Polinail

Leaflet attached to the packaging: patient information

Polinail, 80 mg/g, nail lacquer, medicinal

Ciclopirox

For adults

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 4 weeks there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Polinail and what is it used for

Polinail is a medicinal product with a broad spectrum of antifungal activity, for local use on fingernails, toenails, and directly adjacent skin areas. The product is used to treat mild to moderate fungal nail infections (onychomycosis) caused by dermatophytes and/or other fungi that can be treated with ciclopirox. The active substance of the product, ciclopirox, prevents the growth of the fungus and destroys it, resulting in an improvement in the appearance of the nails.

2. Important information before using Polinail

When not to use Polinail:

• if you are allergic to ciclopirox or any of the other ingredients of this product (listed in section 6),
• in children and adolescents under 18 years of age, due to the lack of sufficient experience with the use of the product in this age group.

Warnings and precautions

Before starting treatment with Polinail, you should discuss it with your doctor or pharmacist. If an allergic reaction occurs, you should discontinue treatment and contact your doctor. As with all topical treatments for fungal nail infections, when the disease process involves several nails (>3 nails) or more than half of the nail plate or the nail matrix, and when there are predisposing factors such as diabetes or immunological diseases, you should consult your doctor. Your doctor will probably recommend additional oral antifungal treatment. If you have diabetes, you should be careful when cutting your nails. You should avoid contact of the product with your eyes or mucous membranes. Polinail is intended for external use only. You should not use nail polish or other nail care cosmetics on the treated nails. If you have a history of diabetes, immune system disorders, peripheral vascular disease (narrowing of the arteries), injured, painful, or severely damaged nails, skin diseases such as psoriasis, or yellow nail syndrome (a disease that causes thickening and yellowing of the nails, chronic swelling of the limbs, and chronic breathing difficulties), you should consult your doctor before starting treatment with Polinail.

Children and adolescents

Polinail is contraindicated in children and adolescents under 18 years of age (see section 2 "When not to use Polinail").

Polinail and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Pregnancy If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this product. Treatment with Polinail is possible only in cases of absolute necessity, after careful consideration by the treating doctor of the benefits versus the possible risks. Breastfeeding It is not known whether ciclopirox passes into breast milk. Treatment with Polinail is possible only in cases of absolute necessity, after careful consideration by the treating doctor of the benefits versus the possible risks.

Driving and using machines:

No special precautions are necessary.

Polinail contains cetostearyl alcohol.

This may cause local skin reactions (e.g., contact dermatitis).

Polinail contains alcohol (ethanol).

This product contains 730 mg of alcohol (ethanol) in each gram of solution (medicinal nail lacquer). It may cause a burning sensation on damaged skin. This product is flammable. You should keep it away from heat and open flames.

3. How to use Polinail

This product should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you should speak to your doctor or pharmacist. Method of administration Cutaneous use (only on nails and directly adjacent skin areas). Polinail should be used only in adult patients. Recommended doseUsually, a thin layer of Polinail is applied to the affected nail(s) once a day. Before applying the product, the nails should be clean and dry. The medicinal nail lacquer should be applied to the entire surface of the nail and 5 mm around the surrounding skin. If possible, Polinail should also be applied under the free edge of the nail. Polinail should be left to dry for about 30 seconds. The treated nail(s) should not be washed for at least six hours - for this reason, it is recommended to apply the product in the evening before bedtime. After this time, you can perform your usual hygiene activities. To remove Polinail, you do not need to use any solvents or abrasive substances (e.g., nail file), it is enough to wash your nails with water. Sometimes, after a few days of treatment, due to improper washing of the nails, a white layer may appear on their surface. It can be removed by washing with neutral soap and, if necessary, using a nail brush or sponge. If the lacquer is accidentally washed off, Polinail can be reapplied. It is recommended to regularly remove all unattached parts of the nail, e.g., by cutting the nails. Treatment should be continued until complete disappearance of symptoms, i.e., until the nail(s) are completely clean or almost clean and a healthy nail grows back. Usually, complete healing of fingernails occurs after about 6 months, and healing of toenails after 9 to 12 months. If after 4 weeks there is no improvement or you feel worse, you should contact your doctor. If the infection of one fingernail or toenail is extensive or if the infection affects several nails, additional oral antifungal treatment may be indicated. In such cases, you should consult your doctor. If you feel that the effect of Polinail is too strong or too weak, you should contact your doctor or pharmacist.

Using more than the recommended dose of Polinail

So far, no cases of overdose have been reported.

Missing a dose of Polinail

If you miss a dose, you should not use a double dose to make up for the missed dose. You should continue using the product as directed by your doctor or according to the instructions in section 3 (How to use Polinail). If you have not used the product for several days, its effectiveness may be reduced.

Stopping treatment with Polinail

If treatment is stopped before the nail(s) are cured or almost cured, the fungal infection may not disappear. In such cases, the condition of the nails may worsen again. If you have any further doubts about the use of this product, you should speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them. Very rare (less than 1 in 10,000 patients):

• redness at the application site, flaking, burning sensation, and itching.

Frequency not known (cannot be estimated from the available data)

• rash, eruption, and allergic contact dermatitis, also outside the application site;
• (transient) discoloration of the nails (this reaction may also be a symptom of fungal infection).

The side effects reported at the application site were mild and short-lived.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this product.

5. How to store Polinail

The product should be stored out of the sight and reach of children. Do not use this product after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month. Store the bottle in the outer packaging to protect it from light. Store the bottle tightly closed. Do not store in the refrigerator. The product is flammable. You should avoid exposing the product to heat and open flames. Shelf life after first opening the bottle: 6 months. At temperatures below 15°C, the medicinal lacquer may become gel-like. It may also become slightly cloudy or a small sediment may form at the bottom of the bottle. You can remove it by rubbing the bottle between your hands for about 1 minute. The solution will then be clear again. This does not affect the quality and efficacy of the product. Before using the product, you should check if the solution is clear again. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Polinail contains

The active substance of the product is ciclopirox. One gram of medicinal nail lacquer contains 80 mg of ciclopirox. The other ingredients of the product are: ethyl acetate, ethanol 96%, cetostearyl alcohol, hydroxypropyl chitosan, and purified water.

What Polinail looks like and what the pack contains

Medicinal nail lacquer. Polinail is a clear, colorless to slightly yellowish solution. Packaging: A glass bottle containing 3.3 ml or 6.6 ml of medicinal nail lacquer, with a PP cap and brush, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polichem S.A., 50, Val Fleuri, 1526 Luxembourg, Luxembourg

Manufacturer

Almirall Hermal GmbH, Scholtzstraße, 3, 21465 Reinbek, Germany, Alfasigma S.p.A., Via Enrico Fermi, 1, 65020 Alanno (PE), Italy, Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1, 29016 Cortemaggiore, Italy. For more information, you should contact the representative of the marketing authorization holder: Egis Pharmaceuticals PLC, phone number: +48 22 417 92 00

This product is authorized in the Member States of the European Economic Area under the following names:

Austria: Kitonail 80 mg/g wirkstoffhaltiger Nagellack, Bulgaria: Polinail, France: ONYTEC 80 mg/g, vernis a ongles medicamenteux, Greece: Kitonail, Spain: ONY-TEC 80 mg/g barniz de unas medicamentoso, Germany: Hauticum 8% wirkstoffhaltiger Nagellack, Poland: Polinail, Portugal: Niogermos, Czech Republic: Polinail, Romania: Kitonail, Slovakia: Polinail, Hungary: Kitonail, Italy: Niogermox 80 mg/g smalto medicato per unghie

Date of last revision of the leaflet: