Do Your Legs Feel Heavy, Swollen and Sore?
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:
Looks familiar?
Take our quick self-assessment quiz and use your result to help guide your next steps.
Does Your Bum Itch and Bleed?
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:
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:
- 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
- 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.
- Godeberge P. Daflon 500mg is significantly more effective than placebo in the treatment of hemorrhoids. Phlebology. 1992;7(suppl 2):61-63.*
2024