Quick Facts

• Therapeutic Domain: Assists in managing painful, involuntary muscle contractions (spasms).
• Primary Use: Used for supporting symptom control in spasmodic conditions of the digestive, biliary, urological, and gynecological systems.
• Targeted Areas: Supports relief from discomfort associated with intestinal, bile duct, bladder, and uterine spasms.

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What Spasfon-Lyoc Treats: Main Uses and Benefits

Spasfon-Lyoc is utilized to offer therapeutic support for individuals experiencing uncomfortable, involuntary contractions across various smooth muscle systems in the body. Its main purpose is to help manage these painful spasms. This medication is clinically used in the context of functional discomfort in the digestive tract, as well as symptoms related to the biliary system, such as those that occur during hepatic colic.

Furthermore, the drug is relevant for providing symptomatic support for acute, painful spasmodic manifestations of the urinary tract, including conditions like renal colic (kidney stones). In the gynecological domain, Spasfon-Lyoc may assist in managing painful spasms, such as those associated with dysmenorrhea (painful periods). It is also considered an adjuvant (supportive) therapy for uterine contractions that may occur during pregnancy, when utilized in combination with rest. Healthcare professionals determine if this treatment is appropriate based on individual clinical need and presentation. The goal of treatment is to support improved comfort and management of spasmodic pain.

Who Can and Cannot Use Spasfon-Lyoc?

This section defines the officially documented population eligibility and restrictions for Spasfon-Lyoc (Phloroglucinol), as stated in regulatory prescribing information.

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Contraindicated Populations (Must Not Use)

Classification	Population/Condition
Absolute Contraindication	Patients with known hypersensitivity (allergy) to the active substance, Phloroglucinol, or any of the product's excipients.
Excipient-Based Restriction	Patients with Phenylketonuria (PKU) due to the presence of aspartame in certain formulations.
Excipient-Based Restriction	Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (due to the presence of lactose in the formulation).

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Age-Group and Special Population Eligibility

Population Group	Regulatory Status
Adults	Approved for use under standard labeled conditions.
Children over 2 years	Approved for use.
Children under 2 years	Efficacy has not been established.
Pregnant Individuals	Use should only be considered if medically necessary.
Breastfeeding Women	Use is not recommended due to a lack of sufficient data.

The official eligibility profile limits use based on allergic status and specific metabolic conditions. Use in pregnant and breastfeeding women is restricted, and efficacy is officially not established for children under two years of age.

Interactions with other medicines and products

The official regulatory documents for Spasfon-Lyoc (Phloroglucinol) define the interaction profile primarily through pharmacodynamic restrictions and excipient-related constraints. No mandatory timing separation rules or clinically significant pharmacokinetic interactions that alter the drug's systemic exposure are documented in the available regulatory labeling.

Pharmacodynamic Interaction and Avoidance

The combination with major analgesics, specifically morphine and its derivatives, is officially restricted and must be avoided. This restriction is mandated because these analgesics may exert a spasmogenic effect (causing muscle spasms), which directly antagonizes (opposes or reduces the effectiveness of) the spasmolytic action of Phloroglucinol. Avoidance is similarly required for medicinal herbs containing Morphine compounds and derivatives. Regarding food, the absorption of Phloroglucinol is officially stated to be not affected by meals.

Population-Specific Constraints (Excipient-Related)

The composition of the Spasfon-Lyoc lyophilisate formulation imposes specific constraints on use in certain populations, which are formally classified as contraindications. The product is formally contraindicated in patients with phenylketonuria (PKU) due to the presence of the excipient aspartame (a source of phenylalanine). Furthermore, due to the presence of the excipient lactose, the medicine is formally restricted for use in individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Direct Modulation of Smooth Muscle Contraction

Spasfon-Lyoc exerts a musculotropic action through its active ingredients, Phloroglucinol and its derivatives, which act directly on visceral smooth muscle cells in the gastrointestinal, biliary, and genitourinary tracts. The mechanism involves modulating the Intracellular Calcium ( Ca^2+) pathway, primarily by suppressing the influx or availability of Ca^2+ within the cell. This action is peripheral, localized to the muscle tissue, and independent of the autonomic nervous system.

Targeted Inhibition of the Contraction Cascade

The modulation of Ca^2+ concentration inside the cell suppresses the activation of Myosin Light Chain Kinase (MLCK), the enzyme critical for initiating the muscle contraction sequence. By preventing the phosphorylation of myosin light chains, the drug inhibits the formation of cross-bridges between muscle proteins. This sequential mechanistic cascade results in the physiological relaxation of the smooth muscle tissue. The components work together synergistically, producing a combined effect on muscle tone.

How to Use Spasfon-Lyoc

Spasfon-Lyoc (Phloroglucinol Lyophilisate) is designated for use as an intermittent, on-demand treatment, administered at the time of an acute spasmodic crisis. The administration protocol involves specific methods, dose limits, and interval timing.

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Administration Methods and Precautions

The specialized lyophilisate dosage form allows for two distinct routes of administration. The tablet can be dissolved in a glass of water and swallowed, or, for adult administration, it may be placed sublingually (under the tongue) to dissolve. The lyophilisate is a fragile pharmaceutical form and must be handled with care when removed from its blister packaging.

Standard Dosing Regimens

For adults, the standard dose is 160 mg of Phloroglucinol, taken at the time of the spasm. Dosage renewal is possible if symptoms persist, but a minimum interval of two hours must be respected between doses. The maximum dose permitted is 480 mg over a 24-hour period.

Age-Specific Rules

Different regimens apply to the pediatric population. For children over 2 years of age, the dose is 80 mg at the time of the crisis, administered dissolved in a glass of water. This dose may be renewed once, without exceeding a total of 160 mg per 24 hours. The 160 mg strength is explicitly restricted and not adapted for use in children.

Research Evidence / Overview of Studies

Phase 3 Trials: Study Scope and Design

Phloroglucinol, the active substance in Spasfon-Lyoc, is a compound studied for its effects as a musculotropic antispasmodic. The clinical evidence is primarily drawn from controlled studies examining its use for spasmodic pain in specific organs.

These findings were gathered from randomized, double-blind, and open-label comparative studies focusing on adult patients with various pain conditions:

• Study A (Primary Endpoint): Studies examined the use of the drug in specific patient populations, with a focus on adult patients experiencing spasmodic pain related to functional disorders of the digestive tract and bile ducts.
• Study B (Urological and Gynecological Pain): Phase 3 multicenter studies evaluated the drug's use in acute spasmodic painful disorders of the urinary tract (such as renal colic) and painful spasmodic manifestations in gynecology.
• Comparative Assessment: Comparative trials have assessed phloroglucinol preparations (oral and parenteral) against other therapeutic options, finding the measured effects in reducing pain and spasms associated with renal or biliary colic to be comparable.

Pharmacodynamic Markers and Profile Documentation

Research included studies that documented the side effect profile in various populations.

Research investigated findings documented in a subgroup of patients with pre-existing mild renal impairment. Specifically, an outcome was documented regarding plasma concentration levels. It is not yet clear what this finding indicates. Non-clinical data from conventional studies on repeated-dose toxicity, genotoxicity, and reproductive functions have not revealed any particular risk for humans.

• Adverse Event Monitoring: Registry studies and clinical trial data document adverse events, which generally include skin and subcutaneous disorders such as rash, urticaria, and, rarely, severe allergic reactions like anaphylactic shock.

Common questions about Spasfon-Lyoc (FAQ)

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Q: How long does the effect of Spasfon-Lyoc last?

Studies on the active substance, Phloroglucinol, indicate it has a half-life of approximately 1 hour and 40 minutes, which reflects how quickly the substance is processed by the body. Regulatory guidance defining the minimum time interval required between doses is two hours.

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Q: Is Spasfon-Lyoc commonly used for period pain?

According to official regulatory documents, the medicine is indicated for the symptomatic treatment of painful spasms in gynecology. This category of use includes painful periods, which is medically known as dysmenorrhea.

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Q: Are there any common side effects people report when taking Spasfon-Lyoc?

Official product labeling primarily focuses on the documentation of hypersensitivity reactions. Documented adverse reactions, such as rash, urticaria (hives), and anaphylactic shock, are generally classified as rare or of unknown frequency in official data.

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Q: Can Spasfon-Lyoc cause drowsiness?

Based on official product information, Spasfon-Lyoc is stated to have no or negligible effect on a person's ability to drive or operate machinery. The regulatory assessment indicates that no sedative effects are expected that would impair these activities.

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Q: Can Spasfon-Lyoc be taken with other pain relief medicines like paracetamol?

Official regulatory texts restrict co-administration with morphine and its derivatives, classifying them as major analgesics that may counteract the drug's effect. The required safety data does not explicitly address interactions with other specific non-opioid pain relievers.

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Q: Is Spasfon-Lyoc considered safe for children?

The medicine is approved for use in children over two years of age, but use is restricted to specific dosage conditions defined in the regulatory documents. The official label notes that efficacy has not been established for children under two years old.

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Q: What is the legal classification of Spasfon-Lyoc (e.g., is it prescription-only)?

Phloroglucinol is classified as an over-the-counter (OTC) medicine in some regulatory jurisdictions. Its classification may vary depending on the country, the dosage strength, and the specific formulation available.

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Q: Where is the research evidence for Spasfon-Lyoc usage documented?

Clinical data and safety reviews are maintained by national regulatory bodies, such as the French National Agency for Medicines and Health Products Safety (ANSM). These documents are also summarized by intergovernmental bodies like the European Medicines Agency (EMA) in their safety reports.

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Q: Does taking Spasfon-Lyoc affect blood pressure?

Official regulatory documents list hypotension (low blood pressure) as a vascular disorder among the possible adverse reactions. This effect is classified as being of unknown frequency, meaning it cannot be estimated from the available data.

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Q: Does Spasfon-Lyoc contain any sugar or sweeteners?

The formulation contains the sweetener aspartame, which is a source of phenylalanine, and the sugar lactose. The presence of these excipients leads to formal contraindications for patients with Phenylketonuria and certain hereditary metabolic conditions.

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Q: What should be done if someone misses a dose of Spasfon-Lyoc?

Regulatory guidance outlines a protocol for handling a missed dose based on the timing relative to the next scheduled dose. This protocol generally states that if the interval is too close to the next scheduled dose, the missed dose should be passed over, and the administration amount should not be doubled.

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Q: Can Spasfon-Lyoc be used by elderly patients?

The medicine is approved for use in adults, and the regulatory profile does not list any specific contraindications or precautions unique to the elderly population.

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Q: Does Spasfon-Lyoc contain lactose or gluten?

The medicine contains lactose, which is a formal contraindication for individuals with certain rare hereditary problems. Regulatory documents do not list gluten as an excipient.

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Q: Is it common for Spasfon-Lyoc to be prescribed for IBS symptoms?

The drug is officially indicated for the treatment of pain related to functional disorders of the gastrointestinal tract. This category includes conditions like Irritable Bowel Syndrome (IBS), for which it may be utilized by prescribing physicians.

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Q: Do studies suggest Spasfon-Lyoc is generally well-tolerated?

Non-clinical studies examining repeated-dose toxicity and reproductive functions have not revealed any particular risk to humans. Furthermore, most documented adverse reactions are classified as rare or of unknown frequency.

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Q: Are there any dietary restrictions mentioned in the official documents for Spasfon-Lyoc?

Official labeling explicitly states that the absorption of the active ingredient is not affected by meals. No other specific food or dietary restrictions are mentioned in the core regulatory texts.

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Q: Does Spasfon-Lyoc affect fertility?

Non-clinical data from conventional studies on reproductive functions have not revealed any particular risk to humans.

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Q: Is there any difference in effect between the Lyoc form and a liquid form of the drug?

The Lyoc form is designed for rapid dissolution and swift potential absorption to provide quick relief for acute spasms. Regulatory documents note that injectable solutions are also available for very rapid but short-lived effects, while other oral forms may have a different action profile.

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Q: Does Spasfon-Lyoc interact with herbal supplements?

Official documentation states that medicinal herbs containing morphine compounds and derivatives must be avoided. This is due to the potential for these substances to cause muscle spasms, which would counteract the drug's intended spasmolytic action.

Storage and Disposal of Spasfon-Lyoc

The official requirements for Spasfon-Lyoc (phloroglucinol) storage are defined by the product's dosage form to maintain its labeled 3-year shelf life.

Storage Conditions

Storage rules are packaging-specific:

• Over-wrapped Blister Packs (in Aluminium Sachet): The product must be stored at a temperature not exceeding 30°C.
• All Presentations: Must be stored away from heat and moisture to protect the oral lyophilisate from degradation.

All medicinal products must be stored out of the sight and reach of children.

Disposal Instructions

Regulatory documentation states that no special requirements for disposal are needed for Spasfon-Lyoc. Unused or expired medication must be disposed of according to local requirements for household pharmaceutical waste.