Ony-Tec 80 mg/g medicated nail lacquer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ony-Tec 80 mg/g medicated nail lacquer
ciclopirox
For adults
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if the reaction is not listed in this leaflet. See section 4.
Leaflet contents:
- What Ony-Tec is and what it is used for
- What you need to know before using Ony-Tec
- How to use Ony-Tec
- Possible adverse effects
- How to store Ony-Tec
- Contents of the pack and other information
1. What Ony-Tec is and what it is used for
Ony-Tec is generally an effective antifungal agent (a broad-spectrum antimycotic agent) for topical use on 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 by other fungi that could be cured with ciclopirox.
The active substance, ciclopirox, prevents the growth of fungi and destroys them, thus improving the appearance of the nails.
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 to any of the other ingredients of this medicine (listed in section 6).
- in children and adolescents under 18 years of age, as there is insufficient experience in this age group.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Ony-Tec.
If signs of sensitization occur, discontinue treatment and consult your doctor.
As with all topical treatments for onychomycosis, if several nails are affected (> 3 nails), or if more than half of the nail plate is involved or the nail matrix is affected, or in cases of predisposing factors such as diabetes and immunodeficiency disorders, consult your doctor regarding the possible need for additional oral therapy alongside your nail lacquer.
If you are diabetic, take care when trimming your nails.
Avoid contact with the eyes and mucous membranes.
Ony-Tec, medicated nail lacquer, is for external use only.
Do not apply nail polish or any other cosmetic nail product to 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 conditions such as psoriasis, or yellow nail syndrome (a condition causing thickening and yellow discoloration of the nails, chronic swelling of 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 of age (see section 2 "Do not use Ony-Tec").
Use of other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Treatment with Ony-Tec should only be carried out, if urgently needed, after the responsible physician has carefully evaluated the benefits against the potential risks.
Breastfeeding
It is not known whether ciclopirox passes into human breast milk. Treatment with Ony-Tec should only be carried out, if urgently needed, after the responsible physician has carefully evaluated the benefits against the potential risks.
Driving and using machines
No special precautions are required.
Ony-Tec contains cetostearyl alcohol
This medicine may cause local skin reactions (such as contact dermatitis).
Ony-Tec 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.
3. How to use Ony-Tec
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.
Method of administration:
Cutaneous use (for use only on the nails and adjacent skin).
Ony-Tec is intended for adult use only.
The recommended dose is to apply a thin layer once daily to the affected nail(s).
To do this, the nails must be clean and dry. The medicated nail lacquer should be applied to the entire surface of the nails and to approximately 5 mm of the surrounding skin. 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 it at night before going to bed. After this time, normal hygiene practices may be resumed.
Ony-Tec does not need to be removed with solvents or abrasive products (e.g., nail file). It is sufficient to wash the nails carefully with water. Occasionally, due to inadequate washing of the nails, a white layer may appear on the nail surface after several days of treatment. Thorough washing with neutral soap and, if necessary, a nail brush or sponge will help remove it. If Ony-Tec is accidentally washed off, it may be reapplied. It is recommended to trim the nails regularly to remove infected parts.
Treatment should continue until the problem has disappeared, meaning until the nail(s) are clean or almost clean and healthy nail(s) have regrown. Typically, complete healing of fingernails takes about 6 months, and toenails approximately 9 to 12 months.
If a fingernail or toenail is extensively or severely affected, oral treatment may be advisable. Please consult your doctor in such cases.
If you think that the effect of Ony-Tec is too strong or too weak, inform your doctor or pharmacist.
If you use more Ony-Tec than you should:
Cases of overdose have not been reported to date.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed doses. Continue treatment as recommended by your doctor or as explained in section 3 of this leaflet (How to use Ony-Tec). If the medicated nail lacquer is not used for several days, effectiveness may be reduced.
If you stop treatment with Ony-Tec:
If you stop treatment with Ony-Tec before your nail(s) are clean or almost clean, the fungi may not have been eradicated. 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 adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Very rare adverse effects (may affect up to 1 in 10,000):
- redness, scaling, itching, and burning at the application site
Not known (frequency cannot be estimated from 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).
The adverse effects were mild in intensity and short in duration.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ony-Tec
Keep out of sight and reach of children.
Do not use the medicine after the expiry date stated on the container and on the bottle after EXP. The expiry date refers to the last day of the month indicated.
Keep the bottle in its box 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 the bottle: store for a maximum of 6 months.
At temperatures below 15°C, the medicated nail polish may gel; slight flocculation or formation of minor sediments at the bottom of the bottle may occur. This can be resolved by shaking the bottle gently between the hands for approximately 1 minute. Afterwards, the solution becomes clear again. The quality or efficacy of the product is not affected.
Before use, visually check that the solution in the bottle is clear (transparent) again.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.
6. Contents of the package and other information
What Ony-Tec contains:
The active substance is ciclopirox. 1 gram of medicinal nail polish contains 80 mg of ciclopirox.
The other components are: ethyl acetate, ethanol (96%), cetostearyl alcohol, hydroxypropyl-chitosan, and purified water.
What Ony-Tec looks like and contents of the pack:
Ony-Tec 80 mg/g medicinal nail polish is a transparent, colourless or slightly yellow solution supplied in glass bottles with screw caps fitted with a brush.
Pack sizes are 3.3 ml and 6.6 ml.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almirall, S.A.
General Mitre, nº 151
08022 – Barcelona (Spain)
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
This medicinal product 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 the most recent review of this summary: November 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/