PANTHENOL-

PANTHENOL Spray

Important notes (mandatory information)

Panthenol Spray. Active ingredient: Dexpanthenol. Areas of application: for the supportive treatment of healing skin and mucous membrane damage.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Panthenol Spray
Active ingredient: Dexpanthenol

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. 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 you do not feel better or even worse, contact your doctor.

What this package leaflet contains

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

1. WHAT IS PANTHENOL SPRAY AND WHAT IS IT USED FOR?

Agent to support wound healing. Panthenol Spray is used for the supportive treatment of healing skin and mucous membrane damage.

2. WHAT SHOULD YOU CONSIDER BEFORE USING PANTHENOL SPRAY?

Panthenol Spray must not be used if you are allergic to dexpanthenol or any of the other ingredients of this medicine listed in section 6. Panthenol Spray is not intended for use on the eye.

Warnings and precautions

Please talk to your doctor or pharmacist before using Panthenol Spray. Asthmatics or people with bronchopulmonary diseases (diseases of the bronchi and/or lungs) should not inhale the propellant when spraying Panthenol Spray, as this may cause irritation of the mucous membranes and even trigger an asthma attack.

Panthenol Spray contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

Children

There are no age restrictions for the use of Panthenol Spray. It should only be used on children under the supervision of an adult.

Warnings - Caution:

• Do not spray into the eyes!
• Do not spray directly into the mouth or nose!
• Container is under pressure: May burst if heated.
• Protect from sunlight and temperatures above 50 °C.
• Do not open or burn even after use.
• Dispose of completely empty spray can only in the waste.
• Do not spray against a flame or on a glowing object.
• Keep away from sources of ignition - No smoking.
• Keep out of reach of children.

Using Panthenol Spray with other medicines

Interactions with other agents are not known when Panthenol Spray is used as directed. Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or intend to take/use any other medicines. If Panthenol Spray is used at the same time in the genital or anal area and condoms, the paraffin it contains may reduce the tear resistance and thus impair the safety of condoms.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Since it is not known how much dexpanthenol is absorbed into the bloodstream through the skin, the benefits of using Panthenol Spray during pregnancy and breast-feeding should be carefully weighed against any possible risks if it is used over a large area.

Driving and using machines

No special precautions are required.

3. HOW TO USE PANTHENOL SPRAY?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, Panthenol Spray should be applied or sprayed evenly to the affected skin or mucous membrane damage one to several times a day.

Type of application

When using on the face, Panthenol Spray should not be sprayed directly. It is recommended to spray it onto the hand and apply the foam to the corresponding part of the face. Do not spray into the eyes! Do not spray directly into the mouth or nose! When using, hold the container upright, with the valve facing upwards. For the formation of a good quality foam, it is important to shake the can vigorously before each use, especially after prolonged non-use. When using the spray for the first time, it is possible that only propellant will be sprayed for a short time before the normal foam appears.

Duration of use

There are no known restrictions on the duration of treatment with Panthenol Spray. It depends on the type and course of the disease.

If you have used more Panthenol Spray than you should

An overdose is unlikely when Panthenol Spray is used as directed. If larger amounts of Panthenol Spray are accidentally swallowed, no harmful effects are to be expected.

If you stop using Panthenol Spray

This measure will jeopardize the success of the treatment. Please continue to proceed as described under "How to use Panthenol Spray".

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare (may affect up to 1 in 10,000 people)

Intolerance reactions in the form of contact allergies.

Reporting of side effects

If you get 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 provide more information on the safety of this medicine.

5. HOW TO STORE PANTHENOL SPRAY?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the spray can and the outer carton after "use by". The expiry date refers to the last day of the month indicated.

Storage conditions

Do not store above 25°C. See "Warnings and precautions".

Note on shelf life after opening

Usable until the expiry date indicated after opening.

Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Panthenol Spray contains

The active ingredient is: 100 g of foam for application to the skin contains 4.63 g of dexpanthenol. The other ingredients are: (2-ethylhexyl) alkanoate (C10-C16) (liquid wax), emulsifying cetyl stearyl alcohol (type A) (Ph.Eur.), liquid paraffin, peroxyacetic acid, purified water and propane, butane and 2-methylpropane as propellants.

What Panthenol Spray looks like and contents of the pack

Pressurized container with foam for application to the skin (emulsion and propellant); 138 ml = 130 g.

Pharmaceutical entrepreneur

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165 - 173
13581 Berlin
E-mail: kontakt@bausch.com

Manufacturer

Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Myslowice
Poland

This leaflet was last revised in June 2020.

Source: Information from the package leaflet
Status: 01/2021
Active ingredient: Dexpanthenol. Areas of application: for the supportive treatment of healing skin and mucous membrane damage.