Quick Facts

• Therapeutic Domain: Benign Prostatic Hyperplasia (BPH)
• Primary Benefit: May contribute to the management of BPH symptoms
• Associated Use: May influence the progression of BPH

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What АФАЛАЗА Treats: Main Uses and Benefits

АФАЛАЗА is indicated for the management of symptoms associated with Benign Prostatic Hyperplasia (BPH) in adult males. BPH is a non-cancerous enlargement of the prostate gland which can influence the lower urinary tract.

The medication is used to help alleviate the lower urinary tract symptoms (LUTS) that often accompany BPH. Clinical studies suggest that the use of this drug may contribute to an improvement in the overall International Prostate Symptom Score (IPSS), which measures the severity of these symptoms. These symptoms may include urinary frequency, urgency, and a weakened stream.

Furthermore, evidence indicates that АФАЛАЗА may be relevant in the context of BPH progression. Clinical research is being analyzed to evaluate its long-term influence on key markers of disease progression, such as prostate volume and the risk of complications. The therapeutic goal is to assist in supporting the function of the lower urinary tract.

Eligibility Map: Who can and cannot use АФАЛАЗА — Official Regulatory Information

The eligibility profile for Afalaza is strictly defined by regulatory documents, which establish clear restrictions based on age, hypersensitivity, and specific metabolic conditions.

Eligibility Scope

Classification	Status as per Official Labeling
Populations Allowed	Adult males (18 years and older)
Populations Contraindicated	Individuals under 18 years of age
Use Not Established	Pediatric population (safety and efficacy not established)

Contraindications and Restrictions

Contraindications are absolute prohibitions listed in the official prescribing information:

• Hypersensitivity: Patients with known individual hypersensitivity to the drug's active substances or excipients.
• Age: Individuals under 18 years of age.
• Metabolic Disorders: Patients with lactase deficiency, hereditary galactose intolerance, or glucose-galactose malabsorption.

Special Population Status:

• Women: The medicine is not intended for use in women, including during pregnancy or lactation, due to its male-specific indication.
• Renal/Geriatric Use: Use is permitted without dose adjustment for older adult patients and those with renal impairment, affirming their eligibility under standard conditions.

Interactions with other medicines and products

The official regulatory documentation for АФАЛАЗА primarily defines the interaction profile by the absence of registered drug–drug incompatibilities. Due to the composition of released-active antibodies, the medicine does not typically involve the cytochrome P450 (CYP) enzyme system or other common metabolic pathways that lead to pharmacokinetic interactions with small-molecule drugs.

Documented Interaction Status

Classification	Official Regulatory Status
Drug–Drug Interactions	Cases of incompatibility with other medicinal products have not been registered to date in the official labeling.
Metabolic Interactions	No specific pharmacokinetic, transporter-mediated, or pharmacodynamic interactions are formally documented.

Restrictions and Administration Rules

While formal drug–drug interactions are not registered, regulatory documents list restrictions related to co-administration with products and specific patient populations:

• Timing Requirement: Administration of the sublingual tablets requires a mandatory separation from food intake; the medicine must be taken outside of meal intake to ensure appropriate absorption.
• Excipient Caution: A specific precaution is documented for individuals with congenital lactase deficiency, congenital galactosemia, or glucose or galactose malabsorption syndrome. This is due to the presence of lactose monohydrate as an excipient in the tablet formulation, which is an interaction-related constraint for this specific patient population.

No medicinal products are listed as being contraindicated for co-administration with АФАЛАЗА based on interaction risk.

Modulation of Endogenous Regulatory Proteins

This drug acts by modulating the activity of two specific biological targets: Prostate-Specific Antigen (PSA) and the enzyme endothelial Nitric Oxide Synthase (eNOS). This action involves the drug's components binding to these molecules and inducing a conformational change, which alters their activity state, influencing their internal regulatory functions within the tissue.

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Influence on Tissue Function and Microcirculation

The drug's dual mechanism of action influences key regulatory systems. By modulating PSA, it influences functional and metabolic processes within the targeted tissue. Simultaneously, by stimulating eNOS, it increases the local generation of Nitric Oxide (NO), a signaling molecule that promotes the relaxation of local blood vessels. This cascade promotes changes in local blood flow and modulates local inflammatory signals, contributing to specific alterations in local physiological dynamics.

How to Use АФАЛАЗА

This section outlines the general administration and dosing guidelines for the medicinal product АФАЛАЗА.

АФАЛАЗА is an oral medication specifically designed for sublingual administration (dissolving under the tongue) and is for use in adult males with Benign Prostatic Hyperplasia (BPH).

Administration and Dosing

Administration of АФАЛАЗА follows a standardized, fixed-dose regimen that does not typically involve titration.

Feature	Instruction
Route of Administration	Oral, strictly Sublingual (dissolved in the mouth).
Standard Adult Dose	Two tablets per dose.
Dosing Frequency	Twice daily (b.i.d.).
Dosing Schedule	Fixed daily dose of two tablets, two times per day.
Treatment Duration	A full course is typically 12 months.

Key Usage Instructions

For proper administration, the tablet must be placed in the mouth and held there until it is completely dissolved; it should not be chewed or swallowed whole. The prescribed dose should be taken at a specific time in relation to food intake.

• The medication must be taken 15 to 30 minutes before consuming meals.

These administration guidelines are established to ensure standardized use throughout the typically recommended one-year treatment course for BPH. No specific dose adjustments for older adults or individuals with renal or hepatic impairment are noted.

Research Evidence / Overview of Studies for АФАЛАЗА

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Evidence for Use in Benign Prostatic Hyperplasia (BPH) and LUTS

The clinical evaluation of АФАЛАЗА has concentrated on adult males diagnosed with Benign Prostatic Hyperplasia (BPH) who exhibit moderate Lower Urinary Tract Symptoms (LUTS). A multicenter, double-blind, placebo-controlled Randomized Clinical Trial (RCT) is the primary controlled study available for this indication. This section summarizes the structure of the controlled studies that examined outcomes related to urinary symptoms and progression factors.

This research was studied for change in LUTS severity. Studies explored how symptoms evolved in the observed populations over defined time intervals. The findings describe patterns observed in the specific groups studied. Research has also examined outcomes related to systemic or functional imbalance that researchers monitored in the BPH population.

Key Outcomes Studied in Clinical Trials

Researchers structured the studies to track several specific, measurable endpoints over the treatment period.

• Symptom Assessment: The primary measure in the controlled trials was studied for change in the International Prostate Symptom Score (IPSS). Studies also monitored the patient-reported Quality of Life (QoL) Index.
• Functional and Progression Measures: Other key outcomes included evaluating functional measures like changes in the maximum urinary flow rate (Q max) and tracking objective measurements that researchers studied in the context of BPH progression. These measurements included changes in Total Prostate Volume (TPV). Studies also monitored the occurrence of clinical events, such as Acute Urinary Retention (AUR) or the need for BPH-related surgery.

Long-Term Studies and Extended Observation

The main RCTs involved a follow-up duration of 12 months. These studies measured the observed short-term changes in LUTS in the study groups over that year. For evidence beyond one year, the information is primarily derived from retrospective observational studies that have monitored patients for longer periods, reaching up to 41 months. This evidence describes long-term patterns observed in conditions where symptoms may vary in intensity, although certainty remains low due to the retrospective nature of the observational studies.

What is Still Uncertain About the Research Evidence

Follow-up durations were limited in the most rigorous trials, meaning long-term effects are not fully established. The primary research was conducted on men, typically between 45 and 60 years old, with BPH characterized by moderate LUTS. The results apply only to the populations studied. Data for certain groups, such as those with severe symptoms, remain insufficient. According to published statements from researchers, research is ongoing to further characterize the long-term patterns and explore the factors associated with BPH progression.

Common questions about АФАЛАЗА (FAQ)

Q: What is АФАЛАЗА and what is it used for?

АФАЛАЗА (Aphalaza) is a homeopathic medicine that is used for the treatment of benign prostatic hyperplasia (BPH), also known as an enlarged prostate, and for chronic prostatitis in adult men.

It is available in the form of oral lozenges.

Q: How does АФАЛАЗА work?

АФАЛАЗА contains a combination of highly diluted antibodies to prostate-specific antigen (PSA) and antibodies to endothelial nitric oxide synthase (eNOS).

The manufacturer suggests that the combination of these components may help to reduce inflammation and swelling in the prostate gland and improve blood flow and function in the prostate.

Q: What are the common side effects of АФАЛАЗА?

As a homeopathic product, АФАЛАЗА is generally well-tolerated. In rare cases, individuals may experience hypersensitivity reactions to the components of the product.

If you experience any severe or unexpected side effects, you should stop taking the product and consult your healthcare provider.

Q: What is the recommended way to take АФАЛАЗА?

АФАЛАЗА lozenges are typically taken twice daily (morning and evening), dissolved completely in the mouth, not to be swallowed whole. The lozenge should be taken separately from meals.

The specific duration of treatment will depend on the condition being treated (BPH or chronic prostatitis) and should be discussed with a healthcare provider. Do not exceed the recommended dose.

Q: Can АФАЛАЗА be taken with other medications?

There are no known significant drug interactions with АФАЛАЗА. However, it is always important to inform your doctor or pharmacist about all prescription, over-the-counter, and herbal products you are currently taking before starting any new treatment.

Q: What should I do if I miss a dose?

If you miss a dose of АФАЛАЗА, you should take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

Q: How should I store АФАЛАЗА?

АФАЛАЗА should be stored at room temperature, typically below 25°C (77°F). It should be kept in its original packaging and out of the reach of children.

How to Store and Dispose of АФАЛАЗА

Official regulatory documents define specific environmental and container requirements for storing АФАЛАЗА tablets to ensure product stability throughout its 3-year shelf life.

Storage Requirement	Specification
Temperature	Must be stored at a temperature not exceeding 25, C.
Light Protection	Must be stored protected from light.
Packaging	The blister pack must be stored in the manufacturer's original cardboard box.
Child Safety	Must be kept out of the reach of children.
Disposal	No specific consumer disposal instructions are documented in the official labeling for unused or expired product.

Strict adherence to these official conditions is required, and the medication must not be used after its expiration date. There are no documented special handling or environmental waste requirements.