Label: information for the patient

Ciclonic 80 mg/g medicated nail polish

Ciclopirox

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only 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 type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this label. See section 4.

1. What is Ciclonic and how it is used

2. What you need to know before starting to use Ciclonic

3. How to use Ciclonic

4. Possible adverse effects

5. Storage of Ciclonic

6. Contents of the package and additional information

Ciclonic 80 mg/g is a medicated nail polish. It contains the active ingredient ciclopirox, which belongs to a group of medications known as antifungals. The ciclopirox penetrates the nail plate and presents a fungicidal effect on all the main agents causing onychomycosis.

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

Do not use Ciclonic:

• if you are allergic to ciclopirox or any of the other ingredients of this medication (listed in section 6).
• in children due to insufficient experience in this age group to date.
• 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 produce adverse reactions. In these situations, treatment should be interrupted and appropriate therapeutic measures should be taken. Avoid contact with the eyes and mucous membranes.

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

Children and adolescents

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

Other medications and Ciclonic

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

Use of Ciclonic with food, drinks, and alcohol

Not applicable.

Pregnancy, breastfeeding, and fertility

Ciclonic is generally contraindicated during pregnancy and breastfeeding.

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

Driving and operating machines

The influence of Ciclonic on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Unless otherwise indicated, apply a thin layer of Ciclonic medicated nail polish over the affected nail once a day.

Presentations without nail file included

Before the first application of Ciclonic, remove as much as possible of the affected part of the nail, for example, with scissors, and as much as possible of the hyperkeratotic material, with a disposable commercially available nail file.

Presentations with nail file included

Before the first application of Ciclonic, remove as much as possible of the affected part of the nail, for example, with scissors, and as much as possible of the hyperkeratotic material, with one of the disposable nail files included.

During the entire application period, once a week, remove the entire layer of polish with a commercially available cotton swab with alcohol. Also during this process, remove as much as possible of the hyperkeratotic material from the nail plate, always with a disposable nail file.

If, between one application and another, the polish layer is damaged, simply reapply Ciclonic over the parts that have peeled off.

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

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

Do not let the solution come into contact with the neck of the bottle to prevent the cap from sticking.

If you use more Ciclonic than you should:

No cases of overdose have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Ciclonic:

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

If you interrupt treatment with Ciclonic:

If you interrupt treatment with Ciclonic before your nails are whitened or their appearance has improved significantly and healthy nails have regrown, it is possible that the fungus has not disappeared. In this case, onychomycosis could worsen again.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Very frequent: affects more than 1 in 10 people.

Frequent: affects between 1 and 10 in 100 people.

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

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

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

Unknown frequency: cannot be estimated from available data.

In rare cases, allergic dermatitis has been observed when the skin around the nail has come into contact with Ciclonic. In very rare cases, redness and peeling have been observed.

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

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require any special preservation conditions.

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

Do not use this medication after the expiration date that appears in the packaging after «CAD». The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Ciclonic

The active principle is ciclopirox. 1 gram of medicated nail polish contains 80 mg of ciclopirox.

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

Appearance of the product and content of the container:

Ciclonic is a transparent, colorless or slightly yellowish solution that is presented in an amber-colored glass bottle with a screw cap provided with a brush.

The sizes of the containers are 3.3 ml (3g), 6.6ml (6g), 3.3 ml (3 g) with 30 disposable nail files and 6.6 ml (6 g) with 30 disposable nail files.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Galenicum Derma, S.L.

Ctra. N-1, Km 36

San Agustin de 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 nail polish, medicinal

Slovakia:Ciclopirox AXXON 80mg/g medicated nail lacquer

Spain:Ciclonic 80mg/g medicated nail polish

Hungary:Kitolak 8 % medicinal nail polish

Estonia:Ciclopirox Terix

Last review date of this leaflet: August 2024