Engflag

Spasmo Cibalgin

Quick links to important sections

Spasmo Cibalgin

Spasmo Cibalgin_EN

Treatment option:

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 Spasmo Cibalgin

Property Description
Active ingredient Drofenine and Phenazone (Antipyrine)
Form Oral Tablet
Pharmacological class Antispasmodic and Analgesic Combination
General purpose Relief of muscle spasms and pain
Origin Synthetic

Spasmo Cibalgin: Definition and Pharmacological Class

Spasmo Cibalgin is a trademarked, fixed-dose combination preparation supplied as an oral tablet, and is primarily classified as an Antispasmodic and Analgesic Combination.

This medicine is entirely synthetic in origin and is defined by its inclusion of two distinct active ingredients: Drofenine and Phenazone. The combination is clinically recognized for its dual purpose: targeting symptoms that involve both smooth muscle tension and general systemic discomfort. Phenazone belongs to the pyrazolone class, which is characterized by antipyretic and analgesic properties. This indicates the drug works to reduce fever and lessen pain sensations.

Composition and Therapeutic Dual Action

The medicine's function is determined by its active ingredients: Drofenine and Phenazone, the latter of which is also known by its international synonym, Antipyrine.

Drofenine is classified as an anticholinergic antispasmodic drug that acts to promote smooth muscle relaxation. Conversely, Phenazone has known analgesic and antipyretic properties, and belongs to the pyrazolone class of drugs. The resulting dual mechanism of action means the medicine is designed to provide simultaneous relief for discomfort linked to muscle spasms, often associated with tension or cramping, and general systemic pain.

Distinctions in Form and Presentation

Spasmo Cibalgin is predominantly manufactured as an oral tablet, a standardized dosage form designed for reliable delivery via the oral route.

This presentation as a fixed-dose combination preparation is a key differentiating factor from single-ingredient medicines, such as standalone Antipyrine formulations. The tablet format ensures that both the antispasmodic drug and the analgesic drug are administered together, resulting in the integrated therapeutic effect defined by the Drofenine and Phenazone combination.

Regulatory References

  1. NCI Thesaurus

What side effects are possible with Spasmo Cibalgin?

Possible side effects and safety information

The safety profile of Spasmo Cibalgin, a combination of the antispasmodic Drofenine and the analgesic Phenazone, is characterized by adverse reactions related to both active components, as documented in official regulatory prescribing information.

Official Classification of Adverse Reactions

The most commonly documented adverse effects stem from the anticholinergic activity of the Drofenine component. These effects are often classified as common in official documents and primarily affect the digestive and nervous systems. This includes symptoms such as dry mouth, constipation, dizziness, and mild visual accommodation disturbances (e.g., blurred vision).

Reactions related to the Phenazone component, a pyrazolone derivative, include the risk of hypersensitivity reactions, which range from uncommon skin manifestations, such as rash, to rare and severe systemic responses.

Serious and Clinically Significant Safety Patterns

The most serious, though rare, documented adverse effect associated with the pyrazolone component is the potential for blood dyscrasias, specifically agranulocytosis (a severe drop in white blood cells). The risk of severe, systemic anaphylactic shock is also noted in regulatory documentation as a potential serious reaction.

Population-Specific Safety Constraints

Official labeling defines specific patient groups requiring particular safety consideration. Older adults (geriatrics) may exhibit increased susceptibility to the anticholinergic effects, leading to a heightened potential for confusion or urinary retention. Furthermore, the medicine is explicitly constrained or contraindicated in individuals with severe pre-existing hepatic (liver) or renal (kidney) impairment, or conditions like mechanical narrowing (stenosis) of the gastrointestinal or urinary tracts, due to the established pharmacological properties of the active ingredients.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — official regulatory information for Spasmo Cibalgin

Overdose scope

Domain Official Regulatory Statement
Documented overdose presentations: Overdose manifests primarily through symptoms associated with Acquired Methemoglobinemia. Clinical signs include cyanosis (discoloration of the skin, lips, or nail beds), headache, fatigue, and tachycardia.
Physiological systems affected (as stated in label): The Hematological system (Methemoglobinemia, Hemolytic Anemia) and Cardiovascular system are officially noted as subject to severe effects.
Dose-related or exposure-related factors (if applicable): Acute massive overexposure or high-dose ingestion is associated with life-threatening toxicities.
Population-specific overdose notes (if applicable): No specific altered emergency actions for a particular population are explicitly documented in regulatory texts regarding the core acute management of methemoglobinemia.
Emergency-response statements (as written in official documents): Management requires immediate initiation of Supportive Therapies (airway, ventilatory, and circulatory support) and administration of the antidote, Methylene Blue.
When immediate medical help is required (label-derived phrasing only): Seek immediate medical attention for any suspected overdose due to the high risk of organ dysfunction and death. Hospitalization for treatment and monitoring is required.

Overdose classifications (high-level)

Classification Official Regulatory Statement
Severity classification (as defined in official documents): Overdose is classified as Severe and potentially Life-threatening.
Regulatory basis (EMA / FDA / etc.): Information is based on official government documents detailing the toxicity profile of the Phenazone component and mandated treatment.
Overdose-context constraints (as defined in official documents): Management is constrained to regulator-defined procedures, including continuous monitoring of Methemoglobin levels via co-oximetry.

Resulting overdose structure

Official overdose statements:

  • The primary documented overdose manifestation is Acquired Methemoglobinemia, leading to clinical signs such as cyanosis, headache, and shortness of breath.
  • Overdose carries a risk of life-threatening complications, including organ dysfunction and fatal outcomes.
  • Immediate medical attention is required for any suspected overdose event.

Connection to the overall overdose profile (2–4 sentences): Official regulatory documents strictly define the overdose profile by the severe, life-threatening risk of Acquired Methemoglobinemia, which is the direct result of massive overexposure. This risk mandates that individuals experiencing signs of overdose seek immediate medical attention for required procedural interventions, including antidote administration and critical hospital monitoring. The structure of the official labeling ensures all emergency actions are directly aligned with treating this specific, severe physiological outcome.

Therapeutic Uses of Spasmo Cibalgin

Spasmo Cibalgin is commonly used to provide symptomatic relief for acute conditions involving both pain and involuntary muscle tension, addressing symptoms that create noticeable physiological strain across several key domains. The medicine is considered relevant for easing symptoms that interfere with daily functioning and is applied across domains where additional symptomatic support is needed. It generally offers supportive therapeutic benefit, contributing to easing the overall symptom load.

The medication is applicable within clinical settings that involve acute or disruptive symptom patterns, and is used to help with symptomatic discomfort associated with headaches, toothaches, dysmenorrhea (menstrual cramps), colicky pain in the gastrointestinal, biliary, and urogenital tracts, and fever.

“It is applied during phases when symptoms become more noticeable and supportive relief is needed.”

Quick Fact: Relief for Pain and Spasm

It is relevant for managing symptoms related to physical discomfort and heightened physiological activity, assisting with maintaining functional stability when symptoms escalate temporarily. It is commonly used across conditions presenting with acute episodes.

Regulatory References

  1. National Institutes of Health MedlinePlus overview

Eligibility and Restrictions for Use

The official eligibility for Spasmo Cibalgin is defined by regulatory guidelines and formal contraindications, primarily linked to its Phenazone (Antipyrine) component, which is a pyrazolone-class analgesic.

Formal Contraindications

The medicine is formally prohibited for use in populations presenting with the following conditions, as stated in regulatory documents:

  • Hypersensitivity: Known allergy to pyrazolines, pyrazolidines, or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
  • Metabolic Disorders: A diagnosis of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency or Acute Hepatic Porphyria (AHP).

Restricted and Conditional Use Populations

Use is subject to specific limitations and is often not recommended or restricted by regulatory bodies in the following special populations:

Population Category Official Regulatory Status
Pregnancy (Last 3 months) Not recommended or prohibited due to potential fetal risks.
Breastfeeding Women Not recommended due to the transfer of the drug substance to the infant.
Severe Organ Impairment Avoidance or use with extreme caution in patients with severe hepatic (liver) or renal (kidney) impairment.
Pediatric Use Conditional; minimum age thresholds and weight-based dosing apply.

The standard adult population is considered eligible for use only if none of the documented contraindications or restrictive conditions apply.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The combination of analgesic and antispasmodic agents in Spasmo Cibalgin creates a complex interaction profile derived from its components, Phenazone, Propyphenazone, and the anticholinergic component Drofenine.

Potential Analgesic Interactions

Propyphenazone, a pyrazolone derivative and nonsteroidal anti-inflammatory drug (NSAID)-like agent, is known to interact with several classes of medication, primarily through affecting metabolism or increasing the risk of adverse effects. Clinically important interactions may occur with anticoagulants (such as warfarin) due to an enhanced risk of bleeding. Concurrent use with other analgesics, especially other NSAIDs or related compounds, may also heighten the risk of gastrointestinal side effects. Additionally, drugs that affect liver enzymes, such as certain antiepileptics (e.g., barbiturates) and rifampicin, may alter the metabolism of Propyphenazone, potentially reducing its effectiveness.

Interactions Related to Anticholinergic Activity

The presence of an anticholinergic agent (Drofenine) carries a risk of additive effects when used with other medications possessing anticholinergic properties, such as certain antidepressants or antihistamines. This additive effect can increase the likelihood and severity of side effects like dry mouth, blurred vision, constipation, and urinary retention. Caution is warranted when combining this product with any other central nervous system (CNS) depressants, including alcohol, as it may intensify effects such as drowsiness and dizziness.

Mechanism of Action

The core pharmacological activity of Spasmo Cibalgin is defined by its two primary components: a non-steroidal analgesic (Propyphenazone) and a spasmolytic agent (such as Butylscopolamine or Drofenine, depending on the formulation).Propyphenazone exerts its action by modulating the eicosanoid pathway. This compound functions as an inhibitor of cyclooxygenase (COX) enzymes, thereby reducing the biosynthesis of prostaglandins. The subsequent decrease in local prostaglandin levels results in diminished sensitization of peripheral nociceptors and central modulation of thermoregulatory centers.The Spasmolytic Component (e.g., Butylscopolamine) operates via a distinct mechanism by acting as a competitive antagonist at muscarinic acetylcholine receptors, primarily the M3 subtype, on the smooth muscle cells of visceral organs. By competitively occupying the receptor binding site, it blocks the endogenous binding of acetylcholine. This interruption of the parasympathetic cholinergic signal cascade prevents calcium-dependent events necessary for cellular contraction. The combined actions culminate in both a reduction in peripheral signaling mediated by eicosanoids and the relaxation of involuntary smooth musculature across the gastrointestinal and genitourinary tracts.

Dosage and Administration Information

The instructions for using the combination medicine Spasmo Cibalgin are structured to specify the route, dose, and frequency of administration. Standardized documentation for the branded product outlines the general framework for its application.

Historically, the product has been marketed in various international regions and contains analgesic/antispasmodic components, such as Drofenine (also known as Hexahydroadiphenine) and a pyrazolone analgesic like Propyphenazone or Phenazone. The instruction structure for this type of medication generally follows these domains:

Administration Scope Official Labeled Instruction
Route of Administration Oral. The tablet is typically swallowed whole with water, not chewed or crushed.
Dosing Schedule Generally based on the needs of the patient, such as one tablet every 4 to 6 hours. This frequency is constrained by the maximum daily dose set by health authorities.
Missed-Dose Rules If a dose is missed, guidance often suggests taking it as soon as remembered, unless it is close to the time for the next scheduled dose. Double dosing is avoided to stay within daily limits.
Age-Group Rules Specific documentation often defines limitations, such as caution or avoidance in children under 12 years of age.

These labeled instructions define the standardized approach to using the medicine. The framework serves to structure the administration procedure, detailing the method and interval for each dose, without providing clinical advice or therapeutic claims.

Recent Clinical Evidence

Spasmo Cibalgin is a combination medication historically composed of Propyphenazone, a non-opioid analgesic and antipyretic, and Drofenine hydrochloride (also known as Hexahydroadiphenine), an antispasmodic agent. The primary clinical research focus is on the distinct effects and safety profiles of these two active ingredients.

Propyphenazone: Analgesic and Antipyretic Profile

Propyphenazone, a pyrazolone derivative, is studied for its properties in addressing pain and fever. Research suggests its mechanism involves inhibiting the synthesis of prostaglandins, which are signaling molecules involved in pain and inflammation responses. In clinical evaluations, Propyphenazone has been associated with temporary relief from acute pain conditions. However, due to its classification within the pyrazolone group, some studies have investigated potential risks, including the rare possibility of blood dyscrasias, such as agranulocytosis. Pharmacovigilance data remains important for monitoring the full safety profile of this component.

Drofenine: Antispasmodic Activity

Drofenine hydrochloride is classified as an antimuscarinic drug and is investigated for its capacity to act as a smooth muscle relaxant. Clinical observations suggest its utility in addressing visceral spasms associated with conditions like irritable bowel syndrome and colic. Preclinical studies have also identified Drofenine as an agonist of the TRPV3 ion channel, which is a subject of ongoing research to further understand its full biological and therapeutic effects. The combination of its antispasmodic effect with the analgesic component of Propyphenazone has been the basis of the formulation's use in managing pain associated with spasms.

Component Primary Action (Research Focus)
Propyphenazone Non-opioid analgesia and antipyresis
Drofenine HCl Smooth muscle relaxation/Antispasmodic activity

Overall, the evidence for Spasmo Cibalgin focuses on the established pharmacological activities of its components, with clinical data supporting their use in combination for conditions where both pain and spasm are present. Further large-scale, recent clinical trials on the specific combination product are limited in major international registries.

How should Spasmo Cibalgin be stored and disposed of?

How to Store and Dispose of Spasmo Cibalgin?

To maintain the stability and effectiveness of Spasmo Cibalgin, it must be stored in specific conditions as defined by regulatory standards. The medication should be kept at a controlled room temperature, which is typically defined as 15 C to 30 C or below 25 C.

Storage Requirements

Storage Factor Official Requirement
Temperature Controlled room temperature (e.g., below 25 C)
Container Keep in the original, tightly closed container
Protection Protect from light and excess moisture
Child Safety Keep out of the sight and reach of children

Disposal Instructions

Do not dispose of unused or expired Spasmo Cibalgin by flushing it down a toilet or pouring it down a sink. The proper method is to dispose of it through a community drug take-back program. If a take-back program is unavailable, consult a pharmacist for guidance on safe disposal practices.

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

Available in countries:

flagEgypt

Equivalent of Spasmo Cibalgin found in:

A-Z Index: