NOTICE
ANSM - Last updated: 06/07/2017
Name of the medicinal product
DIFRAREL 100 mg coated tablet
Anthocyanosidic extract of Vaccinium myrtillus / Beta-carotene
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed 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 experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is DIFRAREL 100 mg, coated tablet and in which cases it is used?
2. What should I tell you before taking DIFRAREL 100 mg coated tablet?
3. How to take DIFRAREL 100 mg, coated tablet?
4. What are the possible side effects?
5. How to store DIFRAREL 100 mg coated tablet?
6. Package contents and other information.
1. WHAT IS DIFRAREL 100 mg coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - VASCULOPROTECTEUR
(C: cardiovascular system)
(S: sensory organs)
ATC code: C05CX
Therapeutic indications :
This medication is indicated for adults:
· In venous circulation disorders,
· In the fragility of small blood vessels,
· In visual disorders of circulatory origin.
Medical advice is needed for the treatment of the fragility of small blood vessels and visual disturbances of circulatory origin.
2. BEFORE YOU TAKE DIFRAREL 100 mg coated tablet?
Cons-indications
Do not take DIFRAREL 100 mg, coated tablet:
· If you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine. If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warning and precautions for use; special warnings
Talk to your doctor or pharmacist before taking DIFRAREL 100 mg coated tablet .
Precautions for use
This medication is effective when combined with a healthy lifestyle.
Avoid exposure to sunlight, heat, prolonged standing, overweight.
Walking and possibly wearing appropriate stockings promotes blood circulation.
If the discomfort and fragility of the vessels increase (blues and bruises spread), consult your doctor immediately.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
children
Not applicable.
Other medicines and DIFRAREL 100 mg coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DIFRAREL 100 mg tablet coated with food and beverages
Not applicable.
Pregnancy and breast feeding
It is best not to use this medication during pregnancy.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
The use of this medication should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
DIFRAREL 100 mg, coated tablet contains sucrose.
3. HOW TO TAKE DIFRAREL 100 mg coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
MEDICAMENT RESERVED FOR ADULTS
Dosage:
For information, the recommended dose is 3 to 6 tablets per day.
Treatment should be done by 20 days per month and then renewed if necessary.
You must follow the dosage indicated by your doctor.
Method and route of administration :
Oral use
The tablets should be swallowed without chewing them with a glass of water.
Duration of treatment :
Treatment should be taken for 20 days per month, and renewed if necessary.
Follow your doctor's advice.
If you take more DIFRAREL 100 mg, coated tablet than you should have
No case of overdose has been reported. However, excessive use may lead to worsening of undesirable effects.
If you think you may have taken more DIFRAREL 100mg, coated tablets than you should, contact your doctor or pharmacist.
If you forget to take DIFRAREL 100 mg, coated tablet
Not applicable.
If you stop taking DIFRAREL 100 mg, coated tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Declaration 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 adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE DIFRAREL 100 mg coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month .
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
Store at a temperature not exceeding 25 ° C.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DIFRAREL 100 mg contains: coated tablet
· The active substances are:
Anthocyanosidic extract of Vaccinium myrtillus ............................................. ........ 100,000 mg
Beta-carotene ................................................................................. .. 5,000 mg
For a coated tablet.
· The other components are:
Kieselguhr (diatomite for oenology), starchy icing sugar, talcum, corn starch, magnesium stearate, rosin, pinus pinaster terebentin essential oil, shellac, sucrose, gelatin, gum arabic, titanium dioxide, talc of corn, blue patented V, opaglos 6000.
What is DIFRAREL 100 mg, coated tablet and contents of the pack
This medication is in the form of coated tablets.
Box of 20, 30, 60 or 80 coated tablets.
Marketing Authorization Holder
BIOCODEX
7 AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Marketing Authorization Operator
BIOCODEX
7 AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Maker
FAMAR THE EAGLE
INDUSTRIAL ZONE N ° 1
ROUTE OF CRULAI
61300 THE EAGLE
LA FRANCE
Or
Cenexi
52, RUE MARCEL and Jacques GAUCHER
94120 FONTENAY-SOUS-BOIS
LA FRANCE
Names of the medicinal product 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).
ADVICE / HEALTH EDUCATION
You suffer from vein-lymphatic circulation disorders of the legs:
· Avoid sitting or standing too long,
· Lightly raise the feet of your bed,
· Practice regular physical activity, such as walking, swimming or cycling,
· Avoid strong sources of heat (solar exhibitions, hot baths, sauna ...),
· Shower your legs with cold water to stimulate blood circulation,
· Be sure to have a healthy and balanced diet,
· Wear loose clothing,
· Wear socks, stockings or tights.