NOTICE
ANSM - Updated on : 12/06/2025
Product name
BECOZYME, solution for injection in ampoule
Thiamine hydrochloride / Riboflavin sodium phosphate / Nicotinamide / Pyridoxine hydrochloride / Dexpanthenol
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine in accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and 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 do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is BECOZYME, solution for injection in ampoule and what is it used for?
2. What do I need to know before using BECOZYME, solution for injection in ampoules?
3. How do I use BECOZYME, solution for injection in ampoules?
4. What are the possible side effects?
5. How to store BECOZYME, solution for injection in ampoule?
6. Package contents and other information.
1. WHAT IS BECOZYME, solution for injection in ampoule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - VITAMINS (A. Digestive system and metabolism) ATC code: A11EA.
This drug is indicated to prevent vitamin B deficiency in cases of exclusive parenteral nutrition.
2. WHAT DO I HAVE TO KNOW BEFORE USING BECOZYME, solution for injection in ampoule?
Never use BECOZYME, solution for injection in ampoules:
- if you are allergic to the active substances or to any of the other ingredients of this medicine, as listed in section 6.
- in association with levodopa.
Warnings and precautions
Talk to your doctor or pharmacist before using BECOZYME, solution for injection in ampoules.
- Do not exceed the recommended dosage.
- Consult your doctor before taking this medicine if you are already taking vitamin preparations or any other treatment.
- The risk of an allergic reaction is increased in the case of repeated I.M. or I.V. injections. Oral administration should therefore be preferred wherever possible.
- If you have kidney problems, consult your doctor before taking BECOZYME, solution for injection in ampoule.
- If you are scheduled to undergo a biological examination, inform your doctor, as taking BECOZYME, solution for injection in ampoules could alter the results.
Children and adolescents
Not applicable.
Other medicinal products and BECOZYME, solution for injection in ampoule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine is contraindicated in combination with levodopa.
BECOZYME, solution for injection in ampoule with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
Under normal conditions of use, this medicine may be used during pregnancy and lactation.
There are no data demonstrating an effect of BECOZYME, solution for injection in ampoules on fertility.
Driving and use of machinery
Not applicable.
BECOZYME, solution for injection in ampoule contains
Not applicable.
3. HOW DO I USE BECOZYME, solution for injection in ampoules?
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
1 to 2 ampoules per day.
Method of administration
IM, IV or IV infusion.
If you have taken more BECOZYME, solution for injection in ampoules than you should have
Overdosage is not expected at the recommended doses, especially as all reported cases were associated with the concomitant use of high-dose mono- or poly-vitamin preparations.
Symptoms of overdosage may include confusion, gastrointestinal disorders (such as constipation, diarrhoea, nausea and vomiting).
If such symptoms occur, discontinue treatment and consult a doctor.
If you forget to take BECOZYME, solution for injection in ampoule
Not applicable.
If you stop taking BECOZYME, solution for injection in ampoules
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.
Undesirable effects have been reported with undetermined frequency (cannot be estimated on the basis of available data):
- Digestive disorders: abdominal pain, nausea, vomiting, constipation and diarrhea
- Allergic manifestations: asthma, moderate reactions affecting the skin, respiratory tract, gastrointestinal tract and/or cardiovascular system. Symptoms may include rash, nettle rash, facial swelling, pruritus, wheezing, erythema, cardiorespiratory distress, and severe reactions including anaphylactic shock. In the event of an allergic episode, treatment should be discontinued immediately and medical advice sought.
- Headache
- Slight discoloration of urine
- Moderate reaction at the injection site
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect 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: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE BECOZYME, solution for injection in ampoule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging after EXP. The expiration date refers to the last day of that month.
After opening: store at a temperature not exceeding 25°C.
Do not dispose of any medicine in the drain or with the 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 BECOZYME, solution for injection in ampoule contains
- The active ingredients are :
Thiamine hydrochloride (Vitamin B1)......................................................................... 10.00 mg
Riboflavin sodium phosphate (Vitamin B2)............................................................. 5.47 mg
Nicotinamide (Vitamin PP).......................................................................................... 40.00 mg
Pyridoxine hydrochloride (Vitamin B6)........................................................................ 4.00 mg
Dexpanthenol (Vitamin B5).......................................................................................... 6.00 mg
For one 2-ml ampoule.
- The other components are :
Phenol, concentrated hydrochloric acid, water for injection.
What BECOZYME, solution for injection in ampoule is and what it contains
This medicine is supplied as a solution for injection in 2 ml ampoules.
Boxes of 6, 12 or 30 ampoules.
Marketing authorization holder
BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE SAS
33 RUE DE LINDUSTRIE
74240 GAILLARD
Manufacturer
DOPPEL FARMACEUTICI S.r.l.
VIA VOLTURNO, 48
QUINTO DE' STAMPI
20089 ROZZANO (MI), ITALY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
MM/YYYY
Other
Detailed information on this drug is available on the ANSM France website.