NOTICE
ANSM - Updated on: 20/06/2017
Name of the medicinal product
CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-coated tablet
L-cystine
Pyridoxine Hydrochloride
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, pharmacist or nurse.
· 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, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 1 month.
Do not use this medication for children.
What is in this leaflet?
1. What is CYSTINE / VITAMIN B6 BIOGARAN COUNCIL 500 mg / 50 mg film-coated tablet and in which cases is it used?
2. What should I tell you before taking CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-coated tablet?
3. How to take CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-coated tablet?
4. What are the possible side effects?
5. How to store CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg / 50 mg film-coated tablet?
6. Package contents and other information.
1. WHAT IS CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: D11, A11JC.
OTHER DERMATOLOGICAL PREPARATIONS.
VITAMINS, OTHER ASSOCIATIONS.
(D. Dermatology)
This medication constitutes a supply of cystine, sulfated amino acid and vitamin B6.
This medication is recommended as an adjunct to nails or fragile hair.
You should contact your doctor if you experience no improvement or feel less well after 1 month.
2. BEFORE YOU TAKE CYSTINE / VITAMIN B6 BIOGARAN COUNCIL 500 mg / 50 mg film-coated tablet?
Do not take CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg / 50 mg film-coated tablets:
· if you are allergic to L-cystine or pyridoxine hydrochloride or any of the other ingredients of this medication mentioned in section 6.
· If you are allergic to peanut or soy because this medicine contains soy lecithin.
· cystinuria.
· (see "Other medicines and CYSTINE / VITAMIN B6 BIOGARAN COUNCIL 500 mg / 50 mg film-coated tablet").
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg / 50 mg film-coated tablet.
Special warnings :
Treatment with this medication does not preclude any specific treatment.
If symptoms persist beyond one month of treatment, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
Children and Youth
Not applicable.
Other medicines and CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Inhibition of the activity of levodopa when used without a peripheral dopadecarboxylase inhibitor.
Avoid any intake of pyridoxine in the absence of dopadecarboxylase inhibitor.
In order to avoid possible interactions between several medicines, you should systematically report any other treatment in progress to your doctor or pharmacist.
CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg, film-coated tablets with food and beverages
Not applicable.
Pregnancy and breast feeding
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.
Driving and using machines
Not applicable.
CYSTINE / VITAMIN B6 BIOGARAN COUNCIL 500 mg / 50 mg film-coated tablet contains soya lecithin.
3. HOW TO TAKE CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-coated tablet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
RESERVED FOR ADULTS.
Dosage
4 tablets per day in 2 doses to be taken during meals.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION:
· IT MAY NOT BE ADAPTED TO ANOTHER CASE.
· DO NOT ADVISE IT TO ANOTHER PERSON.
Administration mode
Swallow the tablets with a large glass of water.
Frequency of Administration
2 take to take during meals.
Duration of treatment
The duration of treatment is 1 month; At the end of this period, if the symptoms persist, the patient should contact his doctor or pharmacist.
If you take more CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg, film-coated tablet you should not have
Immediately consult your doctor or pharmacist.
If you forget to take CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg / 50 mg, film-coated tablet
Do not take a double dose to make up for a forgotten dose.
If you stop taking CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg, film-coated tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
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, pharmacist or nurse. 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 CYSTINE / VITAMIN B6 BIOGARAN TIP 500 mg / 50 mg film-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 carton. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CYSTINE / VITAMIN B6 contains contains BIOGARAN CONSEIL 500 mg / 50 mg film-coated tablet
· The active substances are:
L-cystine ............................................... .................................................. ........................ 500.00 mg
Pyridoxine hydrochloride (vitamin B6) ........................................... ................................ 50.00 mg
For a film-coated tablet.
· The other components are:
Microcrystalline cellulose, talc, magnesium stearate.
Laminating:
Opadry II Yellow *, macrogol 6000.
* Composition of Opadry II Yellow: polyvinyl alcohol, talc, macrogol 4000, titanium dioxide (E171), soya lecithin, quinoline yellow aluminum lacquer, yellow iron oxide (E172).
What is CYSTINE / VITAMIN B6 BIOGARAN CONSEIL 500 mg / 50 mg film-coated tablets and contents of the pack
This medication is in the form of a film-coated tablet, 20, 60 or 120 tablets.
Marketing Authorization Holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
BTT LABORATORIES
KRAFT ZI
67150 ERSTEIN
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).
Health Education Council:
· Fragile hair and nails are disorders of the appendages that may occur in certain situations that may be considered normal or pathological (related to a specific disease or disorder of the body).
· When a specific disease or disorder of the organism is causing disorders of the appendages, a treatment will be determined by your doctor.
Hair loss
· Hair loss (or alopecia) is frequently associated with capillary fragility.
· Sudden hair loss over a short period of time may be diffuse or patchy (alopecia areata) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, certain medications, psychic shock, stress. ..).
· Chronic (long-term) hair loss (or alopecia) is almost always diffuse. They are sometimes due to a specific disease (thyroid, metabolic ...). In the vast majority, these chronic alopecia are of poorly known origin, usually of hereditary character.
· Normally the hair has a lifetime of 3 to 6 years and it drops 50 to 100 hair per day. A greater fall in hair may occur seasonally (in the fall) or after delivery: this fall is normal, transient and there is no need to start treatment. Alopecia is defined as hair loss greater than 100 hairs per day.
Fragile nails
· The fragility of the nails is manifested by a splitting of the nail tablet, a hyperstriation on the length of the nail.
· Larger anomalies of the nails may be due to infection (eg mycosis) or other dermatological disease (psoriasis). An isolated abnormality of a nail may be due to a tumor of the nail.
· Frailty of the nails can be linked to a deficiency (especially iron deficiency), it can be associated with a fragility of the hair or alopecia.
· It is recommended to protect the hands from moisture and trauma.