Leaflet: information for the user

Ciclopirox Isdin 80 mg/g medicated nail polish

ciclopirox

Read this leaflet carefully before you start using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isCiclopiroxIsdinand what is it used for

2. What you need to know before you start usingCiclopiroxIsdin

3. How to useCiclopiroxIsdin

4. Possible side effects

5. Storage ofCiclopiroxIsdin

6. Contents of the pack and additional information

Ciclopirox Isdin 80 mg/g nail polish medicamentoso belongs to the group of external dermatological antifungals, medications for the treatment of infections caused by fungi.

Ciclopirox Isdin 80 mg/g nail polish medicamentoso is used for the treatment of nail mycoses (onychomycosis) of hands and feet. The active ingredient, ciclopirox, penetrates the nail and kills the fungi.

Ciclopirox Isdin 80 mg/g nail polish medicamentoso is indicated for adults.

Ciclopirox Isdin 80 mg/g medicated nail polish must be applied only to the nails.

Do not useCCiclopirox Isdin

• if you are allergic (hypersensitive) to ciclopirox or to any of the other components of Ciclopirox Isdin 80 mg/g medicated nail polish (see section 6).

• if you are under 18 years old.

Warnings and precautions

• Do not swallow.
• Avoid contact ofCiclopirox Isdin with the eyes and mucous membranes until it has dried.
• Ciclopirox Isdin 80 mg/g medicated nail polish should only be applied locally.
• In case of allergic reaction, discontinue treatment and contact your doctor.
• In case you need to treat multiple nails or in case of diabetes or immunological disorders, consult your doctor as you may need additional oral treatment.

Consult your doctor or pharmacist before starting to use Ciclopirox Isdin 80 mg/g medicated nail polish.

Children

Due to lack of clinical experience, Ciclopirox Isdin 80 mg/g medicated nail polish is contraindicated in children.

Other medicines and Ciclopirox Isdin

To date, there are no known interactions with other medicines.

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine.

Pregnancy and breastfeeding

Due to lack of clinical experience, treatment with Ciclopirox Isdin 80 mg/g medicated nail polish is not recommended during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Since the preparation does not affect the patient's attention, Ciclopirox Isdin 80 mg/g medicated nail polish does not affect the ability to drive vehicles or operate machinery.

Follow exactly the administration instructions for Ciclopirox Isdin 80 mg/g medicated nail polish as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Ciclopirox Isdin 80 mg/g medicated nail polish. Do not discontinue treatment beforehand, as the medication would not be effective. If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Before starting treatment withCiclopirox Isdin80mg/g medicated nail polish:

• remove all damaged parts of the nails, if possible using scissors, a nail clipper, or a nail file.

During the entire treatment:

• apply a thin layer ofCiclopirox Isdin80mg/g medicated nail polish, over the entire surface of all affected nails. Unless otherwise prescribed, Ciclopirox Isdin 80 mg/g medicated nail polish will be applied every two days for the first month. In the second month, the application can be reduced, at a minimum, to two times a week, and from the third month onwards, the application can be performed once a week.
• at the same time, you should also remove as much of the damaged nail as possible.

Duration of treatment:

The duration of treatment depends on the severity of the infection.

The minimum duration of treatment will be 3 months (nail fungus on the hands) and a maximum of 6 months (nail fungus on the feet).

If you have doubts about whether to continue or not with the treatment, consult your doctor or pharmacist.

After each application of Ciclopirox Isdin 80 mg/g medicated nail polish, the bottle must be kept tightly closed, to prevent the solution from evaporating. In order to prevent the plug from sticking to the bottle, it should be avoided that the polish moistens the threads of the same.

If you use more Ciclopirox Isdin than you should

No cases of overdose have been reported with Ciclopirox Isdin 80 mg/g medicated nail polish.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount used.

If you forgot to use Ciclopirox Isdin

Do not use a double dose to compensate for the missed applications. Continue with the treatment as indicated in section 3 of this prospectus.

If you interrupt the treatment with Ciclopirox Isdin

If you abandon or interrupt the treatment too soon, the fungus may reappear. If you are unsure whether the state of your nails has improved, consult your doctor or pharmacist.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Ciclopirox Isdin 80 mg/g medicated nail polish may cause adverse effects, although not everyone will experience them.

In very isolated cases, redness and peeling of the skin around the nail that has come into contact with Ciclopirox Isdin 80 mg/g medicated nail polish have been reported.

Prolonged use of the product may lead to sensitization phenomena, resulting in undesirable effects. In such cases, treatment must be interrupted and a healthcare professional consulted. If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Ciclopirox Isdin 80 mg/g medicated nail polish should be stored at room temperature and protected from light (keep the bottle tightly closed in its case after each application).

Do not use this medication after the expiration date indicated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Once the packaging is opened, it should be used within a period of 6 months.

Keep this medication out of the sight and reach of children.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ciclopirox Isdin

• The active ingredient is ciclopirox. One gram of medicated nail polish contains 80 mg of ciclopirox.
• The other components are: methoxyethoxy polymer with 2-butendioic acid, monobutyl ester; ethyl acetate and isopropyl alcohol.

Appearance of the product and content of the container

Ciclopirox Isdin 80 mg/g medicated nail polish is a topical solution, presented in a glass bottle containing3 gof transparent solution, provided with a brush.

Holder of the marketing authorization and manufacturer responsible:

Holder:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Manufacturer:

LABORATORIOS SERRA PÀMIES

Ctra. Castellvell, 2443206

Reus (Tarragona)

Spain

Last review date of this leaflet:October 2022

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”