Spasmalgon

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Spasmalgon

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Medically reviewed

Marina Burgos

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 Spasmalgon

Property Description
Active Ingredient Sodium Metamizole, Fenpiverinium Bromide, Pitofenone
Form Tablets, Solution for Injection
Pharmacological Class Analgesic and Antispasmodic Combination
General Purpose Relief of pain associated with smooth muscle spasm
Origin Synthetic Small Molecule Derivatives

Spasmalgon is a synthetic, fixed-dose combination medicinal product, principally classified as an analgesic and antispasmodic preparation. Its design is engineered for concurrent action against pain and the underlying smooth muscle spasms that cause it. Clinical experience indicates that this medicine provides potent relief primarily through its ability to powerfully diminish pain sensation.


What Type of Medicine is Spasmalgon?

Spasmalgon is a combination preparation that simultaneously addresses both pain and involuntary muscle contractions. This analgesic and antispasmodic classification signifies its dual therapeutic intent: to reduce the perception of pain while actively relieving the excessive tension in smooth muscles. The medicine is based on synthetic small molecule derivatives, reflecting its origin through chemical synthesis.


Spasmalgon's Triple-Action Composition and Forms

The medication's unique profile is derived from the precise blend of three active ingredients. These include the non-opioid analgesic Sodium Metamizole, combined with two distinct smooth muscle relaxants: the M-cholinoblocker Fenpiverinium Bromide and the myotropic spasmolytic Pitofenone. This synergistic blend is manufactured in two primary dosage forms: tablets for oral administration and a solution for injection for parenteral administration. The availability of both forms allows for flexible application depending on the required speed and setting of administration.


What is the General Purpose of Combining these Ingredients?

The primary therapeutic purpose of combining these ingredients is to achieve comprehensive relief from pain associated with involuntary muscle cramps or excessive smooth muscle tension. This formulation integrates potent pain reduction (analgesia) with a dual mechanism of muscle relaxation (spasmolysis). This general benefit defines the medication's utility in managing spasms that arise from the smooth muscle organs, such as the urinary, biliary, or gastrointestinal tracts. For instance, it is typically used for the acute, severe discomfort felt during the passage of kidney or gallbladder stones.

Regulatory References

  1. analgesic and antispasmodic
  2. [Metamizole Review, Drug Safety 2021]

What side effects are possible with Spasmalgon?

The safety profile of Spasmalgon, a fixed-dose combination, is predominantly shaped by the well-documented risks associated with its analgesic component, Sodium Metamizole, as officially classified in government regulatory documents.

Serious Adverse Reactions

The most clinically significant adverse events are hematological and immunologic, and these are often classified as rare (1/10,000 to <1/1,000) or very rare in national labels. These serious reactions include:

  • Agranulocytosis: A potentially fatal condition involving a sudden and severe decrease in white blood cells (Blood and lymphatic system disorders).
  • Anaphylactic Shock: A severe, immediate, life-threatening allergic reaction, categorized under Immune system disorders.
  • Severe Skin Reactions: Rare, serious conditions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (Skin and subcutaneous tissue disorders).

General Safety Patterns and System Effects

Adverse reactions are formally grouped by System-Organ Class. Reported effects also include hepatobiliary disorders (acute liver injury) and renal and urinary disorders (kidney dysfunction). The combination's other components may contribute to common anticholinergic effects, such as dry mouth or vision disturbances.

Regulatory documents emphasize that the risk of agranulocytosis is not necessarily related to the dose or duration of treatment and can occur at any time during or shortly after stopping the medicine.

Population-Specific Constraints

The medicine is officially contraindicated in patients with a prior history of Metamizole-induced agranulocytosis or pre-existing bone marrow problems. Furthermore, official labeling advises against use during the last trimester of pregnancy due to potential risks to the fetal circulatory and renal systems. Caution is advised for use in patients with pre-existing impaired renal or hepatic function.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes overdose manifestations and required emergency actions for Spasmalgon's active components.

Documented Overdose Presentations

Overdose may present with central nervous system (CNS) disturbances, including restlessness, vertigo (dizziness), and somnolence, potentially progressing to convulsions and coma. Gastrointestinal symptoms like nausea, vomiting, and abdominal pain are also documented. Due to the spasmolytic components, anticholinergic signs such as dry mouth and accommodation disorder (impaired vision) may be present.

Serious Outcomes and Emergency Action

Severe intoxication is associated with the risk of dose-dependent hypotension, which can lead to shock or hypodynamic cardiac arrest. Other life-threatening outcomes include acute kidney failure and liver damage. Immediate medical attention or presentation to an emergency department is required upon suspicion of overdose.

Supportive Management

No specific antidote is known for the Metamizole component. Management is defined as symptomatic and supportive treatment. Procedural measures described in official documents may include gastric lavage or administration of activated charcoal if ingestion was recent, and advanced elimination techniques like forced diuresis or hemodialysis for severe cases.

Therapeutic Uses of Spasmalgon

What Spasmalgon Treats: Main Uses and Benefits

Spasmalgon is a fixed-dose combination medicine applied across domains where additional symptomatic support is needed. The medicine's main active ingredient, Metamizole (also known as dipyrone), is commonly used to help with severe pain and muscle spasm.

The combination of ingredients is applied in addressing symptom clusters that create noticeable physiological strain, specifically those related to the smooth muscles of internal organs. It is relevant in contexts involving heightened systemic burden, often for conditions presenting with acute episodes like intestinal, biliary, or renal colic, and symptoms associated with acute or episodic changes like functional dysmenorrhea. This approach may assist with managing symptoms that create noticeable physiological strain in those specific scenarios. “It contributes to improved comfort during periods of heightened symptoms,” is one way to describe its supportive role. Ultimately, it assists with maintaining functional stability during symptomatic phases.


Quick Fact: Relief for Smooth Muscle Spasm


Regulatory References

  1. European Medicines Agency recommendation

Eligibility and Restrictions for Use

Who Can and Cannot Use Spasmalgon?

This section summarizes the official eligibility profile for Spasmalgon (a metamizole-containing product) as defined in regulatory documents. Eligibility is constrained by hematological history, age, and physiological status.


Populations for Whom Use is Contraindicated

Official regulatory labeling dictates that Spasmalgon must not be used by the following groups:

  • Individuals with a history of agranulocytosis (severe reduction in white blood cells) caused by metamizole or other pyrazolone substances.
  • Patients with impaired bone marrow function (e.g., following cytostatic treatment) or diseases of the hematopoietic system.
  • Individuals with a known hypersensitivity to the active substance or its excipients.
  • Infants below the age of 3 months or with a body weight below 5 kg.
  • Women in the third trimester of pregnancy.

Populations for Whom Use is Not Recommended

Use is not recommended or requires special caution in:

  • Women who are breastfeeding (lactation) due to potential drug exposure in the infant.
  • Children younger than 15 years of age for certain standard adult formulations.
  • Women in the first six months of pregnancy.

What should I know about interactions with other medicines?

Official Interaction Profile

The interaction profile for this combination medicine is derived from documented pharmacokinetic and pharmacodynamic risks, as specified in regulatory documents.

Exposure-Altering and Contraindicated Combinations

Co-administration with Methotrexate is designated as a contraindicated combination due to the officially documented risk of severe haematologic toxicity when Methotrexate is used at higher weekly doses.

The Metamizole component is an inducer of the hepatic enzymes CYP2B6 and CYP3A4. This pharmacokinetic mechanism may reduce the plasma concentrations of co-administered medicines that are substrates for these enzymes, including the immunosuppressants Ciclosporin and Tacrolimus, as well as Efavirenz, Bupropion, and Methadone.

Timing and Pharmacodynamic Constraints

A specific timing-based interaction rule is required for low-dose Acetylsalicylic acid (Aspirin) used for its antiplatelet effect. To avoid inhibiting this effect, Metamizole must be administered at least 30 minutes after or 8 hours before the aspirin dose. Pharmacodynamic interactions include the risk of additive hypothermia with Chlorpromazine, and the potential for additive peripheral anticholinergic effects when combined with other anticholinergic agents due to the Fenpiverinium component. The regulatory information also notes that the medicine may reinforce the effects of alcohol.

Population Considerations

The potential for interactions is officially noted to be heightened in elderly patients and those with impaired renal or hepatic function, due to the reduced elimination of the drug's active metabolites in these populations.

Mechanism of Action

How Spasmalgon Works

Spasmalgon is a combination formulation that mediates its effects through three distinct mechanisms. The first component, metamizole, functions by mediating the inhibition of COX-1 and COX-2 isoenzymes. This action alters the synthesis of prostaglandins. Furthermore, this agent modulates central pain perception pathways, an action which affects afferent nociception.

The second component, pitofenone hydrochloride, induces direct smooth muscle relaxation. This is achieved through the modulation of intracellular calcium ion flux in the smooth muscle cells, altering their contractile state.

The third component, fenpiverinium bromide, contributes an anticholinergic action. This specific action induces the inhibition of acetylcholine at muscarinic receptors located on smooth muscle cells. This activity affects the intrinsic rhythm and force of gastrointestinal motility. The combination's effects are mediated concurrently across these biological targets.

Dosage and Administration Information

How to Use Spasmalgon

Spasmalgon is a combination medicine approved for use via specific administration protocols. Its usage is defined by dosage forms, routes, and duration constraints.


Official Administration Guidelines

The medicine is available as tablets for oral intake and a solution for injection for intramuscular (IM) administration. The use of the injectable form requires administration under strict medical control in a clinical setting.

Administration Scope Official Labeled Instruction
Standard Adult Dose Oral: 1 to 2 tablets per single dose. IM: 2 to 5 ml of solution per single dose.
Maximum Daily Dose Oral/IM: Should not exceed 6 tablets or 6 ml of solution, respectively.
Dosing Frequency The oral dose may be taken two to three times daily. The IM dose may be repeated after an interval of 6 to 8 hours.
Timing for Oral Intake Tablets are intended to be taken by mouth with water after eating (following a meal).

Population and Duration Constraints

The use of Spasmalgon is intended for short-term treatment only. Treatment with the oral formulation should typically not exceed 3 consecutive days. The parenteral form may be used until an effect is achieved, after which a switch to a suitable oral agent is considered.

Specific dosage rules exist for younger populations:

  • Children 12–15 years: The regimen is 1 tablet, 2–3 times a day, with a maximum daily dose of 3 tablets.
  • Children 9–12 years: The regimen is 1/2 tablet, 2–3 times a day, with a maximum daily dose of 2 tablets.

For patients with mild renal or hepatic impairment, official guidance suggests using half the standard adult dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Spasmalgon

Evidence for use in Kidney and Urinary Tract Spasms

Research has focused on how research on Spasmalgon was conducted in conditions characterized by fluctuating or episodic manifestations of pain in the kidney and urinary tracts. Studies have explored its use, particularly in situations linked to kidney stones or irritation in the bladder where painful spasms occur. The evidence derived from these settings often describes patterns related to how symptoms evolved in the observed populations during the study period.

Findings from some trials explored outcomes related to physical discomfort when Spasmalgon was evaluated in conditions involving periods of heightened symptoms. These studies contribute to what has been observed so far regarding outcomes capturing phases of heightened symptom activity. However, research highlights changes measured only during the short-term study periods, and long-term effects are not fully established.

Evidence for use in Stomach and Intestinal Spasms

Spasmalgon was studied for conditions involving periods of heightened symptoms, such as stomach and intestinal colic and certain gallbladder issues. Research examined how symptoms changed over defined time intervals in people experiencing acute or disruptive episodes. Research has explored outcomes related to physical discomfort in these conditions associated with acute or disruptive episodes.

Studies focusing on episodes where symptoms become more noticeable report how symptoms evolved in the observed populations. Research provides insight into short-term changes and outcomes related to systemic or functional imbalance. It is important to note that comparative evidence against other treatments is sometimes lacking, and the certainty regarding specific symptom reduction remains low in certain subgroups.

Evidence for use in Painful Menstruation

Research has explored Spasmalgon's use in conditions where symptoms may vary in intensity, specifically those marked by functional limitations during painful menstruation. Studies monitored outcomes related to physical discomfort and patient-reported outcomes describing perceived discomfort. Findings indicate patterns observed in the studies related to episodic or acute changes.

Key Studies & References

  1. Metamizole in the Management of Musculoskeletal Disorders: Current Concept Review (Discusses short-term safety and efficacy reviews)
  2. Antispasmodic Medication: Uses & Side Effects (General antispasmodic uses including GI and urinary spasms)

Frequently Asked Questions (FAQ)

Common questions about Spasmalgon (FAQ)


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

A: The official product information indicates that side effects classified as common include nausea, upset stomach, and headache. Dizziness is also listed among the frequently reported adverse events in the regulatory documents.


Q: How long do the effects of Spasmalgon usually last?

A: Studies examining the medicine's components provide pharmacokinetic data, indicating the half-life of the main component's active metabolites is approximately 2 to 10 hours. This data describes the period during which the active substances are present in the body.


Q: Is it safe to drink alcohol while using Spasmalgon?

A: Official regulatory documents include a warning stating that the medicine may reinforce the effects of alcohol. The product information indicates a warning about concurrent use due to this potential pharmacodynamic interaction.


Q: Is Spasmalgon suitable for elderly patients?

A: The official guidance for elderly patients specifies that caution is noted for this population. This is due to the potential for reduced drug elimination, which may lead to an increased risk of adverse effects. Official labeling defines an adjusted dosage regimen for this group.


Q: Is Spasmalgon available over the counter (OTC) or only by prescription?

A: The legal classification of this medicine is determined by the national regulatory authority where it is sold. Official product information defines its dispensing status, indicating whether it is classified as a Prescription Only Medicine or available over the counter. This status may differ depending on the jurisdiction.


Q: Can Spasmalgon cause drowsiness or affect alertness?

A: The official product information indicates that the medicine can cause central nervous system effects. These adverse reactions may include drowsiness, vertigo, or problems with concentration. A person's level of alertness may be affected while using Spasmalgon.


Q: Is Spasmalgon addictive?

A: Spasmalgon is officially classified as a non-opioid analgesic and is not listed in controlled substance schedules in most regions. This classification distinguishes it from other medicines that are categorized as narcotics or high-risk for abuse.


Q: Is it normal to feel dizzy or lightheaded after taking Spasmalgon?

A: Regulatory product information lists dizziness and a spinning sensation known as vertigo among the known adverse events. These feelings are noted in the established safety profile of the metamizole component of the medicine.


Q: Can Spasmalgon cause stomach upset or nausea?

A: Official safety information indicates that effects on the gastrointestinal system are possible. Adverse reactions include nausea, vomiting, and general discomfort or pain in the stomach. These are among the known side effects that have been reported with this medicine.


Q: Does Spasmalgon interact with blood pressure or heart medications?

A: Official documents state that the metamizole component may reduce the antihypertensive effect of certain blood pressure medications. Additionally, hypotension (low blood pressure) is listed as a known adverse effect in the product information.


Q: Can people with glaucoma use Spasmalgon?

A: Official regulatory labeling lists angle-closure glaucoma as a contraindication for the use of this medicine. This restriction is included due to the presence of Fenpiverinium Bromide, which is an anticholinergic component known to affect eye pressure.


Q: Are there specific warnings about driving or operating machinery while using Spasmalgon?

A: The official product information includes specific warnings regarding driving and operating machinery. The document indicates that patients should not engage in these activities if they experience side effects such as dizziness, vertigo, or reduced concentration.

How should Spasmalgon be stored and disposed of?

Storage Conditions and Requirements

Official labeling requires that Spasmalgon be stored at temperatures not exceeding 25, C. The product must be kept out of the sight and reach of children at all times. Protection from environmental factors is mandatory: the medicine must be protected from light and moisture and kept in its original container with the container tightly closed to maintain product integrity.

Specific handling rules apply to the solution for injection, which must not be frozen. The stability of the injection solution is limited after opening, often requiring any unused portion to be discarded after 28 days.

Disposal Instructions

To prevent environmental contamination, unused or expired Spasmalgon must not be disposed of in wastewater or household waste unless specifically authorized. The official instruction is to ask your pharmacist how to properly discard the medicine, directing users toward appropriate drug take-back or pharmaceutical waste programs.

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

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