Pudroderm

INFORMATION LEAFLET FOR THE PATIENT

PACKAGE LEAFLET

Leaflet attached to the packaging: information for the patient

Pudroderm

(9.8 mg + 9.8 mg + 245 mg)/g
(Benzocaine + Menthol + Zinc oxide),suspension for the skin

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

important information for the patient.
This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor
or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Pudroderm and what is it used for
• 2. Important information before using Pudroderm
• 3. How to use Pudroderm
• 4. Possible side effects
• 5. How to store Pudroderm
• 6. Package contents and other information

1. What is Pudroderm and what is it used for

Pudroderm is a medicine with local anesthetic, anti-itching, protective, and astringent effects.
It is a suspension intended for use on the skin.
The active substances of the medicine are benzocaine, menthol, and zinc oxide.
Pudroderm is used:

• as an auxiliary treatment for chickenpox, shingles, skin inflammation with rash, itching, swelling, and neurogenic itching;
• after insect bites (e.g., mosquito, wasp, horsefly bites);
• under medical supervision after radiological exposures.

2. Important information before using Pudroderm

When not to use Pudroderm:

• on wounds;
• on large areas of skin;
• on damaged skin, e.g., without the epidermis;
• for a long time;
• under occlusive dressings.

Warnings and precautions

Before starting to use Pudroderm, you should consult a doctor or pharmacist.
Children and adolescents
Pudroderm should not be used in children under 2 years of age.
Protect your eyes and mucous membranes from contact with the medicine.

Other medicines and Pudroderm

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken
and about medicines you plan to take.
Benzocaine interferes with the action of sulfonamides.
The local anesthetic effect of benzocaine is weakened in the presence of benzoyl peroxide,
which is often a component of topical anti-acne medications. For this reason,
before applying Pudroderm, in patients using products containing benzoyl peroxide,
the skin should be thoroughly cleaned of their residue.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding or if you suspect you are pregnant, or if you plan to become pregnant,
you should consult a doctor or pharmacist before using this medicine.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

3. How to use Pudroderm

This medicine should be used in accordance with the description in the patient leaflet or as directed by a doctor
or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
Pudroderm is a suspension intended for use on the skin. Before use, the contents of the package should be thoroughly mixed by vigorous shaking. Shake before each use.
Usually, a not-too-thin layer of the suspension is applied to the affected areas of the skin 2 to 3 times a day or more often if needed. The medicine should not be rubbed into the skin or covered with a dressing.
The medicine is easily washed off with running, warm water.

Use in children and adolescents

Pudroderm should not be used in children under 2 years of age.

Missing a dose of Pudroderm

You should not use a double dose to make up for a missed dose.

Stopping the use of Pudroderm

If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Pudroderm can cause side effects, although they may not occur in everyone.
After using the medicine, symptoms of local skin irritation may occur. If the symptoms of irritation worsen or do not disappear after a few days, you should stop using the medicine and contact your doctor.
Additional side effects in children
Pudroderm should not be used in children under 2 years of age, as local use of benzocaine may lead to methemoglobinemia and the occurrence of an allergic reaction. You should be cautious when using the medicine in older children.
If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (Aleje Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309), e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Pudroderm

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the label after "Expiry date". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Pudroderm contains

• The active substances of the medicine are: benzocaine, menthol, and zinc oxide.
• The other ingredients are: talc, glycerol 99.5%, purified water.

What Pudroderm looks like and what the package contains

Pudroderm is a suspension.
The medicine is available in a bottle with a dispenser, containing 140 g of suspension.

Responsible entity

Starpharma Sp. z o.o.
ul. Jedności 9,
05-506 Lesznowola

Manufacturer

Starpharma Sp. z o.o.
ul. Kościuszki 24
05-500 Piaseczno
tel. 22 756 76 21
Date of last update of the leaflet:09/2023