Patient leaflet - Onytec 80 mg/g medicated Nail Lacquer
1. What ONYTEC is and what it is used for
Onytec contains the active substance ciclopirox, which belongs to a group of medicines known as antifungals. It kills a wide range of fungi that can cause nail infections.
Onytec is used to treat mild to moderate fungal infections of the nails without nail matrix/lunula (white half-moon of the nail) involvement in adults.
2. What you need to know before you use ONYTEC
Do not use Onytec:
if you are allergic to ciclopirox or any of the other ingredients of this medicine
(listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before using Onytec if:
more than 75% of nail surface, or more than 5 nails, or the nail matrix/lunula
(white half-moon) are infected
you have a history of diabetes, immune disorders, blood circulation disorder
(peripheral vascular disease)
- you have injured, painful or seriously damaged nails
- you have skin conditions such as psoriasis, any other chronic skin condition or oedema (swelling caused by the accumulation of fluid)
- you have a condition that also affects breathing called Yellow nail syndrome
If you become sensitive to the product, please stop treatment and consult a doctor.
If you are a diabetic patient, please take care when trimming the nails.
Onytec is for external use only. Avoid contact with the eyes and mucous membranes (e.g. mouth and nostrils). Avoid biting or sucking nails during the treatment period with Onytec.
Nail polish or other nail cosmetic products should be removed before application of Onytec and should not be used on the treated nails.
Keep the bottle capped when not in use. The product is flammable, keep away from heat and open flames.
Children and adolescents
Onytec should not be used in children and adolescents below 18 years of age due to insufficient experience in this age group.
Other medicines and Onytec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines. You can normally use Onytec if you are taking other medicines.
Pregnancy and breast-feeding
Pregnancy
Do not use Onytec if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your doctor or pharmacist for advice.
Treatment with Onytec should only take place after consulting a doctor.
Breast-feeding
It is not known whether ciclopirox passes into breast milk of humans. If you are breast feeding you should only use Onytec if treatment is urgently required and only after consulting a doctor.
Driving and using machines
Onytec has no influence on the ability to drive and use machines.
Onytec contains alcohol (ethanol)
This may cause a burning sensation on damaged skin.
Onytec contains cetostearyl alcohol
This may cause local skin reactions (e.g. contact dermatitis).
3. How to use ONYTEC
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Onytec should only be used on the infected nails and the skin immediately around them. Onytec is for use in adults only.
Instructions for use:
Step 1: Before each application of Onytec carefully wash and dry the nails. Step 2: Using the applicator, apply a thin layer once a day to each of the infected nail/s. The medicated nail lacquer should be applied over the entire nail surface and 5 mm of surrounding skin. If possible, Onytec should be applied also under the free edge of the nail.
Step 3: Wait about 30 seconds until the lacquer has completely dried before doing any activity.
Do not wash the nails for at least 6 hours. For this reason it is recommended to apply Onytec, in the evening before going to bed. After that time, normal hygienic practices can be followed. In case you accidentally remove it by washing, you can apply it again.
Onytec does not need to be removed by any solvent or abrasives (i.e. nail filing), it is sufficient to wash the nails with water. You should regularly remove unattached parts of the infected nail, e.g. by clipping the nails.
Package leaflet: Information for the patient
Onytec 80 mg/g medicated nail lacquer
For adults Ciclopirox How long to keep using Onytec
Continue using Onytec every day until the nail is/the nails are clear or their appearance is significantly improved and healthy nail has/nails have grown again. This normally takes about 6 months for fingernails and about 9 to 12 months for toenails.
If you use more Onytec than you should:
If you or anyone else accidentally swallows this medicine talk to your doctor or pharmacist or go to the nearest hospital immediately. Take the bottle and packaging with you.
If you forget to use Onytec:
If you forget to apply the product once do not use a double dose to make up for it. Continue with treatment as recommended by your doctor or as explained in section 3 of this leaflet (How to use Onytec). If you do not use the medicated nail lacquer for several days, its effectiveness may be reduced.
If you stop using Onytec:
If you stop treatment with Onytec before your nail is/nails are clear or their appearance is significantly improved and healthy nail has/nails have grown again, the fungi may not have disappeared. In this case, the condition of your nails can get worse again.
If you have any further questions on the use of this medicine, 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 (may affect less than 10,000 people):
- Redness (erythema)
- Skin exfoliation
- Skin burning sensation
- Itching (pruritus)
Not known (frequency cannot be estimated with the available data):
- Nail discolouration (this reaction can be attributed to the onychomycosis itself)
- Nail disorder (nail damage)
- Dermatitis contact (also beyond the application site)
- Eruption (rash)
- Eczema
- Application site pain
- Application site paraesthesia (tingling sensation)
Reporting of side effects
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ONYTEC
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton box and on the bottle. The expiry date refers to the last day of that month.
Keep the bottle in the outer carton, in order to protect from light. Do not refrigerate or freeze.
This product is flammable. Keep away from heat and open flame.
After first opening the container:
Keep the bottle tightly closed to avoid evaporation of the contents. After first opening use within 6 months.
At temperatures below 15°C the medicated nail lacquer may gel. Light settling or formation of a light sediment may also occur which can be reversed by warming up to room temperature (25°C) through rubbing the bottle between hands till the solution is clear again (about one minute). This has no impact on product quality or performance.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Onytec contains:
The active substance is ciclopirox. One gram of medicated nail lacquer contains 80 mg of ciclopirox.
The other ingredients are: ethyl acetate, ethanol, cetostearyl alcohol, hydroxypropyl- chitosan and purified water.
What Onytec looks like and contents of the pack:
Medicated nail lacquer
Onytec is a clear, colourless to slightly yellowish solution supplied in clear glass bottles with screw caps which are fitted with a brush.
Pack sizes are 3.3 ml and 6.6 ml.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain
Manufacturer
Alfasigma S.p.A.
Via Enrico Fermi, 1
65020 Alanno (PE) Italy
This leaflet was last revised in 02/2024.
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