NOTICE
ANSM - Updated: 06/25/2020
Name of the drug
DEXPANTHENOL MYLAN 5%, ointment
Dexpanthenol
Framed
Read all of this leaflet carefully before using this medicine because it contains important information for you.
You should always use this medicine strictly following the information given in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 5 days.
What does this booklet contain ?
1. What is DEXPANTHENOL MYLAN 5%, ointment and in which cases it is used?
2. What information should I know before using DEXPANTHENOL MYLAN 5%, ointment?
3. How to use DEXPANTHENOL MYLAN 5%, ointment?
4. What are the possible side effects?
5. How to store DEXPANTHENOL MYLAN 5%, ointment?
6. Contents of the pack and other information.
1. WHAT DEXPANTHENOL MYLAN 5%, ointment IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group : skin protector - ATC code: D03AX03. (D: dermatology).
This medication is indicated for the treatment of skin irritation, especially in cases of diaper rash (red buttocks) in infants.
You should contact your doctor if you experience no improvement or feel less well after 5 days.
2. WHAT YOU NEED TO KNOW BEFORE USING DEXPANTHENOL MYLAN 5%, ointment?
Never use DEXPANTHENOL MYLAN 5%, ointment:
· if you are allergic to dexpanthenol or any of the other ingredients of this medicine, listed in section 6.
· if you have an infected or oozing skin condition.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using DEXPANTHENOL MYLAN 5%, ointment .
Avoid contact with the eyes, this could be irritating.
Children and adolescents
Not applicable.
Other medicines and DEXPANTHENOL MYLAN 5%, ointment
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
DEXPANTHENOL MYLAN 5%, ointment with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This drug should be used with caution during pregnancy and lactation. In nursing women, if applied to the breasts, clean the skin before each feeding.
Driving and using machines
Not applicable.
DEXPANTHENOL MYLAN 5%, ointment contains lanolin (wool fat), cetyl alcohol and stearyl alcohol.
This medicine can cause local skin reactions (eg contact dermatitis).
3. HOW TO USE DEXPANTHENOL MYLAN 5%, ointment?
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
The recommended dose is one to several applications per day. Apply by massaging lightly.
Method and route of administration
Dermal.
If you use more DEXPANTHENOL MYLAN 5%, ointment than you should:
Not applicable.
If you forget to use DEXPANTHENOL MYLAN 5%, ointment:
Not applicable.
If you stop using DEXPANTHENOL MYLAN 5%, ointment:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DEXPANTHENOL MYLAN 5%, ointment?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube . The expiration date refers to the last day of that month.
Do not keep the opened tube for more than 6 months.
Store at a temperature not exceeding 25 ° C.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What DEXPANTHENOL MYLAN 5% contains, ointment
· The active substance is:
Dexpanthenol ................................................. .................................................. ....................... 5.0 g
For 100 g of ointment.
· The other ingredients are:
Protegin XN * , petroleum jelly, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water
* Composition of Protegin XN: liquid paraffin, petroleum jelly, microcrystalline wax, glycerol monooleate, wool fat alcohols.
What is DEXPANTHENOL MYLAN 5%, ointment and contents of the pack
This medication is in the form of a pale yellow ointment.
Tube of 30 g or 100 g.
Box of 1.
Not all presentations may be marketed.
Marketing authorization holder
MYLAN SAS
117 ALLEE DES PARKS
69800 SAINT-PRIEST
Marketing authorization operator
MYLAN SAS
117 ALLEE DES PARKS
69800 SAINT-PRIEST
Maker
CHEMINEAU LABORATORIES
93 COIN ROUTE
37210 VOUVRAY
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is
[to be completed later by the holder]
Other
Detailed information on this medication is available on the ANSM website (France).
Health Education Council
Skin irritations correspond to an alteration of the natural protective barrier of the skin resulting in redness, possibly associated with peeling or cracking skin. They are due to the action of irritants such as cold, mechanical friction, chemicals, ...
Infant diaper rash is 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 the buttocks clean, dry and cool.
Change your baby's diaper often and keep his bottom exposed as much as possible. This allows the skin to dry out.
At each diaper change, clean your baby's buttocks well with lukewarm (but not hot) water without forgetting the small folds.
Let the buttocks dry well before putting on another diaper, preferably in the open air or using a clean absorbent towel, without rubbing in order to avoid the risk of irritation.
· "What to do in case of diaper rash? "
Avoid adjusting diapers too tight to let your baby's skin “breathe”.
Leave your baby without a diaper as much as possible. Fresh air dries up irritated clammy skin and promotes healing of erythema.
Apply a protective and restorative ointment on the child's buttocks after each change.