Kitonail 80 mg/g wirkstoffhaltiger Nagellack

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

Application

What is Kitonail and what is it used for?

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

It is used to treat mild to moderate fungal infections of the nails (onychomycosis) caused by dermatophytes and/or other fungi that can be cured with Ciclopirox.

The active ingredient Ciclopirox prevents the growth of fungi and destroys them. This improves the appearance of your nail.

How is it used?

What is Kitonail and what is it used for?

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

It is used to treat mild to moderate fungal infections of the nails (onychomycosis) caused by dermatophytes and/or other fungi that can be cured with Ciclopirox.

The active ingredient Ciclopirox prevents the growth of fungi and and kills them. This improves the appearance of your nails.

What should you consider before taking it?

What should you consider 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 (sensitization) occurs, please discontinue treatment
and consult your doctor.

As with all external treatments for nail fungus (onychomycosis), if several nails are affected (> 3 nails), or if more than half of the nail plate is affected or the nail root is affected and in the case of predisposing 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 nail care.

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 vascular disease (blockage of the arteries), if your nails are injured, painful or severely damaged, or if you have skin conditions such as psoriasis or yellow nail syndrome (a condition that leads to thickening and yellowing of the nails, chronic swelling of the limbs and chronic respiratory 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

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or 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 carried out after careful consideration of the benefits and risks by the treating physician if treatment is urgently required.

Breast-feeding:
It is not known whether Ciclopirox passes into human breast milk. Treatment with Kitonail should only be carried out after careful consideration of the benefits and risks by the treating physician if treatment is urgently required.

Driving and using machines

No special precautions are required.
Kitonail contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g.: contact dermatitis).

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.

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

The recommended dose is: Apply a thin layer to the infected nail(s) once a day. For this purpose, the nails should be clean and dry. The medicated nail polish should be applied to the entire nail surface and 5 mm of the surrounding skin. If possible, Kitonail should also be applied under the free edge of the nail.

Let Kitonail dry for 30 seconds.

The nails should not be washed for at least 6 hours afterwards, so it is recommended to apply in the evening before going to bed. 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 loose nail material from the affected nail, e.g. by cutting the nails, is recommended.

Treatment should 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. Complete healing of fingernails is usually achieved after about 6 months, of 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 have the impression that the effect of Kitonail is too strong or too weak, talk to your doctor or pharmacist.

If you have used more Kitonail than you should

No cases of overdose have been reported to date.

If you forget to use Kitonail

Do not use double the amount to make up for the missed application. Continue treatment as recommended by your doctor or as directed in section 3 of this leaflet ("How to use Kitonail?"). If you have not used the medicated nail polish for several days, the effect may be impaired.

If you stop using Kitonail

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

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

What side effects are possible?

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 on the bottle. The expiry date refers to the last day of the month indicated.

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

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

Do not refrigerate.

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

At temperatures below 15°C, the medicated nail polish may gel, 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. The solution will then be clear again. This does not affect the quality or effectiveness of the product.

Check the bottom of the bottle before use to make sure the solution is clear (transparent) again.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage conditions

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 on the bottle. The expiry date refers to the last day of the month indicated.

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

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

Do not refrigerate.

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

Use within 6 months after first opening.

At temperatures below 15°C, the medicated nail polish may solidify; 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. The solution will then be clear again. This does not affect the quality or effectiveness of the product.
Check the bottom of the bottle before use to make sure the solution is clear (transparent) again.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special information on the contents

Contents of the pack and further information

What Kitonail contains

- The active substance is Ciclopirox. 1 g of medicated nail polish contains 80 mg of Ciclopirox.
- The other ingredients are: Ethyl acetate, ethanol (96 %), cetyl stearyl alcohol, hydroxypropyl chitosan and purified water.

What Kitonail looks like and contents of the pack

Medicated nail polish

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.