Pevaril

Package Leaflet: Information for the Patient

PEVARYL, 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Pevaryl and what is it used for

Pevaryl cream for cutaneous use contains the active substance econazole nitrate.
Econazole belongs to a group of antifungal medicines and, when applied locally, has an effect on certain fungi and yeasts.

Indications

Local treatment of fungal skin infections.

2. Important information before using Pevaryl

When not to use Pevaryl

Warnings and precautions

Pevaryl is intended for local use on the skin. Do not use it in the eyes or orally.
Rarely, allergic reactions to the medicine occur. If they occur, discontinue use and contact your doctor. Patients allergic to imidazole derivatives may also be allergic to Pevaryl.

Children and adolescents

Do not use in children under 2 years of age.
It is not recommended for use in children under 16 years of age due to insufficient data on safety and efficacy.

Pevaryl and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Read the information about concomitantly used medicines to check for possible interactions.
Clinically significant interactions are rare. Contact your doctor if you are taking oral anticoagulants (warfarin, acenocoumarol), as when using these medicines and Pevaryl, their anticoagulant effect should be monitored.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Pevaryl contains benzonic acid and butylhydroxyanisole

This medicine contains 60 mg of benzonic acid (E 210) in each 30 g tube, equivalent to 2 mg of benzonic acid per 1 g of cream. Benzonic acid may cause local irritation.
This medicine contains butylhydroxyanisole (E 320), which may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Pevaryl

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for local use on the skin.
Usually, a small amount of the medicine is applied twice a day to the affected areas and gently rubbed into the skin.

How long to use Pevaryl:

Usually, treatment lasts from 2 to 4 weeks.

Your doctor will decide how long you should use this medicine.

Use in children and adolescents

Do not use in children under 2 years of age.
It is not recommended for use in children under 16 years of age.

Elderly

There are insufficient data on the use in elderly patients (over 65 years of age).

Using more than the recommended dose of Pevaryl

The medicine is for use on the skin only.
In case of accidental oral ingestion, symptomatic treatment should be used. If the medicine accidentally gets into the eyes, they should be rinsed with clean water or a physiological saline solution, and if the adverse symptoms do not disappear, consult a doctor.
In case of using a higher dose than recommended or accidental ingestion, contact your doctor.

Missing a dose of Pevaryl

Use the medicine as soon as possible, and then use the next dose at the usual time.

Stopping use of Pevaryl

Use the medicine as your doctor has told you. Treatment should be continued until the disease symptoms disappear.
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common (in less than 1 in 10 people) side effects observed in clinical trials and after the medicine was marketed were: itching, burning sensation of the skin, and pain at the application site.
Uncommon (affecting less than 1 in 100 people) side effects were: redness, discomfort, and swelling at the application site.
Very rare (affecting less than 1 in 10,000 people) side effects were: hypersensitivity, angioedema (sudden swelling of the face or throat, making it difficult to speak, swallow, or breathe), contact dermatitis, rash, urticaria, blisters, and skin peeling.
If you experience any of the above side effects, stop using the medicine and contact your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, 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 Pevaryl

Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date (EXP) 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 Pevaryl contains

• The active substance is econazole nitrate; 1 g of cream contains 10 mg of econazole nitrate.
• The other ingredients (excipients) are: butylhydroxyanisole (E 320), benzonic acid (E 210), liquid paraffin, macrogolglycerides, macrogol-6 and macrogol-32 glycerol stearate, purified water.

What Pevaryl looks like and contents of the pack

Pevaryl is a cream.
The medicine is available in a 30 g aluminum tube coated with epoxy resin inside, closed with a membrane and a PP or PE cap, placed in a cardboard box.

Marketing authorization holder

Karo Pharma AB
Box 16184, 103 24, Stockholm
Sweden
[email protected]

Manufacturer

Lusomedicamenta

• Sociedade Técnica Farmacêutica, S.A. Estrada Consiglieri Pedroso 69 B, Queluz de Baixo 2730-055 Barcarena Portugal

Date of last revision of the leaflet: