Daflon. For the Relief and Prevention of Hemorrhoidal disease.

How does Daflon work?

Daflon is a convenient oral venoactive treatment that gets to the root of hemorrhoid problems by working to treat the veins that become dilated and inflamed during a hemorrhoidal episode. ¹

Daflon quickly works to treat hemorrhoidal disease by reducing the associated signs and symptoms of the disease and can also strengthen the overall tone of your veins, helping to improve blood flow and reducing venous congestion for long term management of hemorrhoids. ¹

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Formulated for Fast Absorption and Relief

Daflon is a clinically proven, effective and discrete oral treatment derived from natural ingredients and specially formulated for maximum absorption. ¹

This improved absorption means Daflon can rapidly get to the root of the problem to conveniently and discretely reduce the duration, intensity and recurrence of hemorrhoid episodes, with different dosing options for fast-acting treatment of acute episodes, or ongoing maintenance for recurring hemorrhoid disease. ²

Improved Absorption

Specially formulated from small, immature oranges using a micronisation process, Daflon is absorbed twice as well as non micronised alternatives for effective relief from painful symptoms. ³

Rapid Relief

Daflon 500 is clinically proven to quickly and effectively treat hemorrhoidal episodes for rapid relief. ^1,2 In just two days, 42% of users demonstrated a reduction in their symptoms and in only three days, 80% reported that their bleeding had stopped. After a single week, most people reported that their symptoms, including bleeding, pain and discharge had resolved.

Daflon can also be used for up to two months to treat chronic and recurring hemorrhoids. With just one pill a day, 71% of users reported fewer instances of acute episodes. ⁵

Rapid relief for Acute Hemorrhoids

At 2 days

42% of patients experienced mild reduction of symptoms

At 3 days

80% of patients' bleeding stopped ²

At 7 days

94% of patients' bleeding stopped ² 84% of patients' pain stopped ⁴ 81% of patients' discharge stopped ⁴

Ongoing treatment for Recurrent Hemorrhoids

At 2 months

31% Less severe symptoms

43% Shorter duration of symptoms

71% fewer recurences

Why you should treat continuously

Hemorrhoidal disease is a progressive inflammatory condition which can be treated but can also recur. In fact, one in four patients may experience hemorrhoids again within 7 months of a resolved episode. ⁷

Daflon is a venoactive drug treatment recommended for the treatment of all grades of hemorrhoidal disease. ¹ By treating early and regularly with Daflon you can help prevent the recurrence of acute hemorrhoidal episodes and reduce the severity of symptoms. ⁵

Convenient Oral Dosing

The personal nature of hemorrhoid symptoms might put you off seeking treatment. Daflon offers the convenience of a discreet over-the-counter oral treatment that quickly and effectively manages hemorrhoid symptoms and treats their root cause, letting you get back to you. ²

One week treatmentfor Acute Hemorrhoids

First 4 days:2 tabletstwice daily

Next 3 days:2 tabletsa day

Ongoing maintenance for recurrent/chronic Hemorrhoids

Up to 2 months1 tableta day

For use beyond 2 months, consult a health care professional

Naturally sourced, scientifically prepared.

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:

What DAFLON 500 mg is and what it is used for
What you need to know before you take DAFLON 500 mg
How to take DAFLON 500 mg
Possible side effects
How to store DAFLON 500 mg
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:

Shelygin Y, Krivokapic Z, Frolov SA, et al. Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets versus 500 mg tablets in patients suffering acute hemorrhoidal disease. Curr Med Res Opin. 2016;32(11):1821-1826.
Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding due to acute internal hemorrhoids. Br J Surg. 2000;87:868-872.
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.
Cospite M. Double-blind, placebo-controlled evaluation of clinical activity and safety of Daflon 500 mg in the treatment of acute hemorrhoids. Angiology. 1994;45:566-573.
Godeberge P. Daflon 500mg is significantly more effective than placebo in the treatment of hemorrhoids. Phlebology. 1992;7(suppl 2):61-63.
Summary of Product Characteristics Daflon 7. Greenspon. Thrombosed external hemorrhoids: outcome after conservative or surgical treatment J.Dis Colon Rectum 2004. 47(9):1493-8.

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