NOTICE
ANSM - Updated: 21/09/2017
Name of the drug
BECILAN 250 mg / 5 ml solution for injection
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 / 5 ml solution for injection and when is it used?
2. What you need to know before using BECILAN 250 mg / 5 ml solution for injection?
3. How to use BECILAN 250 mg / 5 ml solution for injection?
4. What are the possible side effects?
5. How to store BECILAN 250 mg / 5 ml solution for injection?
6. Contents of the package and other information.
1. WHAT BECILAN 250 mg / 5 ml solution for injection 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, when the oral route is not possible.
2. BEFORE YOU USE BECILAN 250 mg / 5 ml solution for injection?
Do not use BECILAN 250 mg / 5 ml solution for injection:
· in the event of a history of allergy to one of the constituents,
· in combination with levodopa.
Warnings and precautions
Special warnings
This product contains sulphites which may cause or aggravate anaphylactic reactions. |
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Other medicines and BECILAN 250 mg / 5 ml solution for injection
This medicine is contraindicated in combination with levodopa.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
BECILAN 250 mg / 5 ml solution for injection with food, drink 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 for advice before taking any medicine.
Driving and using machines
Not applicable.
BECILAN 250 mg / 5 ml solution for injection contains sodium sulphite.
3. HOW TO USE BECILAN 250 mg / 5 ml solution for injection?
Dosage
RESERVED FOR THE ADULT.
1 to 2 ampoules 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
Intramuscular or intravenous way.
Duration of treatment
Do not use for long periods. Respect the recommended doses.
If you use more BECILAN 250 mg / 5 ml solution for injection 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 use BECILAN 250 mg / 5 ml, solution for injection
Not applicable.
If you stop using BECILAN 250 mg / 5 ml, solution for injection
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 / 5 ml solution for injection?
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.
After opening, the product should be used immediately.
Before opening: Store below 25 ° C and protect from light.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What BECILAN contains 250 mg / 5 ml solution for injection
· The active substance is:
Pyridoxine hydrochloride (Vitamin B 6 ) .......................................... ............................ 250.0 mg
For a 5 ml ampoule.
· The other components are:
Excipients: Sodium hydrogen phosphate dodecahydrate, anhydrous sodium sulphite, water for injections.
Inert gas: nitrogen.
What BECILAN 250 mg / 5 ml solution for injection and contents of the pack
This medicine is in the form of an injectable solution. Box of 5 or 50 ampoules of 5 ml.
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 RUE DU COMMANDANT RIVIERE
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).