PEVARYL "50 MG OVULES" 15 OVULES"

Name
Pevaryl 50 mg ovules
Pevaryl 150 mg ovules
Pevaryl 150 mg prolonged-release ovules
Econazole nitrate


What is it and what is it used for?
Pevaryl contains econazole nitrate which belongs to a group of medicines called “antifungals” used to treat mycoses (infections caused by fungi).
Pevaryl ovules and prolonged-release ovules is a medicine for gynecological use used for the local treatment of mycoses of the vaginal region (internal) and genital region (external) in women (vulvovaginal mycoses).

Talk to 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 section 6).


Warnings and precautions
Talk to your doctor or pharmacist before using Pevaryl.
Pevaryl ovules and prolonged-release ovules are for intravaginal use only.
Pevaryl ovules and prolonged-release ovules are not for ophthalmic or oral use.

Avoid contact between Pevaryl ovules and prolonged-release ovules and latex-based contraceptives such as condoms or diaphragms because concomitant use with antimicrobial preparations may reduce the effectiveness of the latex contraceptive. Therefore, Pevaryl ovules and prolonged-release ovules should not be used simultaneously with latex condoms or diaphragms.
Patients using spermicides should consult their doctor as any local vaginal treatment can inactivate the spermicide.
Pevaryl ovules and prolonged-release ovules must 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 allergic to imidazoles (the class of medicines to which Pevaryl belongs), you may also be allergic to econazole nitrate.

Children and adolescents
Do not use this medicine in children and adolescents aged 2 to 16 years. No data are available.

Use in the elderly
There are 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 everybody gets 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 eruptions (rash)
• Burning sensation of the vaginal region (internal) and the genital region (external) of the woman (vulvovaginal)

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

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

Reporting of side effects
If you experience any side effects, including any 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.