Bepanthen Pommade BABY CHANGE 30G

Skin protector

vitamin B5

. Presentations . Composition . Indications . Contraindications . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS ^(summary)

BEPANTHEN 5%: ointment; 30 g tube.
Not refunded - Free price -

BEPANTHEN 5%: ointment; tube of 100 g.
Not refunded - Free price -

Bayer Healthcare SAS Laboratory

COMPOSITION ^(summary)

INDICATIONS ^(summary)

CONTRAINDICATIONS ^(summary)

• allergy to lanolin,
  
• in application to oozing or infected lesions.
  

PREGNANCY and BREASTFEEDING ^(summary)

DIRECTIONS AND DOSAGE ^(summary)

Usual dosage:

TIPS ^(summary)

ADVERSE POSSIBLE EFFECTS ^(summary)

LEXICON ^(summary)

Click here to find the record of this drug on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance : Report an adverse effect (s) related to the use of a drug

NOTICE

ANSM - Updated: 23/10/2017

Name of the drug

BEPANTHEN 5%, ointment

dexpanthenol

framed

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Talk to your pharmacist for any advice or information.

· 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. See section 4.

· You should talk to your doctor if you do not feel better or if you feel worse after 5 days.

What does this booklet contain ?

1. What is BEPANTHEN 5%, ointment and in which cases is it used?

2. What information do you need to know before using BEPANTHEN 5% Ointment?

3. How to use BEPANTHEN 5%, ointment?

4. What are the possible side effects?

5. How to store BEPANTHEN 5%, ointment?

6. Contents of the package and other information.

1. WHAT BEPANTHEN 5% OINTMENT AND WHAT IT IS USED FOR

Pharmacotherapeutic group - PROTECTEUR CUTANE ATC code: D03AX. (D: dermatology).

This drug is indicated for the treatment of skin irritation, especially in cases of diaper rash (red buttocks) of the infant.

You should talk to your doctor if you do not feel better or if you feel worse after 5 days.

2. BEFORE YOU USE 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, listed in section 6.

· if you have an infected or oozing dermatosis

Warnings and precautions

Talk to your doctor or pharmacist before using BEPANTHEN 5% Ointment .

Avoid contact with the eyes, it could be irritating.

Children and adolescents

Not applicable.

Other medicines and BEPANTHEN 5%, ointment

Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.

BEPANTHEN 5%, ointment with food, drinks 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 for advice or pharmacist before taking this medicine.

This medication should be used with caution during pregnancy and lactation. In breastfeeding women, when applied to the breasts, clean the skin before each feeding.

Driving and using machines

Not applicable.

BEPANTHEN 5%, ointment contains lanolin (wool fat) and may cause skin reactions (eg eczema).

3. HOW TO USE BEPANTHEN 5%, Ointment?

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.

The recommended dose is one to several applications per day. Apply by massaging lightly. Dermal.

If you use more BEPANTHEN 5%, you should not have ointment

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 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 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 for the 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 BEPANTHEN 5%, ointment?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of this month.

Store at a temperature not exceeding + 25 ° C.

Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.

6. CONTENTS OF PACKAGING AND OTHER INFORMATION

What BEPANTHEN 5% contains ointment

· The active substance is:

Dexpanthenol ................................................. .................................................. ................ 5.0 g

For 100 g of ointment

· The other components are:

Protegin X®, petrolatum, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.

What BEPANTHEN 5% ointment looks like and contents of the pack

This medicine comes in the form of an ointment.

Tube of 3,5g, 30g, 80g and 100g.

Marketing Authorization Holder

BAYER HEALTHCARE

220 avenue de la Recherche

59120 LOOS

Operator of the marketing authorization

BAYER HEALTHCARE

33, INDUSTRY STREET

74240 GAILLARD

Maker

GRENZACH PRODUKTIONS GmbH

Emil Barell Strasse 7

79639 GRENZACH-WHYLEN

Germany

Names of the drug in the member states of the European Economic Area

Not applicable.

The last date this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM France website.

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 irritating agents such as cold, mechanical friction, chemicals, ...

Diaper rash is an irritation of the skin in the areas covered by diapers. The skin is red and then crack.

· "How to prevent diaper rash? "

To prevent diaper rash, keep your buttocks clean, dry and cool.

Change your baby's diaper often and let the buttocks look as much as possible. This allows the skin to dry.

At each change of diaper, clean the buttocks of your baby with warm water (but not hot) without forgetting the small folds.

Let the buttocks dry before putting another layer, 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 nappy rash of the infant? "

Avoid adjusting diapers too tight to let your baby's skin "breathe".

Leave your baby without a nappy as much as possible. Fresh air dries moist irritated skin and promotes healing of erythema.

Apply a protective and repairing ointment on the child's buttocks after each change

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Bepanthen is a drug indicated for the adjunctive treatment of irritant dermatitis