NOTICE
ANSM - Updated: 23/07/2014
Name of the drug
BEPANTHENE 100 mg tablet
dexpanthenol
framed
Read all of 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 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 undesirable effect that is not mentioned in this leaflet.
Summary notice
In this notice :
1. What is BEPANTHENE 100 mg tablet and when is it used?
2. What information do you need to know before taking BEPANTHENE 100 mg tablet?
3. How to take BEPANTHENE 100 mg tablet?
4. What are the possible side effects?
5. How to store BEPANTHENE 100 mg tablet?
6. Additional information.
1. WHAT BEPANTHENE 100 mg tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic class
VITAMIN B5
(D: Dermatology)
Therapeutic indications
Adjunctive treatment of diffuse alopecia.
2. BEFORE YOU TAKE BEPANTHENE 100 mg tablet?
List of information needed before taking the medication
If you have been told by your doctor that you have 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 to any of the components.
Precautions for use; special warnings
Take special care with BEPANTHENE 100 mg tablets:
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interactions with other drugs
Taking or using other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medicine during pregnancy or while breastfeeding. If you discover that you are pregnant during treatment, consult your doctor because only he 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 medicine.
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 a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
RESERVED FOR THE ADULT.
3 tablets daily for 6 weeks.
Method and route of administration
Oral way.
The pills must be swallowed with a glass of water.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, BEPANTHENE 100 mg tablet is likely to have side effects, although not everyone is concerned:
· Rare cases of allergic skin reactions: urticaria.
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 of 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 about the safety of the medicine.
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 carton.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does BEPANTHENE 100 mg tablet contain?
The active substance is :
Dexpanthenol (vitamin B 5 ) ............................................ .................................................. .................. 100 mg
For a tablet.
The other components are :
Hydrated colloidal silica, gum arabic, lactose monohydrate, corn starch, stearic acid, magnesium stearate.
Pharmaceutical form and content
What is BEPANTHENE 100 mg, tablet and contents of the pack?
Tablet, box of 20 or 60 tablets.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
BAYER HEALTHCARE SAS
33 INDUSTRY STREET
74240 GAILLARD
Maker
Cenexi
52 rue Marcel and Jacques Gaucher
94122 FONTENAY-SOUS-BOIS
or
BAYER FAMILY HEALTH
33 rue de l'Industrie
74240 GAILLARD
Names of the drug in the member states of the European Economic Area
This medicine 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 this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Ansm (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.