NOTICE
ANSM - Updated on: 23/07/2014
Name of the medicinal product
BEPANTHENE 100 mg tablet
dexpanthenol
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet, you may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet.
Review summary
In this notice :
1. What is BEPANTHENE 100 mg tablets and in which cases is it used?
2. What information should I take before taking BEPANTHENE 100 mg tablet?
3. How to take BEPANTHENE 100 mg tablets?
4. What are the possible side effects?
5. How to store BEPANTHENE 100 mg tablets?
6. Additional information.
1. WHAT IS BEPANTHENE 100 mg tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
VITAMIN B5
(D: Dermatology)
Therapeutic indications
Supplemental treatment of diffuse alopecia.
2. BEFORE YOU TAKE BEPANTHENE 100 mg tablets?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take BEPANTHENE 100 mg tablets in the following cases:
· Allergy known to dexpanthenol or any of the components.
Precautions for use; special warnings
Take special care with BEPANTHENE 100 mg tablet:
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interaction with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy or during breastfeeding. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
No effects on the ability to drive and use machines are expected after taking this medication.
List of excipients with known effect
Important information about some of the ingredients of BEPANTHENE 100 mg:
Presence of lactose.
3. HOW TO TAKE BEPANTHENE 100 mg tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
3 tablets daily for 6 weeks.
Method and route of administration
Oral use.
The tablets should be swallowed with a glass of water.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, BEPANTHENE 100 mg tablet is likely to have undesirable effects, although not everyone is subject to it:
· Rare cases of allergic skin reactions: urticaria.
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 through 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 BEPANTHENE 100 mg tablet?
Keep out of sight and reach of children.
Expiration date
Do not use after the expiry date stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does BEPANTHENE 100 mg contain?
The active substance is :
Dexpanthenol (vitamin B 5 ) ............................................ .................................................. .................. 100 mg
For a tablet.
The other components are :
Colloidal hydrated silica, gum arabic, lactose monohydrate, corn starch, stearic acid, magnesium stearate.
Pharmaceutical form and content
What is BEPANTHENE 100 mg tablets and contents of the pack?
Tablet, box of 20 or 60 tablets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
Maker
Cenexi
52 rue Marcel and Jacques Gaucher
94122 FONTENAY-SOUS-BOIS
or
BAYER SANTE FAMILIALE
33 rue de l'Industrie
74240 GAILLARD
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
[to be completed by the holder]
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.