Stopspasm

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Stopspasm

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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 Stopspasm

Property Description
Active ingredient Phloroglucinol, Trimethylphloroglucinol
Form Tablets, Injection solution, Suppository, Orodispersible tablets
Pharmacological class Antispasmodic agent (Spasmolytic agent)
Common use Relief of spastic pain
Origin Synthetic compound (Phenol derivative)

Identity and Pharmacological Classification of Stopspasm

Stopspasm is a pharmaceutical combination product classified as a musculotropic antispasmodic agent, primarily designed to relieve acute, cramping pain caused by internal muscle contractions. This drug belongs to the high-level pharmacological class of spasmolytics, which are substances that directly reduce tension in involuntary smooth muscles found in organs like the intestines, bile ducts, and urinary tract. The primary mechanism of the active components involves direct action on visceral smooth muscle. The agent's classification as a musculotropic type indicates its action is focused directly and selectively on the muscle fiber itself, a mechanism that is clinically recognized for its role in resolving visceral spasms.


Composition and Available Drug Forms

Stopspasm is composed of two distinct active ingredients: Phloroglucinol and its derivative, Trimethylphloroglucinol. This dual-component nature defines it as a fixed combination product engineered to leverage the synergistic action of both compounds to achieve smooth muscle relaxation. The core component, Phloroglucinol, is chemically known as a Phenol derivative. The drug is presented in various dosage forms to accommodate different clinical needs, including standard tablets for oral use, orodispersible tablets for rapid absorption, and injection solutions and suppositories for parenteral and rectal administration, respectively. The availability of multiple forms provides flexible drug delivery for management of sudden spastic episodes.


General Purpose and Action of this Spasmolytic

The overarching purpose of Stopspasm is to address spastic pain by resolving the underlying involuntary muscle contraction that causes the discomfort. Unlike general analgesics, this medicine provides a therapeutic benefit by directly inducing smooth muscle relaxation. The combination is used to reduce muscle spasms, improving clinical symptoms in patients suffering from functional gastrointestinal disorders. This means the drug directly eases the acute cramping that results from the body's internal muscular tension.

What side effects are possible with Stopspasm?

Possible Side Effects and Safety Information

The official safety profile for Stopspasm (Phloroglucinol/Trimethylphloroglucinol) is predominantly characterized by hypersensitivity reactions as documented in regulatory sources.


Documented Adverse Reactions

The documented adverse reactions primarily affect the Immune system and Skin and subcutaneous tissue as per System-Organ Class (SOC) categories. These effects are generally classified as having an unknown frequency due to derivation from post-marketing reports, though some reactions are listed as rare.

Classification Examples of Adverse Reactions (ARs)
Rare Urticaria (Hives)
Unknown frequency Rash (Eruption), Pruritus (Itching), Quincke's Oedema

Serious adverse reactions documented in regulatory labeling include Anaphylactic Shock (a severe, systemic allergic reaction) and Acute Generalized Exanthematous Pustulosis (AGEP), a serious skin reaction that may occur at the initiation of treatment.


Safety-Related Restrictions and Considerations

The use of Stopspasm is subject to specific regulatory constraints:

  • Contraindications: The medicine is strictly contraindicated in cases of known hypersensitivity to the active ingredients or excipients. Specific oral forms are also contraindicated in patients with Phenylketonuria (PKU) due to the presence of aspartame, and in patients with lactose/galactose intolerance due to lactose content.
  • Pregnancy and Lactation: Use during pregnancy should be considered only if medically necessary. Use during breast-feeding is advised to be avoided due to a lack of sufficient safety data.
  • Drug Interactions: Regulatory texts advise against the concurrent use of this antispasmodic with major analgesics, such as morphine derivatives, due to potential pharmacological antagonism.

Overdose and Emergency Response

Overdose and When to Seek Help

This information is based on authoritative government regulatory documents concerning acetaminophen/paracetamol overdose.


Overdose Scope and Risk

Overdose Presentation System Affected Urgent Action Required
Delayed Hepatotoxicity Liver (Hepatic) Immediate Medical Attention
Nausea, Vomiting, Pallor Gastrointestinal Immediate Medical Attention

Overdose presents a critical risk of delayed, serious liver damage (hepatotoxicity), which may not show symptoms until 12 to 48 hours after ingestion. Early symptoms are often mild and non-specific, such as nausea, vomiting, or abdominal pain, but do not reflect the severity of the underlying toxicity. The most serious life-threatening outcomes include acute liver failure, encephalopathy, and multi-organ damage.


When to Seek Immediate Medical Help

Immediate medical advice must be sought in the event of a suspected overdose, even if the patient feels well. This urgency is required because the effectiveness of the specific antidote, N-acetylcysteine, is greatest when administered within eight hours of ingestion. Patients with risk factors, such as chronic alcohol use or malnutrition, may face a higher hazard of liver damage at lower doses.

Therapeutic Uses of Stopspasm

What Stopspasm Treats: Main Uses and Benefits

The primary use of a medicine like Stopspasm is in the symptomatic management of conditions associated with symptoms of increased neurological or muscular activity in the gastrointestinal tract. It is considered relevant for use in conditions like Irritable Bowel Syndrome (IBS) and other functional bowel disorders, which are conditions characterized by periods of heightened symptoms. The primary purpose is in the supportive management of symptoms related to conditions like Irritable Bowel Syndrome (IBS), addressing symptoms related to physical discomfort such as abdominal pain, cramps, and flatulence, which may interfere with daily functioning.


This medicine is applied in addressing symptom clusters that may become intense or disruptive, contributing to easing the overall symptom load. This is relevant in contexts involving heightened systemic burden and may be part of symptomatic management when short-term assistance is appropriate. It thereby contributes to easing the overall symptom burden and supports general well-being during symptomatic phases.

“It is commonly used across conditions presenting with acute episodes where functional stability becomes affected.”


Quick Fact: Supports easing physical discomfort

Eligibility and Restrictions for Use

Stopspasm is an antispasmodic medication primarily used to relieve symptoms associated with Irritable Bowel Syndrome (IBS), such as abdominal pain, cramping, and bloating. It works by relaxing the smooth muscles of the gastrointestinal (GI) tract to ease spasms.


Suitable for Use

  • Adults and children aged 12 years and older who are experiencing intestinal or urinary smooth muscle spasms.
  • Individuals diagnosed with conditions characterized by painful muscle contractions in the digestive or urinary systems.

Contraindications (Should Not Use)

Like many antispasmodics, Stopspasm may not be suitable for people with certain pre-existing medical conditions, as it can potentially worsen their symptoms. Contraindications typically include:

  • Hypersensitivity or allergy to the active ingredients.
  • Gastrointestinal obstruction (e.g., intestinal blockage, paralytic ileus, pyloric stenosis).
  • Narrow-angle glaucoma (uncontrolled).
  • Urinary retention or an enlarged prostate (prostatic enlargement) causing difficulty passing urine.
  • Myasthenia gravis (a condition causing muscle weakness).

Special consideration is required for use during pregnancy and breastfeeding, as well as in children under 12 years of age; a healthcare professional must evaluate the risks and benefits in these cases.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents define the interaction profile of Stopspasm (Phloroglucinol, Trimethylphloroglucinol) based on a specific pharmacodynamic constraint involving antagonism with certain analgesic agents. The profile emphasizes restrictions on co-administration rather than pharmacokinetic interactions.


Interaction Scope

Classification Interacting Agents / Constraint
Pharmacodynamic Antagonism Major Analgesics (e.g., Morphine and its derivatives)
Interaction Restriction Co-administration must be avoided
Mechanistic Basis The analgesic agents cause a spasmogenic effect that directly opposes the action of Stopspasm

Official Regulatory Statements

Co-administration with major analgesics, such as morphine or its derivatives, must not occur, as explicitly stated by national health authorities. The basis for this restriction is the documented risk of functional opposition where the spasm-inducing action of the analgesic counteracts the intended smooth muscle relaxation provided by this medicine. The regulatory profile does not specify interactions with food, alcohol, herbal products, or other medicinal products that alter Stopspasm's plasma exposure ( AUC or C max).

Mechanism of Action

Targeting Smooth Muscle Contraction via Calcium Channels

Stopspasm acts as a selective antagonist (blocker) of the L-type calcium channels (VDCCs) found on smooth muscle cell membranes . This mechanism prevents the necessary influx of extracellular calcium ions ( Ca^2+) into the cell cytoplasm. The intervention occurs early in the Excitation-Contraction (E-C) Coupling cascade, altering the mechanism by which electrical signals translate into mechanical force and thereby reducing the driving force for muscle contraction.

Modulating Visceral Tone and Spasm Activity

By limiting the intracellular availability of Ca^2+, the drug restricts the activation of the contractile machinery, specifically the myosin light chain kinase (MLCK). This effect is primarily peripheral, focusing on tissues where smooth muscle tone is regulated by this specific Ca^2+ pathway. The calcium channel antagonism diminishes the amplitude and frequency of spontaneous depolarizations in the smooth muscle tissue, resulting in a measurable decrease in baseline smooth muscle tension.

Dosage and Administration Information

How to use Stopspasm — Official Administration Guidelines

Stopspasm, a combination product (Phloroglucinol, Trimethylphloroglucinol), is approved for use via multiple delivery routes. The medicine is available in oral tablets, which can be swallowed or taken as orodispersible tablets for sublingual (under the tongue) absorption. For management of acute or severe episodes, it is also approved for parenteral administration through Intravenous (IV) or Intramuscular (IM) injection, alongside a rectal route via suppository.


The standard adult oral dosing regimen is structured for on-demand use when symptoms occur, typically involving a dose of 2 tablets (e.g., 160 mg equivalent). The labeling indicates a strict minimum interval of 2 hours between doses if the spasms persist and requires that the maximum daily intake must not exceed 6 tablets over a 24 hour period.


Administration instructions are specific to the dosage form and patient age. For adults, the orodispersible tablets can be dissolved sublingually without water. Conversely, 1 tablet doses for children over 2 years must be administered after dissolving the tablet in water, with the maximum daily dose limited to 2 tablets/ 24 hours for this group. The injectable form is typically used to stabilize acute episodes, with treatment continued via the oral or rectal route thereafter. This use is designated as symptomatic treatment, and reassessment is necessary if symptoms persist.

Recent Clinical Evidence

Stopspasm: Recent Clinical Evidence

This section outlines the structure of the research evidence for the combination product Stopspasm (Phloroglucinol/Trimethylphloroglucinol), focusing strictly on the scope of clinical studies and the types of outcomes evaluated.


Evidence for Use in Acute Colic of the Urinary and Biliary Tracts

Research has primarily consisted of Phase 3 randomized comparative studies and acute administration trials evaluating outcomes related to systemic or functional imbalance during renal colic (urinary tract pain) and biliary colic (bile duct pain). These studies monitored outcomes related to physical discomfort by recording pain intensity scores and the frequency of spasms.

Studies explored comparisons between the compound and other agents or inactive treatment (placebo) in these acute settings. Despite the existence of large Phase 3 trials, certainty remains low regarding certain research aspects, as some key studies utilized an open-label design. Furthermore, there is limited information for long-term outcomes when the compound was studied in research exploring how symptoms change over time in these conditions.


Evidence for Use in Functional Gastrointestinal Spasms (IBS)

Stopspasm was evaluated in adult patients with Irritable Bowel Syndrome (IBS) who were experiencing periods of heightened symptoms (acute pain exacerbations). The evidence base consists mainly of short-term, randomized controlled trials (RCTs).

Systematic reviews and pooled analyses of these trials suggest that, when combined, the data showed no statistically significant difference from placebo for the main outcome of abdominal pain relief. Certainty remains low for this indication due to the small number of high-quality RCTs available and limited follow-up durations (typically one to two weeks). Pooled findings were mixed, and insufficient data was found to support widespread use for abdominal pain relief in IBS. Research does not determine whether an individual will respond similarly.

Key Studies & References

  1. Phloroglucinol for Acceleration of Labour: Double Blind, Randomized Controlled Trial
  2. TRANSPARENCY COMMITTEE OPINION 22 June 2011 SPASFON, film-coated tablets - HAS (French Regulatory Authority Document)

Frequently Asked Questions (FAQ)

Common questions about Stopspasm (FAQ)

Q: Is Stopspasm intended for short-term use, or can it be taken long-term?

Official prescribing information states that Stopspasm is intended for symptomatic treatment—meaning it is used when symptoms occur. Regulatory guidelines advise that if a patient's symptoms persist or do not improve, the treatment should be formally reassessed by a healthcare provider. This designation as symptomatic treatment is consistent with the goal of managing acute episodes of spasm-related pain.

Q: Why are antispasmodic effects sometimes linked to vision problems?

Other types of antispasmodic medicines, which work through different mechanisms, may be associated with side effects like blurred vision. However, the official product information for Stopspasm describes its mechanism as acting directly on smooth muscle and not relying on the anticholinergic effects that commonly cause these vision issues. Despite this, the medicine is still contraindicated in individuals with uncontrolled narrow-angle glaucoma.

Q: How quickly does Stopspasm usually start to provide relief?

According to the official regulatory documents, the absorption rate is relatively fast. After taking an oral dose, the concentration of the medicine in the blood typically reaches its peak level between 15 and 20 minutes. This pharmacokinetic data describes the timing of the drug's absorption.

Q: How long can a person expect the effects of Stopspasm to last?

The duration of the medicine's presence in the body is described using its elimination half-life, which is approximately 1 hour and 40 minutes. This figure indicates the time it takes for half of the substance to be removed from the body. The medicine is generally used as needed, and official administration guidelines specify a minimum time interval between doses.

Q: Is dry mouth or a change in sweating common with Stopspasm?

Regulatory documents indicate that the drug's mechanism of action is distinct from other antispasmodics and does not have the anticholinergic effects commonly linked to issues like dry mouth or reduced sweating. The full list of documented adverse reactions can be found in the section 'Possible side effects and safety information.'

Q: Does taking Stopspasm affect a person's ability to drive or operate machinery?

The regulatory product information specifically addresses the potential impact on daily activities. The official documents state that no warnings have been specified concerning an impairment of the ability to drive or use heavy machinery.

Q: Can individuals with heart conditions or blood pressure issues use Stopspasm?

While the general safety profile focuses on allergic and skin reactions, adverse event reports have exceptionally included instances of hypotension (low blood pressure) in serious cases. The documentation of this effect is relevant to individuals with pre-existing heart or blood pressure issues.

Q: What is the general guidance on taking Stopspasm with or without food?

Official administration instructions focus on the method and timing of drug delivery (swallowed, dissolved under the tongue, etc.) and the required interval between doses. The regulatory documents do not specify any requirement or guidance regarding whether the medicine must be taken with or without food.

Q: Can Stopspasm be used to manage painful symptoms during menstruation?

Yes, the drug is officially indicated for a range of spastic pain conditions. According to the regulatory documents, this includes the symptomatic treatment of painful spasmodic problems related to the gynaecological system, in addition to urinary and digestive tract issues.

Q: Does Stopspasm interfere with other organ systems, such as the kidneys or liver?

Official pharmacokinetic data describes how the medicine is processed by the body. The drug is metabolized (broken down) primarily in the liver and is then eliminated from the body via the urinary route (kidneys) and biliary route. The official pharmacokinetic data details the specific routes of clearance for the drug.

How should Stopspasm be stored and disposed of?

How to Store and Dispose of Stopspasm?

The following requirements are based strictly on official regulatory product information to ensure the stability and safe handling of Stopspasm (Phloroglucinol/Trimethylphloroglucinol).

Storage Requirement Official Condition
Temperature Store below 30 C in a dry and well-ventilated area.
Protection Must be protected from light and moisture.
Packaging Keep the blister packs in the original package and bottles tightly closed.
Stability Limit The shelf-life for orodispersible tablets after opening the bottle is 1 month.

All forms of the medicine must be kept out of the sight and reach of children to prevent accidental ingestion.

For disposal, unused or expired product and its containers must be taken to an approved waste disposal plant as required by local and national regulations. The product must not be released into the environment or disposed of in household drains or wastewater systems.

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

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