Ciclopirox Isdin 80 mg/g medicated nail lacquer

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciclopirox Isdin 80 mg/g medicated nail lacquer

ciclopirox

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

• 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ciclopirox Isdin is and what it is used for
2. What you need to know before using Ciclopirox Isdin
3. How to use Ciclopirox Isdin
4. Possible side effects
5. How to store Ciclopirox Isdin
6. Contents of the pack and other information

1. What Ciclopirox Isdin is and what it is used for

Ciclopirox Isdin 80 mg/g medicated nail lacquer belongs to the group of topical dermatological antifungals, medicines used to treat infections caused by fungi.

Ciclopirox Isdin 80 mg/g medicated nail lacquer is used in the treatment of nail fungal infections (onychomycosis) of the fingernails and toenails. The active substance, ciclopirox, penetrates into the nail and kills the fungi.

Ciclopirox Isdin 80 mg/g medicated nail lacquer is indicated for use in adults.

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

Ciclopirox Isdin 80 mg/g medicated nail lacquer should only be applied to the nails.

Do not use Ciclopirox Isdin

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

• if you are under 18 years of age.

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 medicated nail lacquer should only be applied topically.
• If an allergic reaction occurs, 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.

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

Children

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

Other medicines and Ciclopirox Isdin

To date, no interactions with other medicines are known.

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

Pregnancy and breastfeeding

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

Driving and using machines

As this product does not affect the patient's ability to concentrate, Ciclopirox Isdin 80 mg/g medicated nail lacquer does not influence the ability to drive or operate machinery.

3. How to use Ciclopirox Isdin

Follow exactly the administration instructions for Ciclopirox Isdin 80 mg/g medicated nail lacquer as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Ciclopirox Isdin 80 mg/g medicated nail lacquer. Do not stop the treatment prematurely, as the medicine will not be effective. If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Before starting treatment with Ciclopirox Isdin 80 mg/g medicated nail lacquer:

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

During the entire treatment:

• apply a thin layer of Ciclopirox Isdin 80 mg/g medicated nail lacquer over the entire surface of all affected nails. Unless otherwise prescribed, Ciclopirox Isdin 80 mg/g medicated nail lacquer should be applied every two days during the first month. In the second month, application may be reduced to at least twice a week, and from the third month onward, application may be performed once a week.
• at the same time, you should also remove as much of the damaged nail parts as possible.

Duration of treatment:

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

The minimum treatment duration will be 3 months (for fingernail fungal infections) and up to 6 months (for toenail fungal infections).

If you have any doubts about whether you should continue the treatment, consult your doctor or pharmacist.

After each application of Ciclopirox Isdin 80 mg/g medicated nail lacquer, the bottle must be kept tightly closed to prevent evaporation of the solution. To avoid the cap sticking to the bottle, ensure that the lacquer does not wet the threads of the container.

If you use more Ciclopirox Isdin than you should

No overdose effects are known with Ciclopirox Isdin 80 mg/g medicated nail lacquer.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone (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 missed applications. Continue the treatment as indicated in section 3 of this leaflet.

If you stop the treatment with Ciclopirox Isdin

If you discontinue or interrupt the treatment too early, the fungal infection may recur. If you are unsure whether the condition of your nails has improved, consult your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, Ciclopirox Isdin 80 mg/g medicated nail lacquer may produce adverse effects, although not everyone will experience them.

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

Prolonged use of the product could lead to sensitization reactions, resulting in undesirable effects. In such cases, treatment must be discontinued and a physician consulted. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciclopirox Isdin

Ciclopirox Isdin 80 mg/g medicated nail lacquer must be stored at room temperature and protected from light (keep the bottle tightly closed in its container after each use).

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiration date refers to the last day of the month indicated.

Once the container has been opened, the product should be used within 6 months.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ciclopirox Isdin

• The active substance is ciclopirox. One gram of medicated nail lacquer contains 80 mg of ciclopirox.
• The other components are: methyl methacrylate / butyl methacrylate / methacrylic acid copolymer; ethyl acetate and isopropyl alcohol.

Nature of the product and contents of the container

Ciclopirox Isdin 80 mg/g medicated nail lacquer is a cutaneous solution, presented in a glass bottle containing 3 g of transparent solution, supplied with a brush.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Manufacturer:

LABORATORIOS SERRA PÀMIES

Ctra. Castellvell, 2443206

Reus (Tarragona)

Spain

Date of the most recent revision of this leaflet: October 2022

"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/"