POLINAIL

Package leaflet: Information for the user

Polinail, 80 mg/g, nail lacquer, medicinal
Ciclopirox
For adults
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 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 adverse reactions 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 your condition worsens, you should contact your doctor.

Contents of the leaflet:

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

1. What Polinail is and what it is used for

Polinail is an antifungal medicine with broad-spectrum activity, intended for topical application on fingernails, toenails, and adjacent skin areas.
It is used to treat mild to moderate fungal infections of the nails (onychomycosis) caused by dermatophytes and/or other fungi susceptible to ciclopirox.
The active substance in this medicine, ciclopirox, inhibits fungal growth and destroys the fungus, thereby improving the appearance of the nails.

2. Information before using Polinail

When not to use Polinail:

• if the patient is allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6),
• in children and adolescents under 18 years of age, due to insufficient experience with the use of this medicine in this age group.

Warnings and precautions
Before starting treatment with Polinail, discuss it with your doctor or pharmacist.
If an allergic reaction occurs, discontinue treatment and contact your doctor.
As with any topical treatment for nail fungal infections, when the disease process
affects several nails (>3 nails) or more than half of the nail plate or the nail matrix,
or when there are predisposing factors such as diabetes or immunological disorders,
you should consult your doctor. Your doctor may recommend additional oral antifungal
treatment.
If the patient has diabetes, caution should be taken when trimming nails.
Avoid contact of the medicine with eyes or mucous membranes.
Polinail is intended for external use only.
Do not apply nail polish or any other cosmetic nail care products on treated nails.
If the patient has a history of diabetes, immune system disorders, peripheral vascular disease (arterial narrowing), injured, painful or severely damaged nails, or skin conditions such as psoriasis or yellow nail syndrome (a condition causing thickening and yellow discoloration of nails, chronic swelling of limbs, and chronic breathing difficulties), medical advice should be sought 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 with 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 use.

Pregnancy and breastfeeding
Pregnancy
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.
Treatment with Polinail is possible only if absolutely necessary, after careful consideration by the treating physician of the benefits versus the potential risks.

Breastfeeding
It is not known whether ciclopirox passes into human milk. Treatment with Polinail is possible only if absolutely necessary, after careful consideration by the treating physician of the benefits versus the potential risks.

Driving and operating machinery:
No special precautions are necessary.

Polinail contains cetostearyl alcohol.
It may cause local skin reactions (such as contact dermatitis).

Polinail contains alcohol (ethanol).
This medicine contains 730 mg of alcohol (ethanol) in each g of solution (medicinal nail lacquer).
It may cause stinging on damaged skin.
This product is flammable. Keep away from heat and open flames.

3. How to use Polinail
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.

Method of administration
Topical application (only on nails and directly adjacent skin areas).
Polinail should be used only in adult patients.

Recommended dose
Typically, a thin layer of Polinail should be applied once daily to the affected nail(s). Before application, nails should be clean and dry. The medicinal nail lacquer should be applied to the entire nail surface and to the surrounding skin within 5 mm of the nail.
If possible, Polinail should also be applied under the free edge of the nail.
Leave Polinail to dry for approximately 30 seconds.
The treated nail(s) should not be washed for at least six hours—therefore, it is recommended to apply the medicine in the evening before going to bed. After this time, normal hygiene practices may be resumed.
No solvents or abrasive substances (e.g., nail file) are required to remove Polinail; thorough washing with water is sufficient.
Sometimes, after several days of treatment, due to inadequate washing, a white layer may appear on the nail surface. This 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. Regular removal of loose nail parts is recommended, e.g., by trimming the nails.

Treatment should continue until complete resolution of symptoms, i.e., until the nail(s) are completely or almost completely clear and healthy nail(s) have fully regrown. Complete healing of fingernails usually occurs after approximately 6 months, and toenails after 9 to 12 months.

If there is no improvement after 4 weeks, or if the patient feels worse, contact your doctor.

If infection of one fingernail or toenail is extensive, or if multiple nails are affected, additional oral antifungal treatment may be indicated.
In such cases, consult your doctor.

If you feel that the effect of Polinail is too strong or too weak, contact your doctor or pharmacist.

Use of a higher than recommended dose of Polinail
No cases of overdose have been reported to date.

Missed dose of Polinail
If a dose is missed, do not use a double dose to make up for the missed dose. Continue treatment as directed by your doctor or according to the instructions in section 3 (How to use Polinail).
If the medicine has not been used for several days, its effectiveness may be reduced.

Stopping Polinail treatment
If treatment is stopped before the nail(s) are 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare (less frequently than in 1 out of 10,000 patients):

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

Frequency unknown (cannot be estimated from the available data):

• rash, eczema, and allergic contact dermatitis, also occurring outside the application site;
• (transient) discoloration of the nail (this reaction may also be a sign of fungal infection).

Adverse reactions observed at the application site were mild and transient.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Polinail

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
bottle. The expiry date refers to the last day of the stated month.
Store the bottle in the outer packaging to protect it from light.
Keep the bottle tightly closed.
Do not store in the refrigerator.
The product is flammable. Avoid contact of the product with heat and open flame.
Shelf life after first opening of the bottle: 6 months.
At temperatures below 15°C, the medicinal varnish may become gel-like. Slight clumping or a small sediment may also form at the bottom of the bottle. These can be removed by rubbing the bottle between the palms for approximately 1 minute. The solution will then become clear again. This does not affect the quality or efficacy of the medicine.
Before use, inspect the medicine to ensure that the solution at the bottom of the bottle is once again clear.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Polinail contains
The active substance is ciclopirox. Each gram of medicinal nail lacquer contains 80 mg of
ciclopirox.
The other ingredients are: ethyl acetate, 96% ethanol, cetostearyl alcohol,
hydroxypropylchitosan and purified water.

What Polinail looks like and contents of the pack
Medicinal nail lacquer.
Polinail is a transparent, colourless to slightly yellowish solution.
Packaging:
A glass bottle containing 3.3 ml or 6.6 ml of medicinal nail lacquer, with a polypropylene cap and
a brush, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Polichem S.A.
50, Val Fleuri
1526 Luxembourg
Luxembourg

Manufacturer
Almirall Hermal GmbH
Scholtzstraβe, 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 further information, contact the representative of the Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
Telephone number: +48 22 417 92 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Kitonail 80 mg/g nail lacquer containing active substance
Bulgaria: Polinail
France: ONYTEC 80 mg/g, vernis à ongles médicamenteux
Greece: Kitonail
Spain: ONY-TEC 80 mg/g barniz de uñas 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