Bepanthen Plus

Package Leaflet: Information for the User

Bepanthen Plus,(50 mg + 5 mg)/g, cream
Dexpanthenol + Chlorhexidine hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or 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 Package 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 pack 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 into pantothenic acid, which plays an important role in skin construction and skin regeneration during wound healing. Chlorhexidine is an antiseptic 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 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, the patient should discuss it with their doctor or pharmacist, or nurse. Bepanthen Plus should not be used on large, deep, and infected wounds. In such cases, the patient should contact their doctor. Bepanthen Plus should not be used at the same time as other antiseptics. Contact between the medicine and the ears and mucous membranes should be avoided. Bepanthen Plus should not come into contact with the eyes due to the risk of eye damage. If the eyes are exposed, they should be rinsed immediately and thoroughly with water. If irritation, redness, or eye pain occurs, or vision disturbances appear, medical help should be sought immediately. Serious cases of permanent corneal damage (eye surface damage) have been reported, which may require a corneal transplant, when similar products came into contact with the eyes during surgical procedures on the head, face, and neck in patients under general anesthesia (deep, painless sleep). If the infection persists or worsens, the patient should contact their 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), the use of the medicine should be stopped immediately and a doctor consulted.

Bepanthen Plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use, including those available without a prescription. Bepanthen Plus should not be used at the same time as other antiseptics.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Bepanthen Plus may be used during pregnancy and breastfeeding only on the advice of a doctor. The use of the medicine on large areas of skin in pregnant and breastfeeding women should be avoided. 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 cetostearyl 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 package leaflet for the patient or as directed by a doctor or pharmacist, or nurse. In case of doubt, the patient should consult their doctor or 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. The use of a dressing is not necessary. The use of the medicine on extensive skin surfaces should be avoided. Frequent application of the cream to the same skin surfaces may lead to skin irritation.

Missing a dose

A double dose should not be used to make up for a missed dose.

Stopping the use of Bepanthen Plus

In case of any further doubts about the use of this medicine, the patient should consult their 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 dermatitis, itching, redness, rash, hives, skin irritation, and blisters at the application site, hypersensitivity, severe allergic reactions, such as anaphylactic reactions, anaphylactic shock (potentially life-threatening) with symptoms of respiratory disorders, mild to moderate reactions involving the skin (rash, hives, swelling, itching), gastrointestinal tract, cardiovascular system (heart rhythm disorders). Other possible side effects, whose frequency is not known:

• corneal damage (eye surface damage) and permanent eye damage, including permanent vision loss (after accidental exposure of the eye during surgical procedures on the head, face, and neck in patients under general anesthesia).

If any of the side effects get worse or any side effects not listed in the package leaflet appear, the patient should tell their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the patient should tell their doctor or 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, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE BEPANTHEN PLUS

Bepanthen Plus should be stored at a temperature below 25°C. The medicine should be kept out of the sight and reach of children. After each use, the tube should be tightly closed. This medicine should not be used after the expiry date stated on the carton. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bepanthen Plus contains

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

What Bepanthen Plus looks like and contents of the pack

Bepanthen Plus is a cream. The medicine is available in aluminum tubes containing 3.5 g, 30 g, or 100 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Phone number: 022 572 35 00

Manufacturer

GP Grenzach Produktions GmbH
Emil-Barell-Strasse 7
79639 Grenzach-Wyhlen
Germany
In case of questions or doubts, the patient should consult their doctor or pharmacist. For more detailed information, the patient should consult the marketing authorization holder.

Date of last revision of the package leaflet: June 2024