PEVARYL*TOPICAL SOLUTION GYN 60ML 1%

Pevaryl 1% cutaneous solution for external genitalia
Econazole

What it is and what it is used for
Pevaryl contains econazole, which belongs to a group of medicines called "antifungals" used to treat mycoses (fungal infections).
Pevaryl cutaneous solution for external genitalia is a medicine used for the local treatment of:
• mycoses of the vaginal (internal) and genital (external) region in women (vulvovaginal mycoses)
• mycoses of the external genitalia in men (Mycotic Balanitis).

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 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 cutaneous solution for external genitalia is not for ophthalmic or oral use.

Avoid contact of Pevaryl cutaneous solution for external genitalia with latex-based contraceptives such as condoms or diaphragms because simultaneous use with antimicrobial preparations may decrease the effectiveness of the latex contraceptive. Therefore, Pevaryl cutaneous solution for external genitalia should not be used simultaneously with latex condoms or diaphragms.
Patients using spermicides should consult their doctor as any local vaginal treatment may inactivate the spermicide.
Pevaryl should not be used together with other products for the internal or external treatment of the genitals.
If sensitization or marked irritation occurs, treatment should be discontinued.

If you are hypersensitive to imidazoles (the class of medicines to which Pevaryl belongs) you may also be hypersensitive to econazole.
Children and adolescents
Do not use this medicine in children and adolescents aged between 2 and 16 years. No data are available.

Use in the elderly
Insufficient data. Do not use this medicine in elderly patients over 65 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
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 of the skin

Uncommon side effects (may affect up to 1 in 100 people) include:
• Skin rashes (rash)
• Burning sensation of the vaginal (internal) and genital (external) region in women (vulvovaginal)

Very rare side effects (may affect up to 1 in 10,000 people) include:
• Erythema

Side effects with unknown frequency include:
• Hypersensitivity
• Angioedema (swelling of the face, lips, mouth and/or tongue)
• Contact dermatitis
• Urticaria
• Skin exfoliation
• Pain at the application site
• Irritation at the application site
• Swelling at the application site

With the cutaneous solution, phenomena of local sensitization may occur.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.