Pevazol

Package Leaflet: Information for the Patient

PEVAZOL, 10 mg/g, cream

Econazole nitrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Pevazol and what is it used for

Pevazol is a cream for topical use, containing the active substance econazole nitrate. It is a substance with a broad spectrum of antifungal activity.
The Pevazol cream is intended for the local treatment of all types of fungal skin infections and mixed infections. It is used in fungal skin infections caused by dermatophytes, yeast, mold fungi, including the treatment of foot and hand fungus, jock itch, fungal infections of the scalp, skin and nail yeast infections, pityriasis versicolor, fungal otitis externa, as well as in fungal infections complicated by bacterial infections with Gram-positive bacteria.
In the case of nail fungus, in addition to local treatment, oral antifungal therapy should be used.

2. Important information before using Pevazol

When not to use Pevazol:

Warnings and precautions

Protect your eyes from contact with Pevazol.

Pevazol and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pevazol cream should not be used in pregnant women unless the doctor considers it necessary, after weighing the benefit to risk ratio.

Driving and using machines

Pevazol has no influence or negligible influence on the ability to drive and use machines.
Pevazol contains polysorbate 20 (E 432). Polysorbates may cause allergic reactions.

3. How to use Pevazol

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Pevazol is intended for topical use.
Usually, the cream should be applied to the affected skin 2 times a day, preferably in the morning and evening, gently rubbing in.
In the case of nail fungus, the cream should be used under a closed dressing.
Exudative changes (e.g. areas between the fingers, gluteal folds) should be dried first using gauze or a gauze bandage.
Treatment should be continued for 7 days after the symptoms have disappeared.
The duration of treatment is from 2 to 6 weeks, depending on the location and severity of the changes.
In skin candidiasis, body fungus, nail fungus, and pityriasis versicolor, treatment usually lasts 2 weeks; in foot fungus, 4 to 6 weeks.

Missing a dose of Pevazol

Do not use a double dose to make up for a missed dose.
If you miss a dose of the medicine, use it as soon as possible and continue treatment as usual, applying the cream to the skin in the same amount as before.

Stopping the use of Pevazol

Treatment should be continued for 7 days after the symptoms have disappeared.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data):
various skin symptoms may occur: local allergic reaction, itching, redness, transient skin irritation.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, please 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
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pevazol

Store below 25°C.
Keep the tube tightly closed.
Medicines should be kept out of the sight and reach of children.
Check the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube and carton.
The expiry date refers to the last day of the month stated.
Medicines should 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 pack 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 petrolatum, glycerol 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 mass.
The pack contains a tube with 20 g of cream. The tube, along with the leaflet, is placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA−ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]

Date of last revision of the leaflet: