In this manual :
1. WHAT IS CYSTINE B6 BAILLEUL, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING CYSTINE B6 BAILLEUL, film-coated tablet
3. HOW TO TAKE CYSTINE B6 BAILLEUL, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE CYSTINE B6 BAILLEUL, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS CYSTINE B6 BAILLEUL, 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 B6 BAILLEUL, film-coated tablet
List of information needed before taking the medicine
Not applicable.
Never take CYSTINE B6 BAILLEUL, 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 care with CYSTINE B6 BAILLEUL, film-coated tablet:
Precautions for use
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 B6 BAILLEUL, 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)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, CYSTINE B6 BAILLEUL, 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 B6 BAILLEUL, film-coated tablet?
Keep out of the reach and sight of children.
Do not use CYSTINE B6 BAILLEUL, film-coated tablet after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain 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 B6 BAILLEUL, film-coated tablet contain?
The active ingredients are:
L-cystine ...................................................................................................................................... 500.0 mg
Pyridoxine hydrochloride ............................................................................................................... 50.0 mg
For one film-coated tablet.
The other components are :
Sodium carboxymethylcellulose, talc, microcrystalline cellulose (Avicel PH 102), magnesium stearate, sepifilm LP 010 (hypromellose, microcrystalline cellulose, stearic acid), sepisperse AP 3083 yellow (propylene glycol, hypromellose, titanium dioxide (E171), quinolene yellow (E104)), carnauba wax
Pharmaceutical form and content
What is CYSTINE B6 BAILLEUL, film-coated tablet and what does it contain?
This medicine is presented as a film-coated tablet in boxes of 20, 60 or 120.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
LABORATOIRES BAILLEUL-BIORGA
8, rue Laugier
75017 PARIS
Operator
Laboratoires BAILLEUL
7, rue Michelet
93364 NEUILLY-PLAISANCE CEDEX
Manufacturer
GALENIQUES VERNIN Laboratories
20, rue Louis Charles Vernin
77190 DAMMARTE LES LYS
or
OPODEX Laboratories
34-46, avenue du vieux chemin de Saint Denis
92391 VILLENEUVE LA GARENNE
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 of approval of this leaflet was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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