PEVARYL*15 VAGINAL OVULES 50MG

Pevaryl 50 mg pessaries
Pevaryl 150 mg pessaries
Pevaryl 150 mg prolonged-release pessaries
Econazole nitrate

What it is and what it is used for
Pevaryl contains econazole nitrate, which belongs to a group of medicines called "antifungals used to treat mycoses (infections caused by fungi)."
Pevaryl pessaries and prolonged-release pessaries are gynecological medicines used for the local treatment of mycoses of the vaginal (internal) and genital (external) regions in women (vulvovaginal mycoses).

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 section 6).

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

Avoid contact of Pevaryl pessaries and prolonged-release pessaries with latex-based contraceptives such as condoms or diaphragms because simultaneous use with antimicrobial preparations may reduce the effectiveness of the latex contraceptive. Therefore, Pevaryl pessaries and prolonged-release pessaries should not be used concurrently with latex condoms or diaphragms.
Patients using spermicides should consult their doctor as any local vaginal treatment may inactivate the spermicide.
Pevaryl pessaries and prolonged-release pessaries 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 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 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 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 rashes
• Burning sensation in the vaginal (internal) and genital (external) regions in women (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
• Urticaria
• Skin exfoliation
• Pain at the application site
• Irritation at the application site
• Swelling at the application site

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.