NOTICE
ANSM - Updated on: 23/07/2014
Name of the medicinal product
BEPANTHEN 5%, cream
dexpanthenol
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS BEPANTHEN 5%, cream AND WHAT IT IS USED FOR?
2. BEFORE YOU USE BEPANTHEN 5%, cream?
3. HOW TO USE BEPANTHEN 5%, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BEPANTHEN 5%, cream?
6. ADDITIONAL INFORMATION
1. WHAT IS BEPANTHEN 5%, cream AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
D03AX - OTHER HEALING SCARVES
(D. Dermatology)
Therapeutic indications
Treatment of skin irritations.
Reserved for adults only.
2. BEFORE YOU USE BEPANTHEN 5%, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use BEPANTHEN 5%, cream in the following cases:
· Allergy to one of the components.
· Disease of infected skin.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Not applicable.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: propylene glycol, wool grease.
3. HOW TO USE BEPANTHEN 5%, cream?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Apply by gently massaging one to several times a day.
If you feel that the effect of BEPANTHEN 5%, cream is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Dermal.
Symptoms and Instructions for Overdose
If you used more than 5% BEPANTHEN, cream you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to use BEPANTHEN 5%, cream:
Do not use double quantity to compensate for the amount you forgot to use.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, BEPANTHEN 5%, cream is likely to have side effects, although not everyone is subject to it:
· Risk of eczema due to one of the constituents (wool grease or lanolin, propylene glycol).
Do not hesitate to seek the advice of your doctor or pharmacist.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE BEPANTHEN 5%, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use BEPANTHEN 5%, cream after the expiry date which is stated on the carton.
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 BEPANTHEN 5% contain, cream?
The active substance is:
Dexpanthenol ................................................. .................................................. ...................................... 5 g
For 100 g.
The other components are:
DL-pantolactone, phenoxyethanol, amphisol K, cetyl alcohol, stearyl alcohol, wool fat, isopropyl myristate, propylene glycol, purified water.
Pharmaceutical form and content
What is BEPANTHEN 5%, cream and contents of the pack?
This medication is in the form of a cream. Tube of 3.5 g, 30 g, 90 g or 100 g.
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
GP GRENZACH PRODUKTIONS GMBH
EMIL BARREL STRASSE 7
79639 GRENZACH-WYHLEN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.