Mycodefen 6.6 ml.

What Mycodefen is and what it is used for

Mycodefen 8% healing nail polish is intended for the treatment of fungal nail infections.
The active substance cyclopirox penetrates through the nail plate and has a fungicidal effect on all major causes of fungal diseases of the nails.

2. What you need to know before you use Mycodefen

Do not use Mycodefen:

if you are allergic to the active substance or to any of the other ingredients of Mycodefen (listed in section 6);
in children;
during pregnancy and lactation.
Take special care with Micodefen
Talk to your doctor, pharmacist or nurse before using Mycodefen. Prolonged use of topical products may lead to hypersensitivity or side effects. In these cases, the use should be discontinued and adequate treatment measures taken.
Avoid contact with mucous membranes and eyes.
The additional hygiene measures recommended by the doctor must be strictly observed.
Wash hands thoroughly after handling.
The use of decorative varnish and other cosmetic nail products is not recommended during treatment with Mycodefen varnish.

Children and adolescents
Mycodefen nail polish should not be used in children and adolescents due to lack of clinical data.

Pregnancy, lactation and fertility
The use of Mycodefen nail polish is not recommended during pregnancy and lactation due to lack of clinical data.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
There are no reports of effects on the ability to drive and use machines.

3. How to use Mycodefen

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

Unless otherwise prescribed, Mycodefen is applied in a thin layer:

every other day during the first month;
at least twice a week in the second month;
once a week from the third month onwards.
The duration of treatment depends on the severity of the infection, but should not exceed the treatment period of 6 months.

Application method:
Before the first application of Mycodefen varnish, as much as possible of the affected nail should be removed with scissors or a one-way file.
Use a marked file for the affected nails and remove the applied varnish once a week with nail polish remover. During this procedure, remove as much hyperkeratotic layer as possible from the nail plate.
If between two coats the varnish layer is damaged, it is enough to re-apply Mycodefen on the damaged areas.
It is recommended to close the cap tightly after each use to avoid drying the solution.
Avoid contact of the brush with the opening of the bottle to prevent the cap from sticking.

How can you further support the treatment?
Avoid clothing or shoes that retain heat and moisture.
In case of fungal disease of the feet, you should, if possible, protect your shoes from infection. This can be achieved by spraying antifungal powder in the shoes. At the slightest suspicion of recurrence of the infection, you should see your doctor.

If you use more Micodefen than you should
No cases of overdose have been reported.

If you forget to use Mycodefen
Do not use a double dose to make up for a forgotten dose. Continue treatment as recommended by your doctor, pharmacist or nurse, or as described in section 3 of this leaflet (How to use Mycodefen).

If you stop using Mycodefen
If you stop using Mycodefen before your nails have cleared or before their appearance has significantly improved and a healthy nail has sprouted, the fungus may not have 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, pharmacist or nurse.

4. Possible side effects

Like all medicines, Mycodefen can cause side effects, although not everybody gets them.
In some cases, redness and flaking of the skin around the affected nail may occur during treatment with Mycodefen nail polish. In rare cases, allergic contact dermatitis may occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Mycodefen

Keep out of reach of children.

This medicine does not require any special storage conditions.

Use within 6 months of first opening the bottle.

Keep the bottle tightly closed to prevent the solution from drying out.

Do not use this medicine after the expiry date which is stated on the pack. It corresponds to the last day of that month.
This product is flammable. Keep away from heat and open flames.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What Micodefen contains

The active substance is ciclopirox.
The other ingredients are: methoxyethene polymer with 2: 1-butynediolic acid monobutyl ester, ethyl acetate, isopropyl alcohol
What Micodefen looks like and contents of the pack
Mycodefen is a clear, colorless to slightly yellow solution. Comes in a dark glass bottle with a screw cap and an applicator brush attached to it. It is available in packs of 3.3 ml and 6.6 ml.

Not all pack sizes may be marketed.

 

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