Label: Information for the User

Ciclochem nail 80 mg/g medicated nail polish

Ciclopirox

Read the entire label carefully before starting to use the medication.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Ciclochem nails is a medicated nail polish.

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

This medication is indicated for the treatment of nail infections caused by fungi.

Do not use Ciclochem nails

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

Warnings and precautions

• Apply the product only on the nails. Avoid contact with eyes and mucous membranes.
• In case of allergic reaction, suspend treatment and contact your doctor.
• In case of treating multiple nails or in case of diabetes or immunological disorders, consult your doctor as you may need additional oral treatment.

Use of Ciclochem nails with other medications

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

No incompatibilities with other medications have been observed.

Once Ciclochem nails is dry, a second layer of cosmetic nail polish may be applied without affecting the efficacy of Ciclochem nails. In this case, before the next application of Ciclochem nails, the cosmetic polish should be removed with a commercial nail polish remover.

Pregnancy and breastfeeding

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

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

Driving and operating machines

Ciclochem nails does not affect your ability to drive or operate machines.

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

Adults:

Unless otherwise indicated, apply Ciclochem nails every two days during the first month. In the second month, the application may be reduced to at least twice a week. From the third month, the application may be performed once a week.

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

Method of use:

Ciclochem nails 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 loose parts of the affected nails using a nail clipper, nail file, or scissors.

Throughout the treatment, once a week, remove the lacquer layer with a commercial nail polish remover. If between applications the lacquer layer is damaged, it is sufficient to treat only the affected areas again.

Do not reuse nail hygiene materials, especially the nail file, on healthy nails.

After each application of Ciclochem nails, keep the bottle tightly closed to prevent the solution from evaporating. Also, avoid having the solution moisten the bottle cap, so that the stopper does not stick.

If you use more Ciclochem nails than you should

No overdose effects with Ciclochem nails are known.

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

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

Like all medications, Ciclochem nails may produce adverse effects, although not everyone will experience them.

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

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

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 Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use Ciclochem nails after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Ciclochem nails if more than 6 months have passed since opening the bottle.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ciclochem nails

The active ingredient is Ciclopirox. One gram of medicated nail polish contains 80 mg of ciclopirox.

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

Appearance of the product and content of the packaging

Colourless and transparent glass vial containing 3 g or 6 g of medicated nail polish, provided with a brush for its application.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing:

Delpharm Bladel, B.V. Industrieweg 1 Bladel (Netherlands)

Date of the last review of this leaflet: July 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.