Ciclochem Uñas 80 mg/g medicated nail polish
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Ciclochem nails 80 mg/g medicated nail polish
Ciclopirox
Read the entire leaflet carefully before you start using this medicine.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Ciclochem nails is and what it is used for
- What you need to know before using Ciclochem nails
- How to use Ciclochem nails
- Possible side effects
- How to store Ciclochem nails
- Contents of the pack and other information
1. What Ciclochem Nail is and what it is used for
Ciclochem Nail is a medicated nail polish.
Ciclochem Nail belongs to a group of medicines called topical antifungals, which inhibit the growth of various types of fungi at the skin level.
This medicine is indicated for the treatment of nail infections caused by fungi.
2. What you need to know before using Ciclochem nails
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 an allergic reaction, stop treatment and contact your doctor.
- If you need to treat several nails, or if you have diabetes or immune system disorders, consult your doctor, as you may require additional oral treatment.
Use of Ciclochem nails with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No incompatibilities with other medicines have been observed.
Once Ciclochem nails has dried, a second layer of cosmetic nail polish may be applied without affecting the efficacy of Ciclochem nails. In such case, before the next application of Ciclochem nails, the cosmetic nail polish must be removed with a commercial nail polish remover.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Ciclochem nails is not recommended during pregnancy and breastfeeding due to lack of information on the use of Ciclochem nails in these situations.
Driving and operating machinery
Ciclochem nails has no influence on the ability to drive or operate machinery.
3. How to use Ciclochem Nail
Follow exactly the administration instructions for Ciclochem Nail provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Adults:
Unless otherwise instructed, apply Ciclochem Nail 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 onwards, the application may be performed once a week.
The duration of treatment depends on the severity of the infection; exceeding six months is not recommended.
Method of use:
Apply Ciclochem Nail as a thin layer over the affected nail, ensuring that the nail is completely covered with the active substance. Before starting treatment, it is recommended to remove loose parts of the affected nails using nail clippers, a file, or scissors.
During treatment, remove the nail lacquer layer once a week using a commercial nail polish remover. If the lacquer layer becomes damaged between applications, it is sufficient to reapply only to the affected areas.
Do not reuse hygiene materials from infected nails, especially the nail file, on healthy nails.
After each application of Ciclochem Nail, keep the bottle tightly closed to prevent evaporation of the solution. Also avoid contact of the solution with the bottle threads, to prevent the cap from sticking.
If you use more Ciclochem Nail than you should
No effects of overdose with Ciclochem Nail are known.
In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone (91) 5 62 04 20, indicating the medication and amount used.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Ciclochem uñas may cause adverse effects, although not everyone will experience them.
Very rarely, redness and scaling of the skin around the nail in contact with Ciclochem uñas may occur.
Prolonged use of the product may cause allergic-type reactions; in this case, treatment must be discontinued and you should consult your doctor.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ciclochem nails
Keep out of sight and reach of children.
Do not use Ciclochem nails after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use Ciclochem nails more than 6 months after opening the bottle.
Keep the bottle tightly closed. Store the bottle in the outer packaging to protect it from light.
Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the package and other information
Composition of Ciclochem Nail Lacquer
The active substance is Ciclopirox. One gram of medicated nail lacquer 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 medicinal product and contents of the container
Colorless transparent glass bottle containing 3 g or 6 g of medicated nail lacquer, supplied with an applicator brush.
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 most recent revision of this leaflet: July 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.