Daflon. For Heavy, Painful legs and Varicose Veins

The #1 Doctor recommended, non prescription brand for treating chronic venous insufficiency symptoms. 1

How does Daflon work?

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Venoactive treatments, like Daflon, are designed to help improve our leg vein health by strengthening the tone of our veins, which continue to weaken as chronic venous insufficiency progresses.

Daflon has a dual mechanism of action; its venous anti-inflammatory action venoprotective reduces pain and swelling; it also protects the capillaries or tiny blood vessels to improve microcirculation and venous tone for better vein health and relief of symptoms such as leg pain, and swelling. 2

Tackle leg pain from the inside

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Daflon is a clinically proven, effective and convenient oral treatment derived from immature oranges and specially formulated for maximum absorption. 2

This improved absorption means Daflon can get to the root of the problem and effectively treat veins from the inside, improving the tone of veins, potentially protecting against disease progression and providing relief from heavy, painful leg symptoms. 2

Demonstrated effect of Daflon Over 8 weeks

4 weeks 4

8 weeks 4

Leg pain

50%

63%

Sensation of heaviness

50%

65%

Sensation of swelling

50%

63%

Relieves Symptoms

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Daflon is the #1 doctor recommended, non prescription brand for treating the symptoms of chronic venous insufficiency. 1

Clinical Studies have shown that Daflon can reduce leg pain and the sensations of heaviness and swelling by up to 50% after only one month of use. These figures were even higher after two months of treatment.

To benefit from your Daflon treatment, you should take your medication as recommended. Be sure to monitor your condition closely and speak with a health care professional if you have any concerns.

Daflon. Naturally sourced, scientifically prepared.

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The active ingredient in Daflon is a micronized purified flavonoid fraction (MPFF)6 containing 90% diosmin and 10% other flavonoids expressed as hesperidin.

Daflon’s flavonoids are extracted from immature oranges that are rich in these naturally occurring plant chemicals. The compounds undergo a process of purification and refinement where the particles are made to collide with each other at high speeds (micronization), reducing them to tiny particles, less than 2 μm in size (micronized). These smaller particles are absorbed twice as easily by the body and are a key ingredient of Daflon’s success as a treatment for improving vein health and tone in Chronic Venous Insufficiency and Hemorrhoids. 6

Safety Information:

Daflon 500mg Safety Information

DAFLON 500 mg Safety Information

Package leaflet: Information for the user

DAFLON 500 mg film-coated tablets Micronized purified flavonoid fraction

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse after seven days.

What is in this leaflet:

  1. What DAFLON 500 mg is and what it is used for
  2. What you need to know before you take DAFLON 500 mg
  3. How to take DAFLON 500 mg
  4. Possible side effects
  5. How to store DAFLON 500 mg
  6. Contents of the pack and other information

WHAT DAFLON 500 mg IS AND WHAT IT IS USED FOR

DAFLON 500 mg is a venotonic (it increases venous tone) and a vasculoprotector (it increases resistance in small blood vessels). It is recommended for treating venous circulation disorders (swollen legs, pain, restless legs) and for treating symptoms due to acute hemorrhoidal attack.


WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFLON 500 mg

Do not take DAFLON 500 mg

If you are hypersensitive (allergic) to micronized purified flavonoid fraction or any of the other ingredients of this medicine.

Take special care with DAFLON 500 mg

  • Acute hemorrhoidal attack: If the hemorrhoid symptoms do not disappear within 15 days, you should ask your doctor for advice.
  • Venous circulation disorders: The most effective way of taking this treatment is in combination with a healthy lifestyle. Avoid exposure to the sun, heat, excessive standing, and being overweight. Walking and wearing special support stockings stimulate blood circulation.

If you are in any doubt, do not hesitate to ask your doctor or your pharmacist for advice.

Taking other medicines No cases of interaction have been reported during treatment with DAFLON 500 mg. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think that you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • Pregnancy: As a precautionary measure, it is preferable to avoid the use of Daflon during pregnancy.
  • Breast-feeding: In the absence of data on excretion in milk, DAFLON 500 mg is not recommended during breast-feeding.

Driving and using machines DAFLON 500 mg has no influence on the ability to drive or use machines.


HOW TO TAKE DAFLON 500 mg

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure. The tablets should be taken at meal times.

  • Venous insufficiency: 2 tablets daily, one at midday and one in the evening.
  • Acute hemorrhoidal attack: a 4-day course of 6 tablets daily, followed by 4 tablets daily over the next 3 days.

If you take more DAFLON 500 mg than you should If you have taken more Daflon than you should, contact your doctor or pharmacist immediately. The experience of overdoses with Daflon is limited but reported symptoms include diarrhea, nausea, abdominal pain, pruritus, and rash.

If you forget to take DAFLON 500 mg If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


POSSIBLE SIDE EFFECTS

Like all medicines, DAFLON 500 mg can cause side effects, although not everybody gets them.

These side effects include:

  • Commonly (less than 1 per 10 but more than 1 per 100): gastro-intestinal disorders (diarrhea, indigestion, nausea, vomiting).
  • Uncommonly (less than 1 per 100 but more than 1 per 1000): colitis.
  • Rarely (less than 1 per 1000 but more than 1 per 10,000): neurovegetative disorders (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).
  • Frequency not known: abdominal pain, isolated face, lip, eyelid oedema (swelling). Exceptionally Quincke's oedema (rapid swelling of tissues such as the face, lips, mouth, tongue or throat that may result in breathing difficulty).

These side effects have been reported, not requiring discontinuation of treatment.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.


HOW TO STORE DAFLON 500 mg

Keep out of the reach and sight of children.

Store below 30°C. Do not use DAFLON 500 mg after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


CONTENTS OF THE PACK AND OTHER INFORMATION

What DAFLON 500 mg contains The active substance is Micronized purified flavonoid fraction 500 mg corresponding to Diosmin (90 %) 450 mg and Flavonoids expressed as hesperidin (10 %) 50 mg for a film-coated tablet.

The other ingredients are:

  • Gelatin
  • Magnesium stearate
  • Microcrystalline cellulose
  • Sodium starch glycolate
  • Talc for the tablet core
  • Glycerol
  • Macrogol 6000
  • Magnesium stearate
  • Methylhydroxypropylcellulose
  • Red iron oxide (E172)
  • Sodium lauryl sulfate
  • Titanium dioxide
  • Yellow iron oxide (E172) for the film-coating

What DAFLON 500 mg looks like and contents of the pack DAFLON 500 mg tablets are film-coated. The tablets are available in blister packed in cartons of 30, 36, 60, 120 and 180 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and Exceptional Marketing Authorisation Holder:

  • Les Laboratoires Servier
  • 50, rue Carnot
  • 92284 Suresnes cedex – France

Local representative in Malta:

  • V.J. Salomone Pharma Ltd
  • Tel: + 356 21 22 01 74

Manufacturer:

  • Les Laboratoires Servier Industrie
  • 905, route de Saran
  • 45520 Gidy
  • France

This leaflet was last approved in November 2022.

References:

1. IQVIA Daflon sales data MAT Q2 2021 2. Adapted from Nicolaides A, Kakkos S, Baekgaard N, et al. Management of chronic venous disorders of the lower limbs. Guidelines according to scientific evidence. Part I. Int Angiol. 2018;37(3):181-254.1 3. Garner RC, Garner JV, Gregory S, Whattam M, Calam A, Leong D. Comparison of the absorption of micronized (Daflon 500 mg) and nonmicronized 14C-diosmin tablets after oral administration to healthy volunteers by accelerator mass spectrometry and liquid scintillation counting. J Pharm Sci. 2002;91:32-40. 4. Gilly R, Pillion G, Frileux C. Evaluation of a new venoactive micronized flavonoid fraction (S 5682) in symptomatic disturbances of the venolymphatic circulation of the lower limb: a double-blind, placebo-controlled study. Phlebology. 1994;9:67-70. 5. Pascarella L, Lulic D, Penn AH, et al. Mechanisms in experimental venous valve failure and their modification by Daflon 500 mg. Eur J Vasc Endovasc Surg. 2008;35(1):102-110. 6. Summary of Product Characteristics Daflon

2024