Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Bepanthen Plus (Bepanthene Plus)
(50 mg + 5 mg)/g, cream
Dexpanthenolum + Chlorhexidini dihydrochloridum
Bepanthen Plus and Bepanthene Plus are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or
as directed by a doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If symptoms persist or worsen, consult your doctor.

Table of contents:

What Bepanthen Plus is and what it is used for
Important information before using Bepanthen Plus
How to use Bepanthen Plus
Possible side effects
How to store Bepanthen Plus
Contents of the pack and other information

1. WHAT BEPANTHEN PLUS IS AND WHAT IT IS USED FOR

Bepanthen Plus contains two active substances: dexpanthenol and chlorhexidine.
After penetrating the skin, dexpanthenol is rapidly converted into pantothenic acid, which plays an important role in skin structure and skin regeneration during wound healing.
Chlorhexidine is an antiseptic agent effective against Gram-positive bacteria, including sensitive strains of Staphylococcus aureus, which are the most common cause of skin infections.
Chlorhexidine is less effective against Gram-negative bacteria and has no activity against bacteria of the genus Pseudomonas and Proteus.
Indications
Treatment and disinfection of superficial wounds of various types when there is a risk of infection (e.g. scratches, cuts, abrasions, skin fissures, burns, scalds, skin inflammation), as well as treatment of wounds following minor surgical procedures.

2. IMPORTANT INFORMATION BEFORE USING BEPANTHEN PLUS

When not to use Bepanthen Plus

if the patient is allergic to the active substances dexpanthenol or chlorhexidine, or to any of the other ingredients of this medicine (listed in section 6),
in case of perforated eardrum.

Warnings and precautions
Before starting treatment with Bepanthen Plus, consult your doctor, pharmacist, or nurse.
Do not use Bepanthen Plus on large, deep, or infected wounds. In such cases, the patient should contact a doctor.
Do not use Bepanthen Plus simultaneously with other antiseptic agents.
Avoid contact of the medicine with eyes, ears, and mucous membranes.
If infection persists or worsens, consult a doctor.
Bepanthen Plus should not be used for skin irritations that are not prone to infection (e.g. sunburn).
If symptoms of a severe allergic reaction occur (e.g. wheezing or difficulty breathing, facial swelling, urticaria which may rapidly progress to more serious symptoms, severe rash or shock), discontinue use immediately and consult a doctor.

Bepanthen Plus and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use, including those available without a prescription.
Do not use Bepanthen Plus simultaneously with other antiseptic agents.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Bepanthen Plus may be used during pregnancy and breastfeeding only under medical supervision.
Avoid applying the medicine to large areas of skin in pregnant and breastfeeding women.
When applied to nipples in breastfeeding women, the nipples must be washed before breastfeeding.

Driving and operating machinery
Bepanthen Plus has no influence on the ability to drive or operate machinery.

Bepanthen Plus contains cetyl alcohol, stearyl alcohol, and lanolin
This medicine may cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE BEPANTHEN PLUS

This medicine should always be used exactly as described in this patient information leaflet or
as directed by the physician, pharmacist, or nurse. If in doubt, consult the physician, pharmacist, or nurse.
This medicine is intended for topical application to the skin.
Unless otherwise advised by a physician, the medicine is usually applied several times daily, as needed,
to cleaned wounds or inflamed areas. It is not necessary to use a dressing.
Avoid use over large areas of skin.
Frequent application of the cream to the same areas may cause skin irritation.
Missed dose
Do not use a double dose to make up for a missed dose.
Discontinuation of Bepanthen Plus
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Allergic skin reactions may occur, such as: contact dermatitis, allergic dermatitis, itching, erythema, rash, urticaria, skin irritation and vesicles at the application site, hypersensitivity, severe allergic reactions such as anaphylactic reactions, anaphylactic shock (potentially life-threatening), manifested by respiratory disturbances, mild to moderate reactions involving the skin (rash, urticaria, swelling, itching), gastrointestinal system, cardiovascular system (cardiac disorders).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the package leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE BEPANTHEN PLUS

Do not store above 25°C.
Keep the medicine out of sight and reach of children.
After each use, the tube should be tightly closed.
Do not use Bepanthen Plus after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Bepanthen Plus contains
The active substances in this medicinal product are: dexpanthenol and chlorhexidine dihydrochloride.
1 gram of cream contains 50 mg of dexpanthenol and 5 mg of chlorhexidine dihydrochloride.
The other ingredients are: D,L-pantolactone, cetyl alcohol, stearyl alcohol, white vaseline,
liquid paraffin, lanolin, polyglycol stearate, purified water.

What Bepanthen Plus looks like and contents of the pack
Bepanthen Plus is a cream.
The available pack is an aluminium tube with a polypropylene cap containing 100 g of cream,
housed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Bayer Portugal, Lda.
Avenida Vitor Figueiredo nº4 - 4º floor
2790-255 Carnaxide
Portugal

Manufacturer:
GP Grenzach Produktions GmbH
Emil-Barrell-Strasse 7
D-793639 Grenzach–Wyhlen
Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 5802475
Parallel Import Licence Number: 4/24