Label: information for the user

Ony-Tec 80 mg/g medicated nail polish

ciclopirox

For adults

Read this label carefully before starting to use this medication because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Ony-Tec and how is it used

2. What you need to know before starting to use Ony-Tec

3. How to use Ony-Tec

4. Possible adverse effects

5. Storage of Ony-Tec

6. Contents of the package and additional information

Ony-Tec is a general effective antifungal agent (broad-spectrum antimycotic agent) for topical use on the fingernails, toenails, and adjacent skin.

It is used for the treatment of mild to moderate fungal infections of the nails (onychomycosis) caused by filamentous fungi and/or other fungi that could be cured with ciclopirox.

The active ingredient ciclopirox prevents the growth of fungi and destroys them, thereby improving the appearance of the nails.

Do not use Ony-Tec:

• if you are allergic to ciclopirox or any of the other components of this medication (listed in section 6).
• in children and adolescents under 18 years of age since there is not enough experience in this age group.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ony-Tec.

Stop treatment and consult your doctor in case of sensitization.

As with all topical treatments for onychomycosis, if multiple nails are affected (> 3 nails), or in the case of more than half of the nail plate being altered or the nail matrix being affected, and in cases of predisposing factors, such as diabetes and immunodeficiency disorders, consult your doctor for the possible addition of oral therapy to your nail polish.

If you are diabetic, be careful when cutting your nails.

Avoid contact with the eyes and mucous membranes.

Ony-Tec, medicated nail polish, is only for external use.

Do not use nail polish or any other type of cosmetic product on the treated nails.

If you have a history of diabetes, immunological disorders, peripheral vascular disease (problems with blockage of your arteries), painful, damaged, or severely damaged nails, skin diseases such as psoriasis or yellow nail syndrome (a disease that causes thickening and yellow discoloration of the nails, chronic swelling in the extremities, and chronic respiratory problems), consult your doctor before starting treatment with Ony-Tec.

Children and adolescents

Ony-Tec is contraindicated in children and adolescents under 18 years of age (see section 2 “Do not use Ony-Tec”).

Use of other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Treatment with Ony-Tec will only be performed if necessary, after the responsible doctor has carefully evaluated the benefits against the possible risks.

Breastfeeding

It is not known if ciclopirox passes into human breast milk. Treatment with Ony-Tec will only be performed if necessary, after the responsible doctor has carefully evaluated the benefits against the possible risks.

Driving and operating machinery

No special precautions are required.

Ony-Tec contains cetoestearic alcohol

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

Ony-Tec contains alcohol (ethanol)

This medication 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration method:

Topical use (only for use on nails and adjacent skin).

Ony-Tec is only for use in 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 polish will be applied over the entire surface of the nails and on the surrounding skin for about 5 mm. If possible, Ony-Tec should also be applied underneath the nail.

Allow Ony-Tec to dry for about 30 seconds.

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

Ony-Tec does not need to be removed with solvents or abrasive products (e.g., nail file), a careful wash of the nails with water is sufficient. Sometimes, due to inadequate nail washing, a white layer may appear on the surface of the nail after several days of treatment. A thorough wash with neutral soap and, if necessary, a nail brush or sponge, will help to remove it. In case of accidental removal by washing, Ony-Tec can be reapplied. It is recommended to trim the nails regularly to remove the infected parts of the nail.

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

If a finger or toe nail is wide or severely affected, it may be recommended to use oral treatment. Consult your doctor in these cases.

If you consider that the effect of Ony-Tec is too strong or weak, inform your doctor or pharmacist.

If you use more Ony-Tec than you should:

Up to now, no cases of overdose have been described.

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

If you forgot to use Ony-Tec:

Do not use a double dose to compensate for the missed doses. Continue treatment as recommended by your doctor or as explained in point 3 of this leaflet (How to use Ony-Tec). In the case of not using the medicated nail polish for several days, the effectiveness may be reduced.

If you interrupt the treatment with Ony-Tec:

If you interrupt the treatment with Ony-Tec before your nail(s) is/are clean or almost clean, the fungi may not have disappeared. In this case, the nail situation may worsen again.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very rare adverse effects (may affect up to 1 in 10,000):

• redness, scales, itching, and burning at the application site

Unknown (frequency cannot be estimated from available data):

• skin rash, eczema, contact allergic dermatitis, also beyond the application site
• (transient) nail discoloration (this reaction may also be due to the underlying fungal infection of the nail).

The adverse effects were of mild intensity and short duration.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use the medication after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

Keep the bottle in the box to protect it from light.

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

Do not refrigerate.

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

After the first opening of the bottle: store for a maximum of 6 months.

At temperatures below 15°C, the medicated nail polish may gelify; a slight flocculation or formation of light sediments may occur at the bottom of the bottle. This can be dissolved by shaking the bottle in your hands for approximately 1 minute. After this, the solution is transparent again. The product's quality or efficacy is not affected.

Before use, visually check that the solution at the bottom of the bottle is transparent (clear) again.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

What Ony-Tec contains:

The active ingredient is ciclopirox. 1 gram of medicated nail polish contains 80 mg of ciclopirox.

The other components are: ethyl acetate, ethanol (96%), cetoestearic alcohol, hydroxypropyl-chitosan, and purified water.

What Ony-Tec looks like and contents of the packaging:

Ony-Tec 80 mg/g medicated nail polish is a transparent, colorless, or slightly yellowish solution supplied in glass bottles with screw-top caps provided with a brush.

The packaging sizes are 3.3 ml and 6.6 ml.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder:

Almirall, S.A.

General Mitre, nº 151

08022 – Barcelona (Spain)

Responsible person for manufacturing

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

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Kitonail® 80 mg/g wirkstoffhaltiger Nagellack

Bulgaria: Polinail®

Czech Republic: Polinail®

France: ONYTEC® 80 mg/g, vernis à ongles médicamenteux

Germany: Hauticum® 8% wirkstoffhaltiger Nagellack

Greece: Kitonail®

Hungary: Kitonail®

Italy: Niogermox® 80 mg/g smalto medicato per unghie

Poland: Polinail®

Portugal: Niogermos®

Romania: Kitonail®

Spain: Ony-Tec® 80 mg/g barniz de uñas medicamentoso

Slovakia: Polinail®

Last review date of this leaflet:November 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/