Spasmopyralgin M

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Spasmopyralgin M

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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 Spasmopyralgin M

Property Description
Active Ingredients Sodium Metamizole, Camylofin
Form Tablets, Solution for Injection, Oral Drops
Pharmacological Class Compound Analgesic and Spasmolytic
General Purpose Relief from pain and smooth muscle spasms
Origin Synthetic (Fixed-Dose Combination)

Spasmopyralgin M is a fixed-dose combination medicine classified as a Compound Analgesic and Spasmolytic agent, synthetically formulated for the comprehensive relief of acute pain associated with involuntary muscle contractions. This preparation integrates two distinct pharmacological components to create a synergistic therapeutic effect.

The medicine's primary purpose is to address both the symptomatic discomfort of pain and the underlying hyperactivity of smooth muscles. Its classification under the Antispasmodics in Combination with Analgesics group (WHO ATC A03DA05) reflects this specialized therapeutic design. This dual-action approach distinguishes it from simple single-ingredient painkillers by offering a mechanism specifically geared toward alleviating the intense, cramping sensations characteristic of visceral spasms, such as in instances of renal or biliary colic.

What Active Ingredients are in Spasmopyralgin M?

The formulation relies on the synergistic relationship between its two core active ingredients. Sodium Metamizole (also recognized as Dipyrone or Analgin) functions primarily as a potent non-opioid analgesic and antipyretic, belonging to the Pyrazolone chemical group. Metamizole is clinically recognized for its efficacy in reducing the intensity of pain signals and lowering elevated body temperature.

Complementing this, the second ingredient, Camylofin, acts as a spasmolytic agent that directly induces the relaxation of smooth muscle tissue. This synthetic combination ensures the medicine targets both the perception of pain and the physiological tension causing the discomfort concurrently. Spasmopyralgin M is administered via both the oral and parenteral routes, with common dosage forms including tablets, a solution for injection (ampoules), and oral drops.

What side effects are possible with Spasmopyralgin M?

Possible Side Effects and Safety Information

This section details the officially documented adverse reactions and safety characteristics for Spasmopyralgin M (Sodium Metamizole/Camylofin), based strictly on government regulatory documents.

Serious Adverse Reactions

The most serious documented safety concerns are classified as rare or very rare and are primarily associated with the Metamizole component. These include life-threatening events that are not related to the dose of medicine used:

  • Agranulocytosis: A severe, potentially fatal reduction in specific white blood cells, which can occur at any time during treatment or shortly after stopping the medicine.
  • Anaphylactic Shock: A severe, systemic allergic reaction.
  • Severe Skin Reactions: Such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  • Drug-induced Liver Injury (DILI): Including acute hepatitis and acute liver failure, which may occur from a few days up to several months after treatment initiation.

System-Organ Class (SOC) Effects

Adverse reactions are formally classified across multiple organ systems in regulatory documents, with frequency classifications for many common effects listed as unknown. Affected systems include:

  • Blood and Lymphatic System Disorders
  • Immune System Disorders
  • Hepatobiliary Disorders (Liver)
  • Renal and Urinary Disorders (Kidney)
  • Vascular Disorders (e.g., Hypotension)
  • Nervous System Disorders (e.g., Dizziness, Headache)

Regulatory Safety Constraints

Official labeling includes explicit restrictions on the use of this medicine:

  • Contraindications: The medicine is contraindicated in patients with known impaired bone marrow function, a prior history of agranulocytosis caused by the active ingredients, or conditions like narrow-angle glaucoma and mechanical gastrointestinal obstruction.
  • Population Restrictions: Use is contraindicated in infants below three months of age or weighing less than five kilograms. Monitoring for signs of serious reactions, such as fever or jaundice, is noted in the official safety guidance.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documents define the overdose profile for medicines containing Sodium Metamizole and Camylofin by listing severe, dose-dependent manifestations primarily affecting the central nervous, cardiovascular, and renal systems. The presence of life-threatening risks mandates immediate emergency response.

Element Official Regulatory Documentation Statement
Documented overdose presentations Manifestations include central nervous system effects such as convulsions, coma, and somnolence (drowsiness). Antispasmodic component effects may include dry mouth, mydriasis, and tachycardia (rapid heart rate).
Physiological systems affected CNS, Cardiovascular system (arrhythmias, hypotension, shock), Renal system (acute renal failure, oliguria, anuria), and Gastrointestinal tract (nausea, vomiting).
When immediate medical help is required Patients must seek immediate medical attention or contact emergency services for any suspected overdose. Hospital monitoring may be required due to the potential for complications.
Antidote Information No specific antidote is known for Metamizole intoxication.
Supportive management Treatment must be symptomatic and supportive. Cited procedural steps to reduce absorption and enhance elimination include gastric lavage, administration of activated charcoal, and forced diuresis.

Overdose can lead to severe or life-threatening outcomes, explicitly listing cardiogenic shock and respiratory paralysis. This established critical risk is the basis for the mandate to seek immediate medical attention. The clinical management is focused on providing supportive measures due to the documented absence of a specific reversal agent.

Therapeutic Uses of Spasmopyralgin M

What Spasmopyralgin M treats: main uses and benefits

Spasmopyralgin M is commonly used across domains where additional symptomatic support is needed, due to its function in helping to manage a range of symptoms. The main active substance is considered relevant for easing symptoms related to discomfort, fever, and muscle spasm.

This combination of effects means the product is often used when symptoms intensify and supportive relief is needed across conditions where functional stability becomes affected. It helps address symptom clusters that include symptoms related to physical discomfort, symptoms related to heightened physiological activity, and symptoms of increased neurological or muscular activity.

The medicine is considered relevant for easing acute or disruptive symptom patterns, such as those associated with painful colic, severe discomfort, or other conditions involving episodic or fluctuating manifestations of discomfort. The application generally supports general well-being during symptomatic phases. This may include providing supportive relief when symptoms interfere with routine activities, such as those associated with biliary colic, renal colic, or gastrointestinal spasms.

Quick Fact: Support for Symptoms of increased neurological or muscular activity

Eligibility and Restrictions for Use

The eligibility for using Spasmopyralgin M, a combination of Metamizole and Camylofin, is strictly defined by regulatory documents, focusing on patient history, age, organ function, and specific medical conditions. Use is generally established in adults and adolescents aged 15 years or older.


Contraindicated Populations (Must Not Use)

Contraindication Category Exclusionary Condition
Hematopoietic Risk Impaired bone marrow function or history of agranulocytosis to Metamizole or other pyrazolones.
Allergy/Intolerance Hypersensitivity to active ingredients or excipients; known analgesic-induced asthma syndrome.
Metabolic Disorders Acute intermittent hepatic porphyria or G6PD deficiency.
Anticholinergic Risk Narrow-angle glaucoma; mechanical obstruction in the gastrointestinal or urinary tract; prostatic hypertrophy.

Restricted and Conditional Use

Restriction Category Eligibility Status
Pregnancy/Lactation Contraindicated in the third trimester; not recommended during breastfeeding.
Age Groups Contraindicated in infants under 3 months or 5 kg. Dose reduction is required for the elderly.
Organ Function Severe renal or hepatic impairment requires dose reduction; long-term use is not established.
Circulatory Status Use requires caution in patients with pre-existing hypotension or unstable circulation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Spasmopyralgin M primarily reflects the activity of its Metamizole component with drug-metabolizing systems and other agents. Regulatory documents identify several classes of medicines and substances with which co-administration may alter exposure or intensify pharmacological effects.

High-Risk Co-administration

  • Methotrexate: The combination is associated with an additive risk for haematologic toxicity, particularly when Methotrexate is used at high doses.
  • Ciclosporin: Metamizole is documented to decrease the plasma concentration of Ciclosporin. Co-administration should be avoided unless drug levels are closely monitored.

Metabolic and Exposure Effects The Metamizole component is a documented inducer of CYP3A4, CYP2B6, and CYP2C19, and a moderate inhibitor of CYP1A2. This enzyme modulation can lead to decreased plasma concentrations of co-administered CYP substrates, which may reduce their effectiveness. Examples include Bupropion, Efavirenz, Methadone, Valproate, and Tacrolimus. Conversely, Metamizole may also increase the serum levels of certain medicines by decreasing their excretion rate.

Pharmacodynamic Interactions

  • Low-dose Acetylsalicylic Acid (Aspirin): Concomitant use may reduce the effect of Aspirin on platelet aggregation.
  • Other Anticholinergics: Due to the Camylofin component, co-administration with other anticholinergic agents (e.g., tricyclic antidepressants) carries a risk of additive anti-muscarinic effects.
  • Alcohol: There is a risk of interaction leading to the mutual potentiation of effects.

Population Note In patients with hepatic or renal impairment, the elimination rate of Metamizole metabolites is reduced, and repeated high doses should be avoided.

Mechanism of Action

The mechanism relies on the complementary action of its two components, simultaneously targeting central nociceptive signaling and peripheral smooth muscle hypertonicity.

Central Attenuation of Nociceptive Signals

The Metamizole component acts within the Central Nervous System (CNS). Its active forms achieve inhibition of Cyclooxygenase-3 (COX-3), an enzyme essential for synthesizing Prostaglandin E2 ( PGE2) in the brain. This action also modulates the body's descending pain control pathways. The resulting physiological effect is the attenuation of central nociceptive signal transmission and the modulation of the hypothalamic set point.

Dual-Action Visceral Muscle Relaxation

The Camylofin component employs a two-pronged peripheral mechanism. It uses neurotropic antagonism by blocking Muscarinic Acetylcholine Receptors and musculotropic inhibition by blocking the Phosphodiesterase Type 4 (PDE4) enzyme. These distinct actions converge to reduce the free intracellular calcium concentration ( Ca^2+) required for cellular contraction. This mechanism leads to a significant reduction in visceral smooth muscle tone.

Synergistic Targeting of Pathophysiology

By addressing both central nociceptive transmission and peripheral hypertonicity simultaneously, the components achieve a synergistic physiological outcome, leading to a coordinated physiological modulation of overactive responses.

Dosage and Administration Information

How to Use Spasmopyralgin M: Official Administration Guidelines

This section outlines the standardized administration protocols for Spasmopyralgin M, a fixed-dose combination containing Metamizole, in accordance with established prescribing information. The medicine is used for short-term, intermittent treatment of acute symptomatic episodes.


Administration Scope and Dosing Principles

Property Official Use Principle
Route of Administration Approved for both Oral (e.g., tablets, drops) and Parenteral (Intravenous or Intramuscular injection) delivery.
Standard Adult Dosing The maximum single dose of the Metamizole component is typically 1,000 mg. The overall maximum daily dose is generally limited to 4,000 mg for oral use, and may extend to 5,000 mg for parenteral use.
Dosing Frequency Doses should be separated by a minimum interval of 6 to 8 hours, with administration restricted to a maximum of four times daily.

Procedural and Population Adjustments

Administration technique includes procedural requirements tied to proper use. Intravenous injection must be administered very slowly to comply with procedural standards for parenteral delivery. The medicine can typically be taken with or without food.

Specific dosage modifications are documented for certain patient groups: Older adults and individuals with known hepatic or renal impairment may require a reduced dose due to potential delays in metabolite clearance. For pediatric patients under 15 years of age, dosing is determined by body weight, following specific weight-based guidelines.

These official instructions establish the strict maximum quantity, required timing, and specific delivery conditions that govern the appropriate use of Spasmopyralgin M.

Recent Clinical Evidence

Evidence for Use in Acute Visceral Pain (e.g., Colic)

The combination medicine was evaluated in research contexts involving fluctuating or unstable symptoms, such as renal or biliary colic. Research relevant in trials assessing short-term or episodic symptom patterns in these contexts primarily involves Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews that compared the analgesic component (Sodium Metamizole) to specific comparison treatments in the studies.

Researchers applied in studies examining patient-reported experiences by focusing on outcomes related to physical discomfort. Studies monitored how symptoms evolved in the observed populations by measuring changes in symptom intensity over defined short-term intervals. Other outcomes examined included the time elapsed to a measured endpoint, and the patient-reported requirement for a rescue analgesic medication.

Findings describe patterns observed in the studies where measurements of symptom change for the Metamizole component were documented in comparison to the specific control treatments used. Evidence remains limited documenting the measurements for the specific fixed-dose combination (Sodium Metamizole plus Camylofin) in large, high-quality RCTs for this indication.


Evidence for Use in General Acute Pain and Fever

Research has explored the medicine's use in conditions where symptoms may vary in intensity, such as outcomes related to systemic or functional imbalance, headache, and fever. This research base often relies on systematic reviews of the analgesic component's use, as well as Observational Studies that track utilization patterns.

Research examined outcomes related to systemic or functional imbalance, such as body temperature measurements and general reductions in pain severity. Studies monitored patient-reported outcomes describing perceived discomfort over defined time intervals. Findings describe group patterns related to these outcomes, but much of the available evidence contributes to the broader evidence landscape of the Metamizole component.


Long-Term Studies and Follow-up Duration

The available research primarily focuses on episodes where symptoms become more noticeable, which reflects the nature of conditions associated with acute or disruptive episodes. Consequently, follow-up durations were limited across the high-quality research base.

Long-term outcomes are not fully established with this medicine, and research provides context but not individual predictions regarding the effects of repeated, extended use for symptom management. The existing studies provide limited insight into the effects beyond the short-term treatment of an acute event.


Evidence in Special Populations

Research was evaluated in different age groups, including both Adults and certain cohorts of Children. Findings describe group patterns, and research provides context but not individual predictions.

However, data for certain groups remain insufficient. For instance, findings for older adults or individuals with certain pre-existing chronic conditions may be based on smaller sample sizes. Comparative evidence is lacking, and results apply only to the populations studied.


What Is Still Uncertain About Spasmopyralgin M Research

Research highlights what is known—and what is still uncertain—about the medicine’s research profile.

Research indicates a limitation in comparative evidence to explore whether the measurements observed with the fixed-dose combination differ from those seen with the analgesic component (Metamizole) alone. Evidence quality varies across studies, as variability was observed concerning the dosage and comparison treatments used across trials. Furthermore, long-term effects are not fully established, and data are still emerging regarding certain subgroups, indicating that certainty remains low in these specific areas.

Key Studies & References Camylofin 50 mg and Paracetamol 325 mg in patients with acute colicky abdominal pain: a prospective and open-label study

Frequently Asked Questions (FAQ)

Common questions about Spasmopyralgin M (FAQ)


Q: Is Spasmopyralgin M considered a painkiller?

Spasmopyralgin M is officially classified as a Compound Analgesic (or pain reliever) and a Spasmolytic agent. This classification, found in official regulatory documents, highlights its dual function in addressing both pain signals and involuntary muscle contractions.


Q: Is Spasmopyralgin M an anti-inflammatory medication?

Official documents describe the Metamizole component as a non-opioid analgesic and antipyretic (fever reducer). While its mechanism involves the inhibition of the COX-3 enzyme in the central nervous system, official labeling does not classify it as a Non-Steroidal Anti-inflammatory Drug (NSAID).


Q: Is Spasmopyralgin M a type of muscle relaxant?

The medicine is classified as a Spasmolytic agent, which means it helps relax smooth muscles. The Camylofin component specifically works to reduce the involuntary tension and contractions characteristic of visceral spasms.


Q: What foods or drinks should be avoided when taking Spasmopyralgin M?

Official product information states that Spasmopyralgin M can typically be taken with or without food. However, regulatory documents note an interaction risk with alcohol, which carries a risk of interaction leading to the mutual potentiation of effects.


Q: Is it safe to take Spasmopyralgin M with blood thinners?

Co-administration with low-dose Acetylsalicylic Acid (Aspirin) has been examined, and regulatory information indicates this combination may reduce the intended effect of Aspirin on platelet aggregation. The official label provides details on this known interaction.


Q: Does Spasmopyralgin M affect liver or kidney function?

Official safety information documents potential effects on both the liver and kidneys. Safety concerns, although rare, include Drug-induced Liver Injury (DILI) and effects on the renal and urinary systems. Furthermore, regulatory dosing instructions require a reduced dose for individuals with pre-existing severe hepatic (liver) or renal (kidney) impairment.


Q: What are the known interactions with other central nervous system depressants?

The risk of interaction is noted when Spasmopyralgin M is combined with substances that affect the central nervous system, such as alcohol. Additionally, the Camylofin component may cause additive anti-muscarinic effects when combined with other anticholinergic medicines, a class that includes some antidepressants and certain gastrointestinal drugs.


Q: How long does it take for Spasmopyralgin M to start having an effect?

Based on pharmacokinetic data and patient information, the oral form of the medicine is typically approximated to start its action within 30 to 60 minutes of administration. Individual onset times may vary.


Q: How long does the effect of one dose of Spasmopyralgin M typically last?

The duration of the medicine's effect is reflected in the official dosing instructions. Regulatory frequency guidelines specify that doses should be separated by a minimum interval of 6 to 8 hours, which suggests the duration of the intended therapeutic window.


Q: What is the general recommended length of time to use Spasmopyralgin M?

Official regulatory indications specify that Spasmopyralgin M is intended for the short-term, intermittent treatment of acute symptoms. Its use is generally confined to temporary episodes rather than continuous, long-term symptom management.


Q: Is Spasmopyralgin M safe for use during pregnancy or while breastfeeding?

Official safety documentation indicates that the medicine is contraindicated (must not be used) during the third trimester of pregnancy. It is also not recommended for use while breastfeeding. Use during the first and second trimesters is restricted and conditional.


Q: Does taking Spasmopyralgin M affect driving or operating machinery?

Regulatory guidance advises caution when performing tasks that require concentration, such as driving or operating machinery. This guidance is included because side effects such as dizziness are documented in the official product information.


Q: What are the key benefits described for Spasmopyralgin M?

The key purpose described in official documents is providing coordinated relief from both the pain and the underlying involuntary muscle contractions (spasms). This dual action is the specialized therapeutic goal of the combined ingredients.


Q: Is it possible to have an allergic reaction to Spasmopyralgin M?

Official safety documentation notes the possibility of allergic reactions, ranging from simple hypersensitivity to severe, systemic events. Documented concerns include life-threatening reactions such as Anaphylactic Shock, which are not related to the dose of medicine used.


Q: Is hair loss a known side effect of Spasmopyralgin M?

Hair loss is not listed among the officially documented adverse reactions in the safety profile of Spasmopyralgin M. Regulatory labels list side effects categorized by frequency across various organ systems.


Q: Does Spasmopyralgin M have long-term side effects?

Because Spasmopyralgin M is intended for short-term, intermittent use, long-term outcomes of extended use are not fully established in the high-quality research base. Regulatory documents reflect that research provides context, but long-term effects are not fully established.


Q: Is Spasmopyralgin M an opioid?

The medicine is not classified as an opioid. According to the official pharmacological classification, the Metamizole component is specifically identified as a non-opioid analgesic and antipyretic. It belongs to the Pyrazolone chemical group.


Q: What happens if I miss a scheduled dose of Spasmopyralgin M?

Patient instructions generally state that a double quantity should not be taken to make up for a missed administration. The standard procedure is to take the next scheduled dose at its usual time and continue following the regular regimen.


Q: What is the recommended time interval between doses of Spasmopyralgin M?

The regulated dosing frequency requires that doses be separated by a minimum interval of 6 to 8 hours. This frequency restricts administration to a maximum of four times daily.


Q: Does Spasmopyralgin M build up in the body?

The dosing schedule, which requires a minimum of 6 to 8 hours between administrations, is determined by the half-life and clearance rates of the active ingredients. This regulated frequency is designed to ensure the active components are adequately cleared from the body and prevent significant accumulation.


Q: What is the proper way to dispose of unused Spasmopyralgin M?

Unused or expired medicine must avoid release to the environment, including disposal in household trash or wastewater. Disposal must strictly adhere to local and national pharmaceutical waste regulations.


Q: Is Spasmopyralgin M safe for older adults (seniors)?

Regulatory documents specify that older adults may require a reduced dose compared to the standard adult dose. This adjustment is necessary due to potential delays in how the body processes (clears) the active components, and it is covered in the official administration guidelines.


Q: What is the guidance regarding Spasmopyralgin M for people with asthma?

Official regulatory documents state that the medicine is contraindicated (must not be used) in patients with a history of known analgesic-induced asthma syndrome. This is a specific safety restriction listed in the contraindications section.


Q: What do clinical studies say about the effectiveness of Spasmopyralgin M?

Research has primarily examined the medicine’s use in conditions like acute visceral pain and general acute pain. Studies generally focus on measuring outcomes such as changes in symptom intensity and the requirement for rescue analgesic medication in the populations examined.


Q: Is Spasmopyralgin M described as causing withdrawal symptoms?

The official safety profile for Spasmopyralgin M, which addresses dependence concerns, does not list withdrawal symptoms as a documented adverse reaction. This finding is consistent with its classification as a non-opioid medicine intended for short-term use.


Q: Can the tablets or capsules of Spasmopyralgin M be crushed or split?

The official administration technique outlined in regulatory documents specifies the requirements for the oral dosage forms. These instructions indicate whether tablets are scored (allowing for splitting) or whether they must be swallowed whole to ensure proper delivery of the active ingredients.


Q: What is the proper, non-directive procedure for stopping the use of Spasmopyralgin M?

Because the medicine is intended for short-term, intermittent treatment of acute episodes, the procedure outlined in regulatory instructions reflects discontinuation after the acute symptoms have resolved. A specific tapering schedule is not typically specified for this usage.

How should Spasmopyralgin M be stored and disposed of?

Official Storage and Disposal Instructions

Storage of Spasmopyralgin M must strictly adhere to regulatory requirements to maintain product stability and safety. The medicine must be stored at a controlled ambient temperature, typically between 15 C to 25 C (59 F to 77 F), and kept away from heat, ignition sources, and direct light.

Storage Requirement Condition
Container Kept in the original container and tightly closed when not in use.
Protection Must be stored in a cool, dry place with adequate ventilation.
Safety Always kept out of the sight and reach of children.

For disposal, unused or expired Spasmopyralgin M must avoid release to the environment and should not be discarded in household trash or wastewater. Disposal must follow local pharmaceutical waste regulations to ensure proper handling.

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

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