Apply a protective and restorative ointment to the child's bottom after each diaper change.
In this leaflet:
1. WHAT IS BEPANTHEN 5% Ointment AND WHAT IS IT USED FOR?
2. WHAT DO YOU 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 TO USE BEPANTHEN 5% Ointment?
6. ADDITIONAL INFORMATION
1. WHAT IS BEPANTHEN 5% Ointment AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
SKIN PROTECTOR.
This medicine is indicated for the treatment of skin irritation, particularly in cases of diaper rash (red bottoms) in infants.
2. WHAT YOU SHOULD KNOW BEFORE USING BEPANTHEN 5% Ointment
List of information needed before taking the medicine
Not applicable.
Never use BEPANTHEN 5% Ointment in the following cases:
- A history of hypersensitivity to any of the components.
- Infected or oozing skin.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Be careful with BEPANTHEN 5% ointment:
Special warnings
- This medicine contains lanolin (wool fat) and may cause skin reactions (e.g. eczema).
- Avoid contact with the eyes, as this may be irritating.
If there is no improvement after 5 days and despite strict application of the health education advice, consult a doctor or ask a pharmacist for advice.
IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Interactions 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 drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
This medicine should be used with caution during pregnancy and lactation. In case of application on the breasts, clean the skin before each feeding.
In general, it is advisable to ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect: lanolin (wool fat).
3. HOW TO USE BEPANTHEN 5% Ointment
Instructions for proper use
Not applicable.
Dosage, method and/or route of administration, frequency of administration and duration of treatment
Dosage
Apply with a gentle massage once or several times a day.
Method and route of administration
Dermal route.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, BEPANTHEN 5% Ointment may have side effects, although not everyone is likely to experience them.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE BEPANTHEN 5% Ointment
Keep out of the reach and sight of children.
Do not use BEPANTHEN 5% Ointment after the expiry date stated on the outer packaging.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does BEPANTHEN 5% Ointment contain?
The active substance is:
Dexpanthenol ...................................................................................................................................... 5.0 g
For 100 g of ointment.
The other components are: Protegin X, vaseline, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.
Pharmaceutical form and contents
What is BEPANTHEN 5% Ointment and what does it contain?
This medicine is in the form of an ointment.
Tube of 3.5 g, 30 g, 80 g or 100 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BAYER FAMILY HEALTH
33 RUE DE L'INDUSTRIE
74240 GAILLARD
FRANCE
Operator
BAYER SANTE FAMILIALE
33, RUE DE L'INDUSTRIE
74240 GAILLARD
Manufacturer
GP GRENZACH PRODUKTIONS GMBH
EMIL BARELL STRASSE 7
79639 GRENZACH-WHYLEN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date of approval of this package leaflet was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE
Skin irritations correspond to an alteration in the natural protective barrier of the skin leading to redness, possibly associated with peeling or cracking of the skin. They are due to the action of irritating agents such as cold, mechanical rubbing, chemicals, etc.
Diaper rash is an irritation of the skin in the areas covered by diapers. The skin is red and then cracks.
" How to prevent diaper rash in infants?"
To prevent diaper rash, keep your baby's bottom clean, dry and cool.
Change your baby's diaper often and leave his or her bottom exposed to the air as much as possible. This allows the skin to dry.
At each diaper change, clean your baby's bottom thoroughly with warm (but not hot) water without forgetting the little folds.
Allow the bottom to dry well before putting on another nappy, preferably in the open air or with a clean absorbent towel, without rubbing to avoid the risk of irritation.
" What to do in case of diaper rash in infants?"
Avoid fitting diapers too tightly so that your baby's skin can "breathe".
Leave your baby without a diaper as much as possible. The fresh air dries out the moist, irritated skin and helps the rash to heal.
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