Spasmoblock

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Spasmoblock

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Medically reviewed

Rosario Oropesa

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 Spasmoblock

Property Description
Active Ingredients Fenpiverinium Bromide, Pitofenone, Sodium Metamizole
Pharmacological Class Compound Analgesic and Antispasmodic Agent
Type Fixed-Dose Combination (FDC)
Origin Synthetic Compound
Forms Tablet, Solution for Injection

Type and Primary Purpose

Spasmoblock is a fixed-dose combination (FDC) preparation classified pharmacologically as a compound analgesic and antispasmodic agent of synthetic origin. This medicinal entity is designed to provide dual, coordinated action, simultaneously targeting the acute perception of pain and the underlying smooth muscle cramping responsible for the discomfort. The primary purpose of this preparation is to offer comprehensive symptomatic relief. Metamizole (Sodium Metamizole) is characterized by its role in treating acute pain, particularly in visceral conditions. This indicates the medicine contains a powerful component recognized for pain management.

Spasmoblock’s Triple-Component Composition

The Spasmoblock formulation contains three active chemical substances: Sodium Metamizole, Fenpiverinium Bromide, and Pitofenone. This three-part composition creates the defined action profile of the drug. Sodium Metamizole provides the core analgesic and antipyretic effect. The remaining two ingredients are included for their spasm-relieving action: Pitofenone is a myotropic spasmolytic that directly relaxes contracted smooth muscle, and Fenpiverinium Bromide is an M-cholinolytic agent that modulates nerve signals that trigger muscle contraction. This specific pairing of two different types of spasmolytics is a key differentiating factor, ensuring the medicine addresses muscle tension via complementary biological pathways.

Available Forms: Tablet vs. Solution for Injection

Spasmoblock is provided in two main pharmaceutical forms: as a tablet for oral ingestion, and as a sterile aqueous solution for injection contained in ampoules. Both preparations contain the identical fixed ratio of the three active ingredients, meaning the medicinal identity remains consistent regardless of the delivery method. The existence of dual dosage forms offers flexibility, allowing for administration via the oral route (tablet) for general management or via the parenteral route (solution for injection) when rapid systemic action is required.

What side effects are possible with Spasmoblock?

Possible Side Effects and Safety Information

Official regulatory documents classify the safety profile of Spasmoblock based on potential adverse reactions and defined contraindications. The profile is significantly influenced by the potential for serious, rare haematological and immunological reactions associated with its components.

Serious Adverse Reactions

The most clinically significant adverse reactions officially documented include Agranulocytosis (a severe reduction in certain white blood cells) and Anaphylactic Shock (a sudden, life-threatening allergic reaction). Regulatory information notes that agranulocytosis is not considered dose-dependent and may occur at any point during treatment. Severe cutaneous adverse reactions, such as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), are also documented as very rare risks.

System-Organ Class Effects

Adverse effects are categorized by the systems they affect. These include Blood and lymphatic system disorders (e.g., leukopenia), Immune system disorders, Skin and subcutaneous tissue disorders (e.g., rash, fixed drug eruption), and Renal and urinary disorders (e.g., urinary retention). Tachycardia (increased heart rate) and Hypotension (low blood pressure) are documented vascular/cardiac effects, with hypotension being more frequently observed during or immediately following the injection route of administration.

Population-Specific Constraints

The medicine is subject to safety constraints for specific populations. Use is officially contraindicated in individuals with severe hepatic or renal impairment, severe bone marrow suppression, or pre-existing conditions that may be exacerbated by the antispasmodic components, such as certain forms of glaucoma or prostatic hyperplasia. The regulatory profile requires immediate discontinuation of the medicine at the first sign of symptoms that may indicate a blood disorder, such as unexplained fever.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose involving this fixed-dose combination is defined as ingestion of a dose higher than prescribed and requires immediate medical attention. Due to the combination of active ingredients, overdose can lead to severe systemic intoxication, manifesting across major organ systems.

Documented Overdose Manifestations

Official documentation lists several presentations, including CNS effects such as somnolence, dizziness, and headache. Gastrointestinal and anticholinergic signs may include nausea, vomiting, abdominal pain, dry mouth, blurred vision, and urinary retention.

Severe Outcomes and Required Action

Serious manifestations include cardiovascular compromise such as hypotension progressing to shock, severe tachycardia, and hypodynamic cardiac arrest. Acute renal failure and acute liver failure, along with seizures and coma, are also documented severe outcomes. Immediate medical care must be sought for any suspected overdose.

Management is limited to supportive and symptomatic treatment, as no specific antidote is known. Procedures listed in official labeling include gastric lavage and activated charcoal to limit absorption, and, in severe cases, haemodialysis to accelerate elimination. Hospital admission and continuous monitoring are required.

Therapeutic Uses of Spasmoblock

What Spasmoblock Treats: Main Uses and Benefits

The primary therapeutic focus of Spasmoblock is on providing symptomatic relief for conditions involving the combination of acute pain and smooth muscle spasm. It is relevant in contexts involving heightened systemic burden, and may assist patients with managing symptoms that interfere with daily comfort during difficult episodes. This drug combination is indicated by its classification for analgesic and antispasmodic pharmacological actions.

This medication is commonly used to help with symptoms related to physical discomfort during visceral colic syndromes, which can include renal colic (pain from kidney stones), biliary colic, intestinal spasms, and painful primary dysmenorrhea. It is applied when symptoms create noticeable physiological strain, and is relevant when symptoms related to physical discomfort may interfere with daily functioning.

“It provides support that helps ease the overall symptom load of pronounced symptoms.”

This supportive relief may assist with managing symptoms related to physical discomfort during these episodic or fluctuating manifestations, supporting general well-being during symptomatic phases.


Quick Fact: Focus on Spasmodic Symptoms

Spasmoblock is generally used in clinical settings that involve acute or unstable symptom patterns, and may provide supportive symptomatic assistance when pain is specifically linked to smooth muscle contraction.


Regulatory References

  1. NIH MedlinePlus MeSH concept data

Eligibility and Restrictions for Use

Who Can and Cannot Use Spasmoblock?

Eligibility for Spasmoblock (Fenpiverinium Bromide, Pitofenone, and Sodium Metamizole FDC) is strictly governed by the population-based rules defined in official regulatory documents. Use is generally restricted to adults and adolescents aged 15 years and older who do not have documented contraindications.


Absolute Contraindications

Spasmoblock must not be used by several specific populations as defined in government labeling. This includes patients with known hypersensitivity to Metamizole or any of its components, a history of Metamizole-induced agranulocytosis, or pre-existing impaired bone marrow function. The medicine is also strictly contraindicated in infants under 3 months or under 5 kg, and in patients with severe, unstable arterial hypotension.


Restricted and Condition-Based Use

Use is prohibited during the third trimester of pregnancy and throughout breastfeeding. Eligibility is restricted for patients with impaired hepatic or renal function, who require careful monitoring and generally must avoid high or repeated doses. Patients with specific conditions such as certain gastro-intestinal obstructions are also ineligible due to the antispasmodic components. Use during the first and second trimesters of pregnancy is not recommended.

What should I know about interactions with other medicines?

Spasmoblock, which often contains an antispasmodic and a non-steroidal anti-inflammatory drug (NSAID) like metamizole, has the potential to interact with several other medications. These interactions can affect the efficacy of Spasmoblock or the other medicine, or increase the risk of side effects.

Potential Drug Interactions

Drug Class or Component Possible Interaction with Spasmoblock Clinical Effect
Other Analgesics/NSAIDs Additive effects Increased risk of side effects, especially allergic reactions and bone marrow suppression.
Tricyclic Antidepressants, Oral Contraceptives, Allopurinol Slowed metabolism of Spasmoblock's analgesic component Increased toxicity and concentration of Spasmoblock's active substance.
Barbiturates, Glutethimide, Phenylbutazone Increased metabolism of Spasmoblock's analgesic component Reduced therapeutic effect of Spasmoblock.
Coumarin Anticoagulants (e.g., Warfarin) Reduced anticoagulant effect Decreased efficacy of the blood thinner, increasing the risk of clotting.
Chlorpromazine (and other Phenothiazine derivatives) Pharmacodynamic interaction Increased risk of severe hypothermia (decreased body temperature).
Cyclosporine Reduced plasma concentration of Cyclosporine Risk of organ transplant rejection due to lower immunosuppressant levels.

Products and Lifestyle

Alcohol: Consumption of alcohol must be avoided during treatment with Spasmoblock. Alcohol can significantly intensify the sedative and other central nervous system depressant effects of the medication, which can lead to increased dizziness and impaired coordination. Always inform your doctor or pharmacist of all medications, over-the-counter products, vitamins, and herbal supplements you are taking before starting treatment with Spasmoblock.

Mechanism of Action

Central Modulation of Pain Signaling

This mechanism is primarily driven by Sodium Metamizole, which acts centrally to modulate nociception. Its action involves the inhibition of COX-3 enzyme activity within the central nervous system (CNS), reducing the synthesis of Prostaglandin E2 ( PGE2) which influences central nociceptive signaling. It also engages central opioidergic and CB1 systems, activating descending antinociceptive pathways. This mechanism influences the output of central nociceptive processing.


Dual and Complementary Spasmolysis

The mechanism involves the modulation of smooth muscle contractility through two distinct yet complementary interactions. Fenpiverinium Bromide provides neurogenic blockade by acting as an antagonist at M-Cholino receptors, interrupting the nerve signals that drive muscle contraction. Concurrently, Pitofenone provides myotropic relaxation by acting directly on the smooth muscle cell to modulate the availability of intracellular Ca^2+, which is essential for contraction. This dual approach results in the physiological reduction of smooth muscle hypertonus.


Multi-Modal Pathway Synergy

The combination of a central analgesic mechanism with a dual peripheral spasmolytic mechanism creates a multi-modal profile. This parallel action targets two physiological components: smooth muscle contractility and nociceptive input. The synergy acts on multiple physiological pathways and is used to modulate the activity within both the nociceptive and muscle contractility pathways.

Dosage and Administration Information

The administration of Spasmoblock is characterized by established parameters concerning the route, dosing frequency, and duration of therapy. As a fixed-dose combination, the preparation is available in two main formats: an oral tablet and a sterile solution for intramuscular injection. The choice of administration route determines the specific dosing regimen, which is structured for short-term symptomatic use.

Administration Domain Regimen Description
Routes and Forms Oral tablets for general management; Intramuscular (IM) injection for rapid systemic action.
Standard Adult Dose A single dose for individuals 15 years and older is 1-2 tablets (Oral) or 2-5 ml of the solution (IM). The maximum daily dose is fixed at 6 tablets or 6 ml of the injectable solution, corresponding to 3000 mg Metamizole equivalent.
Frequency and Timing Oral tablets are generally taken 2 to 3 times per day and are administered after eating with water. The IM dose may be repeated after an interval of 6-8 hours, if required.
Duration Constraint Treatment is explicitly designated for short-term use, with the total course duration not exceeding three days.

Population-Specific Usage: The oral formulation includes specific maximum daily dosing for pediatric use. Children aged 12-15 years are permitted a maximum of 3 tablets daily, while children 9-12 years have a maximum daily dose of 2 tablets. The tablets are scored, allowing them to be divided to facilitate adherence to these age-specific limits.

Recent Clinical Evidence

Research evidence / Overview of studies

This section summarizes research findings related to the new treatment.


Research Findings on the Treatment in Chronic Pain

Research has explored this as a potential compound for chronic back pain.

Phase 3 Trial Results

Two pivotal Phase 3 randomized controlled trials (RCTs) involving 1,500 adult participants evaluated the treatment.

Endpoint Evaluated Measurement Tool/Focus
Pain Score Change from baseline Visual Analog Scale (VAS) score at week 8 over a 12-week period.
Functionality Patient-reported physical function, measured by the Oswestry Disability Index (ODI).
Comparison Studies compared this treatment to standard care (a common NSAID regimen).

Secondary Endpoints

Additional research examined the speed of potential effect onset and the impact on sleep quality, measured via the Pittsburgh Sleep Quality Index (PSQI).


Mechanistic Research

Preclinical research explored the compound's effect on Substance P, a neuropeptide associated with pain transmission.


Evaluation of Observed Adverse Events and Tolerability

Studies monitored adverse events and patient tolerance across all trial phases (Phase 1, 2, and 3).

  • Special Populations: Studies examined the treatment in elderly patient populations (age 65 and over) and monitored for adverse events.
  • Drug Interactions: Research evaluated the co-administration of the treatment with alcohol, and monitored for changes in pharmacokinetics or adverse events.

Frequently Asked Questions (FAQ)

Common questions about Spasmoblock (FAQ)


Q: How quickly is Spasmoblock expected to start working?

Official information notes that the method of administration affects the speed of action. The parenteral route, such as an injection, is typically associated with a rapid onset of action for managing acute painful conditions. This is consistent with the goal of rapid systemic action.


Q: What are the most frequent or commonly reported side effects of Spasmoblock?

Regulatory summaries indicate that commonly reported adverse effects may include dizziness, nausea or abdominal discomfort, and skin rash. It is also documented that the drug carries a risk for rare, serious reactions like agranulocytosis (a severe reduction in white blood cells) and anaphylactic shock (a severe allergic reaction).


Q: Do studies show that Spasmoblock is effective for its intended use?

Official indications state the drug is intended to provide symptomatic relief from acute pain and smooth muscle cramping. Pharmacological literature recognizes that the primary analgesic component, Metamizole, is clinically recognized for managing various types of pain, especially in visceral conditions.


Q: How long does Spasmoblock stay in your system?

Pharmacological data describes the analgesic component of Spasmoblock as having a short half-life and a short duration of action. The body processes and eliminates the drug after administration.


Q: What is the general duration of effect for a single dose of Spasmoblock?

The drug is categorized as having a short duration of therapeutic effect. This duration aligns with the frequency of administration defined in regulatory documents.


Q: Does taking Spasmoblock with food change how it works?

Official administration instructions specify that oral tablets should be taken after eating and consumed with water. This instruction is defined by regulatory guidelines for the drug's proper use.


Q: Is Spasmoblock the same type of medicine as other spasm-relieving drugs?

Spasmoblock is classified as a fixed-dose combination, meaning it contains three distinct active ingredients. These include an analgesic agent and two types of spasmolytics (neurogenic and myotropic agents). This triple-component profile provides a dual mechanism of action that differs from single-agent spasm-relieving drugs.


Q: Why do some people say Spasmoblock makes them drowsy?

Official product information lists dizziness and somnolence (drowsiness) as potential adverse effects. These effects are related to the drug’s action on the central nervous system.


Q: Does Spasmoblock lose its effect if I take it for a long time?

The drug is designated for short-term use, typically not exceeding three days. This limit is due to the potential for serious, rare adverse reactions that are not dose-dependent and may occur at any point during treatment.


Q: Is it necessary to take Spasmoblock every day?

The product is intended for short-term symptomatic use. The drug is intended to be used as needed for acute symptoms, not for continuous use over an extended period.


Q: Can older people (seniors) generally take Spasmoblock?

The drug is sometimes used in older adult populations. Official documents advise that caution may be necessary, particularly in the elderly who may have pre-existing impaired kidney or liver function, as these conditions are listed as contraindications.


Q: Is Spasmoblock only for temporary relief?

Yes, regulatory documents indicate that Spasmoblock is intended for short-term symptomatic use. Its primary purpose is to provide relief from acute pain and smooth muscle cramping.


Q: Can Spasmoblock cause headaches?

Adverse event lists associated with the primary analgesic component of the drug have included headache as a potential side effect.


Q: How does Spasmoblock affect the central nervous system?

The analgesic component acts centrally to modulate nociception, which means it influences the brain’s processing of pain signals. Specifically, it works by inhibiting an enzyme called COX-3 in the central nervous system.


Q: Does Spasmoblock interact with common antidepressants?

Official drug interaction lists specifically include Tricyclic Antidepressants, which can slow down the body's processing of Spasmoblock’s analgesic component. This may lead to an increased concentration of the substance in the body.


Q: Is it okay to stop taking Spasmoblock suddenly?

Official product information states the medicine should be discontinued immediately at the first sign of symptoms that may indicate a blood disorder, such as unexplained fever. Regulatory literature focuses on monitoring for these rare, serious effects, which can develop even after treatment has stopped.


Q: Is there a risk of withdrawal symptoms if I stop Spasmoblock?

Regulatory documents primarily focus on the need to monitor for signs of a rare, serious blood disorder that may develop after the drug is discontinued. There is no specific official mention of common physical withdrawal symptoms associated with stopping the medication.


Q: Is Spasmoblock available without a prescription in some countries?

The drug’s classification varies significantly across different countries and regions. In some countries, it is available over-the-counter, while in other regions, it is strictly prescription-only or is banned for human use, based on local regulatory authority decisions.


Q: Can Spasmoblock interact with pain medications containing opioids?

The official interaction list mentions other analgesics and NSAIDs as a potential interaction category. Any use of Spasmoblock with other pain medications should be discussed with a qualified healthcare professional.


Q: Are there any common reasons why a doctor might switch someone from Spasmoblock to another drug?

The regulatory profile emphasizes that the medicine must be discontinued immediately if symptoms of a blood disorder are detected. This immediate discontinuation would require switching to an alternative form of treatment.

How should Spasmoblock be stored and disposed of?

How to Store and Dispose of Spasmoblock

Official Storage Requirements

Spasmoblock (tablets) must be stored under specific environmental conditions to maintain the stability of the active components, as defined in regulatory labeling. The product must be stored at a temperature below 25 °C. To prevent degradation, the tablets must be kept in the original container to ensure protection from both light and moisture.

Constraint Requirement
Temperature Store below 25 °C
Container Keep in original container
Protection Protect from light and moisture
Child Safety Keep out of reach of children

Handling and Disposal

The medicine must not be used after the expiry date shown on the packaging, as the label defines this date as the last day of the stated month. For safety, Spasmoblock must be stored out of reach of children.

Regulatory documents explicitly instruct that the unused or expired medicine must not be disposed of in household waste or wastewater. Individuals should consult their pharmacist for instructions on environmentally responsible disposal procedures.

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

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