ONY-TEC 80 mg/g MEDICINAL NAIL POLISH

2. What you need to know before using Ony-Tec 80 mg/g

Do not use Ony-Tec:

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

Warnings and precautions

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

In case of sensitization, stop treatment and consult your doctor.

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

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

Avoid contact with eyes and mucous membranes.

Ony-Tec, medicinal nail varnish, is for external use only.

Do not use nail polish or other cosmetic products for the nails on treated nails.

If you have a history of diabetes, immunological disorders, peripheral vascular disease (problems with blockage of your arteries), painful, injured, 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 limbs, 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 (see section 2 "Do not use Ony-Tec").

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

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 Ony-Tec 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 Ony-Tec 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.

Ony-Tec contains cetoconazole

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

Ony-Tec contains ethanol

This medicine contains 730 mg of 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.

3. How to use Ony-Tec

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Method of administration:

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

Ony-Tec is for use in adults only.

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 medicinal nail varnish will be applied to the entire surface of the nail and about 5 mm of the surrounding skin. If possible, Ony-Tec should also be applied under the nail.

Let Ony-Tec dry for about 30 seconds.

The nail(s) should not be washed for at least 6 hours after application, so 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), it is enough to wash the nails carefully with water. Sometimes, due to inadequate washing of the nails, 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. Regular trimming of the nails is recommended 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 fingernails is achieved in about 6 months and toenails in about 9 to 12 months.

If a fingernail or toenail is wide or severely affected, oral treatment may be recommended. Consult your doctor in these cases.

If you think that the effect of Ony-Tec is too strong or too weak, talk to your doctor or pharmacist.

If you use more Ony-Tec than you should:

So far, no cases of overdose have been reported.

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 Ony-Tec:

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

If you stop using Ony-Tec:

If you stop using Ony-Tec before your nail(s) is/are clean or almost clean, the fungi may not have disappeared. In this case, the condition of the nails may worsen again.

If you have any further questions about 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.

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

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

Not known (frequency cannot be estimated from the available data):

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

Side effects were of mild intensity and short duration.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ony-Tec

Keep out of the sight and reach of children.

Do not use the medicine after the expiry date which is stated on the packaging and on the bottle after EXP. The expiry date is the last day of the month stated.

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

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

Do not refrigerate.

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

After first opening of the bottle: use within 6 months.

At temperatures below 15°C, the medicinal nail varnish may gel; a slight flocculation or formation of slight sediment may occur at the bottom of the bottle. This can be dissolved by shaking the bottle in your hands for about 1 minute. After this, the solution is clear again. The quality or efficacy of the product is not affected.

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

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 to protect the environment.

6. Contents of the pack and further information

What Ony-Tec contains:

The active substance is ciclopirox. 1 gram of medicinal nail varnish contains 80 mg of ciclopirox.

The other ingredients are: ethyl acetate, ethanol (96%), cetoconazole, hydroxypropyl-chitosan, and purified water.

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

Ony-Tec 80 mg/g medicinal 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:

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

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

This medicine is authorised in the Member States of the European Economic Area under 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®

Date of last revision of this leaflet:November 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/