In this manual :
1. WHAT IS CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet
3. HOW TO TAKE CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
OTHER DERMATOLOGICAL PREPARATIONS
VITAMINS, OTHER COMBINATIONS
(D. Dermatology)
(S. Ophthalmology)
This medicine is recommended as an adjunct to the treatment of corneal healing disorders and in cases of fragile nails or hair.
2. WHAT YOU SHOULD KNOW BEFORE TAKING CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet
List of information needed before taking the medicine
Not applicable.
Never take CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet in the following cases:
- Cystinuria.
- In combination with levodopa (see Taking or using other medicines).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take caution with CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet:
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Inhibition of Levodopa activity when used without peripheral dopadecarboxylase inhibitor.
Pyridoxine intake should be avoided in the absence of a dopadecarboxylase inhibitor.
In order to avoid possible interactions between several drugs, you must systematically inform your doctor or pharmacist of any other treatment in progress.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
4 tablets per day in 2 doses to be taken with meals.
THIS MEDICINE HAS BEEN PERSONALLY DELIVERED TO YOU IN A SPECIFIC SITUATION:
- IT MAY NOT BE SUITABLE FOR ANOTHER CASE
- DO NOT ADVISE IT TO ANOTHER PERSON.
Method and route of administration
ORAL ROUTE
Swallow the tablets with a large glass of water.
Frequency of administration
2 doses to be taken with meals.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
If you forget to take CYSTINE / VITAMIN B6 BIOGARAN CONSEIL, film-coated tablet:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, CYSTINE / VITAMIN B6 BIOGARAN CONSEIL, film-coated tablet is likely to have undesirable effects, although not everyone is subject to them.
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
If you notice any side effects, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50 mg, film-coated tablet
Keep out of the reach and sight of children.
Do not use CYSTINE / VITAMIN B6 BIOGARAN CONSEIL, film-coated tablet after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50mg, film-coated tabletcontain?
The active ingredients are:
L-cystine ..................................................................................................................................... 500.00 mg
Pyridoxine hydrochloride (vitamin B6) .......................................................................................... 50.00 mg
For one film-coated tablet.
The other components are :
Microcrystalline cellulose, talc, magnesium stearate.
Film coating Opadry II Yellow*, macrogol 6000.
*Composition of Opadry II Yellow: polyvinyl alcohol, talc, macrogol 4000, titanium dioxide (E171), soy lecithin, quinoline yellow aluminium lake, yellow iron oxide (E172).
Pharmaceutical form and content
Whatis CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg/50mg, film-coated tablet and what does it contain?
This medicine is presented as a film-coated tablet, box of 20, 60 or 120 tablets.
Not all presentations may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
biogaran
15 boulevard charles gaulle
92700 colombes
Operator
biogaran
15 boulevard charles gaulle
92700 colombes
Manufacturer
Laboratoires btt
zi de krafft
67150 erstein
france
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France) www.afssaps.fr.
Information for health professionals only
Not applicable.
Not applicable.
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