CICLOPIROX ISDIN 80 mg/g NAIL LACQUER MEDICATED

2. What you need to know before starting to use Ciclopirox Isdin

Ciclopirox Isdin 80 mg/g medicinal nail varnish should only be applied to the nails.

Do not useCiclopirox Isdin

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

• if you are under 18 years old.

Warnings and precautions

• Do not swallow.
• Avoid contact of Ciclopirox Isdin with the eyes and mucous membranes until it has dried.
• Ciclopirox Isdin 80 mg/g medicinal nail varnish should only be applied locally.
• In case of allergic reaction, discontinue treatment and contact your doctor.
• In case you need to treat several nails or if you have diabetes or immune system 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 medicinal nail varnish.

Children

Due to the lack of clinical experience, Ciclopirox Isdin 80 mg/g medicinal nail varnish 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 recently used or may need to use any other medicine.

Pregnancy and breastfeeding

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

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

Driving and using machines

Since the preparation does not affect the patient's attention, Ciclopirox Isdin 80 mg/g medicinal nail varnish does not influence the ability to drive vehicles or use machinery.

3. How to use Ciclopirox Isdin

Follow the instructions for administration of Ciclopirox Isdin 80 mg/g medicinal nail varnish indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Ciclopirox Isdin 80 mg/g medicinal nail varnish. Do not discontinue treatment before, as the medicine may not be effective. If you think the action of this medicine is too strong or too weak, inform your doctor or pharmacist.

Before starting treatment with Ciclopirox Isdin 80 mg/g medicinal nail varnish:

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

During the entire treatment:

• apply a thin layer of Ciclopirox Isdin 80 mg/g medicinal nail varnish to the entire surface of all affected nails. Unless otherwise prescribed, Ciclopirox Isdin 80 mg/g medicinal nail varnish should be applied every two days during the first month. In the second month, the application can be reduced to at least twice a week, and from the third month onwards, the application can be done once a week.
• at the same time, you should also remove as much of the damaged part of the nails 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 mycoses of the hands) and a maximum of 6 months (nail mycoses of the feet).

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

After each application of Ciclopirox Isdin 80 mg/g medicinal nail varnish, the bottle should be kept tightly closed to prevent the solution from evaporating. To avoid the cap sticking to the bottle, avoid getting the varnish on the thread of the bottle.

If you use more Ciclopirox Isdin than you should

No effects of overdose with Ciclopirox Isdin 80 mg/g medicinal nail varnish are known.

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

If you forget to use Ciclopirox Isdin

Do not use a double dose to make up for forgotten applications. Continue with the treatment as indicated in section 3 of this leaflet.

If you interrupt the treatment with Ciclopirox Isdin

If you stop or interrupt the treatment too early, the mycosis may reappear. If you are not sure if the condition 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.

4. Possible side effects

Like all medicines, Ciclopirox Isdin 80 mg/g medicinal nail varnish can cause side effects, although not everyone gets them.

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

Prolonged use of the product may lead to sensitization phenomena, resulting in undesirable effects. In such cases, treatment should be discontinued and a doctor consulted. If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciclopirox Isdin

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

Do not use this medicine after the expiry date stated on the packaging, after CAD. The expiry date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Ciclopirox Isdin

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

Appearance of the product and package contents

Ciclopirox Isdin 80 mg/g medicinal nail varnish is a solution for cutaneous use, presented in a glass bottle containing 3 g of transparent solution, provided with a brush.

Marketing authorization holder and manufacturer:

Holder:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Manufacturer:

LABORATORIOS SERRA PÀMIES

Ctra. Castellvell, 24

43206 Reus (Tarragona)

Spain

Date of the last revision of this leaflet:October 2022

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