ROXOLAC 80 mg /G Medykament Na Paznokcie

Treść ulotki

1. ROXOLAC 80 mg/g, medicated nail polish
   1. WHAT IS ROXOLAC 80 mg/g, medicated nail polish AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING ROXOLAC 80 mg/g, medicated nail polish
   3. HOW TO USE ROXOLAC 80 mg/g, medicated nail polish
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ROXOLAC 80 mg/g, medicated nail polish
   6. PACKAGE CONTENTS AND OTHER INFORMATION

ROXOLAC 80 mg/g, medicated nail polish

Ciclopirox
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist
has told you to.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, see section 4, and speak to your doctor or pharmacist.
• See a doctor if you do not feel better or if your symptoms get worse after 6 months.

Contents of this leaflet:

• 1. What ROXOLAC 80 mg/g, medicated nail polish is and what it is used for
• 2. What you need to know before you use ROXOLAC 80 mg/g, medicated nail polish
• 3. How to use ROXOLAC 80 mg/g, medicated nail polish
• 4. Possible side effects
• 5. How to store ROXOLAC 80 mg/g, medicated nail polish
• 6. Contents of the pack and other information

1. WHAT IS ROXOLAC 80 mg/g, medicated nail polish AND WHAT IS IT USED FOR

This medicine is a nail polish containing the active ingredient ciclopirox: an antifungal agent for topical use.
ROXOLAC 80 mg/g, medicated nail polish is indicated in adults for the treatment of mild to moderate nail infections (onychomycosis) of the hands and feet. The active ingredient ciclopirox penetrates
through the nail and kills the fungi.

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

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

• if you are allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Do not ingest.
• Avoid contact with eyes and mucous membranes until ROXOLAC 80 mg/g, medicated nail polish is dry.
• ROXOLAC 80 mg/g, medicated nail polish must be applied only locally.
• Do not apply regular nail polish or any other cosmetic polish to the treated nails.
• If you experience any allergic reaction, stop treatment immediately, carefully remove the medicated polish with a solvent and contact your doctor.
• If the nail comes off during cleaning, and particularly if you suffer from diabetes or immune system disorders, contact your doctor.
• If you have more than 5 nails to treat, or if you have diabetes or immune system disorders, contact your doctor because you may need to add oral treatment.

Other medicines and ROXOLAC 80 mg/g, medicated nail polish
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take
any other medicine.

ROXOLAC 80 mg/g, medicated nail polish with food and drink
Not applicable.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy, ask your
doctor or pharmacist for advice before using this medicine.

Pregnancy
This medicine can be used in pregnant women.

Breastfeeding
There is insufficient information on the excretion of ciclopirox into breast milk. A risk to newborns/infants cannot be excluded. Do not use ROXOLAC 80 mg/g medicated nail polish during
breastfeeding.

Driving and operating machinery
ROXOLAC 80 mg/g, medicated nail polish does not impair the ability to drive and operate
machinery.

Important information about some of the ingredients ofROXOLAC 80 mg/g, medicated nail polish
Not applicable.

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

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Method of administration:
Cutaneous use.
For external use only. This medicine can only be used in adults.
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 polish:

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

For the entire duration of treatment:

• apply a thin layer of ROXOLAC 80 mg/g, medicated nail polish to the entire surface of the affected nails, once a day, preferably in the evening,
• ROXOLAC 80 mg/g medicated nail polish must be applied to the entire nail,
• once a week, before applying ROXOLAC 80 mg/g, medicated nail polish, remove the layer of polish with a commercially available nail polish remover.
• at the same time, it is recommended to remove excess parts of the affected nails.
• do not apply ordinary nail polish or any other cosmetic polish to the treated nails.
• depending on the severity of your condition (extensive involvement of one or more nails of the hands and feet), contact your doctor because you may need additional oral treatment.

Duration of treatment
The duration of treatment depends on the severity of the infection.
The duration of treatment is usually 3 months for nail fungus of the hand, up to 6 months for nail fungus of the foot.
The duration of treatment should not exceed 6 months.
If you have any doubts about whether to continue treatment, ask your doctor or pharmacist for advice.

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

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

If you stop using ROXOLAC 80 mg/g, medicated nail polish
If you stop or interrupt treatment too early, the fungal infection may recur.If you are not sure whether the condition of the nail has improved, ask your doctor or pharmacist for advice.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Not known(frequency cannot be estimated from available data)

• Contact dermatitis (skin rash such as eczema)
• Generalised allergic reactions (hypersensitivity), which can be severe, including swelling (oedema), itching (pruritus), rash, itchy rash (urticaria), difficulty breathing (dyspnoea). If any of these side effects occur, you must stop treatment immediately and consult a doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system available at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety
of this medicine.

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

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the bottle. The expiry date refers to the last day of that month.
Store in the original package, to protect from light.
After opening, keep the bottle tightly closed, in the package.
After the first opening of the bottle, use the product within 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What ROXOLAC 80 mg/g, medicated nail polish contains
The active substance is:Ciclopirox.
One gram of medicated nail polish contains 80 mg (8%) of ciclopirox.

The other ingredients are:
Ethyl acetate, isopropyl alcohol, methyl vinyl ether/maleic acid monobutyl ester copolymer.

Description of the appearance of ROXOLAC 80 mg/g, medicated nail polish and package contents
ROXOLAC 80 mg/g, medicated nail polish is a slightly viscous, clear liquid, from colorless to
light yellow-brown.
ROXOLAC 80 mg/g, medicated nail polish is packaged in a colorless glass bottle with a
white screw cap with an applicator brush (LDPE).
Colorless type III glass bottle with a white screw cap with an applicator brush (LDPE).
Packs: 1 bottle of 3 ml, 2 bottles of 3 ml,
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States with the following denominations:
Belgium: Mycosten
Germany: Miclast
Italy: Roxolac
Spain: Miclast