DAFLON® 500 mg Film-Coated Tablets

Micronized Purified Flavonoid Fraction (MPFF)

Diosmin 450 mg (90%) + Hesperidin 50 mg (10%)

Medical Description

DAFLON® 500 mg contains a micronized purified flavonoid fraction (MPFF) composed of 90% diosmin and 10% flavonoids expressed as hesperidin, equivalent to 450 mg diosmin and 50 mg hesperidin per tablet. MPFF is a well-established oral venoactive therapy used for the management of chronic venous disease (CVD) and hemorrhoidal disease.

DAFLON® improves venous tone, enhances lymphatic drainage, reduces capillary permeability, and exerts anti-inflammatory effects on the venous wall and microcirculation. The micronized formulation enhances gastrointestinal absorption and bioavailability compared with non-micronized flavonoids. Clinical trials and international vascular guidelines support its efficacy in reducing symptoms such as leg heaviness, pain, edema, nocturnal cramps, and hemorrhoidal symptoms.

Therapeutic Indications

DAFLON® is indicated for:

• Chronic venous disease (CVD)
• Chronic venous insufficiency (CVI)
• Varicose veins
• Leg heaviness and fatigue
• Lower limb edema
• Venous pain and discomfort
• Nocturnal leg cramps
• Venous leg ulcers (as adjunctive therapy with compression)
• Acute hemorrhoidal attacks
• Chronic hemorrhoidal disease

These indications are recognized in national formularies and vascular medicine guidelines.

Mechanism of Action

Micronized diosmin and hesperidin exert several beneficial vascular effects:

• Increase venous tone and reduce venous distensibility.
• Improve venous return.
• Enhance lymphatic drainage.
• Reduce capillary leakage and edema.
• Protect the microcirculation.
• Decrease leukocyte activation and inflammation.
• Reduce oxidative stress affecting venous tissues.

Hemodynamic studies have shown significant improvements in venous capacitance and venous emptying time following MPFF therapy.

Clinical Benefits

Evidence from randomized controlled trials, systematic reviews, and international guidelines indicates that DAFLON® may:

• Reduce leg pain and heaviness.
• Improve lower limb swelling.
• Decrease nocturnal cramps.
• Improve quality of life in chronic venous disease.
• Enhance healing of venous ulcers when combined with compression therapy.
• Reduce pain, bleeding, swelling, and discomfort associated with hemorrhoids.

►Adult Dosage

→Chronic Venous Disease

• One tablet twice daily with meals (total daily dose: 1000 mg).

→Acute Hemorrhoidal Attack

Common regimen:

• 6 tablets daily for 4 days
• Then 4 tablets daily for 3 days

Maintenance therapy may continue with 2 tablets daily, according to physician recommendation.

►Pediatric Use

• Safety and efficacy in children have not been adequately established.
• Use in pediatric patients only under medical supervision.

Pregnancy and Breastfeeding

→Pregnancy

Available human data have not shown major fetal risks; however, DAFLON® should be used during pregnancy only if clearly needed and under physician supervision.

→Breastfeeding

Data regarding excretion into breast milk are limited; consult a healthcare professional before use.

Contraindications

Do not use in patients with:

• Hypersensitivity to diosmin, hesperidin, or any excipient.

Warnings and Precautions

• Compression therapy, exercise, leg elevation, and weight control remain essential components of chronic venous disease management.
• Persistent rectal bleeding requires medical evaluation.
• DAFLON® is not intended for treatment of deep vein thrombosis (DVT) or acute vascular emergencies.
• Seek medical advice if symptoms worsen or fail to improve.

Possible Side Effects

Most adverse effects are mild and transient.

Common:

• Nausea
• Dyspepsia
• Diarrhea
• Abdominal discomfort

Less Common:

• Headache
• Dizziness
• Skin rash
• Itching

Rare:

• Allergic reactions, including angioedema.

Drug Interactions

No major clinically significant interactions have been consistently reported, but patients should inform healthcare professionals about all medications and supplements being used.

Storage

• Store below 30°C.
• Protect from moisture and direct sunlight.
• Keep out of reach of children.

Evidence Summary

Micronized purified flavonoid fraction (MPFF) is among the most extensively studied venoactive therapies. Randomized controlled trials have demonstrated improvements in venous hemodynamics, reduction in edema, and symptomatic relief in chronic venous disease. Systematic reviews and international vascular guidelines support MPFF as a first-line pharmacological option for symptomatic chronic venous disorders and hemorrhoidal disease.

Patient Disclaimer

This information is intended for educational purposes only and does not replace professional medical advice. DAFLON® should be used exactly as prescribed by a physician or pharmacist. Seek immediate medical attention if you experience severe allergic reactions, sudden leg swelling with pain, chest pain, or persistent rectal bleeding.

References

• European Society for Vascular Surgery (ESVS): Clinical Practice Guidelines on Chronic Venous Disease.
• Society for Vascular Surgery (SVS) and American Venous Forum Guidelines.
• Cochrane Reviews on venoactive medications for chronic venous insufficiency.
• Brazilian Society of Angiology and Vascular Surgery Guidelines.
• Jantet G. Controlled studies of Daflon 500 mg in chronic venous insufficiency. Angiology.
• National Drug Formulary (Singapore).
• Saudi Food and Drug Authority (SFDA).
• UpToDate®
• Merck Manual Professional Edition
• Medscape
• NIH / PubMed / NCBI.