BEPANTHEN

BEPANTHEN Lösung

Important notes (mandatory information)

Bepanthen solution. Active ingredient: Dexpanthenol. Areas of application: to support healing in the case of superficial minor skin damage and of the oral mucosa.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bepanthen solution
Active ingredient: with 5% 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 directed by your doctor or pharmacist.

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

1. WHAT IS BEPANTHEN SOLUTION AND WHAT IS IT USED FOR?

Bepanthen solution is a remedy to support wound healing. Bepanthen solution is used to support healing in the case of superficial minor skin damage and of the oral mucosa.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BEPANTHEN SOLUTION?

Bepanthen solution must not be used if you are allergic to dexpanthenol, methyl(4-hydroxybenzoate) and propyl(4-hydroxybenzoate) or any of the other ingredients listed in section 6.

Special care when using Bepanthen solution

Not required when used as intended. Avoid contact with the eyes.

When using Bepanthen solution with other medicines

No interactions have become known to date.

Pregnancy, breast-feeding and fertility

There are no restrictions on the use of Bepanthen solution during pregnancy. Breast-feeding women should not use Bepanthen solution in the breast area. No data on fertility are available.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Bepanthen solution

Sodium benzoate can cause mild irritation to the skin, eyes and mucous membranes. Methyl(4-hydroxybenzoate) and propyl(4-hydroxybenzoate) can cause hypersensitivity reactions, including delayed reactions.

3. HOW TO USE BEPANTHEN SOLUTION?

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 quite sure. Unless otherwise prescribed by your doctor, the usual dose is: Apply Bepanthen solution undiluted to the affected areas one to several times a day or use it in the form of rinses or compresses.

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 solution 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 solution can cause side effects, although not everybody gets them.

The following categories are used as a basis for 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 solution after approval. Since these reactions were reported voluntarily by patient groups of unspecified 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 solution 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.

Other possible side effects
Methyl(4-hydroxybenzoate) and propyl(4-hydroxybenzoate) can cause hypersensitivity reactions, including delayed reactions.

Reporting of side effects

If you notice any side effects, contact 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 SOLUTION?

Keep this medicine out of the reach of children! Do not use the medicine after the expiry date which is stated on the label and the folding box. The expiry date refers to the last day of the month. Note on shelf life after opening or preparation: Bepanthen solution should not be used for more than 30 days after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bepanthen solution contains

The active ingredient is: Dexpanthenol. 1 ml solution contains 50.0 mg dexpanthenol. The other ingredients are: Sodium benzoate; methyl(4-hydroxybenzoate); propyl(4-hydroxybenzoate); rac-(3R)-3-hydroxy-4,4-dimethyloxolan-2-one; purified water.

What Bepanthen solution looks like and contents of the pack

Bepanthen solution is a colourless solution and is available in a 50 ml brown glass bottle.

Pharmaceutical entrepreneur

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

Manufacturer

KVP Pharma + Veterinär Produkte
Projensdorfer Str.324
24106 Kiel
Germany

This package leaflet was last revised in September 2013.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Dexpanthenol. Areas of application: to support healing in the case of superficial minor skin damage and of the oral mucosa.