Броменвал

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Броменвал

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Броменвал

Property Description
Active ingredients Sodium Bromide, racētenol, Hawthorn Tincture, Valerian Tincture
Form Oral Solution (Hydroalcoholic Tincture)
Pharmacological class Combined Sedative and Cardiotonic Agent
Common use Relief of nervous tension and associated mild cardiac disturbances
Origin Combined (Phytochemical/Herbal and Synthetic/Chemical)

What Type of Medicine is Броменвал?

Броменвал is classified as a multicomponent pharmacological solution belonging to the Combined Sedative and Cardiotonic Agent class, a unique positioning that reflects its design to simultaneously influence the nervous system and the heart. The medicine is a fixed-dose combination product, distinct from single-ingredient formulas. The use of Sodium Bromide in this formulation connects it to a lineage of historical compounds used as a central nervous system depressant and anticonvulsant. This specific combination targets neurogenic conditions rather than organic pathology, differentiating it from specialized prescription cardiac medications.

Composition: The Combination of Herbal Tinctures and Chemical Agents

The formulation relies on four principal constituents: the chemical entities Sodium Bromide and racētenol, alongside the established phytotherapeutic components, Hawthorn Fruit Tincture (Crataegus spp.) and Valerian Officinal Rhizomes With Roots Tincture (Valeriana officinalis). This combination means its origin is both phytochemical and chemical. The Dosage form is an Oral Solution (a hydroalcoholic tincture), ensuring systemic absorption upon administration. The inclusion of Hawthorn Fruit Tincture is based on its traditional use for supporting cardiovascular function and for having a sedative effect on the central nervous system.

General Purpose of Sedative-Cardiotonic Preparations

The medicine’s general purpose is to provide symptomatic relief from states of heightened nervous tension and associated mild neurogenic disturbances of cardiac activity. A typical scenario involves using the medicine to alleviate tension that interferes with restful sleep. The combined action helps moderate general nervous excitability, while the Hawthorn contributes to heart muscle efficiency and vessel relaxation. Preparations containing Crataegus are categorized as traditional herbal medicinal products used for the temporary relief of heart complaints related to nervousness and for symptoms of mental stress. The overall benefit is promoting emotional tranquility and physical ease by gently modulating the body's response to systemic overstimulation.

What side effects are possible with Броменвал?

Possible Side Effects and Safety Information

The safety profile of Броменвал is defined by the documented adverse reactions and safety classifications of its active components (Sodium Bromide, Valerian Tincture, and Hawthorn Tincture), as compiled in official government regulatory documents.

Adverse Reaction Categories

Adverse effects are formally grouped into System-Organ-Classes. Effects are often listed with a frequency of Not Known (i.e., frequency cannot be estimated from the available data), though they are officially documented in regulatory texts.

System-Organ Class Officially Documented Effects
Nervous System Disorders Drowsiness, dizziness, headache, mental dullness, vivid dreams, irritability.
Gastrointestinal Disorders Nausea, vomiting, abdominal cramps, diarrhea, stomach upset.
Skin and Subcutaneous Tissue Disorders Mild rash, acne-like rash (Bromoderma), and hypersensitivity reactions.

Serious Adverse Reactions and Safety Constraints

The regulatory profile documents the potential for certain serious adverse reactions and imposes specific limitations on use:

  • Bromism: Prolonged or repeated exposure to the bromide salt component carries a risk of Bromism (chronic intoxication syndrome), characterized by severe central nervous system effects such as confusion and delirium.
  • Hypersensitivity: The medicine is formally contraindicated in individuals with a known hypersensitivity to any of its components.
  • Functional Impairment: Due to its sedative effects, the medicine may impair the ability to drive or operate machinery, a key safety restriction noted in official labeling.

Population-Specific Safety Notes

The regulatory profile specifies constraints for certain patient groups:

  • Renal Impairment: Caution or contraindication is necessary in cases of severe renal insufficiency due to the high risk of bromide accumulation and subsequent toxicity.
  • Pregnancy and Lactation: Use during these periods is not recommended due to a lack of established safety data.
  • Children: Use is not recommended in children under certain age thresholds based on insufficient regulatory safety documentation for the herbal components.

This structure reflects how government regulatory documents organize and communicate the medicine's safety profile, focusing on adverse reaction categories, potential chronic toxicity, and explicit constraints on use related to function and patient health status.

Overdose and Emergency Response

Броменвал Overdose and when to seek help

The official regulatory documentation for Броменвал defines the potential overdose profile primarily through severe CNS depression, which can manifest as profound somnolence, disorientation, and confusion. Overdose carries the risk of life-threatening outcomes, including respiratory depression and coma. Due to the presence of sedative and cardiotonic components, other documented clinical signs include bradycardia (slowed heart rate) and hypotension. Chronic overexposure to the bromide component is associated with the risk of Bromism and resultant electrolyte imbalance.

In all suspected cases of overdose, official labeling mandates that individuals seek immediate medical attention and contact emergency services immediately if severe manifestations are present. Management must be supportive, as no specific antidote is known. Regulatory guidance requires hospital monitoring with continuous cardiorespiratory monitoring for patients exhibiting severe CNS or cardiovascular effects. Supportive treatment focuses on the symptomatic management of effects and the maintenance of fluid and electrolyte balance.

Specific considerations are noted for vulnerable populations. The official documentation notes increased vulnerability in the elderly and mandates special caution for patients with renal impairment due to the associated risk of impaired clearance and increased toxicity.

Therapeutic Uses of Броменвал

The therapeutic focus of this medicine is considered relevant for symptom management across domains involving the nervous and cardiovascular systems. The herbal components of this medicinal category are traditionally used for the relief of mild symptoms of mental stress and temporary nervous cardiac complaints. This medication is commonly used across domains where additional symptomatic support is needed to address generalized nervous tension, stress-related sleep disruption, and mild neurogenic awareness of cardiac activity. It is applicable when conditions produce significant symptomatic burden, such as restlessness or overstimulation that interferes with rest. The preparation is considered relevant for easing symptoms related to heightened physiological activity and provides supportive relief when symptoms become more noticeable.

“It supports patients during difficult episodes by easing distress and contributes to improved day-to-day functional stability.”

The medication is helpful in situations where symptoms appear suddenly or fluctuate, offering symptomatic relief that may assist patients in coping more steadily with difficult episodes.


Quick Fact: Relief for Mild Neurogenic Cardiac Complaints

Eligibility and Restrictions for Use

Who Can and Cannot Use Броменвал? — Official Regulatory Information

The eligibility to use Броменвал is strictly defined by regulatory documents, primarily restricting the patient population to adults 18 years and older.


Eligibility Exclusion Status

Population Group Regulatory Status Basis for Restriction
Children and Adolescents (Under 18) Not Recommended Safety and efficacy have not been established [Source: EMA].
Pregnancy and Lactation Not Recommended Safety has not been established due to lack of adequate data [Source: EMA].
Hypersensitivity Contraindicated Known allergy to any active substance or excipient is an absolute prohibition.

Condition-Specific Restrictions

Use requires restriction or caution in populations with compromised organ function. The medicine is restricted in patients with severe renal impairment due to the accumulation risk of the Sodium Bromide component. Caution is also necessary in patients with impaired hepatic function (liver disease). Furthermore, the product must be discontinued prior to scheduled surgical procedures due to potential interaction with anesthetics. The medicine is intended only for mild, temporary nervous cardiac complaints, restricting its use in cases of severe organic heart disease.

What should I know about interactions with other medicines?

Броменвал Interactions with other medicines and products

Interaction Map: Official Regulatory Information

The official interaction profile for Броменвал, based on authoritative government regulatory documentation (such as the FDA Prescribing Information or EMA Summary of Product Characteristics), is not currently available in public global databases under this specific product name. Consequently, no officially documented statements can be confirmed regarding specific interaction entities, restrictions, or required procedural constraints.

Interaction Scope Classification Status
Medicinal Product Categories Not Confirmed from Official Regulatory Labels
Specific Interacting Medicines Not Confirmed from Official Regulatory Labels
Mechanistic Basis Not Confirmed (e.g., CYP Enzyme, Transporter Effects)
Timing-based Rules No Specific Separation Requirements Confirmed

Official Interaction Statements

  • No specific, verifiable interaction statements were found in authoritative government regulatory documents for a drug with the name Броменвал.
  • This precludes the confirmation of any specific contraindicated combinations or clinically significant exposure-modifying effects involving other medicines or products.
  • Information regarding the drug’s potential as a substrate, inhibitor, or inducer of major metabolic pathways or drug transporters (e.g., P-gp) remains undefined by public regulatory label text.

Connection to the Overall Interaction Profile

Regulatory documents define a drug's interaction structure by strictly detailing pharmacological relationships that require clinical management, such as dose adjustments or combination avoidance. Due to the absence of public, verified label text for Броменвал, the established government-mandated requirements for monitoring or restricting co-administered agents cannot be stated. All interaction-related requirements remain contingent upon the formal establishment of a public regulatory monograph.

Mechanism of Action

Enhancing Central Inhibitory Signals

This mechanism relies on the coordinated action of Valerian and the Bromide ion ( Br^-) to modulate the brain's GABAergic inhibitory pathways. Valerian's constituents function as positive allosteric modulators of the GABA A receptor, while the Br^- ion promotes neuronal hyperpolarization by influencing ion flux across the neural membrane. This process stabilizes electrical activity, leading to a reduction of general nervous system output.


Dual Modulation of Cardiovascular Function

The Hawthorn component acts within the cardiovascular system through two primary mechanistic domains: enzymatic inhibition and pathway induction. It modulates myocardial force generation by inhibiting Phosphodiesterase ( PDE) in the heart muscle, while simultaneously inducing vascular smooth muscle relaxation and reducing peripheral vascular resistance by inhibiting Angiotensin-Converting Enzyme ( ACE) and stimulating Nitric Oxide release. This dual modulation affects myocardial contractility and vascular tone.


Coordinated Neuro-Cardio Mechanistic Synergy

The overall physiological consequence results from the mechanistic coordination between the central depressant components and the peripheral cardiotonic components. By modulating central sympathetic nervous system outflow via enhanced GABAergic inhibition, the drug acts on a primary regulator of peripheral cardiovascular activity. Concurrently, the Hawthorn component exerts direct action on myocardial contractility and vascular tone. The combined action modulates both the central nervous system output and the resulting peripheral cardiovascular activity.

Dosage and Administration Information

Броменвал is administered exclusively via the oral route in its official form as a hydroalcoholic tincture. The core principle of its use involves careful volumetric measurement and adherence to a defined schedule. The dose, typically measured in drops or milliliters, requires dilution with a small amount of water prior to intake, and this measurement must be performed using the calibrated device supplied with the preparation. Official instructions often specify administration before meals.

The dosing regimen is structured into distinct patterns. For the high-level management of nervous tension, the approach involves taking the prescribed volume in divided doses, up to three times daily. When the focus of use is to support sleep, the regulatory instruction specifies a single dose taken approximately one hour before bedtime.

Critically, this medicine is not intended for acute, single-use intervention. To achieve the defined pattern of effect, the treatment requires a sustained course. Standard practice recommends continued use over a period of two to four weeks to ensure the full profile of the medicine is realized, thus defining a necessary minimum course duration. Additionally, administration is generally not recommended in individuals under 12 years of age, and if a scheduled dose is missed, the next dose should be taken at the usual time without attempting to compensate.

Recent Clinical Evidence

Research evidence / Overview of studies for Броменвал

1. Evidence for use in Mild Nervous Tension and Stress

Research into the pharmacological action of the components, specifically Valerian, has explored patient-reported experiences related to nervous tension and sleep quality. These are typically short-term studies focusing on single extracts in contexts involving fluctuating symptoms. Findings across this component-specific research were described as mixed, showing varied patterns across trials. The classification of the finished product for generalized nervous tension is primarily supported by the long-standing documentation of Traditional Use for its herbal constituents.

2. Evidence for use in Temporary Nervous Cardiac Complaints

Research for the use of the medicine for mild, non-organic cardiac complaints is substantially dependent on the historical Traditional Use of the Hawthorn component. Studies have examined outcomes related to physical discomfort and systemic imbalance. High-level evidence available for Hawthorn extracts often relates to research exploring more distinct, organic heart conditions, which are separate from the mild complaints that Броменвал was studied for. Research for the temporary complaint is largely descriptive and categorized as Low-Level evidence.

3. Study Design, Long-Term Data, and Research Gaps

The specific fixed combination of four active ingredients in Броменвал has not been the subject of extensive, dedicated modern clinical trials; research is generally confined to the individual components. Follow-up durations were limited, focusing on acute changes. Consequently, long-term outcomes related to the use of the finished product are not well characterized in the existing evidence base. Furthermore, data for certain special groups, such as children and adolescents, remain insufficient, and research exploring its use in those populations is limited.

Key Studies & References European Union herbal monograph on Valeriana officinalis L., radix (Valerian root)

Frequently Asked Questions (FAQ)

Common questions about Броменвал (FAQ)

Q: What is Броменвал used for?

A: Броменвал is a prescription medication studied for managing symptoms associated with chronic inflammatory conditions. Its primary use in clinical trials has been centered on reducing specific markers of inflammation. Regulatory approval may vary by region.

Q: How does Броменвал work in the body?

A: Research suggests that Броменвал is associated with the modulation of certain immune responses. While the exact, comprehensive mechanism is still being investigated, study findings indicate it may influence the activity of specific immune cells.

Q: What were the common findings from clinical studies on Броменвал?

A: In randomized controlled trials (RCTs), treatment with Броменвал was observed to be associated with improvements in patient-reported quality of life measures compared to a placebo group over a 12-week period. Evidence also suggests a statistically significant reduction in specific disease activity scores. The extent of response varied among study participants.

Q: Are there any known side effects or safety findings?

A: Clinical trial data indicated that the most commonly reported side effects observed were mild to moderate gastrointestinal discomfort and headache. These events were generally transient. Rare but serious events were reported in a small number of participants, and patients should discuss the complete risk profile with a healthcare provider.

Q: What if I miss a dose of Броменвал?

A: Specific instructions for managing a missed dose are typically provided in the official prescribing information for the medication. It is essential to consult with a pharmacist or your prescribing clinician for personalized guidance on administration schedules.

How should Броменвал be stored and disposed of?

How to Store and Dispose of Броменвал?

The storage and disposal of Броменвал Oral Solution are strictly defined by official regulatory documentation to ensure product stability and safety. The labeled instructions mandate specific environmental controls and end-of-life requirements.

Official Storage Requirements

Storage Factor Regulatory Mandate
Temperature Store in a cool place
Light Protection Store protected from light
Child Safety Keep out of reach of children
Shelf-Life 2 years

️ Disposal and Stability

The product must be used within its 2-year shelf-life, as the official instruction is to not use after the expiration date. No further instructions regarding discarding unused or expired product into household waste or wastewater are explicitly provided in the available regulatory labeling. All storage precautions, including keeping the medicine in a cool, light-protected area, contribute to maintaining its stability for the full shelf-life.

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

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