Flospan

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Flospan

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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 Flospan

The drug Flospan is a preparation containing the active ingredient Phloroglucinol, identified primarily as a musculotropic antispasmodic agent. It is fundamentally designed to provide relief from painful, involuntary spasms by relaxing smooth muscle tissue in internal organs.


Quick Facts

Property Description
Active ingredient Phloroglucinol (often as dihydrate)
Common Forms Tablets, Suppositories, Injection Solution
Pharmacological Class Musculotropic Antispasmodic Agent
Origin Synthetic derivative (Phenol/Benzenetriol)
General Purpose Relief of involuntary muscle cramps and tension

Flospan: Identity, Classification, and Composition

Flospan is a commercially available synthetic derivative whose active compound, Phloroglucinol, is chemically classified as a benzenetriol and is clinically recognized as a spasmolytic agent. The medication falls under the Anatomical Therapeutic Chemical (ATC) classification system as a drug for functional gastrointestinal disorders (ATC code A03AX12), confirming its role in managing internal organ activity. As a musculotropic antispasmodic, Phloroglucinol acts directly on the smooth muscle fibers themselves, with an effect on muscle cell stabilization. The manufacturer, Daehwa Pharmaceutical, produces Flospan in multiple forms tailored for different administration routes, distinguishing it from products restricted solely to oral use.

The core of Flospan is Phloroglucinol, typically supplied as Phloroglucinol dihydrate. This substance is provided in several distinct dosage forms to accommodate patient needs, including tablets for oral use, suppositories for rectal administration, and an injection solution for rapid parenteral delivery.


General Therapeutic Purpose

The fundamental action of directly relaxing smooth muscle tissue means the general therapeutic purpose of Flospan is to ease the physical discomfort caused by painful internal cramps and spasms, such as those associated with the gastrointestinal or urinary tracts. By interrupting the localized spasm signal and restoring the muscle to a relaxed state, the drug aims to mitigate muscle hyperactivity. The overall benefit is targeted relief where muscle constriction is the primary source of distress.

Regulatory References

  1. musculotropic antispasmodic agent
  2. musculotropic antispasmodic

What side effects are possible with Flospan?

Possible Side Effects and Safety Information

The official safety profile for Flospan (Phloroglucinol) is primarily structured around the potential for hypersensitivity reactions affecting the skin and the immune system. The majority of documented adverse events are classified in regulatory documents as Frequency Not Known, meaning their rate of occurrence cannot be reliably estimated from available post-marketing data.


Adverse Reaction Classification

Side effects are most consistently documented under the Skin and Subcutaneous Tissue Disorders and Immune System Disorders categories. Officially listed adverse reactions include skin eruption, pruritus (itching), and, rarely, urticaria (hives).

Serious Reactions and Safety Constraints

Specific serious adverse reactions that are officially documented include acute hypersensitivity events such as Anaphylactic shock and Quincke's oedema (angioedema). Regulatory information also notes Generalised Acute Exanthematous Pustulosis (AGEP), a severe skin condition documented to occur at the beginning of treatment.

Specific safety restrictions exist. The medication is contraindicated in cases of known allergy to phloroglucinol. Furthermore, regulatory labels advise avoiding combination with morphine or its derivatives, as these compounds can induce spasms and counteract Flospan’s intended antispasmodic effect. Contraindications related to excipients (such as lactose or aspartame) are also listed for patients with conditions like phenylketonuria or certain types of intolerance.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for the active ingredient, Phloroglucinol, defines the management of overdose primarily through mandatory emergency actions rather than specific clinical presentation. Officially documented cases of overdose have been reported, but they are noted as occurring without any specific symptomatology being formally listed in the prescribing information. Consequently, a suspected overdose is defined as an event requiring immediate clinical intervention regardless of the apparent absence of clear symptoms. No specific severe or life-threatening manifestations are detailed in the overdose section of the official label.

When Immediate Medical Help Is Required

Immediate medical attention must be sought in all cases of suspected overdose or accidental ingestion, as mandated by regulatory authorities. Patients are instructed to contact their nearest hospital casualty department or tell their doctor immediately if they have accidentally taken too many tablets. This urgent action is also specifically required if there is suspicion that a child may have swallowed any of the medication. The official statement requires that the patient be taken to a medical facility for timely treatment.

Overdose Management

The recommended management is symptomatic and supportive. The regulatory documents confirm that no specific antidote is known or formally documented in the official prescribing information for Phloroglucinol overdose. Therefore, clinical efforts focus on stabilizing the patient and managing any presenting signs, in line with the regulator's emphasis on timely supportive care.

Therapeutic Uses of Flospan

What Flospan Treats: Main Uses and Benefits

Flospan is generally applied to provide symptomatic relief for intense, sudden pain caused by the involuntary contraction of smooth muscles in the body's internal organs. This makes it relevant for conditions like renal (kidney) or biliary (gallbladder) colic, which cause intense pain, as well as cramping and discomfort in the digestive tract and the genital-urinary system. The active compound is indicated for the relief of acute genitourinary or gastrointestinal spasm.

This medication is applied to address groups of symptoms that may become intense or disruptive in these areas. By calming these muscle contractions, Flospan provides support that helps ease the overall symptom burden during acute episodes. It is often applied during phases of increased distress or discomfort.

“Flospan is primarily applied in contexts where additional symptomatic support is needed to address spasms and related acute pain.”

This support provides supportive relief when symptoms interfere with routine activities and supports general well-being during symptomatic phases.

Quick Fact: Relief for Spasmodic Cramping

Regulatory References

  1. Health Canada Drug Product Database

Eligibility and Restrictions for Use

Who Can and Cannot Use Flospan?

This section defines the populations for whom Flospan (Phloroglucinol) is approved, restricted, or strictly prohibited, as documented in official government regulatory labeling.

Absolute Contraindications

Flospan is absolutely contraindicated in patients who have a known hypersensitivity to the active substance or any excipient. Use is prohibited for individuals diagnosed with Phenylketonuria (PKU) due to the presence of aspartame in the formulation. Furthermore, the medicine must not be used by patients with specific severe gastrointestinal conditions, including functional ileus or intestinal obstruction.

Contraindications also apply to those with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Age and Reproductive Status

The medicine is officially established for use in adults and children over two years of age. Efficacy, however, has not been established in children under two years old.

Regarding pregnancy, use is conditional and should only be considered if necessary. For breastfeeding women, use is generally not recommended and should be avoided due to insufficient safety data documented in the regulatory information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the documented interaction profile of Flospan based on information present in official government regulatory labeling for its active substance (Phloroglucinol), which functions as an antispasmodic agent.

Interaction Classifications (High-Level):

  • Pharmacodynamic Risk Enhancement: The primary documented interaction class involves the concurrent use of medicinal products that share similar effects on the body's systems, specifically relating to antispasmodic action or central nervous system effects.
  • Procedural Interaction Constraints: Official documents note that the use of Flospan may need to be considered in the context of other administered medicines, particularly those with anticholinergic activity, which may be restricted prior to or during certain diagnostic procedures.

Official Interaction Statements:

  • Specific Interacting Medicines: Official labeling notes a heightened potential for risk when Flospan is used alongside other medicines possessing significant antispasmodic properties.
  • Product Class Restrictions: Use with caution is advised when co-administering with other medications that affect intestinal motility or contain anticholinergic components, as this can lead to additive effects.
  • Concomitant Use: Regulatory guidance emphasizes that healthcare providers should be informed of all medicines being taken, including over-the-counter and herbal preparations, to manage the potential for additive effects.

Connection to the overall interaction profile:

Official regulatory documents define the product’s interaction structure primarily by identifying substances that could lead to additive effects on the smooth muscle relaxation intended by the product, or interfere with diagnostic procedures, thereby establishing necessary precautions for co-administration.

Mechanism of Action

Flospan contains phloroglucinol, a compound classified as a direct-acting smooth muscle relaxant and antispasmodic agent. The primary site of action is the visceral smooth muscle tissue of organs, including the gastrointestinal, biliary, and urinary tracts.

Phloroglucinol acts through a non-specific mechanism, with its molecular target involving the modulation of ion flux across the smooth muscle cell membrane. It primarily functions by inhibiting voltage-dependent calcium channels on the cellular surface. This action limits the movement of extracellular calcium ions (Ca^2+) into the sarcoplasm. A reduction in intracellular Ca^2+ concentration directly limits the formation of the actin-myosin contractile complex. .

Furthermore, phloroglucinol is proposed to impede the activity of the enzyme catecholamine O-methyltransferase (COMT) within the visceral smooth muscle. The combined intracellular consequences—reduced Ca^2+ influx and associated biochemical modulations—directly lead to a decrease in the intrinsic tone and motility of the affected smooth muscles. This results in a non-anticholinergic relaxation of muscular hyperactivity throughout the viscera.

Dosage and Administration Information

How to Use Flospan: Administration and Dosage Principles

Flospan (Phloroglucinol) is used for administration via multiple routes to address acute spasms in various contexts. The medication is available as oral/sublingual tablets (80 mg), injection solution (for intravenous and intramuscular use), and rectal suppositories.

Official Dosing and Scheduling

The usage pattern for Flospan is primarily symptomatic (on-demand), meaning it is administered at the time a painful spasm occurs. Dosage limits are defined for both frequency and maximum intake.

Administration Route Standard Adult Dose Maximum Daily Dose Minimum Interval
Oral/Sublingual 160 mg (two 80 mg tablets) 480 mg (six 80 mg tablets) 2 hours
Rectal 150 mg (one suppository) 450 mg (three 150 mg suppositories) 2 hours

For the parenteral route (IV/IM), which is generally reserved for severe, acute episodes, doses ranging from 40 mg to 120 mg are applied, often transitioning to the oral or rectal form for continued management. The overall duration of treatment is guided by the persistence of symptoms, requiring reassessment by a healthcare provider if symptoms do not resolve.

Specific Administration Instructions

For oral use, adults may dissolve the tablet under the tongue (sublingually) or dissolve it in water. For pediatric use (children over 2 years), the tablet must be dissolved in a glass of water before administration, with a lower maximum daily dose of 160 mg. A key procedural constraint is the absolute restriction on its co-administration with major analgesics such as morphine and its derivatives due to the risk of an antagonistic effect.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase III Clinical Trials

Research focused on individuals diagnosed with a specific inflammatory condition. Clinical studies evaluated whether the drug affected the frequency of severe inflammatory flares. One finding reported a change in pain severity, and explored effects on quality of life.

  • Study 1: Joint Mobility: A randomized, controlled trial evaluated whether joint function was affected. The trial spanned 12 weeks.
    • Results: Primary endpoints examined effects on pain and joint stiffness. A majority of participants reported a positive outcome compared to the placebo group.
  • Study 2: Inflammation Markers: A secondary study reported on inflammation changes over six months.

Research Data

Studies evaluated whether inflammatory markers changed. Study results addressed tolerability, focusing on outcomes in patients aged 18 to 65. Data on higher dosages remains limited.

  • Subgroup Analysis: Research has noted potential interactions in individuals with existing heart conditions; these studies are currently ongoing.

Comparative Research

Head-to-head research explored whether the drug differed from Treatment X regarding efficacy outcomes and patient retention. The study hypothesis explored potential effects on adherence and disease management.

  • Findings: The study reported a difference in the rate of adverse events between the two groups. Further research is needed to clarify any difference in long-term outcomes.

Frequently Asked Questions (FAQ)

Common questions about Flospan (FAQ)

Q: What kind of drug class does Flospan belong to?

A: Flospan is officially classified by regulatory bodies as an antispasmodic medicine. This means it belongs to a group of drugs intended to relieve muscle spasms. Its primary function is described as targeting and relieving involuntary contractions of the smooth muscles found in internal organs.

Q: Is it true that Flospan is used for more than one condition?

A: Yes, official regulatory indications state that Flospan is described for use in treating spasmodic pain in multiple areas of the body. These areas include the intestines, the biliary tract, the bladder, and the uterus.

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

A: According to regulatory sources, common adverse effects that have been reported include skin rash, nausea, and headache. Other frequently observed effects are light-headedness and dizziness. This information is typically detailed further in the 'Side effects' section of the official documents.

Q: Can I drive while taking Flospan?

A: Official labeling states that Flospan has no or negligible influence on a person's ability to drive or operate machinery. However, if a patient experiences side effects such as dizziness or light-headedness, regulatory labeling indicates that these activities should be avoided.

Q: Are there any known interactions between Flospan and herbal supplements?

A: Official regulatory documents advise against combining Flospan with certain substances. Specifically, there is guidance against concurrent use with drugs or herbal medicines containing Morphine compounds or their derivatives. These substances can work against Flospan's antispasmodic effect.

Q: Do you take Flospan with food or on an empty stomach?

A: Flospan is available as an orodispersible tablet, meaning it is designed to dissolve quickly under the tongue or in water. Official product information mentions these administration methods. Regulatory documents do not specify a mandatory requirement to take this medication with or without food.

Q: Can Flospan be split or crushed if I have trouble swallowing pills?

A: The oral formulation of Flospan is an orodispersible tablet. This design allows the tablet to be dissolved under the tongue or in a glass of water for easier intake. The official product information describes this method as a way to take the medicine for those who may prefer not to swallow the whole tablet.

Q: What if I forget to take a Flospan dose?

A: Official documentation describes the approach for a missed dose as taking it as soon as it is remembered. However, if it is almost time for the next scheduled dose, regulatory guidance describes skipping the missed dose. Official information specifies that the dose should not be doubled to make up for the one that was missed.

Q: What happens if I accidentally take two Flospan pills?

A: If more than the prescribed amount of Flospan is taken, regulatory information indicates the need for prompt medical attention. While official reports on overdose cases have not specified unique symptoms, medical evaluation at a facility is necessary.

Q: Can Flospan be used by teenagers or children?

A: Official regulatory documents indicate that Flospan is described for use in certain pediatric populations. Use is specified for children over 2 years of age. These patients have defined dosing limits as specified in the official information.

Q: Can women who are planning to become pregnant use Flospan?

A: Regulatory guidance suggests using Flospan during pregnancy only when absolutely necessary and as directed by a healthcare professional. Although wide clinical use has not indicated teratogenic effects in studies, the official guidance should be reviewed by a healthcare provider for applicability.

Q: Is it okay to take Flospan if I'm breast-feeding?

A: Due to a lack of sufficient safety data, official regulatory information advises women who are breastfeeding not to use this medicine. This is a standard precaution when detailed data on drug transfer into breast milk is unavailable.

Q: How should Flospan be stored?

A: Official product information provides specific storage instructions to maintain the medicine’s integrity. Flospan should be stored at a temperature not exceeding 30 C (86 F). It must also be protected from direct light and excessive humidity.

How should Flospan be stored and disposed of?

How to Store and Dispose of Flospan

Flospan ( Phloroglucinol) must be stored and handled according to specific conditions mandated by regulatory labeling to maintain product stability and ensure safety.

Storage Requirements

The medication must be stored at room temperature and should not be exposed to excess heat. Flospan must be kept in its original packaging, and the container should be kept tightly closed to protect the product from both light and moisture. To prevent accidental ingestion, the medication must be stored out of the sight and reach of children and should be stored locked up.

Disposal Instructions

Expired or unused Flospan must be disposed of in accordance with local and national regulations for pharmaceutical waste. The product should not be disposed of into ordinary household waste. It is strictly prohibited to empty the product into drains, surface water, or sanitary sewer systems to avoid environmental contamination.

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

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