BEPANTHEN PLUS

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bepanthen Plus, (50 mg + 5 mg)/g, cream
Dexpanthenolum + Chlorhexidini dihydrochloridum
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Contents of this leaflet:

1. What Bepanthen Plus is and what it is 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 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 active against Gram-positive bacteria, including susceptible 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 after minor surgical procedures.

2. Important information before using Bepanthen Plus

When not to use Bepanthen Plus

• if you are 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 perforation of the eardrum.

Warnings and precautions
Before starting treatment with Bepanthen Plus, discuss it with your doctor, pharmacist, or nurse.
Do not use Bepanthen Plus on large, deep, or infected wounds. In such cases, consult your doctor.
Do not use Bepanthen Plus simultaneously with other antiseptic agents.
Avoid contact of the medicine with ears and mucous membranes.
Avoid contact with eyes due to the risk of visual damage.
In case of accidental eye contact, immediately and thoroughly rinse eyes with water. If irritation, redness, eye pain, or visual disturbances occur, seek immediate medical help.
Serious cases of permanent corneal damage (surface damage to the eye) have been reported, which may necessitate corneal transplantation, following accidental exposure of similar products to the eyes during surgical procedures in patients under general anaesthesia (deep, painless sleep).
If infection persists or worsens, contact your 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, hives, which may rapidly progress to more serious symptoms, severe rash, or shock), discontinue use immediately and consult your doctor.

Bepanthen Plus and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use, including those available without a prescription.
Do not use Bepanthen Plus simultaneously with other antiseptic agents.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Bepanthen Plus should only be used during pregnancy and breastfeeding on the advice of a doctor.
Avoid using the medicine on large areas of skin in pregnant and breastfeeding women.
When applied to the 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 leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
This medicine is for topical use on the skin.
Unless otherwise directed by a doctor, the medicine is usually applied several times a day, as needed, to cleansed wounds or inflamed areas. It is not necessary to use a dressing.
Avoid application over large areas of skin.
Frequent application of the cream to the same areas may lead to skin irritation.
Missed dose
Do not apply a double dose to make up for a missed dose.
Stopping Bepanthen Plus
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic skin reactions may occur, such as: contact dermatitis, allergic dermatitis,
itching, erythema, rash, exanthema, urticaria, skin irritation, and vesicles at the application site,
hypersensitivity, severe allergic reactions such as anaphylactic reactions, anaphylactic shock (potentially life-threatening), characterized by respiratory disturbances,
mild to moderate reactions involving the skin (rash, urticaria, swelling, itching),
gastrointestinal system, cardiovascular system (cardiac disorders).
Other possible adverse reactions, the frequency of which is unknown:

• corneal damage (damage to the surface of the eye) and permanent eye damage, including permanent visual impairment (after accidental eye exposure during surgical procedures on the head, face, and neck) in patients under general anaesthesia (deep, painless sleep).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Bepanthen Plus

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

6. Contents of the pack and other information

What Bepanthen Plus contains
The active substances are: dexpanthenol and chlorhexidine dihydrochloride.
1 gram of cream contains 50 mg of dexpanthenol and 5 mg of chlorhexidine dihydrochloride.
Other components are: DL-pantolactone, cetyl alcohol, stearyl alcohol, white soft paraffin,
liquid paraffin, lanolin, polyoxyethylene 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 30 g of cream,
placed in a cardboard box.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Latvia, country of export:
UAB Bayer
Sporto 18
LT-09238 Vilnius
Lithuania

Manufacturer:
GP Grenzach Productions GmbH
D-79639 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 Authorization number in Latvia, country of export: 97-0121
Parallel import authorization number: 48/26