PANTHENOL 4.63MG/G SPRAY 130G

ATC code: R01AB06 

Active substances: Xylometazolini Hydrochloridum, Dexpanthenolum

Vendor, principal: Chauvin Ankerpharm Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PANTHENOL SPRAY 4.63% 130G

PACKAGE LEAFLET: INFORMATION FOR THE USER

PANTHENOL SPRAY 4.63% cutaneous foam Dexpanthenol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Even though this medicine can be obtained without a prescription, you still need to use Panthenol Spray carefully in order to get the best results.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   You must talk to a doctor if you do not feel better or if you feel worse.If any of the side effects gets serious or if you get any side effects not listed in this leaflet, talk to your doctor or pharmacist.

What is in this leaflet:

1.   What Panthenol Spray is and what it is used for
2.   What you need to know before you use Panthenol Spray
3.   How to use Panthenol Spray
4.   Possible side effects
5.   How to store Panthenol    Spray
6.   Other information

1.   What Panthenol Spray is and what it is used for

Panthenol Spray is a supportive and health-promoting aid for mild skin disorders.

2.   What you need to know before you use Panthenol Spray Do not use Panthenol Spray:

-   if you are allergic (hypersensitive) to dexpanthenol or any of the other ingredients of Panthenol Spray;
-   Panthenol Spray must not be sprayed in the eye.

Take special care when using Panthenol Spray:

-   if you have asthma and/or are suffering from bronchopulmonary diseases (bronchial and/or lung diseases). You must not inhale the gas emitted when spraying Panthenol Spray, as it may cause irritation of the mucous membranes or an asthma attack;
-   there are no age restrictions to using Panthenol Spray but children may use the product only under adult supervision.
-   do not spray Panthenol Spray in the eyes, mouth, or nose!
The aerosol container contains pressurised gas. Protect it from direct sunlight and temperatures that exceed 50 °C!
The container must not be forced open or burnt even after finishing the use of this product.
Throw away only after the container is completely empty. Do not spray at fire or embers.
Keep away from combustible objects. Do not smoke near the product.
Keep this medicine out of the sight and reach of children.
The flame symbol (F+) the European Union symbol for highly flammable substances (F+)
Conformity mark - TRG 300 (technical rules for pressurised gases).

Other medicines and Panthenol Spray

In the case of intended use, interaction of Panthenol Spray with other medicines has not been observed.
Concomitant use of condoms and Panthenol Spray in the genital and anal area may reduce the durability of condoms due to the paraffin in the preparation, which may cause the condom to tear more easily and reduce safety.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using the medicine.
As there is no scientific evidence on the proportion of applied dexpanthenol that is excreted in the systemic blood circulation, Panthenol Spray may be used in large areas of skin during pregnancy and breast-feeding only under a doctor’s supervision and if the potential benefits significantly outweigh the risks.
Driving and using machines Not relevant.

Important information about some of the ingredients of Panthenol Spray

Cetostearyl alcohol in the composition of the medicine may cause topical skin reactions (e.g. contact dermatitis).

3. How to use Panthenol Spray

Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.
Unless prescribed otherwise, spray Panthenol Spray evenly on the affected area once or several times a day.
Method of application
If Panthenol Spray is used on the face, it must not be sprayed directly on the affected area of skin, but the foam must first be sprayed on the hand and then applied to the affected area of the face.
Do not spray in the eyes. Do not spray in the mouth or nose.
While spraying, hold the container in a vertical position with the nozzle right-side up.
For the foam to have suitable properties, the container must be shaken well before each use, especially after a longer non-application time. On first use, it may happen than only gas is emitted from the bottle before foam with its usual properties appears.
Duration of treatment
Duration of treatment with Panthenol Spray is not limited. It depends on the nature of the affected area and the progress of healing.

If you use more Panthenol Spray than you should

In the case of intended use of Panthenol Spray, overdose is unlikely. However, if a large amount of Panthenol Spray is accidentally ingested, no dangerous consequences should be feared.

If you stop using Panthenol Spray

Discontinuation of the medicine may hinder the efficiency of treatment.
Please follow section “How to use Panthenol Spray”.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Panthenol Spray can cause side effects, although not everybody gets them.
In very rare cases (may affect less than 1 patient in 10,000, including individual cases), hypersensitivity reactions may occur, including contact dermatitis.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.

5.   How to store Panthenol Spray

Keep this medicine out of the sight and reach of children.
Do not use Panthenol Spray after the expiry date which is stated on the aerosol can and the external package. The expiry date refers to the last day of that month.
Storage conditions:
Do not store at a temperature higher than 25 °C.
See section “Take special care when using Panthenol Spray”.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Other information What Panthenol Spray contains

-   The active substance is dexpanthenol. 100 g of skin foam contains 4.63 g of dexpanthenol.
-   The excipients are: (2-ethylhexyl)alkanoate(C₁₀-C₁₆) (light liquid wax); emulsifying cetostearyl alcohol; light liquid paraffin; acetic acid; peracetic acid; hydrogen peroxide; purified water; propellants (propane, butane and isobutane).

What Panthenol Spray looks like and contents of the pack

Pressure container with foam (emulsion with propellant).
130 g

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
PharmaSwiss Ceska republika s.r.o.
Jankovcova 1569/2c 170 00 Prague 7 Czech Republic

Manufacturer:

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH Brunsbütteler Damm 165-173 13581 Berlin Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
PharmaSwiss Eesti OÜ Tammsaare tee 47 11316 Tallinn Telephone: 6827 400

This leaflet was last revised in December 2015