NOTICE
ANSM - Updated on : 30/05/2024
Product name
BEPANTHEN 5%, ointment
Dexpanthenol
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict 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 after 5 days.
What does this leaflet contain?
1. What is BEPANTHEN 5%, ointment and what is it used for?
2. What do I need to know before using BEPANTHEN 5%, ointment?
3. How do I use BEPANTHEN 5% Ointment?
4. What are the possible side effects?
5. How should BEPANTHEN 5% Ointment be stored?
6. Package contents and other information.
1. WHAT IS BEPANTHEN 5%, ointment AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - CUTANEOUS PROTECTANT ATC code: D03AX. (D: dermatology).
This medicine is indicated for the treatment of skin irritation, particularly diaper rash (red bottom) in infants.
You should contact your doctor if you do not feel any improvement or if you feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING BEPANTHEN 5%, ointment?
Never use BEPANTHEN 5%, ointment :
- 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 have an infected or oozing dermatitis.
Warnings and precautions
Talk to your doctor or pharmacist before using BEPANTHEN 5%, ointment.
Avoid contact with eyes, as this may cause irritation.
Children and teenagers
Not applicable.
Other medicinal products and BEPANTHEN 5%, ointment
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BEPANTHEN 5%, ointment with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This drug should be used with caution during pregnancy and lactation. If applied to the breasts of nursing mothers, cleanse the skin before each feed.
Driving and using machines
Not applicable.
BEPANTHEN 5% ointment contains lanolin (wool fat), stearyl alcohol and cetyl alcohol:
This medicine may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE BEPANTHEN 5%, ointment?
Always use this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is one to several applications per day. Apply by massaging gently. Apply to the skin.
If you have used more BEPANTHEN 5%, ointment than you should have
Not applicable.
If you forget to use BEPANTHEN 5%, ointment
Not applicable.
If you stop using BEPANTHEN 5%, ointment
Not applicable.
If you have any further questions about the use of this medicine, 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.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects 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.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE BEPANTHEN 5%, ointment?
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.
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 BEPANTHEN 5% ointment contains
- The active substance is :
Dexpanthenol................................................................................................................... 5.0 g
Per 100 g of ointment
- Other ingredients are :
Protegin X®, vaseline, wool grease, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid kerosene, purified water.
What BEPANTHEN 5% ointment is and what it contains
This medicine comes in the form of an ointment.
Tube of 3.5 g, 30 g, 80 g and 100 g.
Marketing authorization holder
BAYER HEALTHCARE
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE
33, RUE DE LINDUSTRIE
74240 GAILLARD
Manufacturer
GRENZACH PRODUKTIONS GMBH
EMIL BARELL STRASSE 7
79639 GRENZACH-WHYLEN
GERMANY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on theANSM France website.
Health education advice:
Cutaneous irritations correspond to an alteration in the skin's natural protective barrier leading to redness, possibly associated with peeling or cracking of the skin. They are due to the action of irritants such as cold, mechanical friction, chemicals, etc.
Infant diaper rash is an irritation of the skin around the diaper area. The skin is red and then cracks.
- How can I prevent diaper rash? "
To prevent diaper rash, keep your baby's bottom clean, dry and cool.
Change your baby's diaper often, and leave the bottom open to the air as much as possible. This allows the skin to dry out.
At each diaper change, clean your baby's bottom thoroughly with lukewarm (but not hot) water, not forgetting the little folds.
Let the bottom dry thoroughly before putting on another diaper, preferably in the open air or with a clean absorbent towel, without rubbing to avoid irritation.
- What to do in case of diaper rash? "
Avoid fitting diapers too tightly, so as to let your baby's skin "breathe".
Leave your baby without a diaper as much as possible. Fresh air dries out moist, irritated skin and helps the rash to heal.
Apply a protective, repairing ointment to your child's bottom after every diaper change.