NOTICE
ANSM - Last updated: 29/05/2017
Name of the medicinal product
VITAMIN B1 B6 BAYER, film-coated tablet
Thiamine hydrochloride (vitamin B1)
Pyridoxine hydrochloride (vitamin B6)
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 or pharmacist.
· 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 or pharmacist. 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 4 weeks.
What is in this leaflet?
1. What is VITAMINE B1 B6 BAYER and in which cases it is used?
2. What should be known before taking VITAMINE B1 B6 BAYER?
3. How to take VITAMINE B1 B6 BAYER?
4. What are the possible side effects?
5. How to store VITAMINE B1 B6 BAYER?
6. Package contents and other information.
1. WHAT VITAMIN B1 B6 BAYER IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Vitamin B1 in combination with vitamin B6, ATC code: A11DB.
This medicine is indicated in the states of transient fatigue in the adult (more than 15 years).
You should contact your doctor if you experience no improvement or feel less well after 4 weeks .
2. BEFORE YOU TAKE VITAMIN B1 B6 BAYER?
Do not take VITAMINE B1 B6 BAYER, film-coated tablets:
· if you are allergic to the active ingredients or to any of the other ingredients of this medication mentioned in section 6,
· if you take levodopa,
· if you are pregnant or breastfeeding,
· if you have liver or kidney disease.
Warnings and Precautions
Talk to your doctor or pharmacist before taking VITAMINE B1 B6 BAYER, film-coated tablet.
This medicine contains pyridoxine (vitamin B6). Other medicines contain it. Do not combine them in order not to exceed the recommended daily doses (see Dosage).
Children and Youth
Not applicable.
Other medicines and VITAMIN B1 B6 BAYER, film-coated tablet
This medication is contraindicated in combination with levodopa.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
VITAMIN B1 B6 BAYER, film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This medication is contraindicated during pregnancy and lactation.
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.
VITAMIN B1 B6 BAYER, film-coated tablet contains
Not applicable.
3. HOW TO TAKE VITAMIN B1 B6 BAYER?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
RESERVED FOR ADULTS.
1 to 4 tablets per day.
THIS MEDICINE HAS BEEN PERSONALLY DELIVERED TO YOU IN A SPECIFIC SITUATION.
IT MAY NOT BE ADAPTED TO ANOTHER CASE.
DO NOT ADVISE IT TO ANOTHER PERSON.
Administration mode
Oral use.
The tablets should be swallowed without chewing them with a glass of water.
Duration of treatment
Do not use more than 4 weeks without medical advice.
If you take more VITAMINE B1 B6 BAYER, film-coated tablets than you should have
Not applicable.
If you forget to take VITAMINE B1 B6 BAYER, film-coated tablet
Do not take a double dose to make up for a missed dose.
If you stop taking VITAMINE B1 B6 BAYER, film-coated tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
This medicine may cause:
• allergic reactions: rash, hives, pruritus, sudden swelling of the face and neck (angioedema), cardiorespiratory distress.
IN THESE CASES, STOP THE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.
• skin effects: photosensitivity reaction (sensitivity to light), rash, redness of the skin, itching, urticaria and inflammation of the skin (bullous dermatitis).
• Gastrointestinal effects: diarrhea, difficult digestion, abdominal or stomach pain, nausea, vomiting.
• neurological effects: nerve damage (neuropathy), tingling sensation, tingling (paraesthesia).
An unpleasant odor of urine can be observed.
Declaration of side effects
If you experience any side effects, talk to 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: 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 VITAMIN B1 B6 BAYER?
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 VITAMINE B1 B6 BAYER contains: film-coated tablet
· The active substances are:
Thiamine hydrochloride (Vitamin B1) ........................................... ............................... .250 mg
Pyridoxine hydrochloride (Vitamin B6) ........................................... ............................. 35 mg
For a film-coated tablet
· The other excipients components are:
Mannitol, povidone K 90, talc, magnesium stearate.
Lamination: hypromellose 2910/6 cP, aqueous dispersion of ethylcellulose 30% (ethylcellulose, purified water, sodium laurilsulfate, cetyl alcohol), macrogol 6000, talc, titanium dioxide (E 171).
What is VITAMINE B1 B6 BAYER, film-coated tablets and contents of the pack
This drug is in the form of film-coated tablet.
Box of 20, 40 or 100.
Marketing Authorization Holder
BAYER HEALTHCARE SAS
220 avenue de la Recherche
59120 LOOS
Marketing Authorization Operator
BAYER HEALTHCARE SAS
33, RUE DE L'INDUSTRIE
74240 GAILLARD
Maker
Cenexi
52, RUE MARCEL AND JACQUES GAUCHER
94122 FONTENAY-SOUS-BOIS
Or
GP GRENZACH PRODUKTIONS GMBH
EMIL-BARELL-STRASSE 7
79839 GRENZACH-WYHLEN
GERMANY
Or
DELPHARM GAILLARD
33 STREET OF INDUSTRY
74240 GAILLARD
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:
MM / YYYY
Other
Detailed information on this medicine is available on the ANSM website (France).