BEPANTHEN

BEPANTHEN Wound and Healing Ointment

Important notes (mandatory information)

Bepanthen Wound and Healing Ointment. Active ingredient: Dexpanthenol. Areas of application: to support healing in the case of superficial minor skin and mucous membrane damage.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bepanthen Wound and Healing Ointment, 5% ointment
Active ingredient: Dexpanthenol

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your condition worsens or does not improve after 1 week, contact your doctor.

What this package leaflet contains

1. WHAT IS BEPANTHEN WOUND AND HEALING OINTMENT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BEPANTHEN WOUND AND HEALING OINTMENT?
3. HOW TO USE BEPANTHEN WOUND AND HEALING OINTMENT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BEPANTHEN WOUND AND HEALING OINTMENT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BEPANTHEN WOUND AND HEALING OINTMENT AND WHAT IS IT USED FOR?

Bepanthen Wound and Healing Ointment is a product to support wound healing. Bepanthen Wound and Healing Ointment is used to support healing in the case of superficial minor skin and mucous membrane damage.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BEPANTHEN WOUND AND HEALING OINTMENT?

Bepanthen Wound and Healing Ointment must not be used if you are allergic to dexpanthenol or any of the other ingredients listed in section 6. Special care when using Bepanthen Wound and Healing Ointment is not necessary when used as intended. Avoid contact with the eyes.

When using Bepanthen Wound and Healing Ointment with other medicines

No interactions have become known to date.

Pregnancy, breastfeeding and fertility

There are no restrictions on the use of Bepanthen Wound and Healing Ointment during pregnancy and breastfeeding. No data on fertility are available.

Driving and using machines

No special precautions are necessary.

Important information about certain other ingredients of Bepanthen Wound and Healing Ointment

Cetyl alcohol, stearyl alcohol and wool wax can cause localised skin irritation (e.g. contact dermatitis).

Note

When treating the genital or anal area with Bepanthen Wound and Healing Ointment, the auxiliary substance white petroleum jelly can, when used together with latex condoms, reduce their tear resistance and thus impair the safety of the condoms.

3. HOW TO USE BEPANTHEN WOUND AND HEALING OINTMENT?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Apply Bepanthen Wound and Healing Ointment thinly to the affected areas of skin one to several times a day.

Duration of use

The duration of treatment depends on the type and course of the disease. Please talk to your doctor or pharmacist if you have the impression that the effect of Bepanthen Wound and Healing Ointment is too strong or too weak. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Bepanthen Wound and Healing Ointment can have side effects, although not everybody gets them.

The following categories are used to classify the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

The following side effects have been identified in the context of the use of Bepanthen Wound and Healing Ointment after approval. Since these reactions were reported voluntarily from patient groups of uncertain size, their frequency cannot be reliably determined.

Significant side effects or signs to watch out for, and measures to be taken if you are affected

If you are affected by any of the following side effects, stop using Bepanthen Wound and Healing Ointment and see your doctor as soon as possible.

Immune system disorders and skin and subcutaneous tissue disorders

Allergic reactions and allergic skin reactions such as contact dermatitis, allergic dermatitis, itching, redness, eczema, rash, hives, skin irritation and blisters.

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE BEPANTHEN WOUND AND HEALING OINTMENT?

Keep this medicine out of the reach of children! Do not use the medicine after the expiry date which is stated on the tube crimp and the folding box. The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C! Note on shelf life after opening or preparation: Bepanthen Wound and Healing Ointment can be stored for 3 months after opening. Do not use the medicine after this date.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bepanthen Wound and Healing Ointment contains

The active ingredient is: Dexpanthenol. 1 g of ointment contains 50 mg of dexpanthenol. The other ingredients are: Bleached wax, Liquid paraffin, White paraffin-White petroleum jelly-Ceresine-Glycerol monooleates (veg.)-Wool wax alcohols mixture (Protegin X), Purified water, Cetyl alcohol (Ph.Eur.), Almond oil, Stearyl alcohol (Ph.Eur.), White petroleum jelly, Wool wax.

What Bepanthen Wound and Healing Ointment looks like and contents of the pack

Bepanthen Wound and Healing Ointment is a pale yellow, homogeneous ointment and is available in tubes containing 20 g, 50 g and 100 g of ointment.

Pharmaceutical entrepreneur

Bayer Vital GmbH,
51368 Leverkusen,
Germany
Telephone: (0214) 301
Telefax: (0214) 30 57 209
E-mail address: bayer-vital@bayerhealthcare.com

Manufacturer

GP Grenzach Produktions GmbH,
Emil-Barell-Straße 7,
79639 Grenzach-Wyhlen,
Germany

This package leaflet was last revised in September 2013.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Dexpanthenol. Areas of application: to support healing in the case of superficial minor skin and mucous membrane damage.