NIOGERMOX*NAIL LACQUER 6.6ML

NIOGERMOX 80 mg/g medicated nail lacquer
Ciclopirox

What it is and what it is used for
NIOGERMOX is an antifungal agent with broad efficacy (broad-spectrum antimycotic) for topical use on fingernails, toenails, and adjacent skin areas.

It is used for the treatment of mild to moderate nail infections caused by filamentous fungi and/or fungi sensitive to ciclopirox.

The active ingredient ciclopirox prevents the growth of fungi and destroys them, thereby improving the appearance of the nails.

What you need to know before taking the medicine
Do not use NIOGERMOX
• If you are allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6).
• In children and adolescents under 18 years of age, due to insufficient clinical data in this age group.

Warnings and precautions
Talk to your doctor or pharmacist before using NIOGERMOX.

If sensitization occurs, discontinue treatment and consult a doctor.

As with all topical treatments for fungal nail infections, if multiple nails are involved (> 3 nails) or if more than half of the nail is affected or the nail matrix is involved, and in the presence of predisposing factors such as diabetes and immune system disorders, the addition of systemic therapy should be considered.

If you have diabetes, be especially careful when trimming your nails.

Avoid contact with eyes and mucous membranes.

NIOGERMOX medicated nail lacquer is for external use only.

Do not apply other nail polishes or cosmetic products to the treated nails.

If you have a history of diabetes, immune system disorders, peripheral vascular disease (blockages in your arteries), injured, sore or severely damaged nails, skin diseases such as psoriasis or yellow nail syndrome (a disease that causes thickening and yellowing of the nails, chronic limb swelling and chronic respiratory problems), ask your doctor for advice before starting treatment with Niogermox.

Children and adolescents
NIOGERMOX is contraindicated in children and adolescents under 18 years of age (See section 2 "Do not use NIOGERMOX").

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare side effects: (affecting less than 1 in 10,000 users)
• Redness at the application site, peeling, itching, and burning,

Not known (frequency cannot be estimated from the available data):
• Rash, eczema, allergic contact dermatitis, even outside the application site.
• (Transient) alteration of nail color (this reaction may also be due to the fungal infection itself).

The reported side effects were mild and short-lived.

Reporting of side effects
If you get 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.