PACKAGE LEAFLET: INFORMATION FOR THE USER

ROXOLAC 80 mg/g, medicated nail lacquer

Ciclopirox
Please read all of this leaflet carefully before using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 6 months.

Contents of this leaflet:

What ROXOLAC 80 mg/g, medicated nail lacquer is and what it is used for
What you need to know before using ROXOLAC 80 mg/g, medicated nail lacquer
How to use ROXOLAC 80 mg/g, medicated nail lacquer
Possible side effects
How to store ROXOLAC 80 mg/g, medicated nail lacquer
Contents of the pack and other information

1. WHAT ROXOLAC 80 mg/g, MEDICATED NAIL LACQUER IS AND WHAT IT IS USED FOR

This medicinal product is a nail lacquer containing the active substance ciclopirox, an antifungal agent for topical use.
ROXOLAC 80 mg/g, medicated nail lacquer is indicated in adults for the treatment of mild to moderate fungal infections of the fingernails and toenails (onychomycosis). The active substance ciclopirox penetrates through the nail and kills the fungi.

2. WHAT YOU NEED TO KNOW BEFORE USING ROXOLAC 80 mg/g, medicated nail lacquer

DO NOT USE ROXOLAC 80 mg/g, medicated nail lacquer

if you are allergic to ciclopirox or to any of the excipients of this medicinal product (listed in section 6).

Warnings and precautions

Do not ingest.
Avoid contact with eyes and mucous membranes until ROXOLAC 80 mg/g, medicated nail lacquer has dried completely.
ROXOLAC 80 mg/g, medicated nail lacquer must be applied topically only.
Do not apply regular nail polish or any other cosmetic nail coating on treated nails.
If you experience any allergic reaction, stop treatment immediately, carefully remove the medicated nail lacquer with a solvent, and contact your doctor.
If the nail becomes detached during cleaning, and especially if you have diabetes or immune system disorders, contact your doctor.
If you have more than five nails to treat, or if you have diabetes or immune system disorders, consult your doctor, as you may require additional oral treatment.

Other medicines and ROXOLAC 80 mg/g, medicated nail lacquer
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
ROXOLAC 80 mg/g, medicated nail lacquer with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before using this medicinal product.
Pregnancy
This medicinal product may be used in pregnant women.
Breastfeeding
There is insufficient information regarding the excretion of ciclopirox in human breast milk. A risk to newborns/infants cannot be excluded. You must not use ROXOLAC 80 mg/g medicated nail lacquer during breastfeeding.
Driving and using machines
ROXOLAC 80 mg/g, medicated nail lacquer does not impair the ability to drive or operate machinery.
Important information about certain excipients of ROXOLAC 80 mg/g, medicated nail lacquer
Not applicable.

3. HOW TO USE ROXOLAC 80 mg/g, medicated nail lacquer

Use this medicinal product exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Method of administration:
Cutaneous use.
For external use only. This medicinal product is intended for use in adults only.
The recommended dose is one application per day, preferably in the evening.
After each use, follow the storage instructions (see section 5).

Before starting treatment with ROXOLAC 80 mg/g, medicated nail lacquer:

it is recommended to remove excess portions of the affected nails using scissors, nail clippers, or a nail file.

During the entire course of treatment:

apply a thin layer of ROXOLAC 80 mg/g, medicated nail lacquer to the entire surface of the affected nails once daily, preferably in the evening,
ROXOLAC 80 mg/g medicated nail lacquer must be applied to the entire nail surface,
once a week, before applying ROXOLAC 80 mg/g, remove the previous layer of lacquer using a commercially available cosmetic nail polish remover,
at the same time, it is recommended to remove excess portions of the affected nails,
do not apply regular nail polish or any other cosmetic nail coating on the treated nails,
depending on the severity of your condition (extensive involvement of one or more fingernails or toenails), contact your doctor, as you may require additional oral treatment.

Duration of treatment
The duration of treatment depends on the severity of the infection.
Treatment usually lasts 3 months for fingernail fungal infections and up to 6 months for toenail fungal infections.
The treatment duration must not exceed 6 months.
If you have any doubts about continuing treatment, consult your doctor or pharmacist.

If you use more ROXOLAC 80 mg/g, medicated nail lacquer than you should
Not applicable.

If you forget to use ROXOLAC 80 mg/g, medicated nail lacquer
Do not apply a double dose to make up for a missed dose. Continue treatment as indicated in section 3 of this leaflet.

If you stop treatment with ROXOLAC 80 mg/g, medicated nail lacquer
If you discontinue or stop treatment too early, the fungal infection may recur. If you are unsure whether the nail condition has improved, consult your doctor or pharmacist.
If you have any questions about the use of this medicinal product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Not known (frequency cannot be estimated from the available data)

Contact dermatitis (skin rash such as eczema)
Generalized allergic reactions (hypersensitivity), which may be severe, including swelling (edema), itching (pruritus), rash, itchy rash (urticaria), difficulty breathing (dyspnea). If any of these side effects occur, treatment must be stopped immediately and a doctor should be consulted as soon as possible.

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

5. HOW TO STORE ROXOLAC 80 mg/g, medicated nail lacquer

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and on the bottle. The expiry date refers to the last day of that month.
Store in the original packaging, to protect it from light.
After opening, keep the bottle tightly closed, inside the carton.
After first opening the bottle, use the product within 3 months.
Do not dispose of any medicinal product down the drain or with household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ROXOLAC 80 mg/g, medicated nail lacquer contains
The active substance is: Ciclopirox.
One gram of medicated nail lacquer contains 80 mg (8%) of ciclopirox.
The other components are:
Ethyl acetate, isopropyl alcohol, methyl vinyl ether-maleic acid monobutyl ester copolymer.

Description of the appearance of ROXOLAC 80 mg/g, medicated nail lacquer and contents of the package
ROXOLAC 80 mg/g, medicated nail lacquer is a clear, slightly viscous liquid, colourless to slightly yellowish-brown.
ROXOLAC 80 mg/g, medicated nail lacquer is supplied in a colourless glass bottle with a white screw cap and an integrated applicator brush (LDPE).
Colourless glass bottle type III with white screw cap and integrated applicator brush (LDPE).
Pack sizes: 1 bottle of 3 ml, 2 bottles of 3 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
PIERRE FABRE ITALIA S.p.A.
Via G. Washington, 70
20146 Milan - Italy

Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
Site de Cahors - Le Payrat
46000 Cahors - France

This medicinal product is authorized in the Member States under the following names:
Belgium: Mycosten
Germany: Miclast
Italy: Roxolac
Spain: Miclast