Kitonail 80 mg/g active nail polish

Kitonail is an effective agent against various fungal diseases (broad-spectrum antifungal agent) for external use on fingernails, toenails and immediately adjacent skin areas.

Application

1. What is Kitonail and what is it used for?

Kitonail is an effective agent against various fungal diseases (broad-spectrum antifungal agent) for external use on fingernails, toenails and the immediately adjacent skin.

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

The active ingredient ciclopirox prevents the fungi from growing and destroys them. This improves the appearance of your nail.

How is it applied?

What is Kitonail and what is it used for?

Kitonail is an effective agent against various fungal diseases (broad-spectrum antifungal agent) for external use on fingernails, toenails and immediately adjacent skin areas.

It is used to treat mild to moderately severe fungal infections of the nails (onychomycosis) caused by filamentous fungi and/or other fungi that can be treated with ciclopirox.

The active ingredient ciclopirox prevents fungi from growing and kills them. This will improve the appearance of your nails.

What should you pay attention to before taking it?

What should you be aware of before using Kitonail?

Kitonail must not be used,

- 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 of age, due to insufficient experience in this age group.

Warnings and Precautions

Please talk to your pharmacist before using Kitonail.
If an allergic reaction (sensitisation) occurs, please stop treatment
and consult your doctor.

As with all external treatments for nail fungi (onychomycosis), if several nails are involved (3 nails), or if more than half of the nail plate is altered or the nail root is damaged, you should contact your doctor.As with all external treatments for nail fungus (onychomycosis), if more than half of the nail plate is affected or the nail root is affected, and in the case of favourable factors such as diabetes (diabetes) and diseases of the immune system, you should consult your doctor about possible additional oral therapy.

If you are diabetic, please take special care with your nails.

Avoid contact with eyes and mucous membranes.

Kitonail is for external use only.

Do not apply cosmetic nail polish or other nail cosmetics to the treated nails.

If you have diabetes, immune disorders or peripheral occlusive disease (blockage of the arteries), if your nails are injured, painful or badly damaged, or if you have skin conditions such as psoriasis or yellow nail syndrome.If you have skin conditions such as psoriasis or yellow nail syndrome (a condition that causes thickening and yellowing of the nails, chronic swelling of the limbs and chronic breathing problems), please contact your doctor before starting treatment with Kitonail.

Children and adolescents
Kitonail must not be used in children and adolescents under 18 years of age (see section 2 "Kitonail must not be used").

Use of Kitonail with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

Pregnancy and breast-feeding
Pregnancy:
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Treatment with Kitonail should only be given after a careful risk-benefit assessment by the doctor treating you if treatment is urgently needed.

Lactation:
It is not known whether ciclopirox passes into human breast milk. Treatment with Kitonail may only be given after a careful risk-benefit assessment by the attending physician if treatment is urgently required.

Driving and ability to operate machinery

No special precautions are necessary.
Kitonail contains cetylstearyl alcohol

Cetylstearyl alcohol may cause localised skin irritation (e.g.: contact dermatitis)

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How should the medicine be taken?

How to use Kitonail?

Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

Method of use
Application to the nails (only for use on the nails and directly adjacent skin areas)
Kitonail is only suitable for use on adults.

The recommended dose is: apply a thin layer to the infected nail(s) 1x daily. For this purpose, the nails should be clean and dry. The nail varnish containing the active substance should be applied to the entire surface of the nail and to 5 mm of the adjacent skin. If possible, Kitonail should also be applied under the free nail edge.

Let Kitonail dry for 30 seconds.

Nails should not be washed for at least 6 hours afterwards, so application in the evening before going to bed is recommended. After this time, normal hygiene can follow.

Kitonail does not need to be removed with special solvents or abrasives (i.e. nail files), it is sufficient to wash the nails thoroughly with water. Occasionally, a white film may appear on the surface after a few days of treatment due to insufficient cleaning of the nails. Thorough washing with neutral soap and, if necessary, a nail brush or sponge will help to remove it. In case of accidental removal during washing, Kitonail can be reapplied. Regular removal of the loose nail material of the diseased nail, e.g. by cutting the nails, is recommended.

Treatment must be continued until the symptoms have completely subsided, i.e. until the nail(s) is/are clear or almost clear again and healthy nail has grown back. Normally, complete healing of fingernails is achieved after about 6 months, for toenails after about 9 to 12 months.

If a fingernail or toenail is severely affected or if several nails are affected, additional oral therapy may be advisable. Please consult your doctor in these cases.

If you feel that the effectiveness of Kitonail is too strong or too weak, talk to your doctor or pharmacist.

If you have used a larger amount of Kitonail than you should

No cases of overdose have been reported so far.

If you forget to use Kitonail

Do not use twice the amount if you have forgotten to use it before. Continue treatment as recommended by your doctor or as instructed in section 3 of this leaflet ("How to use Kitonail"). If you have not used the nail varnish containing the active substance for a few days, the effect may be impaired.
If you stop using Kitonail

If you stop using Kitonail 80 mg/g active ingredient nail varnish before your nail(s) is clear or almost clear, there is a possibility that the fungus has not
disappeared. In this case, the condition of your nails may deteriorate again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Kitonail?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of the month indicated.

Store the bottle in the outer carton to protect the contents from light.

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

Do not store in the refrigerator.

This product is flammable. Keep away from heat and open flames.
Use within 6 months after first opening.

At temperatures below 15°C the nail varnish containing the active ingredient may gel, a slight flocculation or the formation of a slight precipitate at the bottom of the bottle may occur. This can be reversed by rubbing the bottle between your hands for about 1 minute. After that, the solution is clear again. This has no influence on the quality or effectiveness of the product.

Before use, check the bottom of the bottle to see if the solution is clear (transparent) again.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How to store Kitonail?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of the month indicated.

Store the bottle in the outer carton to protect the contents from light.

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

Do not store in the refrigerator.

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

Use within 6 months after first opening.

At temperatures below 15°C, the nail varnish containing the active ingredient may solidify; a slight flocculation or the formation of a slight precipitate at the bottom of the bottle may occur. This can be reversed by rubbing the bottle between your hands for about 1 minute, after which the solution will be clear again. This does not affect the quality or efficacy of the product.
Before use, check the bottom of the bottle to see if the solution is clear again.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Kitonail contains

- The active substance is ciclopirox. 1 g of active nail varnish contains 80 mg of ciclopirox.
- The other ingredients are: Ethyl acetate, ethanol (96 %), cetylstearyl alcohol,hydroxypropyl chitosan and purified water.

What Kitonail looks like and contents of the pack

Activated nail varnish

Kitonail is a clear, colourless to slightly yellowish solution in a transparent glass bottle with screw cap and inserted brush.

Pack size: 3.3 ml and 6.6 ml

Not all pack sizes may be marketed.