NOTICE
ANSM - Updated: 02/08/2017
Name of the drug
BECILAN 250 mg, scored tablet
Pyridoxine hydrochloride
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is BECILAN 250 mg scored tablet and when is it used?
2. What you need to know before taking BECILAN 250 mg scored tablet?
3. How to take BECILAN 250 mg, scored tablet?
4. What are the possible side effects?
5. How to store BECILAN 250 mg, scored tablet?
6. Contents of the package and other information.
1. WHAT IS BECILAN 250 mg scored tablet AND WHAT IT IS USED FOR?
VITAMIN B 6 .
(A. Digestive system and metabolism).
This medicine is indicated in adults for the treatment of vitamin B 6 deficiencies confirmed by the doctor.
2. BEFORE YOU USE BECILAN 250 mg scored tablet?
Do not take BECILAN 250 mg, scored tablet :
· in the event of a history of allergy to one of the constituents,
· in combination with levodopa.
Warnings and precautions
Precautions for use
This medicine should not be used for prolonged periods.
Due to the presence of pyridoxine, the combination with levodopa, which may reduce the activity of L-Dopa, requires precautions for use (see section 4.5).
Talk to your doctor or pharmacist before using BECILAN 250 mg scored tablets .
Other medicines and BECILAN 250 mg, scored tablet
This medicine is contraindicated in combination with levodopa.
IF YOU TAKE OR HAVE RECENTLY TAKEN ANOTHER MEDICINAL PRODUCT, INCLUDING A MEDICINAL PRODUCT OBTAINED WITHOUT ORDER, TELL YOUR DOCTOR OR PHARMACIST.
BECILAN 250 mg, scored tablet with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
It is best not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue this treatment.
If breastfeeding, avoid taking this medicine.
ASK YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINES.
Driving and using machines
Not applicable.
BECILAN 250 mg, scored tablet contains wheat starch
3. HOW TO TAKE BECILAN 250 mg, scored tablet?
Dosage
RESERVED FOR THE ADULT.
1 to 4 tablets a day.
THIS MEDICINE HAS BEEN PERSONALLY DELIVERED TO YOU IN AN ACCURATE SITUATION:
· IT MAY NOT BE ADAPTED TO ANOTHER CASE
· DO NOT ADVISE IT TO ANOTHER PERSON
Method and route of administration
Oral way.
The tablets are swallowed with a little water.
Duration of treatment
Do not use for long periods. Respect the recommended doses.
If you use more BECILAN 250 mg, scored tablet than you should
Neurologic manifestations of somnolence and / or paresthesia have been reported in high doses and / or prolonged courses of pyridoxine hydrochloride. These manifestations are reversible when the treatment is stopped. The treatment is symptomatic.
If you forget to take BECILAN 250 mg, scored tablet
Not applicable.
If you stop taking BECILAN 250 mg, scored tablet
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Exceptional and reversible neurologic manifestations at discontinuation of treatment following high doses and / or prolonged courses of treatment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE BECILAN 250 mg, scored tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
Store at a temperature not exceeding 25 ° C.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What BECILAN contains 250 mg, scored tablet
· The active substance is:
Pyridoxine hydrochloride (Vitamin B 6 ) .......................................... ............................ 250.0 mg
For a scored tablet.
· The other components are:
Excipients: Wheat starch, sodium saccharin, starch icing sugar, hydrated colloidal silica, magnesium stearate.
What BECILAN 250 mg tablets breakable and contents of the pack
This drug is in the form of scored tablets. Box of 40 tablets.
Marketing Authorization Holder
THERANOL DEGLAUDE LABORATORIES
72, RUE DU FAUBOURG SAINT HONORE
75008 PARIS
LA FRANCE
Operator of the marketing authorization
DB PHARMA
1 BIS RIVER COMMANDER STREET
94210 LA VARENNE SAINT-HILAIRE
LA FRANCE
Maker
Cenexi
52, RUE MARCEL AND JACQUES GAUCHER
94120 FONTENAY UNDER WOOD
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
December 2015.
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).