NOTICE
ANSM - Updated on: 14/01/2019
Name of the drug
DAFLON 500 mg film-coated tablet.
Micronized purified flavonoic fraction
framed
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
You should always take this medicine by carefully following the information provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information .
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What DAFLON 500 mg film-coated tablet is and what it is used for
2. What you need to know before you take DAFLON 500 mg film-coated tablet?
3. How to take DAFLON 500 mg film-coated tablet?
4. What are the possible side effects?
5. How to store DAFLON 500 mg film-coated tablet?
6. Contents of the pack and other information.
1. WHAT DAFLON 500 mg film-coated tablet IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: VASCULOPROTECTORS / MEDICAMENTS ACTING ON CAPILLARIES / BIOFLAVONOIDS - ATC code: C05CA53: cardiovascular system
This medication is a veinotonic (it increases the tone of the veins), and a vasculoprotective (it increases the resistance of small blood vessels).
It is recommended in the treatment of venous circulation disorders (heavy legs, pain, impatience of the primo-decubitus) and in the treatment of functional signs related to the hemorrhoidal crisis.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE DAFLON 500 mg film-coated tablets?
Do not take DAFLON 500 mg film-coated tablet:
· if you are allergic to the micronized purified flavonoids fraction or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Hemorrhoidal crisis:
If the hemorrhoidal disorders do not give way in 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, excess weight.
· Walking and possibly wearing adapted stockings promote blood circulation.
Talk to your doctor or pharmacist before taking DAFLON 500 mg film-coated tablet.
children
Not applicable.
Other medicines and DAFLON 500 mg film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DAFLON 500 mg film-coated tablet with food and drink
Not applicable.
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 precaution, it is best to avoid the use of DAFLON during pregnancy.
feeding
In the absence of data on the passage of the drug into breast milk, breastfeeding is not recommended for the duration of 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 directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Venous insufficiency : The recommended dose is 2 tablets per day, one tablet at noon and one tablet in the evening with meals.
Hemorrhoidal crisis : The recommended dose is 6 tablets per day for 4 days, then 4 tablets per day for the next 3 days with meals.
If you take more DAFLON 500 mg film-coated tablet than you should
Immediately consult your doctor or pharmacist.
Data on overdose with DAFLON are limited but reported symptoms include diarrhea, nausea, abdominal pain, pruritus 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 medicines, this medicine can cause side effects, although not everybody gets them.
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 less than 1 user in 10,000)
· frequency unknown (the available data do not allow to estimate the frequency)
They can include:
Common: diarrhea, dyspepsia, nausea, vomiting.
Uncommon: colitis.
Rare: dizziness, headache, malaise, rash, pruritus, hives.
Unknown frequency: abdominal pain, isolated swelling of the face, eyelids, lips. Exceptionally, angioedema.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect that is 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 network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DAFLON 500 mg, film-coated tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box. The expiration date refers to the last day of this month.
No special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment .
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What DAFLON 500 mg contains, film-coated tablet
· The active substances are:
Micronized purified flavonoic fraction .............................................. ............................ 500,000 mg
Corresponding to :
Diosmin 90 percent .............................................. .................................................. .... 450,000 mg
Flavonoids expressed as hesperidin 10 percent ........................................... ................. 50,000 mg
Average humidity ................................................ .................................................. ......... 20,000 mg
For a film-coated tablet.
· The other components are:
Carboxymethyl starch sodium, microcrystalline cellulose, gelatin, magnesium stearate, talc.
Film 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 pack
This drug is in the form of film-coated tablet. Boxes of 15, 20, 30, 36, 60, 100 or 120 film-coated tablets.
Marketing authorization holder
SERVIER LABORATORIES
50 CARNOT STREET
92284 SURESNES CEDEX
Marketing authorization operator
SERVIER LABORATORIES
50 CARNOT STREET
92284 SURESNES CEDEX
Maker
SERVIER INDUSTRY LABORATORIES
905 ROUTE DE SARAN
45520 GIDY
Names of the drug in the member states of the European Economic Area
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 ANSM website (France).