Pirolam lakier

Package leaflet: Information for the user

Pirolam Lacquer, 80 mg/g, medicinal nail lacquer
Ciclopiroxum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used 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 consult your pharmacist.
• If you experience any adverse reactions, 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, contact your doctor.

Contents of the leaflet

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

1. What Pirolam Lacquer is and what it is used for

Pirolam Lacquer, a medicinal nail lacquer, is an antifungal medicine intended for topical application to the nails in the treatment of fungal nail infections (onychomycosis). The active substance contained in the medicine, ciclopirox, penetrates through the nail plate and exerts antifungal activity against fungi causing fungal nail infections.
Fungal nail infection occurs on the surface or beneath the nail plate. Nails become thickened, dull, discolored (white, yellow or brown), thick and brittle. Accumulation of keratinous debris may occur under the free edge of the nail. The nail plate may separate and the nail may be destroyed.
Pirolam Lacquer, medicinal nail lacquer, is indicated for the treatment of mild to moderate infections 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.
To prevent the development of fungal nail infections, the following measures are recommended:

• Ensure 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 between the toes after washing feet,
• Use a separate towel (preferably disposable) and personal nail care tools only (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 well-ventilated footwear; air shoes after each use,
• Wear only footwear not used by others,
• Avoid walking barefoot in public places (e.g. swimming pools, saunas, sports centers),
• Use pedicure services only in reputable establishments where instruments are properly disinfected,
• Avoid skin injuries during self-performed pedicures,
• Avoid any trauma to the nail plate.

Risk factors for developing fungal nail infections:

• Age over 65 years,
• Diabetes,
• Fungal infection at other sites, e.g. skin,
• Obesity,
• Excessive sweating,
• Circulatory disorders in hands and feet,
• Immune system disorders.

2. Important information before using Pirolam Lacquer

When not to use Pirolam Lacquer

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

Warnings and precautions
Before starting treatment with Pirolam Lacquer, discuss with your doctor or pharmacist if:

• the patient has diabetes, or circulatory disorders in the hands and feet,
• the patient has weakened immunity due to immune system 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 disorders).

Do not use Pirolam Lacquer if:

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

Use the medicine only on the nails.
This medicine is flammable. Use away from sources of heat and open flames.
Avoid contact with eyes and mucous membranes. If the medicine gets into the eyes, nose, or ears, rinse immediately with water and contact a doctor or go to the nearest hospital emergency department.
Do not inhale.
During treatment, do not use cosmetic products (e.g. decorative nail varnishes, nail conditioners) or artificial nails on the nail plate.
If allergic reactions occur, discontinue treatment immediately and contact a doctor.

Pirolam Lacquer and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
There are no data available on possible interactions between Pirolam Lacquer and other medicines.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of ciclopirox in pregnant or breastfeeding women.
Pirolam Lacquer should be used during pregnancy and breastfeeding only if, in the opinion of the doctor, it is absolutely necessary.
There is no data available on the effect of the medicine on fertility.

Driving and operating machinery
Pirolam Lacquer has no influence on the ability to drive or operate machinery.

3. How to use Pirolam Lacquer

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 to the nail.
This medicine may only be used in adults.

Before starting treatment with Pirolam Lacquer
Before starting treatment, ensure you have the following:

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

It is recommended to remove as much as possible of the diseased nail surface before starting treatment with Pirolam Lacquer, using nail clippers, nail nippers or a nail file. After contact with infected nails, instruments should be disinfected, and disposable ones should be discarded.

Instructions for use

1. Wash hands or feet with soap and water, then dry thoroughly (preferably with a disposable towel).
2. Gently file the surface of the nail plate using a disposable file. Remove as much of the diseased nail as possible. Caution! After use, the file must be discarded!

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

4. Apply the lacquer evenly with the brush to the affected nail and leave to dry.

Do not apply cosmetic products (e.g. decorative nail varnishes, nail conditioners) or artificial nails to the treated nail.
After use, close the bottle tightly to prevent the solution from drying out.
Avoid spilling the lacquer onto the bottle neck threads to prevent the cap from sticking.

Recommended dosage
During the first month of treatment, apply a thin layer of the lacquer to the affected nail every other day. This ensures adequate 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 onwards, once a week.

Throughout the treatment period:

• remove the entire lacquer layer once a week using a cosmetic nail polish remover to ensure proper penetration of the active substance,
• before each subsequent application, file the nail plate with a disposable nail file (discard the file after use).

If the lacquer layer becomes damaged or worn during treatment, simply reapply to the exposed areas.

Duration of treatment
Treatment of fungal nail infection is a long-term process. The duration of treatment depends on individual factors, primarily the rate of nail growth and severity of the fungal infection. Treatment of fingernails usually lasts about 6 months, while toenail treatment may take up to 12 months.
Treatment should continue until healthy nail regrowth is complete. Therapy is considered effective when healthy nail growth 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.

It is recommended to use the lacquer for at least 3 months in the case of fingernail fungus and at least 6 months in the case of toenail fungus.
Do not use Pirolam Lacquer for longer than 6 months without consulting a doctor.

If you forget to apply Pirolam Lacquer
If you miss an application, apply the lacquer to the affected nail as soon as possible and continue treatment according to the instructions in section 3 (How to use Pirolam Lacquer).
If the lacquer layer becomes damaged or worn during treatment, simply reapply to the exposed areas.

Interrupting treatment with Pirolam Lacquer
If treatment is stopped before the nail(s) are cured or almost cured, the fungal infection may persist. 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.
In rare cases, local irritation (burning, itching, erythema, swelling, redness, and peeling) has been observed at the skin surrounding the nail after contact with Pirolam Lacquer.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pirolam Lakier

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Keep the bottle tightly closed.
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 Pirolam Lacquer contains

• The active substance is ciclopirox. Each gram of lacquer contains 80 mg of the active substance ciclopirox.
• The other ingredients are: isopropyl alcohol, methoxyethylene polymer with monobutyl ester of 2-butenedioic acid.

What Pirolam Lacquer looks like and contents of the pack
Pirolam Lacquer is a medicinal nail lacquer.
The pack consists of an amber glass bottle closed with a cap with a tamper-evident ring, with a brush made of polyethylene (LDPE) stem and nylon bristles, placed in a cardboard box.
1 bottle contains 3 g or 4 g of medicinal lacquer.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz