Relieve, Reduce and Treat with Daflon.

An oral treatment for heavy painful legs, varicose veins and other symptoms of poor leg vein health. 1

Do Your Legs Feel Heavy, Swollen and Sore?

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You could be experiencing the first signs of Chronic Venous Insufficiency. Daflon helps reduce and relieve the following signs and symptoms associated with this progressive condition:

Cramping or Leg pain

feet of a heavy painful swollen leg

Heavy, Painful or Swollen Legs

Spider or Varicose veins

Tired Legs

Looks familiar?

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Does Your Bum Itch and Bleed?

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You could be experiencing the uncomfortable itching and bleeding caused by Hemorrhoids. Daflon works quickly to reduce and relieve the following signs and symptoms of acute and recurring hemorrhoids:

Incomplete evacuation

Itchy bottom

Bleeding

Pain or discomfort

Safety Information:

Daflon 500mg Safety Information

Daflon 500mg 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 want 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. Talk to your doctor if you do not feel better or if you feel worse after seven days.

Contents of this sheet:

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

1. What Daflon 500mg is and what is it used for Daflon 500mg is a 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.

2. What you need to know before taking Daflon 500mg Do not take Daflon If you are hypersensitive (allergic) to micronised purified flavonoic 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 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.

3. How to take DAFLON 500 mg Always take this medicine exactly as described in this leaflet or how your doctor or pharmacist has told you. Check with your pharmacist if you are not sure. Oral route. The tablets should be taken at meal times. Venous insufficiency: 2 tablets daily, one at midday and one in the evening. Acute hemorroidal attack: a 4-day course of 6 tablets daily, followed by 4 tablets daily over the next 3 days. If you take more Daflon 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 diarrhoea, nausea, abdominal pain, pruritus and rash. If you forget to take Daflon 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. If you forget to take Daflon Do not take a double dose to make up for a forgotten dose.

4. Possible side effects Like all medicines, DAFLON 500 m 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.

5. How to store Daflon 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.

6. Contents of the package 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

This leaflet was last updated in 10/2022

References:

  1. 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
  2. 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.
  3. Godeberge P. Daflon 500mg is significantly more effective than placebo in the treatment of hemorrhoids. Phlebology. 1992;7(suppl 2):61-63.*

2024