80 mg / g medical nail polish
ciclopirox
What Onytec is and what it is used for
Onytec contains the active substance ciclopirox which belongs to a group of medicines called antifungals. It kills several fungi that can cause nail infections.
Onytec is used by adults to treat mild to moderately severe fungal infections of the nails without affecting the nail’s growth zone (the white crescent on the nail, the so-called nail matrix, and lunula).
What you need to know before using Onytec
- Mild to moderately severe nail fungus infections that attack up to 75% of the nail surface, on up to 5 nails (toenails and / or fingernails), but without affecting the nail’s growth zone.
Do not use Onytec
- if you are allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6)
- to children and adolescents under the age of 18 due to insufficient experience from this age group.
Warnings and cautions
Talk to your doctor or pharmacist before using Onytec.
- If the infestation covers more than 75% of the nail surface, more than 5 nails or the nail’s growth zone.
- If you become hypersensitive to the product, stop treatment and consult a doctor.
- If you have a history of diabetes , immune system disorders, diseases of blood vessels outside the heart and brain, injury, painful or severely damaged nails, skin condition such as psoriasis or other chronic skin condition, edema , respiratory disorders (yellow nail syndrome).
- If you are diabetic, you should be careful with nail care.
- Avoid contact with eyes and mucous membranes (eg mouth and nostrils).
- Onytec is for external use only.
- Do not use nail polish or other cosmetic nail products on the treated nails.
- Keep the bottle closed when not in use.
- This product is flammable. Do not expose to heat and open flame.
Children and young people
Onytec should not be used by children and adolescents under 18 years of age (see section 2 Do not use Onytec).
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.
Pregnancy and breastfeeding
Pregnancy
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 before taking this medicine.
Treatment with Onytec should only be done after a doctor’s prescription.
Breast-feeding
It is unknown whether ciclopirox passes into human breast milk. Treatment with Onytec should only be done if necessary and after a doctor’s prescription.
Driving and using machines
Onytec does not influence the ability to drive or use machines.
Onytec contains cetostearyl alcohol
This can cause local skin reactions (eg contact dermatitis).
How to use Onytec
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Used on the skin (only for use on nails and the immediate surrounding skin).
Onytec is for adult use only.
The recommended dose is to apply a thin layer once daily on infected nails. The nails should be washed thoroughly and dry before application. The medical nail polish should be applied over the entire nail surface and 5 mm out on the surrounding skin. If possible, Onytec should also be applied under the free nail edge.
Let Onytec dry for about 30 seconds.
The treated nails should not be washed for at least 6 hours and therefore brushing in the evening before bedtime is recommended. After that time, normal hygiene routines can be followed.
Onytec medical nail polish does not need to be removed with any solvent or abrasive (nail file), it is enough to wash the nails with water. In cases where accidental removal is done by washing, Onytec can be applied again. Regular removal of loose parts of the infected nail (eg by cutting the nails) is recommended.
The treatment should continue until the problems have disappeared, that is until the nail/nails are clear (not discolored) or its appearance has improved noticeably and healthy nails have grown out. Usually, the treatment time is about 6 months for fingernails and about 9 to 12 months for toenails.
If you use more Onytec than you should
If you have accidentally swallowed nail polish, consult your nearest doctor or hospital immediately. Take the Onytec 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 a forgotten dose. Continue treatment as advised by your doctor or as described in section 3 (How to use Onytec) in this leaflet. If you forget to use the medical nail polish for several days, the effect may be worse.
If you stop using Onytec
If you stop treatment with Onytec before the nail/nails are ready or their appearance has improved significantly and healthy nails have started to grow back, the fungus may remain. In that case, your nails may get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 users):
- Redness , peeling, burning and itching at the application site.
Has been reported (occurs in an unknown number of users):
- Rash, eczema; allergic dermatitis ( inflammation of the skin), even outside the application site
- (Transient) discoloration of the nail (even the nail fungus infection can cause this reaction).
How to store Onytec
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 and bottle. The expiration date is the last day of the specified month.
Store the bottle in the outer carton. Sensitive to light.
Store in a cold place. Do not freeze.
This product is flammable. Do not expose to heat or open flame.
After first opening: Keep the bottle tightly closed to prevent the contents from evaporating.
Used within 6 months after first opening.
At temperatures below 15 ° C, the medical nail polish can become gelatinous. Slight precipitation or the formation of light sediment may also occur. This is restored by warming to room temperature (25 ° C) by rubbing the bottle between the hands until the solution is clear again (about one minute). This does not affect the product’s quality of workmanship.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ciclopirox. One gram of medicated nail polish contains 80 mg of ciclopirox.
- The other ingredients are ethyl acetate, ethanol (96%), cetostearyl alcohol, hydroxypropyl chitosan, purified water.
What the medicine looks like and contents of the pack
Medical nail polish
Onytec is a clear, colorless to a slightly yellowish solution that is provided in clear glass bottles with a screw cap with a brush.
The pack sizes are 3.3 ml and 6.6 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Polichem SA
50, Val Fleuri, 1526 Luxembourg
Luxembourg
Manufacturer
Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Germany
Alfasigma SpA
Via Enrico Fermi, 1, 65020 Alanno (PE)
Italy
Doppel Farmaceutici Srl
Via Martiri delle Foibe, 1
29016 Cortemaggiore
Italy
This medicinal product is authorized under the European Economic Area under the names:
| Belgium | Myconail 80 mg / g Nail polish |
| Cyprus | Kitonail 80 mg / g medicated nail lacquer |
| Denmark | Onytec |
| Estonia | Onytec |
| Finland | Onytec 80 mg / g Lääkekynsilakka |
| France | Myconail 80 mg / g Vernis for medical drugs |
| Ireland | Onytec 80 mg / g medicated nail lacquer |
| Italy | Polina 80 mg / g Smalto medicated for children |
| Latvia | Onytec 80 mg / g Vaistinis nagu lakas |
| Lithuania | Onytec 80 mg / g ārstnieciskā nagu laka |
| Norway | Onytec 80 mg / g medical nail polish |
| Slovenia | Onytec 80 mg / g zdravilni lak za nohte |
| Spain | Kitonail 80 mg / g Barniz for medicinal products |
| Sweden | Onytec 80 mg / g medical nail polish |
| Germany |