Брал

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Брал

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 Брал

What is Брал? (Overview and Quick Facts)

Property Description
Active Ingredients Fenpiverinium Bromide, Pitofenone, Sodium Metamizole
Forms Tablet, Solution for Injection/Infusion
Pharmacological Class Non-opioid Analgesic, Antispasmodic, Antipyretic
General Purpose Relief of pain associated with smooth muscle spasms
Origin Synthetic

What Type of Medicine is Брал and What is it Made Of?

Брал is defined as a synthetic, fixed-combination medicinal product containing three chemically distinct active ingredients: Sodium Metamizole, Pitofenone, and Fenpiverinium Bromide. It is classified primarily as a potent Non-opioid Analgesic, an Antipyretic, and an Antispasmodic agent. The core component, Sodium Metamizole, is a pyrazolone derivative that functions as an analgesic with spasmolytic properties. This unique formulation is clinically recognized for its comprehensive approach to managing spasmodic pain.

This composition includes the dual spasmolytic agents, Pitofenone (which offers a direct muscle relaxant effect) and Fenpiverinium Bromide (which contributes via anticholinergic nerve signal blockade). This specific triple-drug combination is formally cataloged and its efficacy against painful smooth muscle contractions is supported by pharmacological studies. This combination positions Брал distinctly against single-component pain relievers.

Forms and General Therapeutic Purpose of the Combination

The final forms of Брал include a tablet intended for oral use and a solution for injection/infusion designed for parenteral use. The medicine's general therapeutic purpose is to provide coordinated relief from severe pain that originates specifically from the tightening and cramping of smooth muscles, such as the discomfort experienced during renal or biliary colic. By simultaneously reducing the sensation of pain and relaxing the muscle tissue responsible for the cramping, the medicine is structurally optimized for addressing acute, spasmodic discomfort.

What side effects are possible with Брал?

Possible Side Effects and Safety Information

The safety profile of [Брал] (Metamizole) is documented by government regulatory bodies based on the severity and frequency of reported adverse reactions. This section summarizes the official safety classifications.

Key Adverse Reaction Scope

Category Key Regulatory Examples
Serious Adverse Reactions Agranulocytosis (a potentially fatal blood disorder, generally classified as rare or very rare), Aplastic Anemia, Anaphylaxis/Anaphylactic Shock, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and Acute Generalized Exanthematous Pustulosis (AGEP).
System-Organ Classes Adverse reactions are grouped by affected body system, including Blood and Lymphatic System Disorders, Immune System Disorders, Skin and Subcutaneous Tissue Disorders, Gastrointestinal Disorders, and Renal/Hepatic Disorders.
Frequency Classification Adverse events are formally classified using frequency categories, ranging from Very Common (occurring in ge 1/10 patients) to Rare (ge 1/10,000 to < 1/1,000) and Very Rare (< 1/10,000).

Regulatory Restrictions and Safety Notes

  • Contraindications: Use is formally restricted in patients with a known hypersensitivity to the drug, a history of blood disorders (e.g., agranulocytosis), or impaired hematopoiesis (blood cell formation). The use is also contraindicated during the third trimester of pregnancy due to documented risks to the fetus.
  • Exposure-Related Patterns: The risk of agranulocytosis is not considered dose-dependent, and the risk may increase with a duration of use beyond two weeks.
  • Safety Monitoring: Official documentation specifies a requirement for immediate blood cell count testing and discontinuation of the drug if signs suggestive of blood dyscrasias (e.g., fever, chills, sore throat, mucosal lesions) are observed, as mandated by regulatory authorities.

The official safety information structures the understanding of this medicine's risks by highlighting the critical, though rare, possibility of severe blood and hypersensitivity reactions. This emphasis is reinforced by the presence of specific contraindications and mandated safety monitoring notes, which define the stringent conditions necessary for the acceptable risk profile, as determined by regulatory agencies.

Overdose and Emergency Response

The official regulatory profile for Брал overdose defines it as a potential medical emergency due to the risk of severe, multi-systemic effects. Documented clinical manifestations of overdose include central nervous system signs such as drowsiness, dizziness, and tinnitus, alongside systemic signs like hypotension and tachycardia. Signs specific to the anticholinergic component include urine retention and visual disturbances. Overdose may progress to life-threatening outcomes, including convulsions, coma, and severe cardiac arrhythmias.

Acute toxicity is primarily characterized by the potential for Acute Renal Failure (presenting as oliguria or anuria) and Acute liver injury. Regulators mandate that users seek immediate medical attention and contact emergency services in all suspected overdose cases. Management is defined as symptomatic and supportive treatment, with procedural steps like considering gastric lavage or activated charcoal administration. Official labeling notes that no specific antidote is known. There are specific considerations for pediatric patients and those with pre-existing renal impairment, who may experience increased severity.

Therapeutic Uses of Брал

The primary role of this medication is to provide symptomatic relief across a range of conditions, focusing on easing discomfort and reducing the burden of acute, noticeable symptoms. Medicines in this category are commonly used for managing pain and fever. It is used in contexts where additional support for symptom management is needed to help maintain functional stability.

The medication is relevant for managing symptoms related to physical discomfort and systemic imbalance, typically applied in scenarios where short-term symptomatic assistance is needed. This includes providing relief for acute pain episodes, such as headache, muscle pain, and joint discomfort, as well as managing the generalized body aches and temperature elevation associated with fever.

Easing Acute Symptoms and Discomfort

This supportive relief is helpful in situations where symptoms create noticeable functional strain. The medication contributes to improved comfort during periods of heightened symptoms, which may assist with maintaining functional stability.

“This medication is applied across domains where additional symptomatic support is needed, assisting with maintaining functional stability.”

Symptom Support Fact: Relief for Acute Symptom Clusters

The medicine is relevant for easing symptom clusters that may become intense or disruptive, offering supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. European Medicines Agency (EMA) therapeutic overview

Eligibility and Restrictions for Use

Who can and cannot use Брал?

The official regulatory profile for Брал (Metamizole, Pitofenone, and Fenpiverinium Bromide) strictly defines patient eligibility. This medicine is approved for use in adults and adolescents from 15 years of age.

Specific liquid formulations are permitted for children and adolescents up to 14 years old, with administration based on body weight. However, use is contraindicated for infants under 3 months or those weighing less than 5 kg.

Absolute prohibitions prevent the use of this medicine in several groups, including:

  • Individuals with known hypersensitivity to any component or pyrazolone derivatives.
  • Patients with a history of Metamizole-induced agranulocytosis or impaired bone marrow function.
  • Those with comorbidities such as gastrointestinal obstruction or acute hepatic porphyria.

Eligibility is further restricted for specific physiological states and conditions:

Eligibility Category Regulatory Status
Pregnancy (3rd Trimester) Contraindicated
Lactation Not Recommended (Discard milk for 48 hours)
Hepatic / Renal Impairment Restricted Use (Caution advised)
Older Adults Restricted Use (Caution advised)

This structured regulatory profile defines who can and cannot use the medicine by establishing absolute contraindications based on hypersensitivity and blood disorders, alongside restrictions for age, pregnancy, and organ function.

What should I know about interactions with other medicines?

The official regulatory documents classify the drug Брал as a Cytochrome P450 3A (CYP3A) substrate, meaning its concentration in the body can be significantly altered by other medicines or products that affect this enzyme system.

Pharmacokinetic Interactions (Exposure Alteration)

Interacting Product Category Regulatory Classification Resulting Interaction Constraint
Dofetilide Contraindicated Co-administration is forbidden due to the risk of increased dofetilide exposure, which may lead to serious events.
Strong CYP3A Inhibitors Requires Dose Modification/Interruption Increase Брал exposure (AUC/Cmax). Requires a specific dose reduction of Брал or interruption of treatment if the inhibitor is used short-term.
Strong CYP3A Inducers Requires Dose Modification/Avoidance Decrease Брал exposure (AUC/Cmax). Avoidance is advised, but if necessary, a specific dose increase of Брал is required to maintain efficacy.
Proton Pump Inhibitors (PPIs) Avoidance Required Decrease Брал exposure. Concomitant use with PPIs should be avoided.

Temporal Separation Requirements

The absorption of Брал is sensitive to changes in gastric acidity and the presence of multivalent cations. Official labeling dictates temporal separation for certain agents:

  • H2-Receptor Antagonists: The drug must be taken 2 hours before the H2-receptor antagonist.
  • Antacids, Cation-Containing Oral Supplements (e.g., iron, calcium), or Buffered Medications: Must be taken at least 2 hours before or 6 hours after the drug.

These constraints define the drug's official interaction profile, establishing conditions for safe co-administration based on the mechanisms of metabolic and absorption interference.

Mechanism of Action

Брал (Brivaracetam) functions primarily as a selective, high-affinity ligand, engaging the synaptic vesicle glycoprotein 2A (SV2A) in the central nervous system. SV2A is an integral membrane protein found on all synaptic vesicles. The interaction of Брал with SV2A modulates the process of neurotransmitter release from presynaptic terminals. Specifically, this binding is hypothesized to stabilize the SV2A protein conformation, influencing the readily releasable pool of neurotransmitter vesicles. While the precise molecular cascade downstream of SV2A binding remains under investigation, the resulting modification of release probability contributes to a system-level neuromodulation, decreasing overall neuronal excitability. This dampening of synchronized neuronal firing constitutes the systemic physiological consequence of the interaction with the SV2A target. Additionally, the compound is noted to exhibit antagonistic activity at voltage-dependent sodium channels, which further restricts the generation and propagation of action potentials, contributing to the regulation of neuronal hyperexcitation.

Dosage and Administration Information

How to Use Брал: Official Administration Guidelines

The use of Брал (Metamizole, Pitofenone, and Fenpiverinium Bromide) is strictly governed by the official instructions defined in regulatory documents to ensure proper and safe administration. The medicine is available in two distinct forms with separate rules for application.

Administration Detail Tablets (Oral Use) Solution for Injection (Parenteral Use)
Approved Route Oral (PO) Intramuscular (IM)
Standard Adult Dose 1 to 2 tablets 2 mL (1000 mg Metamizole equivalent)
Dosing Frequency 2 to 3 times daily Can be repeated after an interval of 6 to 8 hours
Maximum Daily Dose 6 tablets (3000 mg Metamizole equivalent) 6 mL (3000 mg Metamizole equivalent)

Administration Conditions and Duration

Official instructions require adherence to specific contextual conditions. Tablets should be taken by mouth with water after eating to aid in gastrointestinal tolerance. The solution for injection must be administered under strict medical control with emergency facilities readily available.

Treatment is intended for short-term use only. The duration of the oral regimen, for instance, should not exceed 3 days. If a patient initially receives the injection, official guidelines permit switching to an oral analgesic/antispasmodic agent once a satisfactory therapeutic effect is achieved.

Population-Specific Rules

Dose adjustments are explicitly required for certain patient groups:

  • Renal/Hepatic Impairment: Patients with mild to moderate impairment of kidney or liver function are generally recommended to receive half (1/2) of the standard adult dose.
  • Older Adults (over 65 years): While often no initial reduction is required, a dose reduction is necessary if the patient presents with age-related disorders of renal or hepatic function.
  • Pediatric Patients: The injection solution is generally contraindicated for use in children under 15 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Брал

The fixed-combination medicine Брал contains three active ingredients: Sodium Metamizole (an analgesic), Pitofenone, and Fenpiverinium Bromide (both spasmolytics). Research examined this combination in conditions associated with acute or disruptive episodes where physical discomfort is linked to the tightening of smooth muscles, such as in the urinary or digestive tracts. Findings describe group patterns and contribute to the broader evidence landscape, but research does not determine whether an individual will respond similarly.


Evidence for Acute Renal Colic Pain

The primary evidence for this combination, or similar products containing the analgesic and spasmolytic components, comes from short-term randomized controlled trials (RCTs). These trials were primarily conducted during periods of increased symptom activity and research examined how symptoms changed over defined time intervals in adult patients presenting with acute symptoms in this setting.

Studies focused on outcomes related to physical discomfort, monitoring the change in pain intensity using scales like the Visual Analogue Scale (VAS). Researchers also monitored the need for rescue pain medication in the observed populations. Findings describe patterns observed in the studies regarding the time taken for a reduction in pain intensity to be measured. Comparative evidence is lacking regarding the triple combination versus single-agent analgesics, and certainty remains low.


Evidence for Biliary Colic and General Spasmodic Pain

Evidence for use in conditions characterized by fluctuating or episodic manifestations like biliary colic (pain in the bile ducts) was evaluated in observational studies and non-randomized research. This research explored outcomes related to the resolution of the acute episode and symptomatic relief. For more general spasmodic pain, research often focuses on the pharmacological role of the components. Data are still emerging, and the overall evidence for the specific triple combination in these diverse settings is limited relative to the renal colic research.


Limitations of Long-Term Studies and Follow-up Data

The research base for this combination is primarily focused on studying acute episodes, where studies conducted during periods of increased symptom activity generally track results over only a few hours.

Consequently, there is limited information for long-term outcomes or sustained use. Long-term effects are not fully established, as clinical trials were not designed to monitor outcomes over extended periods. The research provides context but not individual predictions about long-term use.

Key Studies & References

  1. Comparative effectiveness of NSAIDs and Antispasmodics in pain management for acute biliary colic: a randomized controlled trial

Frequently Asked Questions (FAQ)

Common questions about Брал (FAQ)

Q: Does taking Брал affect the effectiveness of birth control pills?

Official information states that the use of this medicine may reduce the effectiveness of hormonal contraceptives, such as birth control pills. This potential interaction is noted in the regulatory documents. Regulatory documents indicate that discussing the need for additional non-hormonal contraceptive measures with a healthcare provider is generally recommended.

Q: Is Брал the same type of medicine as painkillers I buy over the counter?

No, this medicine is defined in regulatory documents as a fixed-combination medicinal product. It contains not only an analgesic component (pain reliever) but also two spasmolytic agents, which are muscle relaxants that target spasms. This triple composition is distinct from the single-component painkillers commonly available without a prescription.

Q: What is the difference between the uses of Брал and a common NSAID?

The key difference is in its mechanism and official use. The therapeutic purpose of this medicine, as defined by regulatory documents, is for severe pain linked to smooth muscle spasms, such as colic. Common NSAIDs (non-steroidal anti-inflammatory drugs) generally do not contain the dedicated spasmolytic (muscle-relaxing) components found in this specific formulation.

Q: Can I take Брал if I am already taking blood pressure medication?

Official labeling advises caution, as a strong interaction has been noted with the anti-arrhythmic drug Dofetilide, which is contraindicated. Furthermore, the analgesic component, Metamizole, has been noted to potentially cause a temporary drop in blood pressure in some patients. Reviewing all medications, including blood pressure drugs, with a prescribing professional is consistent with official guidance.

Q: Does Брал interact with herbal supplements like St. John's Wort?

Official labeling advises caution with substances classified as strong CYP3A inducers. Since St. John's Wort is a well-known enzyme inducer, regulatory documents note that its co-administration may decrease the exposure of this medicine in the body. This reduction in exposure could potentially lower the medicine's effectiveness.

Q: What do official sources say about the use of Брал in patients with heart conditions?

Regulatory documents state that co-administration with the anti-arrhythmic drug Dofetilide is forbidden (contraindicated). Additionally, patients with heart conditions may need caution, as the medicine may cause a temporary drop in blood pressure in certain instances following administration.

Q: Does Брал help with general aches and pains?

The therapeutic purpose of this medicine is defined by regulatory documents as the relief of severe pain associated specifically with smooth muscle spasms, such as renal colic. Its use is not officially indicated or defined for general aches, minor pains, or non-spasmodic discomfort.

Q: How quickly can I expect Брал to start working?

According to official product information, a clear pain-relieving effect for the oral form is typically expected to begin approximately 30 to 60 minutes after administration. This timeline relates to how quickly the active substances are absorbed into the body.

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

The duration of effect is related to the half-life of its active components and their metabolites, which can last for several hours. Official dosing instructions recommend repeating a dose after an interval of 6 to 8 hours if needed, which provides an indication of the expected symptomatic relief period.

Q: Can Брал affect my stomach or cause nausea?

Yes, official safety documents classify both nausea and vomiting among the commonly reported adverse events. Other side effects affecting the gastrointestinal tract, such as abdominal pain or discomfort, have also been reported with its use.

Q: Does Брал cause drowsiness or affect my ability to drive?

Official warnings state that the medicine, particularly when used in higher doses, can cause central nervous system effects such as drowsiness or dizziness. Because of this potential, official warnings generally advise caution when engaging in activities like driving or operating heavy machinery.

Q: What happens if I drink alcohol while I am taking Брал?

Official labeling advises that this medicine can intensify the effects of alcohol. Furthermore, a patient may exhibit an intolerance reaction to alcohol while taking this medicine, which is documented as a possible indicator of underlying sensitivity to the analgesic component.

Q: Is it necessary to avoid any specific foods or drinks while using Брал?

Official guidance specifically notes that the medicine's absorption is sensitive to the presence of multivalent cations. Therefore, taking the medicine at the same time as supplements or other medications containing agents like iron or calcium should generally be avoided, with a required time separation.

Q: Is there a maximum amount of time a person should use Брал?

Yes. The medicine is intended for short-term use to manage acute symptoms. Regulatory instructions for the oral regimen state that the duration of treatment should generally not exceed 3 days. The research evidence is primarily focused on short-term outcomes.

Q: Is Брал available without a prescription?

The regulatory status of this medicine, determining if it is a prescription (Rx) or over-the-counter (OTC) drug, varies greatly by country. While it requires a prescription in many regions, some national drug authorities have classified it for non-prescription use.

Q: Is there any research that compares Брал to other similar treatments?

Official research evidence notes that comparative evidence is lacking regarding the specific triple-drug combination versus single-agent analgesics. Studies generally focus on the short-term effects within populations experiencing acute spasms rather than comparing it directly to other treatments.

Q: What have the official clinical studies on Брал mainly focused on?

Official clinical studies have focused primarily on the medicine's effect in acute conditions associated with smooth muscle spasms, with a strong emphasis on conditions like renal colic and biliary colic. Researchers monitored outcomes related to changes in pain intensity over short time intervals.

Q: Is it normal for Брал to cause headaches?

Yes, regulatory documents list headaches as an adverse effect that has been reported in connection with the use of the medicine. The full product information provides detailed classification of reported side effects and their frequency.

Q: Do I need to take Брал with food, or can I take it on an empty stomach?

For the oral tablet form, official instructions advise taking it with water after eating. This condition is specified to help aid in gastrointestinal tolerance of the medicine.

Q: Is Брал a controlled substance or addictive?

No. The core analgesic component, Metamizole, is classified in regulatory documents as a non-opioid analgesic that is non-addictive. It is not generally categorized as a controlled substance with a risk of dependence.

Q: Why might a patient be told to stop taking Брал?

A patient is formally required by regulatory instruction to discontinue the medicine immediately if they show signs suggestive of a serious adverse reaction, such as a blood disorder (e.g., agranulocytosis). Discontinuation can also be advised due to non-serious side effects or if the medicine is not providing the expected benefit.

Q: Can I stop taking Брал suddenly, or should I talk to a professional first?

Since this medicine is not classified as an opioid or controlled substance, the official regulatory profile does not generally specify a requirement for a formal tapering schedule. Consistent with general medication safety practices, consulting a healthcare provider before discontinuing any prescribed medicine is recommended.

Q: Is there a risk of withdrawal symptoms when stopping Брал?

Official regulatory documents do not list or describe withdrawal symptoms associated with discontinuing this medicine. This is consistent with its classification as a non-addictive analgesic.

Q: Does Брал have any known effects on mental clarity or mood?

Adverse effects related to the nervous system are reported, including somnolence (drowsiness) and dizziness. General effects on mental clarity or mood beyond these specific adverse events are not described in the regulatory summary of undesirable effects.

Q: How does the mechanism described in official sources relate to the pain relief I feel?

The relief felt is the result of the combined action of the three active ingredients. The analgesic component reduces the sensation of pain, while the two spasmolytic components act to relax the tightened smooth muscle tissue that causes the cramping discomfort (colic).

Q: Is it normal to have to wait a few weeks for the full benefit of Брал?

No. The medicine is indicated and studied for the relief of acute episodes and is intended for short-term use. The primary pain-relieving effect is expected to begin within 30 to 60 minutes of administration, not over a period of several weeks.

How should Брал be stored and disposed of?

How to Store and Dispose of Брал?

This section outlines the official, mandatory requirements for the storage and disposal of Брал (Metamizole/Pitofenone/Fenpiverinium Bromide) based on regulatory labeling.

Official Storage Requirements

Storage Component Mandatory Rule
Temperature Store below 25 C.
Protection Keep in the original container, protected from light and moisture.
Stability Do not use the medicine after the expiry date printed on the carton.
Child Safety Must be stored out of the sight and reach of children.

Official Disposal Instructions

To protect the environment, the official labeling strictly prohibits discarding unused or expired Брал in household waste or wastewater (e.g., sink or toilet). Individuals are required to consult a pharmacist for guidance on the proper method for discarding the medicine according to local pharmaceutical waste protocols.

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

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