PEVARYL*POWDER 30G 1%

Pevaryl 1% cutaneous powder
Econazole nitrate

What it is and what it is used for
Pevaryl is an antifungal medicine for the topical treatment of infections caused by certain fungi and yeasts, including suspected concomitant infections caused by Gram-positive bacteria.
This product is indicated for the treatment of:
- cutaneous mycoses caused by dermatophytes, cutaneous candidiasis and suspected concomitant infections by Gram-positive bacteria;
- Pityriasis Versicolor.
Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
DO NOT use Pevaryl
- if you are allergic to econazole nitrate, or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Consult your doctor or pharmacist before using Pevaryl.
Pevaryl is for external use only.
Pevaryl is not indicated for ophthalmic or oral use.
If allergic reactions or skin irritation occur, discontinue treatment and contact your doctor.
Pevaryl cutaneous powder contains talc.
Avoid inhaling the cutaneous powder to prevent airway irritation, especially in children and infants.

Children and adolescents
No data is available.
Prevent children and infants from inhaling the cutaneous powder to prevent airway irritation.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of topical products, especially if prolonged, can give rise to sensitisation phenomena; if this occurs, discontinue treatment and consult your doctor.
In case of particularly intense local reactions, treatment must be suspended and a doctor consulted.
Below is a list of side effects that have occurred with Pevaryl.

Common side effects (may affect up to 1 in 10 people) include:
• Itching
• Burning sensation on the skin
• Pain

Uncommon side effects (may affect up to 1 in 100 people) include:
• Erythema
• Malaise
• Swelling

Side effects with unknown frequency include:
• Angioedema (swelling of the face, mouth, lips and/or tongue)
• Contact dermatitis
• Rash
• Hives
• Blistering
• Skin exfoliation
• Hypersensitivity

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.