Bepanthen Plus

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Bepanthen Plus(Bepanthene Plus)
(50 mg + 5 mg)/g, cream
Dexpanthenol + Chlorhexidinedihydrochloride
Bepanthen Plus and Bepanthene Plus are different trade names for the same drug.

You should carefully read the contents of the leaflet 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.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Bepanthen Plus and what is it used for
• 2. Important information before using Bepanthen Plus
• 3. How to use Bepanthen Plus
• 4. Possible side effects
• 5. How to store Bepanthen Plus
• 6. Contents of the packaging and other information

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

Bepanthen Plus contains two active substances: dexpanthenol and chlorhexidine.
Dexpanthenol, after penetrating the skin, quickly converts to pantothenic acid, which plays an important role in skin construction and regeneration during wound healing.
Chlorhexidine is a disinfectant that acts on Gram-positive bacteria, including sensitive strains of Staphylococcus aureus, which are the most common cause of skin infections.
Chlorhexidine acts weaker on Gram-negative bacteria and does not act on bacteria of the Pseudomonasand Proteusgenus.

Indications

Treatment and disinfection of superficial wounds of various types, when there is a risk of their infection (e.g., scratches, cuts, abrasions, skin cracks, burns, scalds, skin inflammation) and treatment of wounds after 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 the case of a ruptured eardrum.

Warnings and precautions

Before starting to use Bepanthen Plus, you should discuss it with your doctor, pharmacist, or nurse.
You should not use Bepanthen Plus on large, deep, and infected wounds. In such cases, the patient should contact their doctor.
You should not use Bepanthen Plus at the same time as other disinfectants.
You should avoid contact between the medicine and the eyes, ears, and mucous membranes.
If the infection persists or worsens, you should contact your doctor.
Bepanthen Plus should not be used on skin irritations that are not prone to infection (e.g., sunburn).
If symptoms of a severe allergic reaction appear (e.g., wheezing or difficulty breathing, facial swelling, hives, which can quickly lead to more severe symptoms, severe rash, or anaphylactic shock), you should immediately stop using the medicine and consult a doctor.

Bepanthen Plus and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as about medicines you plan to use, including those that are available without a prescription.
Bepanthen Plus should not be used at the same time as other disinfectants.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Bepanthen Plus may be used during pregnancy and breastfeeding only on the advice of a doctor.
You should avoid using the medicine on large areas of skin in pregnant and breastfeeding women.
When used on the nipples of breastfeeding women, the nipples should be washed before breastfeeding.

Driving and using machines

Bepanthen Plus has no effect on the ability to drive and use machines.

Bepanthen Plus contains cetyl alcohol, stearyl alcohol, and lanolin

The 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 leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, you should consult a doctor, pharmacist, or nurse.
The medicine is intended for topical use on the skin.
Unless otherwise directed by a doctor, the medicine is usually applied several times a day, as needed, to cleaned wounds or areas of inflammation. There is no need to use a dressing.
You should avoid using the medicine on large areas of skin.
Frequent application of the cream to the same areas may lead to skin irritation.

Missing a dose

You should not use a double dose to make up for a missed dose.

Stopping the use of Bepanthen Plus

If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bepanthen Plus can cause side effects, although not everybody gets them.
Allergic skin reactions may occur, such as: contact dermatitis, allergic skin inflammation, itching, redness, rash, hives, skin irritation, and blisters at the site of application, hypersensitivity, severe allergic reactions, such as anaphylactic reactions, anaphylactic shock (potentially life-threatening) characterized by respiratory disorders, mild to moderate reactions involving the skin (rash, hives, swelling, itching), gastrointestinal tract, cardiovascular system (heart rhythm disorders).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. HOW TO STORE BEPANTHEN PLUS

Do not store above 25°C.
The medicine should be stored 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Bepanthen Plus contains

The active substances of the medicine are: dexpanthenol and chlorhexidine dihydrochloride.
1 gram of cream contains 50 mg of dexpanthenol and 5 mg of chlorhexidine dihydrochloride.
The other ingredients of the medicine are: D,L-pantolactone, cetyl alcohol, stearyl alcohol, white petrolatum, liquid paraffin, lanolin, macrogol stearate, purified water.

What Bepanthen Plus looks like and what the packaging contains

Bepanthen Plus is a cream.
The available packaging of the medicine is an aluminum tube with a polypropylene screw cap, containing 100 g of cream, placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Bayer Portugal, Lda.
Avenida Vitor Figueiredo nº4 - 4º piso
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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Portugal, the country of export:5802475

Parallel import authorization number: 4/24

Date of leaflet approval: 08.01.2024

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