Ciccolack

Package leaflet: Information for the patient

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Ciclolack (Ciclocutan), 80 mg/g, medicinal nail lacquer
Ciclopiroxum
Ciclolack and Ciclocutan are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Please keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 4 weeks of treatment, or if your condition worsens, please contact your doctor.

Table of contents

1. What Ciclolack is and what it is 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 Ciclolack is and what it is used for

Ciclolack, medicinal nail lacquer, is an antifungal medicine for topical application to the nails in the treatment of fungal nail infections (onychomycosis). The active substance, ciclopirox, penetrates through the nail plate and exerts antifungal activity against fungi causing nail infections.
In fungal nail infections, nails become thickened, dull, discolored (white, yellow or brown), brittle, and may accumulate keratinous debris under the free edge. Nail plate separation and destruction may occur.
Ciclolack, medicinal nail lacquer, is intended for the treatment of mild to moderate forms of fungal nail infection affecting less than 50% of the nail surface and involving no more than 4 out of 10 nails.
If in doubt, consult your doctor before using this medicine.

2. Important information before using Ciclolack

When not to use Ciclolack:

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

Warnings and precautions
Before starting treatment with Ciclolack, discuss this with your doctor or pharmacist.
If allergic reactions occur, discontinue treatment immediately and contact your doctor.
Consult your doctor:

• if the patient has diabetes, or circulatory disorders in hands and feet,
• if the patient has a weakened immune system due to immunological disorders (e.g. HIV infection, transplant patients, patients receiving corticosteroids, patients with recurrent or persistent shingles or herpes);
• if the nail plate is damaged,
• if the patient has skin diseases, such as psoriasis or other chronic skin conditions;
• if the patient has yellow nail syndrome (a disorder characterized by excessive fluid accumulation in the skin and subcutaneous tissue, slowly growing yellow nails, and chronic respiratory problems).

Do not use Ciclolack if:

• nails are severely damaged,
• the lesions affect more than 50% of the nail surface and more than 4 nails,
• the lesions are very severe or new lesions appear on other nails,
• erythematous, scaling skin changes appear around the affected nails. In such cases, consult a doctor.

Use Ciclolack only on the nail.
Avoid contact with eyes and mucous membranes. If the medicine gets into the eyes, nose or ears, rinse immediately with water, contact your doctor immediately, and go to the nearest hospital emergency department.
During treatment, do not apply cosmetic products (e.g. nail polish, nail conditioners) or artificial nails to the nail plate.
To prevent the development of nail fungal infection, the following measures are recommended:

• ensure that hands and feet are always clean and dry (individuals with excessive foot sweating should use moisture-absorbing powders and change socks and shoes frequently);
• dry thoroughly the spaces between the toes after each washing;
• use a separate towel (preferably disposable) and only personal nail care tools (disinfect after each use or use disposable tools);
• cut nails straight across;
• in case of athlete's foot, always wear clean and dry socks (preferably cotton) and breathable footwear, and air shoes after each use;
• never wear shoes used by other people;
• do not walk barefoot in public places (e.g. swimming pools, saunas, sports centres);
• visit only reputable pedicure salons where instruments are properly disinfected;
• avoid skin injuries during self-performed pedicures;
• avoid any trauma to the nail plate.

Ciclolack and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.
There are no data available on possible interactions between Ciclolack and other medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Due to lack of clinical experience, Ciclolack should not be used during pregnancy and breastfeeding.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

3. How to use Ciclolack

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is intended for topical application on the nail.
This medicine may only be used in adults.

Before starting to use Ciclolack
Before starting treatment with Ciclolack, remove as much as possible of the diseased nail surface using scissors, clippers, or the single-use nail file provided in the package. After contact with infected nails, reusable tools should be disinfected, and single-use tools should be discarded.

Instructions for use

1. Wash feet or hands with soap and water and dry thoroughly (preferably using a disposable towel).
2. Gently file the surface of the nail plate using the single-use file provided. As much as possible of the diseased nail should be removed each time. Warning! After use, the file must be discarded!

3. Wipe the nail plate with an alcohol-soaked swab provided in the package.

4. Apply the medicinal nail lacquer using one of the reusable spatulas provided in the package. The package contains ten individual reusable spatulas connected together. Break off one spatula before use. An additional spatula holder is also included. Connect the spatula with the holder to ensure more convenient application of the nail lacquer.

5. Before applying the lacquer to each nail, dip the uneven surface of the spatula into the glass bottle without touching the neck of the bottle (to avoid the risk of the cap sticking to the bottle).

6. Apply Ciclolack evenly over the entire surface of the infected nail using the spatula.

7. The special design of the spatula holder prevents the spatula from contacting any surface (fungal spores remain on the spatula). The spatula can be temporarily set aside without risk of spreading fungal spores.

8. Immediately after use, close the bottle tightly to prevent the solution from drying out.

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

Do not apply cosmetic nail products (e.g. decorative nail varnishes, nail conditioners) or artificial nails to the nail plate.

Recommended dosage
During the first month of treatment, apply a thin layer of lacquer to the affected nail every other day. This ensures saturation of the nail with the active substance.
In the second month of treatment, application may be reduced to twice a week, and from the third month onward, once a week.

Throughout the treatment period:

• Remove the entire lacquer layer once a week using alcohol-soaked swabs to ensure proper penetration of the active substance;
• Before each reapplication, file the nail plate with a single-use file (discard the file after use).

If the lacquer layer becomes damaged or worn during treatment, simply reapply the lacquer to the exposed area.
Files used for infected nails must not be used on healthy nails. Do not use files if any damage is visible.

Duration of treatment
Fungal nail infection treatment is a prolonged 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 6 months, while toenail treatment may last up to 12 months.
Treatment should continue until a healthy nail has fully regrown. Therapy is considered effective when healthy nail regrowth becomes visible after several weeks of treatment. Nail growth rates differ between fingernails and toenails, approximately 4 mm per month for fingernails and 1–2 mm per month for toenails.
Do not use Ciclolack for longer than 6 months without consulting a doctor.
If there is no improvement or if the condition worsens within 4 weeks of starting treatment, consult your doctor.
Your doctor will decide whether further treatment is necessary.

Missed dose of Ciclolack
If you miss an application, apply the medicine to the affected nail as soon as possible and continue treatment according to the instructions in section 3 "How to use Ciclolack".
If the lacquer layer becomes damaged or worn during treatment, simply reapply the medicine to the exposed areas of the nail.

Interrupting treatment with Ciclolack
If treatment is interrupted before the nail(s) are cured or nearly cured, the fungal infection may not resolve. In such cases, the condition of the nails may worsen again.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Very rarely (may affect up to 1 in 10,000 patients), redness and peeling of the skin have been observed at the site where Ciclolack came into contact with the skin surrounding the nail.
Rarely (may affect up to 1 in 1,000 patients), allergic contact dermatitis occurs.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Ciclolack

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
After use, Ciclolack should be tightly closed to prevent the solution from drying out.
Avoid contact between the solution and the neck of the bottle to prevent the cap from sticking to the bottle.
Information on shelf life after opening
Shelf life after first opening of the bottle: 6 months (if stored according to
recommendations).
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 transparent, colourless or slightly yellowish solution in a brown glass bottle with a
HDPE screw cap, contained 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 spatulas, spatula holder, swabs, and nail files.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
mibe Pharma España SL
C/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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish Marketing Authorisation Number, country of export: 725760.8
Parallel Import Authorisation Number: 26/23
Instructions for nail files and alcohol-impregnated swabs

Follow the information provided in the patient leaflet.

Single-use nail files.

For external use only.