Steper nail

Package leaflet: Information for the user

Steper nail, 80 mg/g, medicinal nail lacquer
Ciclopirox
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Steper nail is and what it is used for
2. Important information before using Steper nail
3. How to use Steper nail
4. Possible side effects
5. How to store Steper nail
6. Contents of the pack and other information

1. What Steper nail is and what it is used for

Steper nail is an antifungal medicine intended for topical application to the nails in fungal infections. The active substance, ciclopirox, penetrates through the nail plate and acts against the fungi causing the infection.
Fungal nail infection develops on or under the nail plate. Infected nails become thickened, dull, discolored (white, yellow or brown), and may become thick and brittle. Accumulation of dead skin or thickened tissue may occur under the free edge of the nail. In advanced cases, nail plate separation or even complete destruction may occur.

Indications
Fungal infections of the nails.
Steper nail is indicated for the treatment of mild to moderate forms of onychomycosis affecting less than 50% of the surface of up to 4 out of 10 nails.
If in doubt, consult your doctor before starting treatment.

To help prevent the development of fungal nail infections, you should:

• Keep hands and feet clean and dry (people with excessive sweating of the feet should use moisture-absorbing powders and change socks and shoes frequently);
• Dry thoroughly between the toes after washing feet;
• Use a separate towel (preferably disposable) and only personal nail care tools (which should be disinfected after each use, or disposable tools should be used);
• Cut nails straight across;
• Wear only footwear that has not been worn by others;
• Avoid walking barefoot in public places (e.g. swimming pools, saunas, sports centers);
• Use pedicure or manicure services only in reputable places where instruments are properly disinfected;
• Avoid skin injuries when performing pedicure or manicure yourself;
• Protect the nail plate from trauma.

Risk factors for developing fungal nail infections:

• Age over 65 years;
• Diabetes;
• Fungal infection in another part of the body (e.g. skin);
• Obesity;
• Excessive sweating;
• Circulatory disorders in hands and feet;
• Weakened immune system.

2. Important information before using Steper nail

When not to use Steper nail

• if the patient is allergic to the active substance ciclopirox or to any of the other ingredients of this medicine (listed in section 6);
• in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Steper nail, discuss with a doctor or pharmacist:

• if the patient has diabetes or circulatory disorders in the hands and feet;
• if the patient has a weakened immune system due to immunological disorders (e.g. HIV infection, post-transplantation state, concomitant treatment with corticosteroids, recurrent or persisting shingles or herpes);
• if the nail plate is damaged;
• if the patient has skin diseases such as psoriasis or other chronic skin disorders;
• 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 respiratory problems).

Do not use Steper nail and consult a doctor if:

• nails are significantly damaged;
• lesions affect more than 50% of the nail surface and more than 4 nails;
• lesions are very severe or new lesions appear on other nails;
• erythematous or desquamative skin changes develop around the affected nails.

The medicine is flammable – keep away from sources of heat and open flames.
Avoid contact of the medicine with eyes and mucous membranes. If the medicine gets into the eyes, nose or ears,
immediately rinse these areas with water and contact a doctor or go to
the nearest hospital emergency department.
Do not inhale the vapors of the medicine.
During treatment, do not apply cosmetic products (such as decorative nail polishes, nail conditioners) to the nail plate, nor use artificial nails.
If allergic reactions occur, discontinue treatment immediately and contact a doctor.
Children and adolescents
Steper nail must not be used in children and adolescents under 18 years of age.
Steper nail and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
There are no data available on interactions between Steper nail and other medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There is insufficient data on the use of ciclopirox in pregnant or breastfeeding women.
Steper nail may be used during pregnancy and breastfeeding only if the doctor considers it absolutely necessary.
There are no data on the effect of the medicine on fertility.
Driving and operating machinery
Steper nail has no influence on the ability to drive or operate machinery.

3. How to use Steper nail

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

Recommended dose
Adults
During the first month of treatment, apply a thin layer of the nail lacquer to the affected nail every other day. This ensures saturation of the nail with the active substance.
During the second month of treatment, the lacquer may be applied twice a week.
From the third month onwards, apply the lacquer once a week.

Before starting treatment with Steper nail, prepare the following:

• an alcohol-based disinfectant;
• disposable cardboard nail files;
• a cosmetic nail polish remover.

Prior to initiating treatment with Steper nail, it is recommended to remove as much as possible of the diseased nail surface using scissors, nail clippers, or a nail file.
After contact with infected nails, reusable instruments should be disinfected, and disposable ones discarded.

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

3. Wipe the nail plate with a swab soaked in an alcohol-based disinfectant.

4. Evenly apply the lacquer with the brush to the affected nail plate and leave to dry.

Do not apply any cosmetic products to the nail plate, such as decorative nail polishes, nail nourishing treatments, or artificial nails.
After use, close the bottle tightly to prevent the lacquer from drying out.
Avoid spilling the lacquer onto the threads of the bottle neck to prevent the cap from sticking.

Throughout the entire treatment period, you should:

• repeat steps 1 and 2 for each infected nail (see: "Instructions for use");
• before each new application, first remove the previous layer of medicinal lacquer using a swab soaked in a cosmetic nail polish remover;
• reapply the lacquer as described above;
• in case of fungal nail infection of the feet, always wear clean and dry socks and well-ventilated footwear; also air shoes after each use.

If the lacquer layer becomes damaged or worn off during treatment, reapply the lacquer to the exposed area.

Duration of treatment
Fungal nail treatment 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, while toenail treatment may take up to 12 months.
Treatment should be continued until healthy nail regrowth is complete. Therapy is considered effective when healthy nail growth appears after several weeks of treatment.
Fingernails grow at a rate of approximately 4 mm per month, whereas toenails grow more slowly—about 1–2 mm per month.

If there is no improvement or if the condition of the nails worsens within 4 weeks of starting treatment, consult your doctor.
Do not use Steper nail lacquer for longer than 6 months without consulting your doctor.

Missed dose
If you miss an application, apply the lacquer to the affected nail as soon as possible, then continue treatment according to the instructions described in section 3 ("How to use Steper nail").

Interrupting treatment
If treatment is interrupted before the nail (or nails) is fully or almost fully healed, the fungal infection may not resolve. In such cases, the condition of the nails may worsen again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Rarely (may occur in up to 1 in 1,000 people):

• allergic contact dermatitis around the nail.

Very rarely (may occur in up to 1 in 10,000 people):

• redness and peeling of the skin.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects 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 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Steper nail

Keep the medicine out of the sight and reach of children.
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.
Shelf life after first opening the immediate packaging: 6 months.
Store the medicine below 25°C. Keep in the original packaging to protect from light.
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 packaging and other information

What Steper nail contains

• The active substance is ciclopirox. Each gram of the nail lacquer contains 80 mg of ciclopirox.
• The other ingredients are: isopropyl alcohol, ethyl acetate, monobutyl ester of methyl vinyl ether/maleic anhydride copolymer: PVM/MA copolymer butyl ester, PVM/MA copolymer isopropyl ester, isopropyl alcohol, n-butyl alcohol.

What Steper nail looks like and contents of the pack
Steper nail is a solution ranging in color from colorless to pale yellow.
The packaging consists of a colorless glass bottle of type III with a polypropylene cap, equipped with an applicator brush made of LDPE and polyamide, in a cardboard box.
The pack contains 6 g of nail lacquer.
Marketing Authorization Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100