DAFLON® 1000 mg Film-Coated Tablets

Micronized Purified Flavonoid Fraction

Diosmin 900 mg + Hesperidin 100 mg

Medical Description

DAFLON® 1000 mg contains Micronized Purified Flavonoid Fraction (MPFF) composed of diosmin 900 mg and flavonoids expressed as hesperidin 100 mg. The micronization process enhances gastrointestinal absorption and bioavailability compared with non-micronized diosmin preparations, contributing to its clinical efficacy.

DAFLON® is a venoactive and vasculoprotective medicine indicated for the treatment of chronic venous disease (CVD), including chronic venous insufficiency, varicose veins, leg heaviness, pain, edema, and venous ulcers (as an adjunct to compression therapy). It is also indicated for the symptomatic treatment of acute hemorrhoidal attacks and chronic hemorrhoidal disease.

MPFF improves venous tone, reduces venous distensibility, enhances lymphatic drainage, decreases capillary permeability, and limits leukocyte activation and endothelial inflammation. These effects help reduce venous hypertension, improve microcirculation, and alleviate symptoms associated with venous disorders.

Current international vascular guidelines recognize MPFF as one of the most extensively studied oral venoactive therapies and recommend it for symptomatic chronic venous disease in appropriate patients.

Therapeutic Indications

DAFLON® 1000 mg is indicated for:

• Chronic venous disease (CVD)
• Chronic venous insufficiency (CVI)
• Varicose veins
• Leg heaviness and fatigue
• Venous leg pain
• Lower limb edema
• Night cramps associated with venous insufficiency
• Venous leg ulcers (adjunct to compression therapy)
• Acute hemorrhoidal attacks
• Chronic hemorrhoidal disease

Mechanism of Action

Micronized purified flavonoid fraction acts by:

• Increasing venous tone and reducing venous capacitance.
• Improving venous return.
• Enhancing lymphatic drainage.
• Reducing capillary permeability and fragility.
• Improving microvascular perfusion.
• Decreasing inflammatory mediator release and leukocyte adhesion.
• Protecting vascular endothelial cells from oxidative stress.
• Reducing tissue edema and venous congestion.

Clinical Benefits

Clinical trials and systematic reviews have shown that MPFF may:

• Reduce leg heaviness and fatigue.
• Relieve venous pain.
• Decrease ankle and leg swelling.
• Improve quality of life in chronic venous disease.
• Accelerate venous ulcer healing when combined with compression therapy.
• Reduce pain, bleeding, edema, and itching during acute hemorrhoidal attacks.
• Shorten recovery time from hemorrhoidal flare-ups.

►Adult Dosage

→Chronic Venous Disease

• One tablet (1000 mg) once daily, preferably with breakfast or a meal.

→Acute Hemorrhoidal Attack

Common recommended regimen:

• One tablet three times daily for the first 4 days
• Then one tablet twice daily for the following 3 days

If symptoms persist beyond approximately one week, further medical evaluation is recommended.

►Pediatric Use

• Safety and efficacy have not been established in children and adolescents under 18 years of age.
• DAFLON® is intended for adult use only unless otherwise directed by a specialist.

Pregnancy

Available human data have not identified a significant increase in adverse pregnancy outcomes. However:

• Use during pregnancy only if clearly needed and after medical evaluation.
• Routine self-medication is not recommended.

Breastfeeding

Because information regarding excretion into human breast milk is limited:

• Use only after discussion with a healthcare professional, weighing the potential benefits and risks.

Contraindications

Do not use DAFLON® in patients with:

• Known hypersensitivity to diosmin, hesperidin, MPFF, or any excipient.

Warnings and Precautions

• Compression stockings, regular exercise, weight management, leg elevation, and avoidance of prolonged standing remain essential components of chronic venous disease management.
• DAFLON® should be used as part of a comprehensive treatment plan rather than as a replacement for lifestyle measures.
• Persistent rectal bleeding or hemorrhoidal symptoms require medical assessment to exclude other anorectal conditions.
• DAFLON® is not indicated for the treatment of deep vein thrombosis (DVT) or acute arterial vascular disease.

Possible Side Effects

Most adverse effects are mild and transient.

Common

• Diarrhea
• Dyspepsia
• Nausea
• Vomiting

Less Common

• Abdominal pain
• Headache
• Dizziness
• Malaise

Rare

• Skin rash
• Pruritus
• Urticaria
• Angioedema or facial swelling (rare hypersensitivity reactions)

Seek immediate medical attention if signs of a severe allergic reaction occur.

Drug Interactions

No clinically significant drug interactions have been consistently identified.

Patients should inform their healthcare provider about all prescription medicines, over-the-counter products, herbal supplements, and vitamins they are taking.

Storage

• Store below 30°C.
• Protect from moisture and excessive heat.
• Keep in the original package.
• Keep out of the reach of children.

Evidence Summary

Micronized Purified Flavonoid Fraction (MPFF) is supported by extensive evidence from randomized controlled trials, systematic reviews, and international guideline recommendations. Studies demonstrate improvements in venous symptoms, reductions in edema and leg pain, better quality of life, and enhanced healing of venous ulcers when used alongside compression therapy. Evidence also supports its effectiveness in reducing pain, bleeding, swelling, and symptom duration during acute hemorrhoidal attacks. International vascular societies recommend MPFF as a first-line oral venoactive treatment for symptomatic chronic venous disease.

Key Patient Counseling Points

• Take the tablet with food to minimize gastrointestinal discomfort.
• Continue prescribed compression therapy if recommended.
• Maintain regular physical activity and avoid prolonged standing or sitting.
• Elevate your legs whenever possible.
• Complete the full treatment course as prescribed.
• Seek medical advice if symptoms worsen or fail to improve.

Patient Disclaimer

This information is intended for educational purposes only and does not replace professional medical advice, diagnosis, or treatment. Always take DAFLON® exactly as prescribed by your physician or pharmacist. Seek immediate medical attention if you develop severe allergic reactions, sudden painful leg swelling, chest pain, shortness of breath, or persistent rectal bleeding.

References

• European Society for Vascular Surgery (ESVS). 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease.
• Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society. 2023 Clinical Practice Guidelines for Varicose Veins.
• International Union of Phlebology (UIP) guidance on chronic venous disease.
• Cochrane Database of Systematic Reviews: Interventions for chronic venous insufficiency and venous leg ulcers.
• Systematic reviews of MPFF in chronic venous disease and hemorrhoidal disease.
• Jantet G. Chronic Venous Insufficiency Study Group. Angiology.
• Guilhou JJ, et al. MPFF as adjunctive therapy for venous leg ulcers. Phlebology.
• Misra MC, Parshad R. Micronized flavonoids in acute internal hemorrhoids. British Journal of Surgery.
• Nicolaides AN. Management of chronic venous disorders.
• Pompilio G, et al. Meta-analysis of venoactive drugs in chronic venous disease.
• UpToDate: Chronic venous disease in adults.
• Merck Manual Professional Edition: Chronic Venous Insufficiency.
• Medscape: Chronic Venous Insufficiency and Varicose Veins.