NOTICE
ANSM - Updated on : 23/05/2024
Product name
CYSTINE B6 BAILLEUL, film-coated tablet
L-cystine/Pyridoxine hydrochloride
Sidebar
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 any advice or information you may need.
- 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 after 1 month.
What does this leaflet contain?
1. What is CYSTINE B6 BAILLEUL, film-coated tablet and what is it used for?
2. What do I need to know before taking CYSTINE B6 BAILLEUL, film-coated tablet?
3. How should CYSTINE B6 BAILLEUL, film-coated tablet be taken?
4. What are the possible side effects?
5. How to store CYSTINE B6 BAILLEUL, film-coated tablet?
6. Package contents and other information.
1. WHAT IS CYSTINE B6 BAILLEUL, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER VITAMINIC DRUGS, ASSOCIATIONS ATC code: A11JC
This drug is recommended for the adjunctive treatment of corneal healing disorders and fragile nails and hair.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CYSTINE B6 BAILLEUL, film-coated tablet?
Never take CYSTINE B6 BAILLEUL, film-coated tablet:
- if you are allergic to L-cystine or pyridoxine hydrochloride, or to any of the other components of this medicine listed in section 6,
- in case of cystinuria,
Warnings and precautions
Do not use for prolonged periods. Follow recommended doses.
Talk to your doctor or pharmacist before taking CYSTINE B6 BAILLEUL, film-coated tablet.
If symptoms persist beyond one month's treatment, if they worsen or if new symptoms appear, ask your pharmacist or doctor for advice.
Children and adolescents
Not applicable.
Other medicines and CYSTINE B6 BAILLEUL, film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CYSTINE B6 BAILLEUL, film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
Pregnancy
No or limited data are available on the use of CYSTINE B6 BAILLEUL in pregnant women.
Studies in animals are insufficient to permit conclusions on reproductive toxicity. CYSTINE B6 BAILLEUL is not recommended during pregnancy.
Breast-feeding
As vitamin B6 passes into breast milk, and due to the high levels of pyridoxine present in CYSTINE B6 BAILLEUL, its use during breastfeeding is not recommended.
Driving and use of machinery
Not applicable.
CYSTINE B6 BAILLEUL, film-coated tablet contains propylene glycol.
This medicine contains 6.16 mg propylene glycol per tablet.
3. HOW DO I TAKE CYSTINE B6 BAILLEUL, film-coated tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
The recommended dose is 4 tablets per day in 2 doses, to be taken with meals.
Duration of treatment
Duration of treatment is 1 month; if symptoms persist after this period, contact your doctor or pharmacist.
Method and route of administration
Oral administration
Swallow the tablets with a large glass of water.
If you have taken more CYSTINE B6 BAILLEUL, film-coated tablet than you should have
Neurological manifestations such as paresthesia may occur with high doses and/or prolonged courses of pyridoxine. If you have taken too much CYSTINE B6 BAILLEUL, contact your doctor immediately.
If you forget to take CYSTINE B6 BAILLEUL, film-coated tablet
Do not take a double dose to make up for the one you have forgotten to take.
If you stop taking CYSTINE B6 BAILLEUL, film-coated tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undetermined frequency (available information does not allow frequency to be evaluated) :
Allergic reaction, itching (pruritus), hives, reddening of the skin, lacnea, abnormal development of the hair system at a distance from the point of application (hypertrichosis), hypersensitivity of the skin to light after the use of vitamin B6, gastrointestinal disorders (abdominal pain, flatulence, abdominal distension and diarrhea) may occur.
Neurological manifestations such as paresthesia have been reported with high doses and/or prolonged courses of vitamin B6.
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 Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE CYSTINE B6 BAILLEUL, film-coated tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
No special storage precautions.
Do not dispose of any medicine with your household waste . Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CYSTINE B6 BAILLEUL contains
- 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), quinoline yellow (E104)), carnauba wax.
What CYSTINE B6 BAILLEUL is and what it contains
This medicine comes in the form of a yellow, shiny, lenticular film-coated tablet.
Boxes of 20, 60 or 120 film-coated tablets.
Not all presentations may be marketed.
Marketing authorization holder
Laboratoires Bailleul S.A.
14/16 avenue Pasteur
L-2310 Luxembourg
LUXEMBOURG
Marketing authorization holder
LABORATOIRES BAILLEUL
264 RUE DU FAUBOURG SAINT-HONORE
75008 PARIS
Manufacturer
LABORATOIRES GALENIQUES VERNIN
20, RUE LOUIS CHARLES VERNIN
77190 DAMMARYE LES LYS
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.