Stop, Relieve and Prevent with Daflon

Daflon is an effective oral treatment for the effective reduction and relief of hemorrhoid symptoms. 1

What are Hemorrhoids?

Hemorrhoids are clusters of swollen veins in your anus and lower rectum, similar to varicose veins..

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They are a result of increased pressure on the blood vessels in your bottom and can develop inside the rectum (internal hemorrhoids) or under the skin around the anus (external hemorrhoids), often leading to pain, itchiness and bleeding.

What do hemorrhoids look like?

Do You Have Hemorrhoids?

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The symptoms of hemorrhoids are many and varied. Typically, hemorrhoidal swelling leads to pain and itchiness and you might feel a bulge in your bottom, experience anal discharge, redness and inflammation, or see blood when using the toilet. If you experience this or any of the illustrated symptoms for the first time (or if your symptoms extend beyond a couple of days), you should consult a health care professional to rule out other conditions instead of self-treating right away.

Bleeding

Itchy bottom

Pain or discomfort

Looks familiar?

Daflon is a medicinal product that treats the underlying cause of hemorrhoids for rapid relief and prevention of recurring symptoms.

Treat Your Symptoms Early

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Hemorrhoidal symptoms can start off quite mildly and often resolve on their own, but this isn’t always the case. Understand the benefits of taking action to treat and prevent hemorrhoid symptoms. 2

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External Hemorrhoids are what most people think of when they picture hemorrhoids. Location is the only difference between the two different types of piles, but the difference in discomfort can be considerable. External hemorrhoids form on the outside of the anus, directly on the opening where there are lots of nerve endings, so can be particularly itchy and painful.

Internal Hemorrhoids are formed deep inside the anus and are not usually visible. They can resolve without treatment, but occasionally they will swell and protrude from the anus. Prolapsed hemorrhoids are internal hemorrhoids that have grown to the point that they protrude from the anus. Severity of internal hemorrhoids is measured using a grading system, based on how far they protrude:

Grade 1

  • Bleeding​,
  • Visible on proctoscopy​,
  • Protrusion on straining​ ,
  • No prolapse
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Grade 1

There may be bleeding, discomfort and itching, and protrusion on straining, but no evidence of prolapse. It is nonetheless essential that you treat from this first stage to avoid worsening symptoms.

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Grade 2

  • Bleeding​,
  • Prolapse visible at anal margin during straining​,
  • Spontaneous return when straining ends​
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Grade 2

Without treatment, your condition may worsen, leading to pain when using the toilet, bleeding and hemorrhoids that tend to prolapse when straining, but reduce when straining ceases.

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Grade 3

  • Bleeding​,
  • Visible on proctoscopy
  • Protrusion on straining
  • Prolapse requiring manual reduction
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Grade 3

When hemorrhoids progress to Grade 3, bleeding is more frequent and your piles will prolapse on straining and need to be pushed back in. You can do this yourself. If there is a thrombosis (blood clot inside the vein) as well, the pain may be very strong.

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Grade 4

  • Permanent and irreducible prolapse​,
  • Bleeding​,
  • Discharge
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Grade 4

Is the most serious stage. You will have permanent piles that you can’t push back in yourself without pain in addition to previous signs and symptoms. Surgery in addition to venoactive treatments such as Daflon becomes essential.

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The main symptoms of hemorrhoidal disease that can occur at all grades of the disease can be bleeding, pain, itching and discomfort.

RISK FACTORS YOU CAN CONTROL 4

Inactivity

Constipation

Heavy lifting

Toilet habits

RISK FACTORS YOU CAN’T CONTROL 4

Age

Pregnancy

Genetics

What are the risk factors for Hemorrhoidal disease?

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Hemorrhoidal disease affect people from all walks of life at various stages in their lives. Main risk factors for hemorrhoidal disease include chronic constipation, obesity, increasing age or pregnancy. But there are many reasons you might find yourself looking for solutions to hemorrhoids, some of which you can take steps to change.

Preventing Hemorrhoids

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Overall lifestyle modifications can help prevent the excess pressure that causes hemorrhoids. Try incorporating some of the following advice into your daily routine to help protect against piles and their recurrence. 2

Eat high fibre foods

Try including more high fibre foods in your diet such as fruits, vegetables, brown rice, wholewheat pasta and wholemeal breads. These will keep your stools soft and avoid constipation (which can lead to straining and result in Hemorrhoids).

Exercise

Regular exercise will help relax muscles and increase blood flow for better healing.

Drink plenty of fluids

Drinking plenty of fluids (especially water) will help keep your stools soft and manageable.

Go when you need to

If you wait to pass a bowel movement, it can result in your stool becoming dry and harder to pass.

Try a fibre supplement

A fibre supplement can help ensure you are getting enough fibre in your diet if you struggle to get enough through foods.

Avoid sitting for too long

Sitting for too long, particularly on the toilet can increase the pressure on the veins around your anus making them more susceptible to Hemorrhoids/prolapse.

Don’t strain

Straining on the toilet can put even more unwanted pressure on the blood vessels and aggravate an already sensitive area.

In addition to lifestyle modifications, there are a range of treatments available for easing the symptoms of hemorrhoids, including gels, creams and suppositories.

Frequently Asked Questions

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Do I need a prescription for Daflon?

Daflon is an over-the-counter treatment so no need for a prescription. If you can’t find it, your pharmacist should be able to order it for you. You might even be able to order it online depending on your location.

What is Daflon used for?

Daflon is an oral treatment that helps to reduce the signs and symptoms associated with hemorrhoids, such as bleeding, anal discharge, pain, inflammation, itching, redness (erythema), discomfort, sensation of needing to pass stools, and swelling (edema).

How do I take Daflon correctly for hemorrhoids?

6 tablets daily for 4 days, then 4 tablets daily for the next 3 days at mealtimes. will provide relief during acute attacks. After this, 1 tablet twice a day for two months will help prevent relapse. For use beyond two months, you should consult your doctor.

How long should I take Daflon for?

You should continue taking daflon 1000 one tablet once a day (or daflon 500 one tablets twice a day) for two months after an acute episode to help prevent relapse.

I take a lot of medication, can Daflon be taken with other medications?

You should speak with your doctor and discuss whether daflon is safe to combine with your other medications.

What is Daflon?

Daflon’s active ingredient is a micronized purified flavonoid fraction (MPFF). It is composed of citrus bioflavonoids, containing 90% diosmin and 10% other flavonoids expressed as hesperidin.

What does micronised mean?

Micronized means that a substance has been broken into very small particles for more effective absorption.

How tolerated is Daflon?

Daflon is well tolerated, and side effects observed in trials were mild. Possible side effects include hypersensitivity/allergy, gastrointestinal discomfort, dizziness, headaches, malaise, and skin reactions.

Does Daflon have any side effects?

Daflon is an oral treatment that helps to relieve the signs and symptoms of mild-to-moderate chronic venous insufficiency, such as varicose and spider veins, leg pain, leg cramps and the sensation of heavy legs. It also helps to reduce lower leg edema associated with the condition.

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. 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.
  2. Lohsiriwat V et al. Hemorrhoids: From basic pathophysiology to clinical Management World.
  3. Journal of Gastroenterology 2012. May 7;18 (17): 2009-2017. Chronic venous and HemORrhoidal diseases evalUation and Scientific research; Godeberge P.J Gastroenerol Hepatol. 2020;35:557-87
  4. Godeberge, Sheikh, Lohsiriwat, Jalife, Shelygin. Micronized purified flavonoid fraction in the treatment of hemorrhoidal disease. J Comp Eff Res 2021; 10(10):801-813. Misra M. et al.. British Journal of Surgery 2000, 87, 868-872.

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