NOTICE
ANSM - Updated on : 05/08/2024
Product name
DIFRAREL E, coated tablet
Blueberry anthocyanosid extract / Dalpha-tocopherol acetate
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and 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 contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is DIFRAREL E, coated tablet and what is it used for?
2. What do I need to know before taking DIFRAREL E, coated tablet?
3. How do I take DIFRAREL E, coated tablet?
4. What are the possible side effects?
5. How do I keep DIFRAREL E, coated tablet?
6. Package contents and other information.
1. WHAT IS DIFRAREL E, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OPHTALMOLOGICAL / VASCULOPROTECTIVE DRUGS (S: sensory organs) - ATC code: S01X
This drug is indicated for the adjunctive treatment of twilight and night vision disorders and myopia.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DIFRAREL E, coated tablet?
Never take DIFRAREL E, coated tablet:
- if you are allergic to the active substances or to any of the other ingredients of this medicine, as listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking DIFRAREL E, coated tablet. In the event of sudden visual disturbance or worsening of a pre-existing visual disturbance, it is necessary to consult your doctor.
Children
Not applicable.
Other medicines and DIFRAREL E, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DIFRAREL E, coated tablet with food and drink
Not applicable.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this product while breast-feeding.
In general, always ask your doctor or pharmacist for advice before taking any medicine during pregnancy or when breast-feeding.
Driving and using machines
Not applicable.
DIFRAREL E, coated tablet contains sucrose and sodium.
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE DIFRAREL E, coated tablet?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage :
The recommended dose is 3 to 6 tablets a day.
Treatment should be carried out in courses of 20 days per month, then repeated if necessary.
Method and route of administration :
Oral route.
Tablets are to be swallowed, without chewing, with a glass of water.
Duration of treatment :
Treatment should be taken in courses of 20 days per month, and repeated if necessary.
Follow your doctor's advice.
If you have taken more DIFRAREL E, coated tablet than prescribed
No cases of overdose have been reported. However, excessive use may aggravate undesirable effects.
If you think you have taken more Difrarel E, coated tablet than you should have, please contact your doctor or pharmacist.
If you forget to take DIFRAREL E, coated tablet
Not applicable.
If you stop taking DIFRAREL E, coated tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Possible side effects include
- Minor digestive disorders.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE DIFRAREL E, coated tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
Store at a temperature not exceeding 30°C.
6. CONTENTS AND OTHER INFORMATION
What DIFRAREL E, coated tablet contains
- The active ingredients are :
Bilberry anthocyanidin extract ............................................................................... 50,000 mg
Alpha-tocopherol acetate concentrate - powder form ...................................... 50,000 mg
For one coated tablet.
- Other components are :
Gelatin, silicic acid, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, gelatin, gum arabic, sucrose, corn starch, talc, titanium dioxide (E171), Opaglos 6000.
What DIFRAREL E, coated tablet is and what it contains
This medicine is a coated tablet.
Box of 24 or 60 coated tablets.
Marketing authorization holder
BIOCODEX
22 RUE DES AQUEDUCS
94250 GENTILLY
Marketing authorization holder
BIOCODEX
22 RUE DES AQUEDUCS
94250 GENTILLY
Manufacturer
FAMAR L'AIGLE
ZONE INDUSTRIELLE N°1,
ROUTE DE CRULAI
61300 L'AIGLE
France
Or
CENEXI - FONTENAY SOUS BOIS
52 rue Marcel et Jacques Gaucher
94120 FONTENAY SOUS BOIS
France
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
October 2020
Other
Detailed information on this drug is available on the ANSM (France) website.