Spasmoglucinol

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Spasmoglucinol

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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 Spasmoglucinol

Quick Facts

Property Description
Active Ingredients Phloroglucinol and Trimethylphloroglucinol
Form Film-coated tablets, Injection solution, Suppositories
Pharmacological Class Spasmolytic agent (Direct-acting smooth muscle relaxant)
Common Use Relief of pain associated with smooth muscle spasm
Origin Synthetic phenol derivatives

What Type of Medicine is Spasmoglucinol?

Spasmoglucinol is a specialized pharmaceutical agent classified as a spasmolytic agent, primarily used for the symptomatic relief of pain stemming from the involuntary tightening of smooth muscle fibers. This classification places it under the category of direct-acting smooth muscle relaxants, which function locally on the muscle tissue itself rather than through the central nervous system. The drug is formally categorized under the Anatomical Therapeutic Chemical (ATC) code A03AX12 for functional gastrointestinal disorders. Pharmacological studies have consistently supported the efficacy of this class of agents in providing focused relief from visceral pain, particularly in scenarios involving acute, sharp pain where muscle relaxation is key.


Composition and Form: Phloroglucinol and Trimethylphloroglucinol

The core composition of Spasmoglucinol features a fixed combination of two related synthetic phenol derivatives: Phloroglucinol (specifically, Phloroglucinol dihydrate) and Trimethylphloroglucinol. This precise combination is clinically recognized for leveraging Phloroglucinol as the principal antispasmodic agent, with Trimethylphloroglucinol included to potentiate and sustain the desired muscle-relaxing effect. The medication is provided in several high-level dosage forms, including film-coated tablets for oral ingestion, suppositories for rectal administration, and an injection solution suitable for parenteral routes. The availability of the injection solution is a distinguishing feature, allowing for rapid administration in acute care settings. Review of its chemical properties confirms the action of Phloroglucinol on inhibiting contractions, which means the drug effectively stops the muscle from over-tightening.


How Does Spasmoglucinol Generally Relieve Spasms?

Spasmoglucinol provides relief by exerting a direct smooth muscle relaxant effect, focusing solely on the muscle tissue experiencing hypercontractility. This mechanism involves altering the cellular signals that drive these involuntary, painful spasms, allowing the affected smooth muscle to relax. This focused intervention delivers effective symptomatic relief by directly addressing the physical tightening that causes visceral pain.

What side effects are possible with Spasmoglucinol?

Possible Side Effects and Safety Information

The official safety information for Spasmoglucinol, based on regulatory documentation, details a risk profile primarily centered on hypersensitivity phenomena affecting the immune system and the skin. Due to the nature of post-marketing surveillance, most documented adverse reactions are classified as Unknown frequency.

Adverse Reaction Scope

Classification Detail based on Official Regulatory Documents
System-Organ Classes Immune System Disorders and Skin and Subcutaneous Tissue Disorders.
Common Effects Rash, itching (pruritus), and urticaria (hives).
Serious Reactions Anaphylactic shock, Angioedema, and Generalized Acute Exanthematous Pustulosis (AGEP) are explicitly documented.

Safety Considerations and Restrictions

The regulatory profile highlights specific constraints for the medicine's use. It is noted that the serious skin condition AGEP occurs primarily when treatment starts. A clear restriction is detailed regarding concomitant use with certain major analgesics. Use of Spasmoglucinol with morphine or its derivatives must be avoided due to an antagonistic effect that can induce spasms.

Safety statements for vulnerable groups are also documented. Use during pregnancy should only be considered if necessary due to the absence of conclusive human data. Similarly, avoiding use during breast-feeding is advised, as there is no data concerning the excretion of the active ingredients into breast milk.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation for Phloroglucinol and Trimethylphloroglucinol strictly describes the recognized clinical signs and required emergency actions in the event of an overdose. Overdose may result from accidental or excessive exposure, leading to an exaggeration of the drug's effects on the body's systems.

Category Documented Manifestations and Actions
Documented Manifestations Hypotension (abnormally low blood pressure) and physical collapse.
Severe Outcomes The risk documented in labeling includes circulatory depression.
Emergency Action Required Regulators mandate to seek immediate medical attention and contact a doctor or pharmacist immediately upon suspicion of overdose.

Official prescribing information notes that no specific antidote is known for this overdose. Consequently, management is officially defined as requiring symptomatic and supportive treatment only. Depending on the clinical status, this treatment may include a requirement for clinical monitoring or prolonged observation in a hospital setting to manage the physiological manifestations.

Therapeutic Uses of Spasmoglucinol

What Spasmoglucinol Treats: Main Uses and Benefits

Spasmoglucinol is associated with symptomatic relief across domains involving symptoms related to organ-specific functional stress. The core therapeutic use aligns with established applications for this class of medication. These applications involve managing painful manifestations across several key systems.

The medication is commonly applied in clinical settings that involve acute or disruptive symptom patterns. This includes conditions presenting with renal colic, biliary colic, functional gastrointestinal spasms (such as those associated with IBS), and painful spasmodic gynecological problems. By addressing these episodes of heightened physiological activity, Spasmoglucinol contributes to an easing of the overall symptom load. It offers symptomatic relief that may assist patients in coping more steadily with difficult episodes.

Quick Fact Relief for
Primary Target Painful spasms of the smooth muscle in internal organs
Severity Relevance Acute, severe colic and recurrent moderate pain
Therapeutic Benefit Supportive relief during difficult, spasmodic episodes

Regulatory References

  1. Malta Medicines Authority

Eligibility and Restrictions for Use

Who Can and Cannot Use Spasmoglucinol?

Eligibility to use Spasmoglucinol, which contains Phloroglucinol and Trimethylphloroglucinol, is strictly determined by regulatory prescribing information, defining specific populations who are prohibited or restricted from use.


Contraindicated and Restricted Populations

Population/Condition Eligibility Status Regulatory Basis
Hypersensitivity to active or excipients CONTRAINDICATED Absolute prohibition
Phenylketonuria (PKU) (for aspartame-containing forms) CONTRAINDICATED Excipient-linked metabolic restriction
Children under 2 years of age Use Not Established Efficacy not verified
Breastfeeding Women Not Recommended Insufficient safety data

Key Eligibility Rules

Adults are the standard eligible population for Spasmoglucinol. Use is established for children over 2 years of age for the treatment of severe spasms. The official label advises that use during pregnancy is conditional and should only be considered if explicitly necessary. Additionally, individuals with rare hereditary problems such as galactose intolerance are restricted from using specific formulations that contain lactose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Phloroglucinol and Trimethylphloroglucinol focuses on avoiding pharmacodynamic conflict and managing restrictions related to formulation excipients. No interactions involving pharmacokinetic mechanisms, such as the cytochrome P450 enzyme system or drug transporters, are specified in regulatory documentation.


Pharmacodynamic and Metabolic Constraints

Category Officially Documented Restriction
Pharmacodynamic Conflict The combination with major analgesics, including morphine and its derivatives, should be avoided. This is a functional conflict because these analgesics are known to cause spasms, which directly opposes the spasmolytic action of the medicine.
Excipient Restriction (PKU) The oral form contains aspartame, a source of phenylalanine. A specific restriction is required for patients diagnosed with Phenylketonuria (PKU).
Excipient Precaution A precautionary restriction is noted for individuals with rare hereditary sugar conditions, such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption, due to the presence of lactose in the product.

General Interaction Context

Regulatory documentation does not impose mandatory time-separation rules for any co-administered products. The interaction profile is strictly defined by the need to prevent the opposing effects of pro-spasmodic drugs and by specific metabolic restrictions linked to the product's non-active ingredients.

Mechanism of Action

Spasmoglucinol, containing phloroglucinol, functions as a spasmolytic agent by engaging two primary mechanistic domains that influence smooth muscle contractility across various internal organ systems.


Molecular Modulation of Smooth Muscle Contraction

This mechanism involves direct cellular action by modulating key pathways that regulate smooth muscle fiber contraction. Phloroglucinol is thought to inhibit specific phosphodiesterase enzymes and modulate voltage-dependent calcium channels on the cell membrane. This action decreases the intracellular influx of calcium ions, a molecular requirement for initiating muscle contraction, thereby modulating the contractile state of the smooth muscle.


Targeted Pathway Adjustment and Regulation

A second pathway involves the drug's effect on neurotransmitter systems. Phloroglucinol, including its derivative trimethylphloroglucinol, engages mechanisms that block the catechol-O-methyltransferase (COMT) enzyme. Inhibition of COMT reduces the catabolism of catecholamines, which consequently increases sympathetic tone and further influences the smooth muscle contractile cycle.

Dosage and Administration Information

Spasmoglucinol (Phloroglucinol and Trimethylphloroglucinol) is indicated for administration via three main routes: oral (tablets), rectal (suppositories), and parenteral (injection solution for intravenous or intramuscular use). This range of available forms allows for its deployment as a versatile treatment for acute symptomatic episodes.

The dosing regimen is typically structured for on-demand, intermittent use. For adults, the standard initial oral dose is 160 mg (typically two tablets) to be taken when the painful spasm occurs. The dose may be repeated if symptoms persist, but a minimum interval of 2 hours must be observed between subsequent oral doses. The total daily oral intake is limited and must not exceed 480 mg (six tablets) over a 24-hour period.

Specific procedural instructions apply to the method of intake and pediatric use. Oral tablets can be dissolved under the tongue without water for rapid intake, or dissolved entirely in a glass of water. For children over two years old, the standard maximum daily dose is capped at 160 mg (two tablets), and the tablets must always be dissolved in water prior to administration. The use protocol also stipulates a constraint against co-administration with certain major analgesics, as this combination risks counteracting the drug’s spasmolytic action.

Recent Clinical Evidence

Spasmoglucinol: Recent Clinical Evidence

Spasmoglucinol contains the active substance phloroglucinol, a compound studied for its non-specific antispasmodic properties. The research focus for this compound primarily involves conditions associated with smooth muscle spasms in the digestive and genitourinary tracts, such as renal or biliary colic.

Efficacy and Study Outcomes

Phase 3 clinical trials, including multicenter, open-label, randomized, and comparative studies, have explored the clinical effectiveness of phloroglucinol. These studies examined the compound's use in patients experiencing pain and spasms related to both urinary and biliary colic.

  • Primary Outcomes: The main measures assessed in these trials included changes in patient symptoms and the observed frequency of muscle spasms.
  • Comparative Findings: Phloroglucinol preparations (oral and parenteral) were evaluated against reference drugs, which included non-steroidal anti-inflammatory drugs (NSAIDs) like dexketoprofen or metamizole, or scopolamine-based drugs.
  • Study Conclusion: Research has suggested that phloroglucinol may be comparable in effectiveness to these current therapeutic options for reducing pain and spasms associated with renal or biliary colic.

Safety and Tolerability

Phloroglucinol is generally considered to be well-tolerated. Safety data gathered from clinical trials have reported:

  • Common Side Effects: The frequency of adverse effects is generally low. The most commonly noted events are non-serious, such as skin reactions (rash, hives).
  • Serious Adverse Events: Serious allergic reactions, including angioedema (swelling), hypotension, or anaphylactic shock, are possible but rarely reported.

Evidence gathered to date has not demonstrated any specific concerns regarding the use of phloroglucinol during pregnancy, though usage is typically monitored by a healthcare professional. Available data on its presence in breast milk is insufficient, and its use is often not recommended during the breastfeeding period.

Frequently Asked Questions (FAQ)

Common questions about Spasmoglucinol (FAQ)


Q: Can Spasmoglucinol be taken with common pain relievers like paracetamol?

Regulatory documents explicitly restrict the co-administration of this medicine with certain major analgesics, such as morphine and its derivatives. This is a functional conflict, as these major analgesics are known to cause spasms which directly opposes the medicine's spasmolytic action. The official regulatory profile does not specify a similar restriction for non-opioid pain relievers like paracetamol.

Q: Is Spasmoglucinol safe to use during pregnancy, according to official guidelines?

Official regulatory documents indicate that Phloroglucinol should only be considered for use during pregnancy if it is deemed necessary. While available data has not revealed a teratogenic risk to date (meaning risk of malformation), official sources note that further epidemiological studies are required to verify the absence of this risk.

Q: Do food and drinks affect how well Spasmoglucinol is absorbed?

Pharmacokinetic research, which examines how the body handles the drug, indicates that the absorption of the active ingredient from the oral formulation is not affected by food.

Q: Is Spasmoglucinol suitable for teenagers?

Official instructions define a specific dose for children over two years old and a separate dose for adults. The official product label provides specific dosing for children over two years old and a separate dosage for adults. A separate eligibility statement or dose for the specific age group of teenagers is not defined in these documents.

Q: Is Spasmoglucinol the same kind of medicine as Buscopan or other spasm-relief drugs?

Spasmoglucinol is classified as a direct-acting spasmolytic agent, which means it works directly on the muscle tissue to provide relief. Official literature describes it as a non-atropine and non-papaverine spasmolytic, distinguishing its mechanism of action from certain other classes of antispasmodic medicines, such as those derived from atropine.

Q: How long does it usually take to notice an effect from Spasmoglucinol?

Pharmacokinetic studies indicate that the drug is rapidly absorbed. Data suggests that the peak concentration of the active substance in the bloodstream is reached approximately 15 to 20 minutes after taking the oral dose.

Q: Is Spasmoglucinol safe for people over 65?

Official documentation specifies the adult dose. Clinical studies have specifically examined the therapeutic value of the injection formulation for spasmodic pain in elderly patients in acute care settings.

Q: Does Spasmoglucinol make you drowsy or affect driving?

Official safety information states that Phloroglucinol has no or negligible influence on the ability to drive or operate machinery. This statement is due to the finding that the product has no or negligible influence on the ability to drive or operate machinery.

Q: What kind of research has been done on Spasmoglucinol for non-gastrointestinal issues?

Beyond the gastrointestinal tract, research and official indications have included its use for conditions involving the smooth muscle of the genitourinary tract (such as renal colic) and for spasmodic gynaecological problems.

Q: Why do doctors prescribe Spasmoglucinol for kidney stone pain?

The medicine is officially indicated for the symptomatic treatment of pain associated with acute painful spasmodic urinary tract problems. This medical category specifically includes pain related to renal colic, which is the severe, acute pain caused by kidney stones.

Q: Can people with lactose intolerance use Spasmoglucinol tablets?

The oral tablet formulation contains lactose. Official regulatory documents issue specific warnings that the product is not appropriate for patients with certain rare hereditary sugar conditions, including Lapp lactase deficiency, galactose intolerance, and glucose-galactose malabsorption.

Q: What is the difference between a spasmolytic and an antispasmodic drug like Spasmoglucinol?

Spasmoglucinol is officially classified as a spasmolytic agent. Official drug information often uses this term to refer to its main action, which is a direct smooth muscle relaxant effect. This means the drug works by acting directly on the affected muscle tissue to relieve the involuntary tightening or spasm.

Q: Are there different strengths of Spasmoglucinol available?

The active ingredient, Phloroglucinol, is commonly formulated in 80 mg tablets. The standard adult oral dose is typically described as 160 mg, which is usually administered using two of these 80 mg tablets.

Q: Has any major regulatory body issued warnings about Spasmoglucinol?

Official safety documents detail warnings related to two main areas. These include specific excipient restrictions for patients with conditions like Phenylketonuria, and a functional restriction against co-administration with major analgesics (morphine derivatives) due to an opposing effect on smooth muscle.

Q: Is there research looking at Spasmoglucinol's effect on irritable bowel syndrome (IBS)?

Yes, clinical studies have been conducted to evaluate the efficacy and tolerability of Phloroglucinol for managing symptoms associated with Irritable Bowel Syndrome (IBS), including abdominal pain.

Q: Are there specific food types that interact with Spasmoglucinol?

Pharmacokinetic research indicates that the absorption of the active ingredient is not affected by food. Official regulatory safety documents do not list any specific food types that require a mandatory interaction warning.

Q: Can Spasmoglucinol be given to small children or infants?

The official dosing instructions are only provided for children over two years of age. Regulatory documents state that efficacy and safety for children younger than two years old have not been established.

Q: Is Spasmoglucinol known to cause headaches?

The regulatory safety profile lists adverse reactions primarily related to the immune system and skin. Headache is not listed among the undesirable effects documented in the official summary documents for this medicine.

Q: Do studies show Spasmoglucinol is absorbed quickly?

Pharmacokinetic studies indicate that the drug is rapidly and widely absorbed after oral administration. This is supported by data showing that peak concentrations in the bloodstream occur within 15 to 20 minutes.

Q: Is it typical for a person to only take Spasmoglucinol 'as needed'?

Yes. According to the official product information, the dosing regimen is strictly structured for on-demand, intermittent use. It is intended to be taken when a painful spasm occurs.

Q: Does Spasmoglucinol interact with alcohol?

Official safety documents do not specify a mandatory restriction or interaction warning for the use of Phloroglucinol with alcohol.

Q: What should someone know about stopping Spasmoglucinol after taking it regularly?

The drug is officially intended for on-demand, intermittent use when a painful spasm occurs. Because it is not authorized for continuous, long-term treatment, the official documents do not describe a specific withdrawal or cessation process.

Q: Why do people take Spasmoglucinol if they have stomach problems?

Official indications include the symptomatic treatment of pain associated with functional disorders of the gastrointestinal tract and bile duct. This makes it a potential treatment for pain arising from spasms in those areas.

Q: Is it true that Spasmoglucinol is only for intestinal cramps?

No. The medicine is indicated for a range of spasmodic pain conditions. This includes pain associated with the gastrointestinal tract, the biliary tract, and the urinary tract, such as pain from renal colic.

How should Spasmoglucinol be stored and disposed of?

How to Store and Dispose of Spasmoglucinol

Official regulatory guidelines define precise conditions for storing and disposing of this medicine to ensure its stability.

Storage Requirements

The product must be stored at a temperature that does not exceed 30°C and must be protected from light and moisture. For packaging integrity, the medicine should be kept in the original container; bottles must be kept tightly closed.

Stability Constraint Condition
Temperature Store below 30 C
Post-Opening Limit Use opened bottles within 1 month

Disposal and Safety

The medicine must be kept out of the sight and reach of children. To prevent environmental harm, regulatory documents prohibit disposing of unused or expired product via wastewater or household waste. Consult a pharmacist for instructions on proper pharmaceutical waste handling.

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

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