Warnings and precautions Hemorrhoidal crisis: If hemorrhoidal symptoms do not subside within 15 days, it is essential to consult your doctor.

Venous circulation disorders: This treatment is most effective when combined with a healthy lifestyle. · Avoid exposure to the sun, heat, prolonged standing, and excess weight. · Walking and possibly wearing suitable stockings promote blood circulation.

Talk to your doctor or pharmacist before taking DAFLON 500 mg, film-coated tablet.

Children Not applicable.

Other medications and DAFLON 500 mg, film-coated tablet Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. DAFLON 500 mg, film-coated tablet with food and beverages Not applicable.

Pregnancy and breastfeeding If you are pregnant or breastfeeding, if you think you may be pregnant or planning a pregnancy, seek advice from your doctor or pharmacist before taking this medication.

PUBLIC DATABASE OF MEDICATIONS Visit [medicaments.gouv.fr] Home | Glossary | Help Last update on 06/28/2021 Medication description Information Usage Side effects Storage Additional info. SUMMARY

Pregnancy As a precautionary measure, it is better to avoid using DAFLON during pregnancy.

Breastfeeding In the absence of data on the passage of the medication into breast milk, breastfeeding is not recommended during the duration of the treatment.

Driving and using machines Not applicable.

DAFLON 500 mg, film-coated tablet contains Not applicable.

3. HOW TO TAKE DAFLON 500 mg, film-coated tablet? Always take this medication exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Venous insufficiency: The recommended dose is 2 tablets per day, one tablet at noon and one tablet in the evening during meals.

Hemorrhoidal crisis: The recommended dose is 6 tablets per day for 4 days, then 4 tablets per day for the following 3 days during meals.

If you have taken more DAFLON 500 mg, film-coated tablet than you should Consult your doctor or pharmacist immediately. Data regarding overdosage with DAFLON are limited, but reported symptoms include diarrhea, nausea, abdominal pain, itching, and rash.

If you forget to take DAFLON 500 mg, film-coated tablet Not applicable.

If you stop taking DAFLON 500 mg, film-coated tablet Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS? Like all medications, this medication can cause side effects, but they do not occur systematically in everyone. The frequency of possible side effects listed below is defined using the following system: · very common (affects more than 1 user in 10) · common (affects 1 to 10 users in 100) · uncommon (affects 1 to 10 users in 1,000) · rare (affects 1 to 10 users in 10,000) · very rare (affects fewer than 1 user in 10,000) · unknown frequency (available data do not allow estimating the frequency)

They may include: Common: diarrhea, dyspepsia, nausea, vomiting. Uncommon: colitis. Rare: dizziness, headache, malaise, rash, itching, urticaria. Unknown frequency: abdominal pain, isolated facial edema, eyelid edema, lip edema. Exceptionally, Quincke's edema.

Reporting of side effects If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr By reporting side effects, you help provide more information on the medication's safety.

5. HOW TO STORE DAFLON 500 mg, film-coated tablet? Keep this medication out of the sight and reach of children. Do not use this medicine after the expiry date stated on the box. The expiry date refers to the last day of that month. No special storage conditions are required. Do not dispose of any medication in the sewer or with household waste. Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION What DAFLON 500 mg, film-coated tablet contains · The active substances are: Micronized purified flavonoid fraction .......................................................................... 500,000 mg Corresponding to: Diosmin 90% .................................................................................................... 450,000 mg Flavonoids expressed as hesperidin 10% ............................................................ 50,000 mg Average moisture ........................................................................................................... 20,000 mg For a film-coated tablet. · The other components are: Sodium carboxymethyl starch, microcrystalline cellulose, gelatin, magnesium stearate, talc. Coating: titanium dioxide (E 171), glycerol, sodium lauryl sulfate, macrogol 6000, hypromellose, yellow iron oxide (E 172), red iron oxide (E 172), magnesium stearate.

What DAFLON 500 mg, film-coated tablet looks like and contents of the outer packaging This medicine is presented as a film-coated tablet. Boxes of 15, 20, 30, 36, 60, 100, or 120 film-coated tablets.

Marketing Authorization Holder LES LABORATOIRES SERVIER 50 RUE CARNOT 92284 SURESNES CEDEX

Marketing Authorization Operator LES LABORATOIRES SERVIER 50 RUE CARNOT 92284 SURESNES CEDEX

Manufacturer LES LABORATOIRES SERVIER INDUSTRIE 905 ROUTE DE SARAN 45520 GIDY

Names of the medicine in the European Economic Area member states Not applicable.

The last date on which this leaflet was revised is: [to be completed later by the holder]

Other Detailed information on this medicine is available on the website of the French National Agency for Medicines and Health Products Safety (ANSM).