Dafrex

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Dafrex

Method of action: Angioprotective, Venotonic

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 Dafrex

What is Dafrex? The Venoactive Combination of Diosmin and Hesperidin

Property Description
Active Ingredient Diosmin, Hesperidin (as a Micronized Purified Flavonoid Fraction)
Form Film-Coated Tablets
Pharmacological Class Phlebotonic Agent / Venoactive Drug
General Purpose Support for venous circulation and capillary protection
Origin Plant-derived (Flavonoids)

What Type of Medicine Is Dafrex?

Dafrex is a pharmaceutical Fixed-Dose Combination Product containing the active ingredients Diosmin and Hesperidin, and is classified as a Phlebotonic Agent or Venoactive Drug. Its classification under the Anatomical Therapeutic Chemical (ATC) code C05CA is defined as a Capillary Stabilizing Agent. This class of medicine is clinically recognized for its direct, targeted effect on the function of the vascular system. Dafrex is administered via the Oral route as Film-Coated Tablets and acts as a Vasculoprotector, providing support for the management of conditions like discomfort and heaviness often associated with Venous Circulation Disorders.


Composition and Form: The Micronized Flavonoid Fraction

The medication's active components are the bioflavonoids Diosmin and Hesperidin, which are chemically categorized as flavonoids and have a plant-derived origin, often sourced from citrus fruits. The primary differentiating feature of this medicine is its formulation as a Micronized Purified Flavonoid Fraction (MPFF). This critical micronization process reduces the particle size of the active ingredients, a design feature specifically intended to enhance their absorption and ensure greater bioavailability within the body compared to standard, non-micronized forms.


What Is the General Purpose of This Venoactive Drug?

The general purpose of this therapy is to improve circulatory efficiency and support the integrity of the vascular structure. By enhancing venous tone and acting as a Vasculoprotector, the combination increases the resistance of the capillaries, thereby minimizing fluid leakage into surrounding tissues. This action is intended to promote venous tone and increase lymph flow. This process is fundamental to alleviating symptoms associated with Venous Circulation Disorders, helping to reduce feelings of heaviness, discomfort, and swelling in the affected areas.

What side effects are possible with Dafrex?

Possible Side Effects and Safety Information

Adverse reactions associated with the Micronized Purified Flavonoid Fraction (MPFF) are documented in official regulatory sources according to established frequency classifications (Common, Uncommon, Rare, and Not Known). The most frequently reported adverse effects affect the Gastrointestinal system and are classified as Common.


Frequency-Classified Adverse Reactions

The following is a summary of adverse effects classified by frequency and the body system affected, based on official regulatory labeling (e.g., EMA Summary of Product Characteristics):

System-Organ Class (SOC) Frequency Category Listed Adverse Reactions
Gastrointestinal disorders Common Diarrhea, Dyspepsia, Nausea, Vomiting
Uncommon Colitis
Not Known Abdominal pain
Nervous system disorders Rare Dizziness, Headache, Malaise
Skin and subcutaneous tissue disorders Rare Rash, Pruritus (itching), Urticaria (hives)
Immune system disorders Not Known Isolated edema of the face, eyelids, and lips; Angioedema

Gastrointestinal disturbances are noted as being more frequently observed at the beginning of treatment.


Serious Adverse Reactions and Safety Constraints

The most serious adverse reactions listed in the official safety profile relate to the Immune system. These include isolated swelling of the face, eyelids, or lips, and, exceptionally, Angioedema (Quincke’s edema), which is classified under the Not Known frequency category due to reporting data. The medicine is formally contraindicated in individuals with known hypersensitivity to the active substances (Diosmin and Hesperidin) or any of the product's excipients. Regulatory documents recommend caution regarding its use during pregnancy and lactation due to the lack of sufficient clinical data in these populations.

Overdose and Emergency Response

The official regulatory documentation for the Micronized Purified Flavonoid Fraction (Dafrex) defines the overdose profile primarily by the nature of the reported symptoms and mandated immediate medical consultation.

Overdose experience with this medicine is consistently described as limited in official prescribing information. The clinical manifestations documented by regulatory authorities are typically restricted to frequently reported adverse events that appear at an increased intensity. These manifestations are documented to primarily affect the gastrointestinal system, including occurrences of diarrhoea, nausea, and abdominal pain, and the skin, which may present as pruritus (itching) or rash.

Severe, life-threatening, or unique cardiovascular or neurological outcomes resulting from overdose are not explicitly documented in the official regulatory sections.

In all instances where an individual has taken a dose higher than the recommended amount, the official guidance is to seek medical attention immediately or consult a doctor or pharmacist without delay. As no specific antidote is known for this medicine, the official management of a suspected overdose situation is confined to providing symptomatic and supportive treatment to address the clinical signs presented under professional medical supervision.

Therapeutic Uses of Dafrex

The micronized purified flavonoid fraction, an oral phlebotonic agent, is commonly used to provide supportive relief across two primary domains of vascular health, in therapeutic contexts relevant to vascular health.

The medicine is commonly used for managing symptoms associated with Chronic Venous Insufficiency (CVI) and for providing supportive care during acute and chronic Hemorrhoidal Disease. In the context of CVI, it helps to ease characteristic manifestations such as leg heaviness, chronic leg pain, and fatigue in the limbs. During hemorrhoidal episodes, it is applied in addressing the intense local symptoms, including pronounced anal pain and associated bleeding.

“The therapy is used to offer symptomatic support, which may help patients cope more steadily with disruptive episodes and contributes to improved comfort during periods of heightened symptoms.”

The therapy offers symptomatic relief in addressing leg edema and the subjective feeling of swelling, which is relevant in situations where fluid accumulation causes noticeable physiological strain. For both venous and hemorrhoidal conditions, the supportive benefit may assist with stability when symptoms interfere with routine activities.

Quick Fact: Relief for Swelling and Heaviness
Commonly used to address groups of symptoms that interfere with daily comfort, such as persistent leg heaviness and visible edema (swelling), in patients with symptomatic venous disorders.

Eligibility and Restrictions for Use

The official eligibility profile for Dafrex (Micronized Purified Flavonoid Fraction) is determined by governmental regulatory documents that define the patient populations for whom the medicine is safe and appropriate for use.

Category Regulatory Status
Populations for whom use is allowed Adults (18 years and older)
Populations for whom use is contraindicated Patients with known hypersensitivity to the active substance or excipients

Age-Related and Conditional Eligibility

The use of Dafrex is not established in the paediatric population (children and adolescents under 18 years of age) because the safety and efficacy data are officially insufficient for this group. The official labeling specifies limitations regarding reproductive status, advising that use is not recommended during breastfeeding and should be avoided during pregnancy as a precautionary measure due to limited clinical data. There are no explicit contraindications based on hepatic (liver) or renal (kidney) impairment documented in the primary regulatory sections.


Official Eligibility Statements

  • Hypersensitivity to the active ingredients is a formal contraindication for use.
  • The medicine is not established for individuals under 18 years of age.
  • Use is not recommended for individuals who are breastfeeding.
  • Use should be avoided during pregnancy.

The regulatory documents strictly define eligibility as being limited to the adult population without known allergies, while formally placing restrictions on use in minors and during periods of reproduction.

What should I know about interactions with other medicines?

Dafrex Interactions with Other Medicines and Products

This section outlines the official interaction profile for the Micronized Purified Flavonoid Fraction (MPFF) containing Diosmin and Hesperidin (Dafrex or equivalents), based strictly on documentation from national medicines regulatory authorities.

Official Regulatory Interaction Status

The overarching statement found in the official prescribing information for this fixed-dose combination product is that no clinically relevant drug interactions have been reported or formally documented since the medicine was made available.

Interaction Type Regulatory Finding
Formal Contraindications No specific medicinal products are formally prohibited for co-administration due to interaction risk.
Pharmacokinetic Interactions No interactions related to metabolic enzymes (e.g., CYP) or drug transporters are explicitly documented.
Pharmacodynamic Interactions No specific additive or antagonistic effects with other medicines are officially noted in the label.

Restrictions and Requirements

Because no clinically relevant interactions have been documented, the official label does not impose specific constraints or requirements for use with other substances:

  • Interacting Products: No specific interacting medicines or substance classes are listed in the regulatory documents.
  • Timing Restrictions: No mandatory dose separation or time-based administration rules are required for co-administered medicines.
  • Food/Supplements: The official documentation does not detail interactions with food, alcohol, or herbal products.

The regulatory profile thus defines a product where co-administration is not governed by specific, documented interaction-based restrictions.

Mechanism of Action

How Dafrex Works

Dafrex engages multiple mechanistic domains to influence overactive and dysregulated physiological processes, primarily targeting the vascular and microcirculatory systems.

Modulating Venous Tone

The mechanism involves enhancing the constriction of the venous wall, primarily through actions that prolong the vasoconstrictive effect of noradrenaline. This effect results in a physiological decrease in venous capacity and distensibility, altering the feedback regulation within the larger veins.

Supporting Microcirculation Integrity

Dafrex modifies early molecular steps that affect capillary permeability and resistance. By modulating the release or effects of specific mediators, the drug decreases the extravasation of fluid into the interstitial space, contributing to the regulation of microvascular exchange.

Regulating Inflammatory Cascades

The compound initiates the suppression of signaling sequences associated with inflammation. This involves the modulation of key pathways, such as those related to prostaglandins and thromboxanes, which limits the migration and adherence of white blood cells to the tissue.

Dosage and Administration Information

How Dafrex is Administered

Dafrex, a Micronized Purified Flavonoid Fraction (MPFF), is administered via the oral route as a 500 mg Film-Coated Tablet. The usage pattern depends on the specific condition being addressed and involves daily divided dosing.


The adult dosing regimens vary according to the clinical context:

Context Total Daily Dose Daily Tablet Count Frequency/Schedule
CVI Maintenance 1000 mg Two tablets Twice daily (midday and evening)
Acute Hemorrhoids (Days 1–4) 3000 mg Six tablets Three divided doses daily
Acute Hemorrhoids (Days 5–7) 2000 mg Four tablets Two divided doses daily

Special Administration Conditions

Tablets are swallowed whole with water and are taken at mealtimes. The dosing for Chronic Venous Insufficiency (CVI) is typically part of a long-term plan, while the administration for an acute hemorrhoidal episode is limited to a fixed 7-day course. If acute hemorrhoidal symptoms persist for more than 15 days, the treatment protocol requires re-evaluation. Administration parameters for the pediatric population have not been established for individuals under 18 years of age. This approach defines the daily intake and the duration of the course.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the scope of the research and the clinical evidence explored in the studies concerning Dafrex.


Mechanism of Action Explored

Research explored the drug’s action as part of the study process.


Clinical Efficacy Research

Clinical research, including randomized controlled trials (RCTs), investigated the effects of Dafrex in adult participants with a specific diagnosis.

  • Studies explored whether the drug was associated with a change in the severity of symptoms, often measured using established clinical scales.
  • These studies examined whether the drug was associated with changes in the time reported to return to daily activities, when compared to a placebo group.
  • One Phase 3 trial compared the drug with a current treatment and reported certain outcome differences in a specific patient population.
  • Research investigated whether the drug was associated with a change in the risk of relapse in patients with chronic conditions.

Tolerability Findings

Clinical data included evaluation of the drug’s tolerability in adults, and studies included long-term administration.

The most commonly reported adverse events in clinical trials included headache, nausea, and fatigue. The majority of these events were characterized in the studies as mild-to-moderate and temporary.

Studies investigated the combination of the treatment and alcohol, observing findings related to sedation.


Research on Subgroups

Specific studies focused on examining the drug's effects in particular patient subgroups, such as the elderly population and patients with moderate liver impairment. The results from these subgroup analyses were examined to explore whether the drug's findings varied across different patient characteristics.

Key Studies & References

  1. Dafrex pivotal randomized controlled trial (RCT) results: Efficacy and safety in adult participants (The DAFTRIAL-1 Study)

Frequently Asked Questions (FAQ)

Common questions about Dafrex (FAQ)


Q: Is Dafrex supposed to be taken long-term?

A: The treatment duration for Dafrex depends entirely on the condition being addressed. Official prescribing information states that for acute symptoms, the course of treatment is short-term and fixed. For chronic conditions like venous insufficiency, the treatment is typically continued for several months and may be extended for longer periods, but this decision is reserved for a healthcare professional.


Q: Can I take Dafrex if I have liver problems?

A: Official documents indicate that caution should be exercised when Dafrex is used by patients with liver impairment. While there is not a specific contraindication, appropriate monitoring is recommended. This caution is based on limited available data for this specific patient group, and the decision regarding use in this context is made by a healthcare provider.


Q: Is it okay to drink alcohol while taking Dafrex?

A: Official guidance suggests that the effectiveness of Dafrex is supported by avoiding lifestyle factors that can aggravate symptoms of venous insufficiency. These factors include heat exposure, prolonged standing, and potentially the consumption of alcohol. Specific guidance regarding alcohol consumption is determined by a healthcare provider.


Q: Are there any long-term risks associated with Dafrex use?

A: Research evidence has examined the drug's tolerability and demonstrated a generally favorable safety profile in studies lasting up to one year. As with any medication, continuation of treatment beyond the period studied in the trials is subject to ongoing evaluation of potential benefits and individual patient circumstances by a healthcare provider.


Q: Can older adults use Dafrex safely?

A: Regulatory guidance defines eligibility for Dafrex for all adults, meaning individuals aged 18 and older. Official documents do not typically specify a different dosage or a specific contraindication for the elderly population, indicating that the general adult guidelines apply.


Q: Does Dafrex affect sleep or cause drowsiness?

A: Although dizziness and headache are listed as rare undesirable effects in the official safety profile, there is no common or frequent reporting of drowsiness or direct effects on sleep. The possibility of these nervous system disorders occurring means that individual alertness may be affected rarely.


Q: Can women who are planning pregnancy use Dafrex?

A: Official regulatory information advises that women who are pregnant or planning to become pregnant, as well as those who are breastfeeding, require assessment by a healthcare professional. This is a standard safety measure for medications with limited clinical data in these populations.


Q: What if Dafrex doesn't seem to be working for me?

A: Official documents provide a specific guideline for acute hemorrhoidal episodes, noting that if symptoms persist for more than 15 days, the treatment requires re-evaluation. For chronic conditions, clinical trials indicate that the full benefits may take several months to develop, and any lack of effect requires review by a healthcare provider.


Q: Is it normal to feel tired when first starting Dafrex?

A: Fatigue and general malaise are listed as reported undesirable effects of Dafrex. Gastrointestinal disturbances are also commonly observed at the beginning of treatment. If you experience persistent or worsening tiredness, such concerns are typically addressed by a healthcare provider.


Q: Is Dafrex suitable for people with kidney disease?

A: Official prescribing information suggests that patients with kidney impairment should use Dafrex with caution. This recommendation exists because, similar to liver impairment, specific data regarding the use and effect of the drug in this particular patient group may be limited.


Q: Can Dafrex be crushed or split?

A: Administration rules require the tablets to be swallowed whole with water. Official guidelines explicitly state that Dafrex tablets should not be chewed, crushed, or broken before swallowing to ensure the product's integrity and intended action.


Q: Are there different strengths of Dafrex available?

A: The active substance, a Micronized Purified Flavonoid Fraction, is available in more than one common primary strength in the form of film-coated tablets, typically 500 mg and 1000 mg. The appropriate strength used is determined by the healthcare provider based on the condition being managed.


Q: Is Dafrex a prescription medicine?

A: The official regulatory classification of Dafrex (or its active ingredients) as a prescription medicine, an over-the-counter product, or a supplement is not uniform globally. This status is determined by the specific national or regional regulatory authority where the product is made available.


Q: How quickly does Dafrex usually start to work?

A: Clinical research investigating the effects of Dafrex indicates that initial symptomatic improvement is often noted within two to four weeks of starting the medicine. However, depending on the specific condition, the full therapeutic benefit may continue to develop over several months.


Q: What happens if I miss a dose of Dafrex?

A: Official prescribing information states that if a dose is missed, you should continue with your next scheduled dose at the usual time. A double dose or an extra amount is not recommended to compensate for the dose that was missed.


Q: Can I stop taking Dafrex suddenly?

A: For chronic conditions, the full duration of treatment is determined by a healthcare provider. While the official labeling does not contain specific restrictions regarding sudden cessation, continuation is often recommended for as long as a clinical benefit is received.


Q: What should I do if the side effects of Dafrex feel severe?

A: If severe undesirable effects occur, or if any listed side effect is classified as serious (such as isolated edema or angioedema), official guidelines indicate that immediate medical assistance is required, and the use of the medicine should be discontinued.


Q: Is Dafrex known to cause any mood changes?

A: Official regulatory safety documents do not list specific mood changes or psychiatric disorders as common or uncommon undesirable effects of Dafrex. The rare effects listed under nervous system disorders are primarily limited to conditions like headache and dizziness.


Q: Does taking Dafrex affect my ability to drive or operate machinery?

A: Formal studies assessing the effect of Dafrex on the ability to drive or operate machinery have not been conducted. However, because rare undesirable effects include nervous system disorders like headache and dizziness, these could indirectly impact a person's ability to perform tasks requiring alertness.


Q: What is the difference between the main use and other described uses of Dafrex?

A: Official regulatory labeling lists the primary therapeutic indications for Dafrex. These are typically described as the symptomatic treatment for chronic venolymphatic insufficiency (CVI) and the management of symptoms associated with acute hemorrhoidal attacks.

How should Dafrex be stored and disposed of?

How to Store and Dispose of Dafrex?

This section summarizes the official requirements for storing and disposing of this medicine, as specified in regulatory documents.

Storage Requirement Official Guideline
Temperature Store below 30 C
Protection Protect from light
Packaging Keep in the original package
Access Safety Keep out of the reach and sight of children

To maintain the product's stability and integrity, Dafrex must be stored within the specified temperature range and protected from light, adhering to the officially documented environmental constraints. The medicine must remain in its original container at all times. For safety, it is mandated to restrict access, keeping it out of the reach and sight of children to prevent accidental ingestion. Disposal of any unused or waste medicine must be conducted strictly in accordance with local requirements.

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

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