PUDRODERM

PACKAGE LEAFLET FOR THE PATIENT
/PACKAGE LABEL
Leaflet included in the packaging: information for the patient
Pudroderm
(9.8 mg + 9.8 mg + 245 mg)/g
( Benzocainum + Levomentholum + Zinci oxidum ), cutaneous suspension
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used as described in the patient leaflet or according to the instructions of a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 7 days of treatment, or if symptoms worsen, contact your doctor.

Table of contents of the leaflet

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

1. What Pudroderm is and what it is used for

Pudroderm is a medicinal product with local anesthetic, anti-pruritic, protective and astringent properties. It is formulated as a cutaneous suspension.
The active substances in this medicine are benzocaine, menthol and zinc oxide.
Pudroderm is used:

• as an adjunct in chickenpox, shingles, inflammatory skin conditions associated with rash, itching and swelling, and in neurogenic pruritus;
• following insect bites (e.g. by mosquitoes, wasps, midges);
• under medical supervision after radiological irradiation.

2. Important information before using Pudroderm

When not to use Pudroderm:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6), do not use the medicine:
• on wounds;
• on large areas of skin;
• on damaged skin, e.g. skin lacking epidermis;
• for prolonged periods;
• under occlusive dressings.

Warnings and precautions
Before starting to use Pudroderm, consult a doctor or pharmacist.
Children and adolescents
Not recommended for use in children under 2 years of age.
Protect eyes and mucous membranes from contact with the medicine.
Other medicines and Pudroderm
Tell your doctor or pharmacist about all medicines currently used, recently used, or which the patient intends to use.
Benzocaine interferes with the action of sulfonamides.
The local anaesthetic effect of benzocaine is reduced in the presence of benzoyl peroxide, which is often a component of topical anti-acne medications. Therefore, before applying Pudroderm, patients using products containing benzoyl peroxide should thoroughly cleanse the skin of any residue.
Pregnancy, breastfeeding and fertility
During pregnancy, breastfeeding, if pregnancy is suspected, or if planning a pregnancy, consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
There is no data available regarding the effect of the medicine on the ability to drive and operate machinery.

3. How to use Pudroderm

This medicine should be used as described in the patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Pudroderm is a suspension intended for topical application to the skin. Before use, shake the container well to mix the contents thoroughly. Shake vigorously before each use.
Typically, a not too thin layer of the suspension should be applied to the affected areas of skin 2 to 3 times daily, or more frequently if needed. The medicine should not be rubbed into the skin or covered with a dressing.
The product can be easily washed off with warm running water.
Use in children and adolescents
Pudroderm is not recommended for use in children under 2 years of age.
Missed dose of Pudroderm
Do not use a double dose to make up for a missed dose.
Stopping Pudroderm
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, Pudroderm can cause adverse reactions, although not everyone will experience them.
After application of the medicine, symptoms of local skin irritation may occur. If irritation symptoms worsen or do not resolve within a few days, treatment should be discontinued and a doctor should be consulted.

Additional adverse reactions in children
The use of Pudroderm is not recommended in children under 2 years of age, as topical application of benzocaine may lead to methaemoglobinaemia and hypersensitivity reactions. Caution should be exercised when using the medicine in older children.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (22) 49 21 309), Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pudroderm

Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Pudroderm contains

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

What Pudroderm looks like and contents of the pack
Pudroderm is a suspension.
The medicine is available in a bottle with a dispenser, containing 140 g of suspension.
Marketing Authorisation Holder
Starpharma Sp. z o.o.
Jedności Street 9,
05-506 Lesznowola
Manufacturer
Starpharma Sp. z o.o.
Kościuszki Street 24
05-500 Piaseczno
tel. 22 756 76 21