PUDER 15 mg /G Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. LIQUID POWDER DERMOPUR, 15 mg/g, suspension for the skin
   1. Please read the contents of the leaflet carefully before using the medicine, as it contains
   2. Table of contents of the leaflet
3. What is Liquid Powder Dermopur and what is it used for
4. Important information before using Liquid Powder Dermopur
   1. When not to use Liquid Powder Dermopur:
   2. Warnings and precautions
   3. Children and adolescents
   4. Liquid Powder Dermopur and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and operating machinery
5. How to use Liquid Powder Dermopur
   1. Use in children and adolescents
   2. Missing a dose of Liquid Powder Dermopur
   3. Using more than the recommended dose of Liquid Powder Dermopur
6. Possible side effects
   1. Reporting side effects
7. How to store Liquid Powder Dermopur
8. Contents of the packaging and other information
   1. What Liquid Powder Dermopur contains
   2. What Liquid Powder Dermopur looks like and what the packaging contains
   3. Packaging
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

LIQUID POWDER DERMOPUR, 15 mg/g, suspension for the skin

Benzocaine

Please read the contents of the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or
according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Liquid Powder Dermopur and what is it used for
• 2. Important information before using Liquid Powder Dermopur
• 3. How to use Liquid Powder Dermopur
• 4. Possible side effects
• 5. How to store Liquid Powder Dermopur
• 6. Contents of the packaging and other information

1. What is Liquid Powder Dermopur and what is it used for

Liquid Powder Dermopur is a suspension for the skin.
The medicine has a local anesthetic, protective, and astringent effect.
Indications
Exudative and inflammatory skin conditions with painful and itchy rashes.
As an auxiliary treatment for symptoms such as acne, infantile eczema,
vesicular rash in chickenpox, impetigo, weeping eczema, pruritus, intertrigo, urticaria, insect bites, adolescent acne.

2. Important information before using Liquid Powder Dermopur

When not to use Liquid Powder Dermopur:

• if the patient is allergic to benzocaine or any of the other ingredients of this medicine (listed in section 6),
• on mucous membranes,
• on open wounds,
• on ulcers,
• on skin surfaces without the epidermis,
• in patients treated with sulfonamides, in children under 12 years of age, the medicine may only be used after consulting a doctor.

Warnings and precautions

Before starting to use Liquid Powder Dermopur, the patient should discuss it with their doctor or
pharmacist.
In case of allergic reactions (e.g. increased itching, skin redness), the medicine should be discontinued and the doctor consulted.
The medicine should not be used for a long time. During use, there is a risk of methemoglobinemia (blood disorders), especially in children.
Contact with the eyes should be avoided.

Children and adolescents

In children under 12 years of age, the medicine may only be used after consulting a doctor.

Liquid Powder Dermopur and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use with phenazone, camphor, resorcinol, polyoxyethylene glycols (suppositories, ointments), strongly acidic and alkaline substances, sulfonamides, and oxytetracycline should be avoided.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy and breastfeeding only if, in the doctor's opinion, the benefits of using the medicine outweigh the risks.

Driving and operating machinery

The medicine does not affect the ability to drive or operate machinery.

3. How to use Liquid Powder Dermopur

This medicine should always be used exactly as described in this patient leaflet or
according to the doctor's or pharmacist's instructions. In case of doubt, the doctor or pharmacist should be consulted.
The medicine is for external use on the skin.
Before use, the medicine should be shaken. The affected area of the skin should be smeared with a thin layer of the suspension several (3 or 4) times a day.

Use in children and adolescents

In children under 12 years of age, the medicine may only be used after consulting a doctor.

Missing a dose of Liquid Powder Dermopur

In case of missing a dose of Liquid Powder Dermopur, the treatment should be continued as usual, according to the instructions.

Using more than the recommended dose of Liquid Powder Dermopur

In case of using too much of the medicine, it should be washed off the skin with water and the doctor consulted.
In case of accidental ingestion of the medicine, the doctor should be consulted immediately, as general side effects such as gastrointestinal disorders, vomiting, cramps, accelerated heart rate, loss of consciousness, or methemoglobinemia may occur.

4. Possible side effects

Like all medicines, Liquid Powder Dermopur can cause side effects, although not everybody gets them.
Allergic symptoms such as itching, rash, or redness may occur. In sensitive individuals, there is a risk of more severe reactions, such as local allergic reactions, urticaria, or contact dermatitis.
If the above side effects occur, the medicine should be discontinued and a dermatologist consulted.
There is a risk that the medicine may cause methemoglobinemia (blood disorders) after absorption through the skin during use on extensive weeping skin changes, prolonged use, or use in children.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Liquid Powder Dermopur

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Liquid Powder Dermopur contains

• The active substance of the medicine is benzocaine. 1 g of the skin suspension contains 15 mg of benzocaine.
• The other ingredients of the medicine are: zinc oxide, talc, levomenthol, glycerol 86%, ethanol, purified water.

What Liquid Powder Dermopur looks like and what the packaging contains

Liquid Powder Dermopur is a suspension for the skin.

Packaging

Aluminum tube with a membrane and screw cap or laminated tube with an inner layer of polyethylene and a screw cap made of polypropylene or a polyethylene container with a screw cap or an orange glass bottle with a screw cap, containing 40 g or 60 g of the medicine, placed in a cardboard box.
Not all packaging sizes may be marketed.

Marketing authorization holder

Poznańskie Zakłady Zielarskie "Herbapol" S.A.
ul. Towarowa 47/51, 61-896 Poznań
phone: +48 61 886 18 00

Manufacturer

Poznańskie Zakłady Zielarskie "Herbapol" S.A.
Paterek, ul. Przemysłowa 3, 89-100 Nakło nad Notecią
phone: 52 386 73 10
fax: 52 386 73 23
To obtain more detailed information, the marketing authorization holder should be contacted.
Poznańskie Zakłady Zielarskie "Herbapol" S.A.
ul. Towarowa 47/51, 61-896 Poznań
phone: +48 61 886 18 00

Date of last revision of the leaflet: