Package leaflet: Information for the patient

PEVAZOL, 10 mg/g, cream
Econazole nitrate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Pevazol is and what it is used for
What you should know before using Pevazol
How to use Pevazol
Possible side effects
How to store Pevazol
Contents of the pack and other information

1. What Pevazol is and what it is used for

Pevazol is a topical cream containing the active substance econazole nitrate. It is an agent with broad-spectrum antifungal activity.
Pevazol cream is intended for local treatment of all types of fungal skin infections and mixed infections.
It is used in fungal skin infections caused by dermatophytes, yeasts, and mould fungi, including athlete's foot and hand, tinea cruris, tinea capitis, cutaneous and nail candidiasis, pityriasis versicolor, otitis externa due to fungal infection, as well as fungal infections complicated by Gram-positive bacterial infections.
In onychomycosis, in addition to local treatment, systemic antifungal therapy should be administered.

2. Important information before using Pevazol

When not to use Pevazol:

if the patient is allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6);
if the patient has exfoliative skin disorders;
in children under 12 years of age.

Warnings and precautions
Eyes should be protected from contact with Pevazol.
Pevazol and other medicines
Tell the doctor about all medicines the patient is currently using or has recently used,
as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a baby, she should consult a doctor or pharmacist before using this medicine.
Pevazol cream should not be used in pregnant or breastfeeding women unless the doctor considers it
necessary, after evaluating the benefit-risk ratio.
Driving and operating machinery
Pevazol has no effect or has a negligible effect on the ability to drive and
operate machinery.
Pevazol contains polysorbate 20 (E 432). Polysorbates may cause allergic reactions.

3. How to use Pevazol

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Pevazol is intended for topical use on the skin.
The cream should usually be applied to the affected skin area twice daily, preferably in the morning and evening, gently rubbed in.
In fungal nail infections, the cream should be used under an occlusive dressing.
Weeping lesions (e.g. areas between the toes, gluteal folds) should first be dried using gauze or gauze bandage.
Treatment should be continued for 7 days after the symptoms have resolved.
The duration of treatment ranges from 2 to 6 weeks, depending on the location and severity of the lesions.
In cutaneous candidiasis, tinea corporis, nail infections, and pityriasis versicolor, treatment usually lasts 2 weeks; in tinea pedis, 4 to 6 weeks.
Missed dose of Pevazol
Do not use a double dose to make up for a missed dose.
If a dose is missed, apply the medicine as soon as possible and continue treatment as usual, applying the cream to the skin in the same amount as before.
Stopping Pevazol treatment
Treatment should be continued for 7 days after the symptoms have resolved.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency unknown (frequency cannot be determined from available data):
various skin symptoms may occur: local allergic reaction, itching, redness, transient skin irritation.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on the safe use of the medicine.

5. How to store Pevazol

Store below 25°C.
Keep the tube tightly closed.
Store the medicine out of sight and reach of children.
Take care to observe the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube and cardboard box.
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. This will help protect the environment.

6. Contents of the package and other information

What Pevazol contains

The active substance is econazole nitrate. 1 g of cream contains 10 mg of econazole nitrate.
The other ingredients are: white soft paraffin, glyceryl monostearate, polysorbate 20 (E 432), sorbitan laurate, purified water.

What Pevazol looks like and contents of the pack
Pevazol is a homogeneous white or light cream-colored mass.
The pack consists of a tube containing 20 g of cream. The tube, together with the leaflet, is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
CHEMA−ELEKTROMET
Workers' Cooperative
Przemysłowa Street 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]