PANTHENOL Medical spray 4.63% 130g
Leaflet: information for the user
PANTHENOL MEDICAL SPRAY 4.63% dermal foam
PANTHENOL MEDICAL SPRAY 4.63% cutaneous foam
dexpanthenol ( dexpanthenol )
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What is Panthenol Medical Spray and what is it used for?
2. What you need to know before using Panthenol Medical Spray
3. How to use Panthenol Medical Spray
4. Possible side effects
5. How to store Panthenol Medical Spray
6. Package contents and additional information.
1.. What is Panthenol Medical Spray and what is it used for?
Supports the healing process of injuries.
Panthenol Medical Spray is used as an additional treatment for superficial skin injuries, including burns, as well as for injuries to the mucous membranes.
If you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before using Panthenol Medical Spray
Do not use Panthenol Medical Spray
- if you are allergic to dexpanthenol or any of the other ingredients of this medicine (listed in section 6).
Panthenol Medical Spray is not intended for use in the eyes.
Warnings and precautions
Talk to your doctor or pharmacist before using Panthenol Medical Spray.
There are no age restrictions for the use of Panthenol Medical Spray.
Application to children should only be done in the presence of an adult.
When spraying Panthenol Medical Spray, asthmatics or patients suffering from broncho-pulmonary diseases (diseases of the bronchi and/or lungs) should avoid inhaling the propellant, as this may cause irritation of the mucous membrane or even trigger an asthma attack.
Do not spray into eyes! Do not spray directly into mouth or nose!
The bottle contains gas under pressure. Protect from direct sunlight and heat exceeding 50 ° C!
After using its contents, do not use force to open it or burn it. Dispose of the bottle only after it is completely empty. Do not spray into a flame or against hot objects.
Keep away from sources of ignition and do not smoke near the spray during use.
(“Fire hazard designation” ( F +) Highly flammable!)
Conformity mark TRG 300 (Technische Regeln Druckgase [( German ) technical rules concerning compressed gases ].
Other medicines and Panthenol Medical Spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
When using Panthenol Medical Spray as intended, interactions with other medicinal products are not known.
When applying Panthenol Medical Spray to the genital or anal area and simultaneously using condoms, the tear strength may be reduced due to the paraffin content in the spray, thereby reducing the safety of the condoms.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Since there is no scientific data on how much dexpanthenol enters the bloodstream from the skin, the application of Panthenol Medical Spray to large areas of skin during pregnancy and breastfeeding should only be done if, in the opinion of a doctor, the potential benefits outweigh the possible risks.
Driving and using machines
No specific precautions are necessary.
Panthenol Medical Spray contains cetostearyl alcohol
May cause local skin reactions (e.g. contact dermatitis).
3. How to use Panthenol Medical Spray
Always use this medicine exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist.
Unless otherwise prescribed, Panthenol Medical Spray is applied or sprayed evenly onto the lesion one or more times daily.
Method of administration
When applied to the face, Panthenol Medical Spray should not be sprayed directly. It is recommended to spray onto the hand and apply it to the relevant part of the face.
Do not spray into eyes! Do not spray directly into mouth or nose!
When using, the vial should be held vertically with the valve facing up.
To form a quality foam, the bottle should be shaken vigorously before each application, especially if the product has not been used for a long time.
It is possible that when using the spray for the first time, only gas will escape for a short time at first before the normal foam appears.
Duration of use
There are no known restrictions on the duration of application of Panthenol Medical Spray. It depends on the type and course of the disease.
If you use more Panthenol Medical Spray than you should
It is very unlikely that you will overdose on Panthenol Medical Spray when used as directed. However, if you accidentally swallow large amounts of Panthenol Medical Spray by mouth, do not be afraid of dangerous consequences.
If you stop using Panthenol Medical Spray
This step will jeopardize the success of the treatment.
Please continue as described in the section "How to use Panthenol Medical Spray"
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following frequency categories were used to assess adverse reactions:
Very common: | More than 1 in 10 treated patients |
|---|---|
Common: | Less than 1 in 10 but more than 1 in 100 patients treated |
Uncommon: | Less than 1 in 100 but more than 1 in 1000 patients treated |
Rare: | Less than 1 in 1,000 but more than 1 in 10,000 patients treated |
Very rare: | Less than 1 in 10,000 patients treated, including isolated reports |
Significant side effects or signs to watch out for and measures to take when you are affected by side effects:
In very rare cases, intolerance may occur, expressed in contact allergies.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
Tel.: +35 928903417
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Panthenol Medical Spray
Keep out of the reach of children.
Store below 25°C.
See warnings in the “Warnings and precautions” section.
Do not use this medicine after the expiry date which is stated on the carton and the vial label. The expiry date refers to the last day of that month.
Note on shelf life after opening:
After opening, the spray is suitable for use until the expiration date.
6. Contents of the pack and other information
What does Panthenol Medical Spray contain?
- The active substance is 4.63 g of dexpanthenol (dexpanthenol ) in 100 g of dermal foam.
- Excipients: cetostearyl alcohol, paraffin, light liquid; wax, light liquid; peracetic acid; propellant and purified water.
What does Panthenol Medical Spray look like and what the package contains?
Pressurized bottle with dermal foam (emulsion and propellant)
138 ml=130 g
Marketing Authorisation Holder
Dr. Gerhard Mann Chem.-Phar. Fabrik GmbH
Brunsbuetteler Damm 165-173
13581 Berlin,
Germany
Manufacturers
Dr. Gerhard Mann Chem.-Phar. Fabrik GmbH
Brunsbuetteler Damm 165/173
13581 Berlin,
Germany
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24 PPT3
Ireland
