NOTICE
ANSM - Updated on : 30/05/2024
Product name
BEPANTHENE 250 mg/ml, solution for injection I.M.
Dexpanthenol
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been personally prescribed for you. Do not give it to other people. It could harm them, even if the signs of their illness are the same as yours.
- If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
What does this leaflet contain?
1. What is BEPANTHENE 250 mg/ml, solution for injection I.M. and what is it used for?
2. What do I need to know before using BEPANTHENE 250 mg/ml, solution for injection I.M.?
3. How should BEPANTHENE 250 mg/ml, solution for injection I.M. be used?
4. What are the possible side effects?
5. How to store BEPANTHENE 250 mg/ml, solution for injection I.M.?
6. Package contents and other information.
1. WHAT IS BEPANTHENE 250 mg/ml, solution for injection I.M. AND WHAT IS IT USED FOR?
VITAMIN B5 (D : Dermatology)
Adjunctive treatment of diffuse alopecia.
Consult your doctor if you do not feel any improvement or if you feel worse after 6 weeks.
2. WHAT DO I HAVE TO KNOW BEFORE USING BEPANTHENE 250 mg/ml, solution for injection I.M.?
Never use BEPANTHENE 250 mg/ml, solution for injection I.M. :
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- if you suffer from intestinal obstruction or obstruction.
Warnings and precautions
Talk to your doctor or pharmacist before using BEPANTHENE 250 mg/ml, solution for injection I.M.
Children
Not applicable.
Other medicinal products and BEPANTHENE 250 mg/ml, solution for injection I.M.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
BEPANTHENE 250 mg/ml, solution for injection I.M. with food and drink
Not applicable.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy or while breast-feeding.
If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can decide whether you should continue treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
3. HOW TO USE BEPANTHENE 250 mg/ml, solution for injection I.M.?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
FOR ADULTS ONLY.
In all cases, strictly adhere to your doctor's instructions.
The recommended dose is 1 to 2 ampoules per day by intramuscular injection, 3 times a week for 6 weeks.
Method and route of administration
Solution for intramuscular injection.
If you have used more BEPANTHENE 250 mg/ml, solution for injection I.M. than you should have :
Not applicable.
If you forget to use BEPANTHENE 250 mg/ml, solution for injection I.M. :
Not applicable.
If you stop using BEPANTHENE 250 mg/ml, solution for injection I.M. :
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.
Very rare adverse reactions (which may affect less than one person in 10,000):
- Allergic reactions:
- redness or hives-like reaction (skin rash identical to that caused by a nettle sting),
- exceptionally, angioedema (a type of hives with sudden swelling of the face causing breathing difficulties) and bronchial spasm.
Undesirable effects for which the frequency is undetermined :
- Injection site reaction
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE BEPANTHENE 250 mg/ml, solution for injection I.M.?
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.
Do not dispose of any medicine in the garbage. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BEPANTHENE 250 mg/ml, solution for injection I.M. contains
- The active substance is :
Dexpanthenol (vitamin B5)......................................................................................... 250.0 mg
For 1 ml of injectable solution
- Other ingredients are: pantolactone, water for injection.
What BEPANTHENE 250 mg/ml, solution for injection I.M. is and what it contains
BEPANTHENE 250 mg/ml, solution for injection I.M., 2 ml ampoule, box of 6.
Marketing authorization holder
BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE
33, RUE DE LINDUSTRIE
74240 GAILLARD
FRANCE
Manufacturer
DOPPEL FARMACEUTICI S.R.L
VIA VOLTURNO 48
20089 ROZZANO (MILANO)
ITALY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.