Pirolam Lakier

Package Leaflet: Information for the Patient

Pirolam Lacquer, 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 those not listed in this 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 Pirolam Lacquer and what is it 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 is Pirolam Lacquer and what is it used for

Pirolam Lacquer, 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 causing nail fungus.
Nail fungus occurs on the surface or under the nail plate. The nails become thickened, dull, discolored (white, yellow, or brown), thick, and brittle, with possible accumulation of keratinous masses under the free edge. The nail plate may become layered, and the nail may be destroyed.
Pirolam Lacquer, a medicinal nail lacquer, is intended for the treatment of mild and moderate forms of nail 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, consult a doctor.
To prevent the development of nail fungus, one should:

• ensure that hands and feet are always clean and dry (people with excessive foot sweating should use moisture-absorbing powders and frequently change socks and shoes),
• thoroughly dry the spaces between the toes after each foot wash;
• use a separate towel (preferably disposable) and only personal nail care tools (which should be disinfected or used once after each use);
• cut nails straight;
• in case of foot fungus, always wear clean and dry socks (preferably cotton) and well-ventilated shoes, and air out shoes after each wear;
• use only footwear that has not been worn by other people;
• not walk barefoot in public places (e.g., swimming pools, saunas, sports centers);
• use pedicure services only in verified locations where tools are properly disinfected;
• avoid skin cuts during self-pedicure;
• avoid any damage to the nail plate.

Risk factors for nail fungus:

• age over 65;
• diabetes;
• fungus infection in another location, 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).
• The medicine should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to use Pirolam Lacquer, discuss it with a doctor or pharmacist in the following cases:

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

Pirolam Lacquer should not be used if

• the nails are significantly damaged,
• the diseased changes 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, peeling skin lesions have appeared around the diseased nails. In such cases, consult a doctor.

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

Pirolam Lacquer 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 Pirolam Lacquer and other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
There is insufficient data on the use of ciclopirox in pregnant women and during breastfeeding.
Pirolam Lacquer can be used during pregnancy and breastfeeding only if, in the doctor's opinion, it is absolutely necessary.
There is no data on the effect of the medicine on fertility.

Driving and using machines

Pirolam Lacquer does not affect the ability to drive and use machines.

3. How to use Pirolam Lacquer

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 to use Pirolam Lacquer

Before starting treatment, you should have:

• an alcohol-based disinfectant,
• single-use nail files made of cardboard,
• a nail polish remover.

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

Method of use

• 1. Wash your feet or hands with water and soap and dry them thoroughly (preferably with a disposable towel).

• 2. Using a single-use nail file, gently grind the top layer of the nail plate. Remove as much of the diseased nail as possible each time. Note! After use, the file should be discarded!

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

• 4. Apply the lacquer evenly with the brush to the diseased nail plate and let it dry.

Do not use cosmetic products (e.g., decorative nail polishes, nail nourishing products) or artificial nails on the nail plate.
After use, close the lacquer tightly to prevent the solution from drying out.
Avoid spilling the lacquer on the bottle cap thread to prevent it from sticking.

Recommended dose

For the first month of treatment, apply a thin layer of lacquer to the diseased 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, use it once a week.
Throughout the treatment period, you should

• once a week remove the entire layer of lacquer with a nail polish remover to ensure proper penetration of the active substance
• before reapplying the lacquer, grind the nail plate with a single-use nail file (discard the file after use).

In case of damage or wear of the lacquer layer during treatment, it is enough to repaint the exposed areas.

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 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 rate of nail growth varies for fingernails and toenails and is 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 more than 6 months without consulting a doctor.

Missing a dose of Pirolam Lacquer

If a dose is missed, apply the lacquer to the diseased nail as soon as possible and continue using the medicine according to the instructions in section 3 (How to use Pirolam Lacquer).
In case of damage or wear of the lacquer layer during treatment, it is enough to repaint the exposed areas.

Stopping the use of Pirolam Lacquer

If the treatment is discontinued before the nail (nails) is 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, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them .
In a few patients, local irritation (burning, itching, redness, swelling, redness, and peeling) has been observed after contact of Pirolam Lacquer with the skin surrounding the nail.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Pirolam Lacquer

Keep the medicine out of the 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 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 Pirolam Lacquer contains

• The active substance of the medicine is ciclopirox. Each gram of lacquer contains 80 mg of ciclopirox.
• The other ingredients are: isopropyl alcohol, methoxyethylene maleic acid monobutyl ester copolymer.

What Pirolam Lacquer looks like and contents of the pack

Pirolam Lacquer is a medicinal nail lacquer.
The packaging of the medicine is a bottle made of orange glass, closed with a screw cap with a guarantee ring and a brush with a handle made of low-density polyethylene (LDPE) and nylon bristles, placed in a cardboard box.
1 bottle contains 3 g or 4 g of medicinal lacquer.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: