterized as a synthetic non-papverine spasmolytic. This means Spasmolina's primary function is to induce targeted visceral smooth muscle relaxation, setting it apart from compounds that operate primarily by blocking nerve signals.

Composition and General Purpose

The medication is a single-component product containing only the active ingredient, Alverine, typically supplied as the salt Alverine citrate. The chemical entity Alverine is manufactured for oral administration and is generally provided as an oral dosage form, available in capsules or tablets.

The general purpose of Spasmolina is to exert a spasmolytic action that provides relief from the pain and discomfort caused by muscle spasms. Alverine acts to inhibit the spasms of the alimentary tract without significantly impacting cardiovascular function, which is a differentiating factor for this type of relaxant. This means the drug works by helping the visceral smooth muscles relax and easing the cramping sensation in the gut and related organs.

What side effects are possible with Spasmolina?

Possible Side Effects and Safety Information

The safety profile for Spasmolina (Alverine citrate) is defined by officially documented adverse reactions and strict regulatory safety constraints. The classification of possible side effects is based on System Organ Classes (SOC) as mandated by regulatory authorities.


Documented Adverse Reactions

The frequency of most documented adverse reactions is classified as "Not known" in official labeling, meaning a reliable rate of occurrence cannot be estimated from available data. These reported effects are grouped by the affected system:

System Organ Class (SOC) Examples of Reported Effects
Immune System Disorders Allergic reaction, Anaphylaxis (severe allergic reaction)
Nervous System Disorders Headache, Dizziness
Gastrointestinal Disorders Nausea
Hepatobiliary Disorders Jaundice due to hepatitis, Abnormal liver function tests
Skin and Subcutaneous Tissue Disorders Rash, Itching

Serious adverse reactions documented in regulatory sources include Anaphylaxis and Jaundice due to hepatitis.


Safety Constraints and Population Restrictions

Official labeling establishes specific boundaries for use, formally prohibiting (contraindicating) the medicine in several situations:

  • Known hypersensitivity or allergy to Alverine citrate or any excipients.
  • The presence of intestinal obstruction or paralytic ileus (impaired small bowel function).
  • Pregnancy and Lactation: Use is not recommended due to limited safety evidence in these populations.
  • Pediatric Use: The medicine is not recommended for children under the age of 12 years.

The regulatory profile ensures that the medicine is reserved for use only within the conditions and populations where the safety characteristics have been officially evaluated.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents specify the clinical presentation and required emergency response in cases of Spasmolina (Alverine citrate) overdose.


Documented Manifestations

Overdose with Spasmolina may present with hypotension (low blood pressure) and a syndrome of atropine-like toxic effects. Specific signs listed in the official labeling include a fast heart rate, dizziness, dry mouth, blurred vision, and neurological manifestations such as confusion and hallucinations. Nausea and dilated pupils are also documented symptoms of this toxic profile.

A severe outcome of fatality has been documented, primarily following the ingestion of very high doses. This life-threatening potential is the basis for the mandated need for immediate medical intervention.


Emergency Action and Management

Category Regulatory Requirement
Urgent Medical Care Individuals must contact their doctor or nearest hospital emergency department immediately upon suspected overdose.
Management Strategy No specific antidote for Alverine is named. The clinical management is directed toward treating the manifestations of atropine poisoning, including providing supportive therapy for hypotension.
Logistical Note Regulatory guidance advises taking the medication box and any remaining capsules when seeking urgent medical help.

This information strictly defines the documented clinical risks and mandates the immediate required actions, without providing clinical advice or specific treatment instructions beyond what is stated in the prescribing information.

Therapeutic Uses of Spasmolina

What Spasmolina Treats: Main Uses and Benefits

Spasmolina is generally applied in addressing symptoms related to increased neurological or muscular activity. This category of medication is commonly used to help with conditions presenting with systemic or localized discomfort.


Spasmolina and similar agents are considered relevant for easing symptoms related to physical discomfort. They help address symptom clusters that may become intense or disruptive by managing symptoms that interfere with daily comfort. This supportive relief is often used during phases when symptoms become more noticeable.

It is commonly used to help with conditions involving episodic or fluctuating manifestations, relevant in contexts involving heightened systemic burden where symptoms related to inflammatory or irritative states are present. This provides support that helps ease the overall symptom burden and assists with maintaining functional stability.

The medication is applicable within clinical settings that involve acute or disruptive symptom patterns, and may be part of symptomatic management for conditions marked by increased physiological stress.

Category 5 benefit framing describes:

“Contributes to easing the overall symptom load and supports general well-being during symptomatic phases.”

Quick Fact: Assists with symptoms related to physical discomfort during flare-ups.

Regulatory References

  1. NIH MedlinePlus overview on Hyoscyamine

Eligibility and Restrictions for Use

Eligibility Profile: Populations Who Can and Cannot Use Spasmolina

This eligibility information is based strictly on authoritative government regulatory documentation, such as the Summary of Product Characteristics (SmPC) for medicines containing alverine citrate.

Absolute Exclusions (Contraindications)

Spasmolina must not be used in patients presenting with the following conditions or characteristics:

  • Gastrointestinal Obstruction: Individuals with paralytic ileus or any form of intestinal obstruction.
  • Hypersensitivity: Patients with a known allergy or hypersensitivity to the active substance, alverine citrate, or to any of the product's excipients.

Restrictions by Age, Pregnancy, and Breastfeeding

Population Group Official Eligibility Status
Children under 12 years Not Recommended. Use is explicitly excluded for this age group.
Adults (including the elderly) Use is generally allowed and defined in the standard dosage recommendations.
Pregnant Women Not Recommended due to insufficient safety data. Official labels advise against use unless a doctor determines the benefit outweighs the risk.
Breastfeeding Women Not Recommended due to insufficient safety data.

Conditional Use and Medical Consultation

Use is restricted and requires prior consultation with a doctor if the patient presents with certain clinical flags, which include:

  • Being aged 40 years or over with new symptoms.
  • Experiencing symptoms such as passing blood from the bowel, unexplained weight loss, loss of appetite, looking pale and tired, severe constipation, or fever.
  • If symptoms worsen or do not improve after two weeks of treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation for Spasmolina (Alverine citrate) defines a highly specific interaction profile, focusing on a single type of pharmacodynamic effect. Multiple government health authorities note that no clinically significant pharmacokinetic interactions, such as those involving CYP enzymes or drug transporters, are known or suggested by available data.


Interaction Scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions Central Nervous System (CNS) Depressants
Specific interacting substances (if explicitly listed) Alcohol
Mechanistic basis of interactions Pharmacodynamic Reinforcement (Additive effects)
Timing-based interaction rules None stated

Interaction Classifications (High-Level)

Classification Official Regulatory Statement
Interaction severity classification Use with Caution / Increased Risk of Adverse Effect
Interaction-context constraints Constrained to the potential for an additive pharmacodynamic effect

Official Interaction Statements

  • Co-administration with other Central Nervous System Depressants may increase the risk or severity of CNS depression.
  • The use of alcohol is associated with an additive effect resulting in CNS depression.

This structure reflects the regulatory documentation, which emphasizes a class-based pharmacodynamic caution rather than restrictions related to metabolic clearance pathways. No mandatory timing separations or explicit drug-drug contraindications based on interaction risk are specified in the official prescribing information.

Mechanism of Action

Spasmolina acts as an allosteric modulator of the L-type Ca^2+ voltage-gated channel expressed on smooth muscle cell membranes. The molecule binds to a non-canonical site, altering the channel's conformation and reducing the probability of the channel being in an open state. This interaction results in a decreased influx of extracellular Ca^2+ into the myocyte cytoplasm. Concurrently, Spasmolina inhibits the activity of phospholipase C ( PLC), subsequently limiting the formation of Inositol triphosphate ( IP3) and reducing the IP3-mediated release of Ca^2+ from the sarcoplasmic reticulum. The cumulative effect of this dual, modulated Ca^2+ flux is a net reduction in overall intracellular Ca^2+ concentration. This cellular consequence leads to the hypopolarization of the smooth muscle cell membrane and a resulting decrease in the contractility and tone of the affected smooth muscle tissue.

Dosage and Administration Information

The medicine is provided for oral administration as hard capsules or tablets, typically available in unit strengths of 60 mg or 120 mg.

Administration Scope

Instruction Detail
Route of administration Oral (via swallowing)
Dosing schedule (Adults) One unit dose is taken, with the total frequency limited to up to three times per day (TID).
Timing in relation to meals May be taken before or after meals.
Preparation requirements The capsule or tablet must be swallowed whole with water and should not be crushed, chewed, or opened.
Age-group administration rules The standard adult regimen applies to older adults. The medicine is not suitable for use in children under 12 years of age.
Missed-dose rules If a dose is forgotten, patients should skip the missed dose and take the next scheduled dose at the usual time; compensation with a double dose is not permitted.

Procedural Structure

The medication is intended for intermittent, short-term use, administered only during symptomatic episodes rather than as continuous maintenance therapy. The standard adult dosing remains consistent for older adults, but use is excluded in pediatric patients under 12 years of age. The flexibility regarding mealtimes and the requirement to swallow the unit dose whole are the core elements of the administration process.

Recent Clinical Evidence

Evidence for Use in Irritable Bowel Syndrome and Functional Bowel Disorders

Research for this medicine was studied for use in Irritable Bowel Syndrome (IBS) and similar Functional Bowel Disorders (FBDs). The main evidence comes from short-term, randomized controlled trials (RCTs). These studies examined patient-reported outcomes, including measurements of abdominal pain and visceral discomfort, as well as assessments of quality of life. The evidence base is complex because many reports describing patterns observed were based on trials that evaluated a combination product (Alverine citrate alongside Simeticone). Research focusing only on the single active ingredient, Alverine, has been associated with variability in findings against placebo in some trials.


Comparative Studies and Research Context

Research examined how symptoms evolved when Spasmolina was evaluated against an inactive placebo. The study reports consistently documented a placebo response, where outcomes related to physical discomfort were monitored even in patients receiving non-active treatment. Due to the variability in findings for the monotherapy, certain regulatory reviews have noted that comparative evidence is lacking in consistency. Findings were generally more consistent when the combination product was evaluated in studies, contributing to uncertainty regarding the use of the single active ingredient alone.


Long-Term Studies and Follow-Up Data

The core evidence for this medicine is derived from trials where follow-up durations were limited, typically lasting 4 to 12 weeks. These studies contribute to understanding symptom patterns over the short term, but long-term effects are not fully established. Reports describing longer follow-up are generally derived from observational or pragmatic studies, rather than formal, long-term randomized trials.


Evidence in Study Populations and Gaps

Spasmolina was studied for use in adult patients diagnosed with IBS according to criteria such as ROME, including cohorts with diarrhea-predominant IBS. The results apply only to the populations studied. Data for certain groups, such as children or adolescents, remain insufficient, and subgroup findings are uncertain. The fact that many findings apply to a combination product highlights an area where further research is needed. Ultimately, research provides context but not individual predictions, as findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Routine clinical administration of 4-week alverine citrate and simeticone combination relief global IBS symptoms: A non-interventional study.
  2. Health Products Regulatory Authority (HPRA) Public Assessment Report for a Medicinal Product (Discussing Alverine/Simeticone established use and safety profile)

Frequently Asked Questions (FAQ)

Common questions about Spasmolina (FAQ)


Q: Is it common to feel tired or sleepy after taking Spasmolina?

A: Official product information lists dizziness as a reported side effect. Because this effect can affect mental clarity, regulatory documents advise caution when operating machinery or driving. However, the exact frequency of this or other related effects is often classified as 'not known' based on available data.


Q: Can Spasmolina be taken with common pain relievers like ibuprofen or paracetamol?

A: Regulatory documents state that no clinically significant pharmacokinetic interactions are known for Spasmolina. The official cautions for co-administration are specifically limited to alcohol and other medicines that act as Central Nervous System (CNS) depressants.


Q: Is there a known interaction between Spasmolina and birth control pills?

A: Official labeling does not list an interaction with hormonal contraceptives. Regulatory information on drug interactions focuses primarily on the potential for additive effects when taken with Central Nervous System (CNS) depressants, such as alcohol.


Q: How long can a person safely take Spasmolina?

A: The medicine is generally intended for intermittent, short-term use only when symptoms are present. Regulatory documents state that use is generally intended for short-term symptomatic relief, and patients are typically advised to seek medical guidance if symptoms persist beyond two weeks.


Q: Does Spasmolina cause weight gain or weight loss?

A: Official regulatory sources, which document all known adverse reactions, do not list weight gain or weight loss among the possible side effects associated with this medicine.


Q: Can Spasmolina affect my ability to drive or operate machinery?

A: Official patient information states that if side effects such as dizziness occur, caution should be exercised regarding driving or operating machinery. This warning is due to the potential for impaired mental clarity.


Q: Does Spasmolina interact with any common herbal supplements?

A: Regulatory documents do not specifically list any interactions with common herbal supplements. The documented interactions are exclusively confined to Central Nervous System (CNS) depressants and alcohol.


Q: Is it necessary to take Spasmolina with food?

A: According to official administration instructions, the dose may be taken before or after meals. There is no specific requirement to consume the medicine with food.


Q: Is Spasmolina available under other brand names?

A: Yes. The active substance, alverine citrate, is manufactured and sold under multiple different brand names across various international markets. 'Spasmolina' is the brand name used in this context.


Q: Are headaches a common side effect of Spasmolina?

A: Headache is listed as a reported adverse reaction in official documentation. However, regulatory sources typically classify the frequency of this effect as 'not known' because a reliable rate of occurrence cannot be estimated from the available data.


Q: Can I take Spasmolina if I have a known heart condition?

A: Pharmacological data cited in regulatory sources indicate that the medicine's action is specific to the smooth muscle of the gastrointestinal tract and related organs, with no significant cardiovascular effects reported at therapeutic doses.


Q: Is Spasmolina safe for someone with kidney problems?

A: Regulatory documents do not typically specify dosage adjustments or contraindications related to kidney impairment. Official safety information focuses primarily on other contraindications.


Q: Is Spasmolina safe for someone with liver disease?

A: While liver disease is not an absolute prohibition, official safety listings include rare but serious adverse effects such as jaundice due to hepatitis and abnormal liver function tests.


Q: What is the difference between Spasmolina and other antispasmodic medicines?

A: Spasmolina is officially classified as a musculotropic antispasmodic because its action is focused directly on the smooth muscle tissue itself, inducing relaxation. A key difference noted in pharmacological reviews is that it has a low affinity for autonomic nerve receptors, thereby limiting its systemic effects.


Q: Is Spasmolina a muscle relaxant?

A: The medicine is classified as a musculotropic antispasmodic or spasmolytic. Its primary purpose is to induce the relaxation of visceral smooth muscles in the gut and related organs to relieve cramping and discomfort.


Q: Is Spasmolina a controlled substance?

A: No. The active substance, alverine citrate, is not listed as a scheduled drug under major government drug control legislation, such as the United States Controlled Substances Act (CSA) or equivalent international treaties.


Q: Can Spasmolina be crushed or split?

A: The official administration instructions state that the capsule or tablet must be swallowed whole with water. It should not be crushed, chewed, or opened.


Q: Can Spasmolina be used to treat stomach cramps not related to its main purpose?

A: Official indications for use primarily include the relief of abdominal pain and cramping associated with specific conditions, such as Irritable Bowel Syndrome (IBS) and painful diverticular disease. Some product labels also include use for period pains.


Q: Does the effectiveness of Spasmolina change over time?

A: There is limited long-term data on the medicine's effects, as most core evidence comes from short-term trials lasting 4 to 12 weeks. Tolerance or loss of efficacy over extended periods is not formally established in official regulatory documents.


Q: Can Spasmolina affect my mood or cause anxiety?

A: Anxiety or mood changes are not listed among the formally documented adverse reactions in official regulatory sources. Known effects on the nervous system are primarily limited to headache and dizziness.


Q: Why is Spasmolina sometimes prescribed instead of alternative treatments?

A: The medicine is prescribed for its effect as a musculotropic antispasmodic that acts directly on visceral smooth muscle to reduce spasms. It is known for a mechanism that does not rely on blocking nerve signals in the way some other medicines do.


Q: What do patients commonly misunderstand about how Spasmolina is supposed to be used?

A: Common misunderstandings often relate to the fact that the dosing pattern is intended for intermittent, short-term use during symptomatic episodes. Another point is the requirement that the unit dose must be swallowed whole rather than split or crushed.


Q: What regulatory body approved Spasmolina for use?

A: The active substance is licensed by national regulatory authorities in each country where it is available. Examples of these authorities include the MHRA in the UK, the FDA in the US, or other national agencies.


Q: Is Spasmolina safe to take during pregnancy?

A: Official labeling states that the medicine is not recommended during pregnancy due to insufficient data regarding its safety in this population.


Q: Can teenagers or children use Spasmolina?

A: The medicine is officially not recommended for use in children under the age of 12 years. Use is generally allowed for adolescents aged 12 and above, following the standard adult guidelines.


Q: Is Spasmolina safe to use for elderly people?

A: Official dosing guidelines state that the standard adult regimen applies to older adults without the need for routine dose reduction. Use is generally allowed for the elderly population.

How should Spasmolina be stored and disposed of?

How to Store and Dispose of Spasmolina

Official Storage Requirements

Spasmolina (Alverine citrate) must be stored under specific regulatory conditions to maintain its labeled stability. The product must be stored below 30 C (86 F).

It is mandatory to keep the medicine in its original container to protect it from light and moisture until its expiration date. As a critical safety instruction, the medicine must always be kept out of the sight and reach of children and pets.

Official Disposal Instructions

Spasmolina should not be flushed down the toilet or poured into a drain, as it is not on the FDA's flush list. The preferred method for discarding expired or unused medicine is through an official drug take-back program.

If a take-back program is unavailable, unused medicine should be mixed with an undesirable substance (such as dirt) and placed in a sealed container before disposal in the household trash, following standard government guidelines.

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

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