CICLOCHEM NAILS 80mg/g MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

Ciclochem Nail 80 mg/g Medicinal Nail Varnish

Ciclopirox

Read the entire package leaflet carefully before starting to use the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ciclochem Nail and what is it used for
2. What you need to know before you start using Ciclochem Nail
3. How to use Ciclochem Nail
4. Possible side effects
5. Storage of Ciclochem Nail
6. Package Contents and Additional Information

1. What is Ciclochem Nail and what is it used for

Ciclochem Nail is a medicinal nail varnish.

Ciclochem Nail belongs to a group of medicines called topical antifungals that inhibit the growth of various types of fungi on the skin.

This medicine is indicated for the treatment of fungal nail infections.

2. What you need to know before you start using Ciclochem Nail

Do not use Ciclochem Nail

• if you are allergic (hypersensitive) to ciclopirox or any of the other ingredients of Ciclochem Nail (see section 6).
• in children, as there is no clinical experience.

Warnings and Precautions

• Apply the product only to the nails. Avoid contact with eyes and mucous membranes.
• In case of an 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.

Using Ciclochem Nail with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

No incompatibilities with other medicines have been observed.

Once Ciclochem Nail is dry, a second layer of cosmetic nail varnish can be applied without modifying the efficacy of Ciclochem Nail. In this case, before the next application of Ciclochem Nail, the cosmetic varnish should be removed with a commercial nail varnish remover.

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.

The use of Ciclochem Nail is not recommended during pregnancy and breastfeeding, due to the lack of information on the use of Ciclochem Nail in these cases.

Driving and Using Machines

Ciclochem Nail does not affect the ability to drive or use machines.

3. How to use Ciclochem Nail

Follow exactly the administration instructions of Ciclochem Nail indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:

Unless otherwise indicated, Ciclochem Nail will be applied every two days during the first month. In the second month, the application can be reduced to at least twice a week. From the third month onwards, the application can be done once a week.

The duration of the treatment depends on the degree of the infection, and it is not advisable to exceed six months.

Method of use:

Ciclochem Nail will be applied in the form of a thin layer over the affected nail, ensuring that the nail is covered with the active ingredient. Before starting treatment, it is recommended to remove any loose parts of the affected nails using nail clippers, a file, or scissors.

Throughout the treatment, the layer of varnish should be removed once a week with a commercial nail varnish remover. If the layer of varnish becomes damaged between applications, it is sufficient to treat only the affected areas again.

Do not reuse the nail hygiene material from infected nails, especially the file, on healthy nails.

After each application of Ciclochem Nail, the bottle should be kept tightly closed to prevent the solution from evaporating. You should also avoid getting the solution on the bottle's thread, so the cap does not become stuck.

If you use more Ciclochem Nail than you should

No effects of an overdose with Ciclochem Nail are known.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone (91) 5 62 04 20, indicating the medicine and the amount used.

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

4. Possible side effects

Like all medicines, Ciclochem Nail can cause side effects, although not everybody gets them.

Very rarely, redness and peeling of the skin around the nail in contact with Ciclochem Nail may appear.

Prolonged use of the product can cause allergic reactions; in this case, you should discontinue treatment and consult your doctor.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciclochem Nail

Keep out of the sight and reach of children.

Do not use Ciclochem Nail after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Do not use Ciclochem Nail if more than 6 months have passed since the bottle was opened.

Keep the bottle tightly closed. Store the bottle in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any doubts, 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 Ciclochem Nail

The active ingredient is Ciclopirox. One gram of medicinal nail varnish contains 80 mg of ciclopirox.

The other ingredients are: methoxyethylene polymer with 2-butenedioic acid, monobutyl ester, ethyl acetate, and isopropyl alcohol.

Appearance of the Product and Package Contents

Colorless and transparent glass bottle with 3 g or 6 g of medicinal nail varnish, provided with a brush for application.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer:

Delpharm Bladel, B.V.

Industrieweg 1

Bladel (Netherlands)

Date of the Last Revision of this Package Leaflet: July 2024

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