Ciclolack

Leaflet accompanying the packaging: patient information

Ciclolack, 80 mg/g, medicinal nail lacquer

Ciclopirox

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or the patient feels worse, 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. Contents of the pack 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 antifungally on the fungi that cause nail fungus.
In nail fungus, the nails become thickened, dull, discolored (white, yellow or brown) and brittle, and under the free edge of the nail, there may be an accumulation of keratin debris.
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 nail fungus, affecting less than 50% of the nail surface and a maximum of 4 out of 10 nails.
In case of doubt, before using the medicine, consult a doctor.

2. Important information before using Ciclolack

When not to use Ciclolack:

• the medicine must not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Ciclolack, discuss it with your doctor or pharmacist.
If allergic reactions occur, treatment should be discontinued and medical attention sought immediately.
Consult a doctor:

Do not use Ciclolack if:

• the nails are severely damaged,
• the diseased areas affect 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, consult a doctor.

Use the medicine only on the nails.
Avoid contact with the eyes and mucous membranes. If the medicine gets into the eyes, nose, or ears, rinse them immediately with water and consult a doctor and go to the nearest hospital emergency department.
During treatment, do not use cosmetic products (e.g. nail polish, nail care products) or artificial nails on the nail plate.
To prevent the development of nail fungus, you should:

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

Ciclolack and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
There is no data on the interaction between Ciclolack and other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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

No effects on the ability to drive and use machines have been found.

3. How to use Ciclolack

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a 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, remove as much of the diseased nail surface as possible using nail scissors, nail clippers, or the enclosed disposable nail file. After contact with diseased nails, disinfect the used tools, and dispose of the disposable ones.

Method of use

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

• 3. Wipe the nail plate with a cotton swab soaked in alcohol, 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. Before use, break off a single reusable spatula. Additionally, a spatula handle is included. Connect the single spatula and the spatula handle to ensure more convenient application of the nail lacquer.

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

• 6. Apply Ciclolack 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, close the bottle tightly to prevent the solution from drying out.

• 9. To reuse the spatula, clean it with an alcohol-soaked cotton swab immediately after use.

Do not use cosmetic products (e.g. nail polish, nail care products) or artificial nails on the nail plate.

Recommended dose

For the first month of treatment, apply a thin layer of lacquer to the infected nail every other day. This ensures saturation of the nail 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, use once a week.
Throughout the treatment period, you should:

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

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. Do not use nail files if they are damaged.

Duration of treatment

Treating nail fungus is a long process. The duration of treatment depends on individual factors, primarily the rate of nail plate growth and the severity of the fungal infection. Treatment of fingernails usually takes 6 months, and toenails 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 nail growth rate varies for fingernails and toenails and is approximately 4 mm per month for fingernails and 1-2 mm per month for toenails.
Do not use Ciclolack for more than 6 months without consulting a doctor.
If there is no improvement or the disease has worsened after 4 weeks of treatment, consult a doctor.
The doctor will decide whether further treatment is necessary.

Missing a dose of Ciclolack

In case of a missed dose, 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.

Stopping treatment with Ciclolack

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

4. Possible side effects

Like all medicines, this medicine 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 you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciclolack

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
After use, close the Ciclolack bottle tightly to prevent the solution from drying out.
Avoid contact between the solution and the bottle neck to prevent the cap from sticking to the bottle.

Information on the shelf life after first opening

Shelf life after first opening the bottle: 6 months (if stored according to the recommendations).
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ciclolack contains

• The active substance 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 contents of the pack

Ciclolack is a clear, colorless or slightly yellowish solution in a glass bottle with a white cap, in a cardboard box.
Ciclolack is available in packs of 3 g and 6 g (2 x 3 g) of medicinal nail lacquer;
the pack also contains: a set of connected reusable spatulas, a spatula handle, cotton swabs, and nail files.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki

Date of last revision of the leaflet:

Instructions for nail files and alcohol-soaked cotton swabs

Distributor in Poland: SUN-FARM Sp. z o.o., 05-092 Łomianki, Poland

Follow the instructions in the patient leaflet.

Single-use nail files.

For external use only.