Cyclonic 80 mg/g medicated nail lacquer

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Ciclonic 80 mg/g Medicinal 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Ciclonic is and what it is used for

Ciclonic 80 mg/g is a medicated nail lacquer. It contains the active substance ciclopirox, which belongs to a group of medicines known as antifungals. Ciclopirox penetrates into the nail plate and has a fungicidal effect against all the main causative agents of fungal nail infections.

Ciclonic 80 mg/g is used to treat fungal infections of the nails (onychomycosis).

2. What you need to know before using Ciclonic

Do not use Ciclonic:

• if you are allergic to ciclopirox or to any of the other components of this medicine (listed in section 6).
• in children due to insufficient experience in this age group so far.
• during pregnancy and breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ciclonic.

The use, especially if prolonged, of topical products may lead to sensitization phenomena or cause adverse reactions. In such situations, treatment must be discontinued and appropriate therapeutic measures should be taken. Contact with the eyes and mucous membranes should be avoided.

Do not use nail polish or other cosmetic nail products during treatment with Ciclonic.

Children and adolescents

Due to inadequate clinical experience, Ciclonic 80 mg/g medicated nail polish should not be used in children.

Other medicines and Ciclonic

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines.

Use of Ciclonic with food, beverages and alcohol

Not applicable.

Pregnancy, breastfeeding and fertility

Ciclonic is generally contraindicated during pregnancy and breastfeeding.

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

Driving and operating machinery

The influence of Ciclonic on the ability to drive and operate machinery is none or negligible.

3. How to use Ciclonic 80 mg/g medicated nail lacquer

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Unless otherwise indicated, a thin layer of Ciclonic medicated nail lacquer should be applied to the affected nail once daily.

Presentations without nail files included

Before the first application of Ciclonic, as much as possible of the affected portion of the nail should be removed, for example with scissors, and as much as possible of the hyperkeratotic material should be filed down using a commercially available disposable nail file.

Presentations with nail files included

Before the first application of Ciclonic, as much as possible of the affected portion of the nail should be removed, for example with scissors, and as much as possible of the hyperkeratotic material should be filed down using one of the disposable nail files provided.

Throughout the treatment period, once a week, the entire layer of lacquer should be removed using a commercially available alcohol-soaked swab. During this process, as much as possible of the hyperkeratotic material from the nail plate should also be removed, always using a disposable nail file.

If, between applications, the lacquer layer becomes damaged, simply reapply Ciclonic to the areas where the lacquer has chipped.

The duration of treatment depends on the severity of the infection, but should not exceed 6 months.

After each use, it is advisable to tightly close the cap of the bottle to prevent the solution from drying out.

Avoid allowing the solution to come into contact with the neck of the bottle to prevent the cap from sticking.

If you use more Ciclonic than you should:

Cases of overdose have not been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Ciclonic:

Do not use a double dose to make up for missed doses. Continue treatment as recommended by your doctor or as explained in section 3 of this leaflet (How to use Ciclonic).

If you stop using Ciclonic:

If you stop treatment with Ciclonic before your nails have cleared or significantly improved in appearance and healthy nails have regrown, the fungi may not have been eradicated. In such a case, the onychomycosis could worsen again.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everybody experiences them.

The frequency of the possible adverse effects listed below is defined as follows:

Very common: affects more than 1 in 10 people.

Common: affects between 1 and 10 in 100 people.

Uncommon: affects between 1 and 10 in 1,000 people.

Rare: affects between 1 and 10 in 10,000 people.

Very rare: affects fewer than 1 in 10,000 people.

Frequency not known: cannot be estimated from the available data.

Allergic dermatitis has been observed on rare occasions when the skin surrounding the nail has come into contact with Ciclonic. Very rarely, redness and scaling have been observed.

Following the instructions in this leaflet reduces the risk of experiencing adverse effects.

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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciclonic

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

After first opening, use within 6 months. Keep the bottle tightly closed to prevent evaporation of its contents.

Do not use this medicine after the expiry date stated on the outer carton after "EXP". The expiry date refers to the last day of the month indicated.

This product is flammable. Keep away from heat and open flames.

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

6. Contents of the container and other information

Composition of Ciclonic

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

The other components are methoxyethylene polymer with 2-butenedioic acid, monobutyl ester, 1:1, ethyl acetate and isopropyl alcohol.

Appearance of the product and contents of the container:

Ciclonic is a transparent, colourless or slightly yellow solution supplied in an amber glass bottle with a screw cap fitted with a brush.

Pack sizes are 3.3 ml (3 g), 6.6 ml (6 g), 3.3 ml (3 g) with 30 disposable nail files, and 6.6 ml (6 g) with 30 disposable nail files.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Galenicum Derma, S.L.U.

Ctra. N-1, Km 36

San Agustin del Guadalix

+34 932 011 750

Manufacturers

Doppel Farmaceutici S.R.L.

Via Martiri delle Foibe, 1

29016 Cortemaggiore (PC)

Italy

Qualimetrix S.A.

579 Mesogeion Avenue

Agia Paraskevi

Athens 15343

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Axopirox 8% w/w lakier do paznokci, leczniczy

Slovakia: Ciclopirox AXXON 80mg/g liecivý lak na nechty

Spain: Ciclonic 80mg/g barniz de uñas medicamentoso

Hungary: Kitolak 8 % gyógyszeres körömlakk

Estonia: Ciclopirox Terix

Date of the most recent review of this leaflet: August 2024