Ciclolack

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ciclolack (Ciclocutan), 80 mg/g, medicinal nail lacquer

Ciclopirox
Ciclolack and Ciclocutan are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 4 weeks, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ciclolack and what is it used for
• 2. Important information before using Ciclolack
• 3. How to use Ciclolack
• 4. Possible side effects
• 5. How to store Ciclolack
• 6. Package contents and other information

1. What is Ciclolack and what is it used for

Ciclolack, a medicinal nail lacquer, is an antifungal medicine for local use on nails in cases of nail fungus. The active substance in the medicine, ciclopirox, penetrates the nail plate and acts against the fungi that cause nail fungus.
In nail fungus, the nails become thickened, dull, discolored (white, yellow, or brown), and brittle, with a possible accumulation of keratin debris under the free edge. The nail plate may become separated, and the nail may be destroyed.
Ciclolack, a medicinal nail lacquer, is intended for the treatment of mild and moderate forms of fungus, covering less than 50% of the nail surface and a maximum of 4 out of 10 nails.
In case of doubt, before using the medicine, the patient should consult a doctor.

2. Important information before using Ciclolack

When not to use Ciclolack:

• if the patient is allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6);
• the medicine should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Ciclolack, the patient should discuss it with their doctor or pharmacist.
If allergic reactions occur, treatment should be discontinued, and the patient should immediately consult their doctor.
The patient should consult their doctor:

• if they have diabetes, circulatory disorders in the hands and feet,
• if they have impaired immune function due to immune system disorders (e.g., HIV infection, post-transplant patients, patients treated with corticosteroids, patients with recurring or persistent herpes or eczema);
• if the nail plate is damaged,
• if they have skin diseases, such as psoriasis or other chronic skin diseases;
• if they have yellow nail syndrome (a disease characterized by excessive fluid accumulation in the skin and subcutaneous tissue, slow-growing, yellow nails, and chronic respiratory disorders).

Ciclolack should not be used if:

• the nails are significantly damaged,
• the diseased areas cover more than 50% of the nail surface and more than 4 nails,
• the changes are very severe or new changes have appeared on the remaining nails,
• redness and peeling changes have appeared on the skin around the diseased nails. In such cases, the patient should consult their doctor.

The medicine should only be applied to the nails.
Contact between the medicine and the eyes or mucous membranes should be avoided. If the medicine gets into the eyes, nose, or ears, they should be rinsed immediately with water, and the patient should consult their doctor and go to the nearest emergency department.
During treatment, cosmetic products (e.g., nail polish, nail care products) or artificial nails should not be used on the nail plate.
To prevent the development of nail fungus, the patient should:

• ensure that their hands and feet are always clean and dry (people with excessive foot sweating should use moisture-absorbing powders and change their socks and shoes frequently);
• thoroughly dry the spaces between their toes after each foot wash;
• use a separate towel (preferably disposable) and only use personal nail care tools (which should be disinfected or used once after each use);
• cut their nails straight;
• in case of foot fungus, wear clean and dry socks (preferably cotton) and breathable shoes, and ventilate their shoes after each wear;
• never use shoes worn by other people;
• not walk barefoot in public places (e.g., swimming pools, saunas, sports centers);
• only use pedicure services in verified locations where the tools are properly disinfected;
• avoid skin cuts during self-pedicure;
• avoid any damage to the nail plate.

Ciclolack and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There is no data on the interaction between Ciclolack and other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Due to the lack of clinical experience, Ciclolack should not be used during pregnancy and breastfeeding.

Driving and using machines

It has not been found that the medicine affects the ability to drive or use machines.

3. How to use Ciclolack

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for local use on the nails.
The medicine can only be used in adults.

Before starting treatment with Ciclolack

Before starting treatment with Ciclolack, the patient should remove as much of the diseased nail surface as possible using nail clippers, nail scissors, or the enclosed disposable nail file. After contact with diseased nails, the used tools should be disinfected, and the disposable ones should be discarded.

Method of use

• 1. Wash the feet or hands with water and soap and dry them thoroughly (preferably with a disposable towel).
• 2. Using a disposable nail file, gently grind the surface of the nail plate. Remove as much of the diseased nail as possible each time. Note: After use, the nail file should be discarded!

• 3. Wipe the nail plate with an alcohol-soaked swab included in the packaging.

• 4. The medicinal nail lacquer should be applied using one of the reusable spatulas included in the packaging. The packaging contains ten single reusable spatulas connected together. A single reusable spatula should be broken off before use. Additionally, a spatula handle is included. The single spatula and spatula handle should be connected to ensure more convenient application of the nail lacquer.

• 5. Before applying the lacquer to each nail, the non-uniform surface of the spatula should be dipped into the glass bottle without touching the bottle neck (due to the risk of the cap sticking to the bottle).

• 6. Ciclolack should be applied evenly to the entire surface of the infected nail using the spatula.

• 7. The special shape of the spatula handle prevents the spatula from coming into contact with any surface (fungal spores remain on the spatula). The spatula can be put down temporarily without worrying that fungal spores will be transferred.

• 8. Immediately after use, the bottle should be tightly closed to prevent the solution from drying out.

• 9. To reuse the spatula, it should be cleaned with an alcohol-soaked swab immediately after use.

Cosmetic products (e.g., nail polish, nail care products) or artificial nails should not be used on the nail plate.

Recommended dose

For the first month of treatment, a thin layer of lacquer should be applied to the infected nail every other day. This ensures that the nail is saturated with the active substance.
In the second month of treatment, the use of lacquer can be limited to twice a week, and from the third month, it can be used once a week.
Throughout the treatment period, the patient should:

• once a week, remove the entire layer of lacquer using alcohol-soaked swabs to ensure proper penetration of the active substance;
• before reapplying the lacquer, grind the nail plate with a disposable nail file (after use, the nail file should be discarded).

In case of damage or wear of the lacquer layer during treatment, it is sufficient to repaint the exposed areas.
Nail files used for infected nails should not be used for healthy nails. Nail files should not be used if they are damaged.

Duration of treatment

Treatment of nail fungus is a long-term process. The duration of treatment depends on individual factors, primarily the rate of nail growth and the severity of the fungal infection. Treatment of fingernails usually lasts about 6 months, and toenails can take up to 12 months.
Treatment should be continued until a healthy nail has grown out. The therapy is effective when, after a few weeks of treatment, a healthy nail growth is visible. The growth rate of nails is different for fingernails and toenails and is approximately 4 mm per month for fingernails and 1-2 mm per month for toenails.
Ciclolack should not be used for more than 6 months without consulting a doctor.
If there is no improvement or the disease has worsened within 4 weeks of treatment, the patient should consult their doctor.
The doctor will decide whether further treatment is necessary.

Missed application of Ciclolack

In case of a missed application, the patient should apply the medicine to the infected nail as soon as possible and continue using the medicine according to the instructions in section 3 "How to use Ciclolack".
In case of damage or wear of the lacquer layer during treatment, it is sufficient to apply the medicine to the exposed areas on the nail.

Discontinuation of Ciclolack

If treatment is discontinued before the nail (nails) is (are) cured or almost cured, the fungal infection may not resolve. In such a case, the condition of the nail may worsen again.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ciclolack can cause side effects, although not everybody gets them.
Very rarely (may affect up to 1 in 10,000 people), redness and peeling of the skin at the site where Ciclolack came into contact with the skin around the nail are observed.
Rarely (may affect up to 1 in 1,000 people), allergic contact dermatitis occurs.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ciclolack

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 30°C.
After use, Ciclolack should be tightly closed to prevent the solution from drying out.
Contact between the solution and the bottle neck should be avoided to prevent the cap from sticking to the bottle.

Information on the shelf life after opening

Shelf life after first opening the bottle: 6 months (if stored according to the recommendations).
This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ciclolack contains

• The active substance of the medicine is ciclopirox. 1 g of medicinal nail lacquer contains 80 mg of ciclopirox.
• The other ingredients are: copolymer of methyl vinyl ether and maleic acid monobutyl ester, ethyl acetate, isopropyl alcohol.

What Ciclolack looks like and what the package contains

Ciclolack is a clear, colorless or slightly yellowish solution in a brown glass bottle with an HDPE cap, in a cardboard box.
Ciclolack is available in packages of 3 g and 6 g (2 x 3 g) of medicinal nail lacquer;
the package also contains: a set of connected reusable spatulas, a spatula handle, swabs, and nail files.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

mibe Pharma España SL
Rec de Dalt 21-23
Pol.Ind. Can Magarola

• 08100 - Mollet del Vallès Spain

Manufacturer:

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish export authorization number: 725760.8

Parallel import authorization number: 26/23 Date of approval of the leaflet: 24.02.2023

[Information about the trademark]

Instructions for nail files and alcohol-soaked swabs

The patient should follow the information contained in the patient information leaflet.

Single-use nail files.

For external use only.