Espasmo Biotenk

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Espasmo Biotenk

Method of action: Antiparkinsonian

Treatment option:

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 Espasmo Biotenk

Quick Facts

Property Description
Active Ingredients Hyoscine Butylbromide, Sodium Metamizole (Dipyrone)
Form Coated Tablets, Oral Drops, Injectable Solution
Pharmacological Class Antispasmodic-Analgesic Combination
Common Use Type Relief of severe visceral pain caused by spasm
Origin Synthetic Fixed-Dose Combination (FDC)

What Kind of Medicine is Espasmo Biotenk?

Espasmo Biotenk is defined as a Fixed-Dose Combination (FDC) pharmaceutical product classified as an Antispasmodic-Analgesic Combination. This formulation integrates two distinct therapeutic effects into a single preparation, ensuring that the medication can simultaneously address both the cause of cramping pain and the resulting painful sensation. The combination is widely recognized in clinical practice for its speed and efficiency in resolving acute episodes of pain.

Composition and Differentiation: Is Espasmo Biotenk a Combination Drug?

Yes, Espasmo Biotenk is a synthetic combination drug containing the two distinct active pharmaceutical ingredients: Hyoscine Butylbromide and Sodium Metamizole. Hyoscine Butylbromide acts as an anticholinergic agent, focusing on the spasmolytic effect by exerting an antimuscarinic effect on smooth muscle and blocking signals that trigger muscle tightening in organs like the intestines. The co-administered Sodium Metamizole (Dipyrone) provides the strong analgesic effect. Its efficacy in treating acute pain, particularly for colic, is a recognized clinical approach for severe cramping pain in various countries. The product is supplied in various dosage form(s), including tablets, drops, and an injectable solution, supporting both oral and parenteral routes of administration.

What is the General Purpose of Espasmo Biotenk?

The general purpose of Espasmo Biotenk is to efficiently achieve symptomatic relief from intense, cramping visceral pain. This pain originates from the involuntary tightening of the smooth muscles in hollow organs, such as those that contract during a kidney stone passage or biliary event. The medication utilizes its dual mechanism of action to first reduce the physical muscular contraction (spasm) and then diminish the perception of the resulting ache (analgesia), offering a rapid and targeted therapeutic outcome.

What side effects are possible with Espasmo Biotenk?

Possible Side Effects and Safety Information

Official safety documents indicate that products marketed as Espasmo Biotenk are subject to regulatory alerts due to the presence of undeclared, potent pharmaceutical ingredients (adulteration). The safety profile is determined by the risks associated with these prescription-only substances, which may include Nonsteroidal Anti-inflammatory Drugs (NSAIDs) like Diclofenac and potent corticosteroids like Dexamethasone and Clobetasol propionate.


Serious and Clinically Significant Adverse Reactions

The most serious risks are those of the undeclared ingredients when used without medical supervision. These include:

  • Gastrointestinal damage: Risk of gastric bleeding, ulceration, and perforation from NSAIDs (e.g., Diclofenac).
  • Cardiovascular events: Increased risk of serious events like heart attack or stroke associated with Diclofenac/NSAIDs.
  • Endocrine and systemic harm: Development of Cushing's syndrome (characterized by a 'moon face' appearance and upper body obesity) from prolonged, unsupervised corticosteroid use, and severe withdrawal symptoms (e.g., fatigue, confusion, low blood pressure) upon sudden cessation of steroids.
  • Hepatotoxicity: Potential for liver damage or dysfunction, particularly from undeclared Acetaminophen/Paracetamol overdose.

Safety Restrictions and Context-of-Use Notes

This product is not an approved medicine and its use is strongly advised against by regulatory authorities due to the inherent dangers of consuming potent, undeclared ingredients. These substances require strict medical monitoring, and their inappropriate use can lead to permanent disability or death. Individuals with pre-existing conditions (e.g., hypertension, heart disease, diabetes, peptic ulcers) are at heightened risk. Any person who has consumed this product and feels unwell should seek immediate medical attention.

Overdose and Emergency Response

Overdose with Espasmo Biotenk, a combination of Hyoscine Butylbromide and Sodium Metamizole, presents with documented manifestations from both active ingredients. Overdose signs may include pronounced anticholinergic effects such as tachycardia, urinary retention, dry mouth, confusion, and accommodation disorders. Concurrently, systemic toxicity is marked by severe hypotension, convulsions, somnolence, abdominal pain, and potential signs of acute renal failure or liver damage. Severe intoxication can escalate rapidly to life-threatening outcomes, including shock, circulatory failure, and respiratory failure. Special considerations apply to the elderly and children, who face increased risks of central nervous system effects and rapid temperature increase, respectively.

When to Seek Immediate Medical Help

Regulatory documentation mandates that immediate medical attention be sought if specific, serious symptoms arise. This urgency applies upon the development of signs consistent with agranulocytosis, which includes fever, chills, a persistent sore throat, or painful sores on the mucosa. Urgent ophthalmological consultation is also required if a painful, red eye with vision loss occurs. In managing an overdose, regulatory documents note that gastric lavage and activated charcoal are procedural steps to reduce absorption, followed by symptomatic and supportive treatment. While the anticholinergic effects may respond to certain medications, the label states that no specific antidote is known for Metamizole toxicity.

Therapeutic Uses of Espasmo Biotenk

Quick Facts: Uses of Espasmo Biotenk

  • Addresses: Symptoms related to smooth muscle spasms.
  • Relief for: Functional discomfort in the digestive tract.
  • Support for: Painful conditions associated with spasms in the biliary and genitourinary systems.

Espasmo Biotenk is a combination product used to manage discomfort related to various smooth muscle spasms throughout the body. The medication contains a spasmolytic agent (Hyoscine N-butylbromide) and an analgesic component (Metamizole/Dipyrone).

The primary function of the product is to provide symptom relief for acute spasms in several organ systems, including the gastrointestinal tract and the genitourinary system.

It is applied in contexts involving painful contractions such as those associated with biliary colic (gallstones) and renal colic (kidney stones). Furthermore, the medicine is utilized to address spasms linked to other digestive system disorders.

This agent is part of a therapeutic regimen that aims to ease painful episodes. In its pure antispasmodic form, it is recognized as an essential medicine for palliative care, indicating its value in symptom management in various medical settings.

Regulatory References

  1. FDA Verification Portal therapeutic overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Espasmo Biotenk?

Eligibility to use Espasmo Biotenk is defined by regulatory labels and is based on a patient's existing conditions, age, and physiological status. The medicine is primarily approved for adults and adolescents over 12 years old (injectable solution) and children over 6 years old (tablets), provided no contraindications are present.

Absolute Contraindications

Patients must not use this medicine if they have:

  • A known hypersensitivity to Hyoscine Butylbromide, Sodium Metamizole, or related substances.
  • Pre-existing conditions like untreated narrow-angle glaucoma, myasthenia gravis, or certain conditions causing gastrointestinal obstruction (e.g., paralytic ileus, megacolon).
  • Severe tachycardia, certain hematologic disorders, or hereditary metabolic disorders (for the tablet form).

Use in Specific Populations

Population Regulatory Status
Pregnancy Contraindicated in the third trimester; use is not recommended otherwise.
Breastfeeding Not recommended; a milk-discard interval is required after a single dose.
Children Not recommended under 6 years (tablets) or 12 years (injectable solution).
Liver/Kidney Impairment Special care is required due to potential changes in drug clearance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the product's interaction profile based on the dual nature of its active components, encompassing both pharmacokinetic and pharmacodynamic constraints.

Classification Official Regulatory Statements
Interaction Severity Contraindicated/Restricted Combination (IM Route with Anticoagulants); Clinically Significant Interaction (Reduced Efficacy of CYP Substrates, Antagonism of Aspirin).
Regulatory Basis Based on EMA SmPC and FDA-aligned national prescribing information.

Officially Documented Interactions:

  • Pharmacokinetic Interference: The Metamizole component is a moderate-to-strong Inducer of CYP3A4, CYP2B6, and CYP2C19 and a weak inhibitor of CYP1A2. This enzyme induction can result in a reduced plasma concentration of co-administered drugs like Ciclosporin and Midazolam.
  • Pharmacodynamic Reinforcement: The anticholinergic effect of Hyoscine Butylbromide may be intensified by co-administration with other agents possessing anticholinergic properties, including Tri- and Tetracyclic Antidepressants, Antihistamines, and Antipsychotics.
  • Antagonistic Effects: Dopamine Antagonists (e.g., Metoclopramide) may diminish the effects of both agents on gastrointestinal motility. Furthermore, Metamizole inhibits the antiplatelet effect of low-dose Acetylsalicylic Acid (Aspirin).
  • Procedural Restrictions: The Intramuscular (IM) route of administration is officially restricted or cautioned against in patients receiving Anticoagulant Drugs due to the documented risk of intramuscular haematoma.
  • Timing Rules: A mandatory separation window between the administration of Metamizole and Acetylsalicylic Acid (Aspirin) is required to prevent compromise of the latter's cardioprotective function.

Mechanism of Action

How Espasmo Biotenk Works — Mechanism of Action

Espasmo Biotenk operates through the synergistic action of two distinct pharmacological components, each targeting a different biological pathway to modulate involuntary muscular contraction and nociceptive signaling. This dual approach engages mechanisms that regulate two core physiological processes: contraction and afferent pain signaling.

The N-butylscopolamine component functions as a competitive antagonist at muscarinic acetylcholine receptors, primarily within the smooth muscle of the visceral tracts. By suppressing acetylcholine binding, it interrupts the Ca^2+-driven cascade that promotes contraction, resulting in a reduction in smooth muscle contractile tone (spasmolysis).

The Dipyrone component modifies early molecular steps by inhibiting Cyclooxygenase ( COX) enzymes, specifically reducing the synthesis of fever and nociceptive mediators, such as prostaglandins ( PGE2). This inhibition occurs centrally and peripherally, suppressing nociceptive transmission and generating analgesia (decreased pain perception) and antipyresis.

Dosage and Administration Information

Espasmo Biotenk is administered using two distinct official routes: Oral (available as Coated Tablets and Oral Drops) and Parenteral (Intravenous (IV) or Intramuscular (IM) injection). This protocol establishes that the medicine is used in both self-administered outpatient settings and acute, supervised clinical environments.

The official administration pattern is governed by strict, component-specific dose and frequency limits. For oral use, the maximum single dose for adults (aged 15 years or 53 kg) is typically 1,000 mg of the Metamizole component. This may be repeated up to four times daily, provided that the required interval of six to eight hours between administrations is maintained. The tablets are instructed to be swallowed whole with fluid.

For the parenteral solution, which is reserved for acute relief, the standard single adult dose of the Hyoscine component is 20 mg. Administration instructions permit repetition after approximately thirty minutes, but the total daily dose is strictly limited to 100 mg. Intravenous administration must adhere to a slow injection rate and the injectable solution is designated for single use only.

A notable distinction in usage protocol applies to pediatric patients, where dosing for the Metamizole component is explicitly based on a weight-based calculation (mg/kg), rather than a fixed adult dose. The overall regimen is officially designated for short-term use to manage acute episodes, establishing a time boundary that prevents unauthorized continuous daily administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Espasmo Biotenk

The combination of Hyoscine Butylbromide and Sodium Metamizole (Espasmo Biotenk) was studied for its use in conditions involving acute cramping and pain. The research base helps contextualize how patients reported their experience and how symptoms were measured in controlled settings.


Research Evidence for Acute Visceral Pain (Colic Episodes)

Research primarily involved Randomized Controlled Trials (RCTs), where the combination or its analgesic component was evaluated in adult patients presenting with acute renal colic (kidney stone pain) or biliary colic (gallstone pain). The studies often measured outcomes related to physical discomfort, primarily by quantifying pain intensity at short intervals. Research highlighted changes measured during the study period and reported patterns related to the requirement for rescue analgesic medication compared to control groups.

Key Endpoints Studied in Colic Trials

This subsection outlines the specific tools and measurements used in research exploring short-term or episodic symptom patterns. Researchers monitored outcomes describing episodic or acute changes by using standardized scales to get patient-reported outcomes describing perceived discomfort.


Research Evidence for General Spasmodic Abdominal Pain

Evidence for functional discomfort includes placebo-controlled studies of the spasmolytic component and Retrospective Cohort Studies (RWE) on the utilization patterns of the analgesic component. Studies explored the level of symptom change in cramping severity and quantified the time taken to observe the reported effect. Formal RCTs focusing specifically on the FDC for non-colic functional gastrointestinal disorders evidence is limited.


Duration of Evidence, Populations, and Uncertainty

Follow-up durations were limited to acute episodes or short-term recurrent use, meaning long-term outcomes are not well characterized. While rigorous trials primarily studied adult populations, RWE shows utilization patterns of the analgesic component across all age groups, including children and older adults. Data for certain groups remain insufficient for reliable pattern detection. Findings were mixed regarding the specific contribution of the spasmolytic component, and heterogeneity has been observed across studies, meaning further research remains an area of interest to expand the evidence landscape.

Key Studies & References

  1. Philippines FDA: Summary of Product Characteristics (Example FDC)

Frequently Asked Questions (FAQ)

Common questions about Espasmo Biotenk (FAQ)


Q: How quickly can I expect Espasmo Biotenk to start working?

A: Clinical research on this combination has focused on measuring changes in symptoms over short time intervals. While studies have examined the time it takes for a reported effect to be observed, specific onset times may not be detailed in the summary of product characteristics.

Q: Does Espasmo Biotenk work instantly or does it take time to build up?

A: Official research evidence and clinical trials focus on measuring outcomes related to acute (short-term) episodes. This focus is consistent with the medication being used for acute symptom management rather than requiring a cumulative build-up of effect over days or weeks.

Q: How long does the effect of one dose of Espasmo Biotenk usually last?

A: The oral formulation of the medicine has official instructions that require patients to wait at least six to eight hours between administrations. This interval is specified in product information to maintain safe levels of the drug's components.

Q: Can Espasmo Biotenk be used for different kinds of spasms, not just one type?

A: Studies have examined the effect of the drug's components in treating different types of acute, cramping pain. Research evidence has been conducted on conditions such as renal colic and biliary colic, in addition to general spasmodic abdominal pain.

Q: Is feeling dizzy a common effect of Espasmo Biotenk?

A: Official product documents indicate that dizziness is a possible side effect of the Hyoscine Butylbromide component. Patients are generally advised in product information to be aware of this potential side effect, especially when operating machinery or driving.

Q: Is it true that Espasmo Biotenk can cause dry mouth?

A: Yes, official product information describes dry mouth as a common side effect of the medication. This effect is related to the anticholinergic properties of one of the active components in the drug.

Q: Does Espasmo Biotenk interact with common over-the-counter cold medicines?

A: Official interaction information notes that the drug’s anticholinergic effect may be intensified by co-administration with other agents that have similar properties. These other agents can include certain types of over-the-counter cold medicines, such as those that contain Antihistamines.

Q: Is it safe to take Espasmo Biotenk with herbal supplements?

A: Official regulatory advice is that patients should consult with a healthcare professional regarding the use of herbal remedies or supplements alongside this medication. The consultation can help determine if there are any known or potential interactions with specific supplements.

Q: Can Espasmo Biotenk be taken with vitamins or minerals?

A: Patients are generally advised to discuss all vitamins and mineral supplements with a healthcare professional before combining them with this medication. This is a common precaution to address any potential interaction or overlap with the drug's effects.

Q: What happens if I take Espasmo Biotenk with alcohol?

A: Official warnings advise caution regarding the consumption of alcohol while taking this medication. Alcohol use may increase side effects, such as drowsiness and dizziness, that are associated with the anticholinergic component of the drug.

Q: Does the medicine interact with any specific foods or beverages?

A: The official product information generally indicates that this medicine is not known to interact with specific foods or beverages. No specific instructions regarding food intake are usually provided.

Q: Can people who are pregnant use Espasmo Biotenk?

A: Regulatory guidance states that the Metamizole component should not be used during the last three months of pregnancy due to documented fetal risks. For the first six months, use is generally not recommended unless a physician determines other analgesic options have failed.

Q: Is Espasmo Biotenk suitable for use by children?

A: Official product information notes that dosing for the Metamizole component in pediatric patients is explicitly based on a precise weight-based calculation (mg/kg). Regulatory information notes that some strengths or formulations of the drug may be unsuitable for very young patients.

Q: Is Espasmo Biotenk safe for people with kidney problems?

A: Official product precautions advise caution for patients who have pre-existing kidney problems. In cases of severe kidney disease, the medication may be listed as contraindicated, meaning its use is generally restricted.

Q: Is Espasmo Biotenk considered a controlled substance?

A: The regulatory status of the medication’s components varies significantly around the world. In some jurisdictions, the components are prescription-only, while in others, they are available over-the-counter, but they are not uniformly classified as a controlled substance.

Q: Will Espasmo Biotenk make me sleepy or affect my driving?

A: Official warnings state that the medication may cause side effects such as sleepiness, dizziness, or blurred vision. Official product information advises caution when driving or operating heavy machinery.

Q: Can I become dependent on Espasmo Biotenk if I use it for a long time?

A: Official information for the Hyoscine Butylbromide component notes a low incidence of abuse or dependence because it has limited action on the brain. The overall regulatory regimen is also designated for short-term use for acute episodes.

Q: Is Espasmo Biotenk only available by prescription?

A: The prescription status of the drug's components is regulated differently depending on the country. Some jurisdictions list the components as prescription-only medications, while other regulatory bodies permit their use over-the-counter.

Q: Is Espasmo Biotenk known to cause allergic reactions?

A: Yes, official regulatory documents describe the possibility of allergic reactions to the drug's components. These reactions can range from a rash or swelling to sudden, severe allergic reactions, which are known as anaphylaxis.

Q: Does Espasmo Biotenk affect blood pressure?

A: Regulatory documents indicate that side effects can include a temporary decrease in blood pressure (hypotension). Caution is noted in regulatory information for patients who have pre-existing heart conditions or high blood pressure.

Q: Can Espasmo Biotenk cause changes in vision?

A: Yes, official product information lists changes in vision as possible side effects. These changes can include blurred vision and accommodation disorders, which refer to difficulty focusing the eyes.

Q: Why do some people say Espasmo Biotenk works better than others for them?

A: Research outcomes have shown 'heterogeneity' across studies. This term describes variability in patient response observed in research and may explain differences in individual experiences.

Q: Does Espasmo Biotenk have any specific warnings for people with glaucoma?

A: Yes, official product information states that the drug is contraindicated (should not be used) in patients diagnosed with primary angle closure glaucoma. This is because the drug can potentially increase pressure inside the eye, meaning its use is generally restricted.

Q: Does taking Espasmo Biotenk affect lab test results?

A: Routine laboratory tests are not typically required for patients taking this medication. However, official precautions note that monitoring may be advised for patients with certain pre-existing conditions.

Q: Is it necessary to take Espasmo Biotenk with food?

A: Official instructions do not specify that the medication must be taken with food. The product is generally not known to interact negatively with specific foods or beverages.

Q: Can I crush or split the Espasmo Biotenk tablet?

A: Official administration instructions state that tablets should be swallowed whole with fluid. This instruction suggests that the integrity of the tablet should be maintained and alteration is not recommended.

Q: Is Espasmo Biotenk an anti-inflammatory drug?

A: While one of the drug's components works by inhibiting the production of inflammatory mediators, it is described in official documents as having weak anti-inflammatory properties. The primary effects are classified as analgesia (pain relief) and antipyresis (fever reduction).

Q: Is it normal to feel a bit restless after taking Espasmo Biotenk?

A: Official safety documents describe the possibility of feeling agitated or confused, particularly after the injectable (parenteral) administration. This is reported very rarely.

Q: What does 'contraindication' mean in relation to Espasmo Biotenk?

A: In official documents, a contraindication describes a specific condition or circumstance where the product is generally not administered because the risks are deemed too high. Examples for this product include conditions like primary angle closure glaucoma.

Q: How to Store and Dispose of Espasmo Biotenk?

A: The required storage conditions are defined by regulatory labeling to maintain the product's integrity. Disposal procedures are also defined, and typically require returning any expired or damaged product to a pharmacist or healthcare professional for proper handling.

How should Espasmo Biotenk be stored and disposed of?

How to Store and Dispose of Espasmo Biotenk?

The official storage and disposal requirements for Espasmo Biotenk are defined by regulatory labeling to maintain product integrity and ensure environmental safety.


Storage Conditions

Requirement Application
Temperature Injectable solution must be stored below 25 C or 30 C in some regions. Tablets require no special temperature conditions.
Protection Keep injectable ampoules in the outer carton to protect from light. Do not store the medicine in a bathroom or near a sink.
Child Safety Keep out of the sight and reach of children.

Stability and Disposal

The injectable solution is for single use only and must be used immediately after opening; any remaining liquid must be discarded. Do not use the product past the expiry date (EXP) printed on the packaging.

For disposal, the product must not be thrown away via household waste or wastewater. Unused or expired medicine must be returned to a pharmacist or disposed of in accordance with local regulatory requirements for medicinal waste.

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

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