KITONAIL 80 MG/G MEDICINAL NAIL POLISH

2. What you need to know before you start using Kitonail

• A fungal infection of a mild to moderate nature is considered to be one that affects up to 75% of the nail surface, affecting a maximum of five nails in total (including fingernails and/or toenails), without affecting the nail matrix (lunula).

Do not use Kitonail:

• if you are allergic (hypersensitive) to ciclopirox or any of the other ingredients of this medicine (listed in section 6).
• in children under 18 years of age, as there is not enough experience in this age group.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Kitonail.

• In case the infection affects 75% of the nail surface, affecting more than five nails, without affecting the nail matrix (lunula).
• If you develop sensitivity to the product, stop treatment and consult your doctor.
• Patient with a history of diabetes, immunological disorders, peripheral vascular disorders, wounds, pain, or severely damaged nails, skin conditions such as psoriasis, or any chronic skin condition, edema, respiratory disorders (yellow nail syndrome).
• If you are diabetic, be careful when cutting your nails.
• Avoid contact with the eyes and mucous membranes.
• Kitonail is for external use only.
• Do not use nail polish or other cosmetic products for the nails on the treated nails.
• Keep the container closed when not in use.

Children and adolescents

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

Using Kitonail with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Treatment with Kitonail will only be carried out if necessary, after the doctor has carefully evaluated the benefits against the possible risks.

Breastfeeding

It is not known whether ciclopirox passes into human breast milk. Treatment with Kitonail will only be carried out if necessary, after the doctor has carefully evaluated the benefits against the possible risks.

Driving and using machines

No special precautions are required.

Kitonail contains alcohol (ethanol)

This medicine contains 730 mg of alcohol (ethanol) in each gram of solution.

It may cause a burning sensation on damaged skin.

This product is flammable. Keep away from heat and flames.

Kitonail contains cetoconazole

This may cause local skin reactions (such as contact dermatitis).

3. How to use Kitonail

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Method of administration:

Topical use (for use on the nails or immediate surrounding skin only).

Kitonail should only be used by adults.

The recommended dose is to apply a thin layer once a day to the infected nail(s). To do this, the nails must be clean and dry. The medicated nail varnish will be applied to the entire surface of the nail and to about 5 mm of the surrounding skin. If possible, Kitonail should also be applied under the nail.

Allow Kitonail to dry for about 30 seconds.

The nail(s) should not be washed for at least 6 hours after application of the medicated nail varnish, therefore, it is recommended to apply at night before bedtime. After this time, normal hygiene practices can be continued.

Kitonail does not need to be removed with solvents or abrasive products (e.g. nail file), it is sufficient to wash the nails with water. In case of accidental removal by washing, Kitonail can be reapplied. It is recommended to regularly trim the nails to remove the infected parts of the nail.

Treatment should continue until the problem has disappeared, which means until the nail(s) are clean or almost clean and the healthy nail(s) have grown back. Normally, complete healing of the fingernails is achieved in about 6 months and that of the toenails in approximately 9 to 12 months.

If you use more Kitonail than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Kitonail

Do not use a double dose to make up for forgotten doses. Continue with the treatment as your doctor recommended or as explained in point 3 of this leaflet (How to use Kitonail). If you do not use the medicated nail varnish for several days, the effectiveness may be reduced.

If you stop using Kitonail

If you stop using Kitonail before your nail(s) are clean or almost clean, the fungus may not have disappeared. In this case, your nail condition may worsen again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

General disorders and administration site conditions:

Very rare: may affect up to 1 in 10,000 people.

• Redness, scales, itching, and burning at the application site.

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

• Rash, eczema; allergic dermatitis, also outside the application site.
• Change in color (transient) of the nails (this reaction can also be attributed to the fungal nail infection itself).

Reporting of side effects

If you experience 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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Kitonail

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Store the bottle in the carton, in order to protect it from light.

Do not refrigerate or freeze.

This product is flammable. Keep away from heat and flames.

After first opening the bottle:

Keep the bottle tightly closed to prevent evaporation of the contents.

Store for a maximum of 6 months.

At temperatures below 15°C, the medicated nail varnish may gelify. A slight flocculation or formation of a slight sediment may occur at the bottom of the bottle, which can be dissolved by gently rubbing the bottle between your hands for about 1 minute. After this, the solution will become clear again. The quality or effectiveness of the product is not affected.

Medicines should not be disposed of via wastewater or household waste. Return the container and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

What Kitonail contains

• The active substance is ciclopirox. One gram of medicated nail varnish contains 80 mg of ciclopirox.
• The other ingredients are: ethyl acetate, ethanol (96%), cetoconazole, hydroxypropyl chitosan, and purified water.

Appearance and packaging

Kitonail 80 mg/g medicated nail varnish is a clear, colorless or slightly yellow solution supplied in glass bottles with screw caps provided with a brush.

The pack sizes are 3.3 ml and 6.6 ml.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Polichem SA

50, Val Fleuri,

1526 Luxembourg

Manufacturer:

Alfasigma S.p.A.

Via Enrico Fermi nº1,

65020 Alanno (PE)

Italy

or

Doppel Farmaceutici S.r.l.

Via Martiri delle Foibe, 1

29016 Cortemaggiore

Italy

or

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

You can obtain further information on this medicine from the representative of the marketing authorisation holder

Almirall, S.A.

General Mitre, 151

08022 Barcelona – Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

BE Myconail 80 mg/g medicated nail lacquer

CY Kitonail 80 mg/g medicated nail lacquer

DE Decme 80 mg/g medicated nail lacquer

DK Onytec

ES Kitonail 80 mg/g medicated nail varnish

FI Onytec 80 mg/g medicated nail lacquer

FR Myconail 80 mg/g medicated nail lacquer

IE Onytec 80 mg/g medicated nail lacquer

LT Onytec 80 mg/g medicated nail lacquer

LV Onytec 80 mg/g medicated nail lacquer

NO Onytec

SE Onytec 80 mg/g medicated nail lacquer

SI Onytec 80 mg/g medicated nail lacquer

Date of last revision of this leaflet: November 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (website: www.aemps.gob.es)