NOTICE
ANSM - Updated: 27/10/2016
Name of the drug
DAFLON 1000 mg film-coated tablets
Purified micronized flavonoid fraction
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable 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.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is DAFLON 1000 mg film-coated tablet and what is it used for?
2. What you need to know before taking DAFLON 1000 mg film-coated tablets.
3. How to take DAFLON 1000 mg film-coated tablets?
4. What are the possible side effects?
5. How to store DAFLON 1000 mg film-coated tablets?
6. Contents of the package and other information.
1. WHAT DAFLON 1000 mg film-coated tablet IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: VASCULOPROTECTIVES / DRUGS ON CAPILLARY / BIOFLAVONOIDS - ATC code: C05CA53.
This drug is a veinotonic (it increases the tone of the veins) and a vasoprotector (it increases the resistance of small blood vessels).
This drug is recommended in the treatment of functional signs related to the hemorrhoidal crisis.
If the hemorrhoidal disorders do not give in 15 days, it is essential to consult your doctor.
2. BEFORE YOU TAKE DAFLON 1000 mg film-coated tablets.
Do not take DAFLON 1000 mg film-coated tablets:
· if you are allergic (hypersensitive) to the purified micronized flavonoid fraction or any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking DAFLON 1000 mg film-coated tablets .
children
Not applicable.
Other medicines and DAFLON 1000 mg film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DAFLON 1000 mg film-coated tablets with food and drink
Not applicable.
Pregnancy and breast feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice or pharmacist before taking this medicine.
feeding
In the absence of data on the passage of the drug into breast milk, breastfeeding is not recommended during the course of treatment.
Ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
DAFLON 1000 mg film-coated tablet contains
Not applicable.
3. HOW TO TAKE DAFLON 1000 mg film-coated tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
The recommended dose is 3 tablets daily for 4 days, then 2 tablets daily for the next 3 days at mealtimes.
If you take more DAFLON 1000 mg film-coated tablets than you should:
Immediately consult your doctor or pharmacist.
Overdose may aggravate the side effects.
If you forget to take DAFLON 1000 mg film-coated tablets:
Not applicable.
If you stop taking DAFLON 1000 mg film-coated tablets:
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
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)
· frequent (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)
· unknown frequency (available data do not allow estimation of frequency)
They can include:
Common: diarrhea, indigestion, nausea, vomiting.
Uncommon: colitis.
Rare: dizziness, headache, malaise, rash, pruritus, urticaria.
Frequency unknown: abdominal pain, isolated edema 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 undesirable 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 the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE DAFLON 1000 mg film-coated tablets
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 carton. The expiry date refers to the last day of this month.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What DAFLON contains 1000 mg film-coated tablets
· The active substances are:
Purified micronized flavonoid fraction ............................................................... 1000.000 mg
Corresponding to :
.. Diosmine 90 percent .......................................................................................... .900,000 mg
... Flavonoids expressed as hesperidin 10 percent ...................................................... 100,000 mg
Average humidity ................................................................................. ................ 40,000 mg
For a film-coated tablet.
· The other components are:
Sodium carboxymethyl starch, microcrystalline cellulose, gelatin, magnesium stearate, talc.
Film coating : titanium dioxide (E 171), glycerol, sodium lauryl sulphate, macrogol 6000, hypromellose, yellow iron oxide (E 172), red iron oxide (E 172), magnesium stearate.
What DAFLON 1000 mg film-coated tablet looks like and contents of the pack
This drug is in the form of film-coated tablet. Boxes of 18, 30, 36 or 40 film-coated tablets.
Not all presentations may be marketed.
Marketing Authorization Holder
SERVIER LABORATORIES
50 CARNOT RUE
92284 SURESNES Cedex
Operator of the marketing authorization
SERVIER LABORATORIES
50 CARNOT RUE
92284 SURESNES Cedex
Maker
SERVIER INDUSTRIE LABORATORIES
905 Saran Road
45520 Gidy
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Drink 1.5 to 2 liters of water a day, consume high fiber foods to avoid constipation (fruits, green vegetables, whole grains).
Avoid fats, coffee, alcohol and spicy foods.
Exercise regularly to stimulate blood flow.
Avoid wearing heavy objects.