MIKOCARE 5% Medicated nail polish

Зміст інструкції

1. Mikocare 5% medicated nail polish
   1. WHAT IS MIKOCARE AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE MIKOCARE
   3. HOW TO USE MIKOCARE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MIKOCARE
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Mikocare 5% medicated nail polish

Amorolfine
Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if your symptoms worsen after 3 months.

Contents of this leaflet:

• 1. What Mikocare is and what it is used for
• 2. What you need to know before you use Mikocare
• 3. How to use Mikocare
• 4. Possible side effects
• 5. How to store Mikocare
• 6. Contents of the pack and other information

1. WHAT IS MIKOCARE AND WHAT IS IT USED FOR

Mikocare contains the active substance amorolfine (in the form of hydrochloride) which belongs to a group of
medicines known as antimycotics. It kills a wide variety of fungi that can cause nail infections.
Mikocare is used to treat fungal nail infections.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MIKOCARE

Do not use Mikocare

• if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).
• If you are under 18 years of age.

These medicines can cause allergic reactions, some of which may be severe. In this case,
stop using this medicine, remove it immediately with a nail polish remover or with the alcohol-soaked pads
provided in the package and consult a doctor. The medicine should not be reapplied. If
you experience any of the following symptoms, seek immediate medical attention:

• If you have difficulty breathing.
• If you notice swelling of the face, lips, tongue or throat.
• If you develop a severe skin rash.

Warnings and precautions
Consult your doctor or pharmacist before using Mikocare
After applying Mikocare, a 10-minute interval must be respected before using any
cosmetic nail polish. Before repeating the application of Mikocare, the cosmetic nail polish must be removed.
Considering the supply regime of the medicine (medicine not subject to prescription to be dispensed exclusively in pharmacies), the medicine should not be dispensed in the situations described below
unless medically indicated:
if you suffer from diabetes,
if you are being treated for disorders of the immune system (a disorder that causes a reduction in the body's defenses),
if you suffer from circulatory problems in the hands and feet
if you have a history of nail injuries, skin problems such as psoriasis, or other chronic skin conditions, swelling, yellow nails associated with respiratory problems, nail pain, deformed nails or other
problems around the nail
if the nail is very damaged (more than two-thirds of the affected nail surface) or infected. In these
cases, the doctor may prescribe oral therapy in association with the application of Mikocare medicated nail polish
if you are pregnant or breastfeeding
if you have nail dystrophy and/or a destroyed nail plate.
Special recommendations:

• Avoid contact of the polish with the eyes, ears or mucous membranes.
• Mikocare is not recommended in children under 18 years of age.
• The nail file used for diseased nails should not be used for healthy nails.
• Cosmetic nail polishes or artificial nails should not be used during treatment with Mikocare
• Patients who work with organic solvents (thinners, turpentine, etc.) should wear waterproof gloves to protect the Mikocare nail coating.
• Mikocare should not be applied to the skin around the nail. Following the use of this medicine, a local or systemic allergic reaction may occur. In this case, the use of the medicine must be immediately stopped and a doctor must be consulted. Carefully remove the medicine using a nail polish remover. The medicine should no longer be applied.

Other medicines and Mikocare
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No studies are available on the interaction of Mikocare with other medicines. Tell your doctor or pharmacist
if you notice the appearance of any undesirable effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Clinical experience regarding the use of amorolfine during pregnancy and/or breastfeeding is limited.
Mikocare should not be used during pregnancy and/or breastfeeding unless it is clearly
necessary.
This medicine contains alcohol (ethanol). Ethanol is flammable and Mikocare should not be used
near open flames, lit cigarettes or some devices (e.g. hair dryers).

3. HOW TO USE MIKOCARE

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Mark on the diagram below the portion of the nail affected by the infection. This will help you remember, in
follow-up, how the nail looked before starting therapy. Every 3 months, mark on the
diagram how the affected area looks until the diseased nail has completely regrown. If
more than one nail is affected by the infection, choose the most damaged one for this exercise.
of the progress of treatment so far.

Before treatment 3 months 6 months 9 months
Mikocare must be applied to the diseased nails of the hands one or two times a week or to the nails
of the feet once a week, according to your doctor's instructions (usually one application a
week is sufficient).

• 1. File the nail File the diseased area of the nail as deeply as possible, including the surface, using the nail file that is provided.

WARNING: Do not use the nail file used for diseased nails on
healthy nails, otherwise you could spread the infection. To prevent the
spread of infection, make sure no one else uses the file from your
kit.

• 2. Clean the nail
• 3. Take the polish from the bottle
• 4. Apply the polish
• 5. Let it dry

Use one of the pads provided to clean the surface of the nail.
Keep the pad or cotton ball to clean later
the spatula. Repeat steps 1 and 2 for each diseased nail.

Dip one of the reusable spatulas into the bottle of polish. The
polish should not be rubbed on the edge of the bottle before
applying it.
Apply the polish evenly over the entire surface of the nail. Clean the
reusable spatula between applications to the nail, to avoid
contaminating the polish.
Repeat steps 3 and 4 for each diseased nail. Immediately close the
bottle after each application.

Let it dry for about 3 minutes.

• 6. Clean the spatula

The spatulas provided are reusable. However, it is important to clean them thoroughly
after completing each treatment procedure, using the same pad
used to clean the nail. Avoid touching the newly treated nails with the pad. Close the bottle carefully
of the polish. Dispose of the pad carefully as it is flammable.
Before reusing Mikocare, remove the old polish from the nails with the pad, then if necessary
file the nails again. Reapply the polish as described above.
When the polish is dry, it is not damaged by soap or water, so you can wash your hands and feet normally.
If you need to use chemicals such as solvents or turpentine, you should wear rubber gloves
or other waterproof material to protect the nail polish.

Average treatment duration
Treatment should continue uninterrupted until the healthy nail has completely grown
and the affected areas heal. The duration of treatment depends essentially on the intensity, the
location of the infection and the ability of the nails to grow. In general, it takes 6 months for the
nails of the hands and from 9 to 12 months for the nails of the feet.
If you do not see improvements after 3 months of treatment, you should consult your doctor.

Important
Wait until the medicated polish is dry before washing your hands or
feet.
If Mikocare comes into contact with the eyes or ears, wash immediately with water and
contact your doctor or pharmacist or the nearest hospital immediately.
Do not use artificial nails during treatment with Mikocare.
Avoid contact of the polish with mucous membranes (e.g. mouth and nose).
Do not inhale.
Wear waterproof gloves when using solvents or thinners (e.g. turpentine) to
avoid removing the medicated polish.
Do not apply Mikocare to the skin around the nail. This medicine contains ethanol
(alcohol). Incorrect use of Mikocare may cause irritation or dryness of the skin around
the nail.
Do not inhale the medicated polish.
If you or someone else accidentally ingests the polish, contact your doctor or pharmacist immediately
or the nearest hospital.
Cosmetic polishes based on nitrocellulose (cellulose nitrate) can be applied (check the list of
ingredients; most cosmetic polishes contain nitrocellulose). You must respect an interval
of at least 10 minutes after applying Mikocare before applying cosmetic polish. Before repeating
the application of Mikocare, the cosmetic polish must be removed carefully. Until a new
application of Mikocare is made, the use of cosmetic nail polish removers must be avoided.

If you stop treatment with Mikocare
It is important to continue using Mikocare until the infection is healed and the healthy nails have regrown.
This generally takes 6 months for the fingernails and 9 to 12 months for the toenails. The doctor will probably check the progress of the treatment every 3 months or so.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of this medicine are rare or very rare.

Rare(may affect up to 1 in 1,000 people): damaged, discolored or brittle nails.

Very rare(may affect up to 1 in 10,000 people): a burning sensation may appear
in the area around the nail.

Frequency not known(cannot be estimated from the available data): systemic allergic reaction (a
serious allergic reaction that may be associated with swelling of the face, lips, tongue or throat,
difficulty breathing and/or severe skin rash).
Redness of the skin, itching, contact dermatitis, hives or
blisters may occur in the area around the nail.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE MIKOCARE

Store at a temperature below 30°C.
Protect from heat. Keep the bottle tightly closed and in an upright position.
Do not use this medicine after the expiry date which is stated on the package and the bottle after EXP. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mikocare contains
The active ingredient is Amorolfine hydrochloride.
The other components are ammonium methacrylate copolymer (Type A), triacetin, n-Butyl acetate, ethyl
acetate, anhydrous ethanol.

Description of the appearance of Mikocare and contents of the pack
Mikocare is a transparent solution from colorless to pale yellow.
Mikocare is available in an amber glass bottle with 2.5 ml or 5 ml of medicinal nail lacquer.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Difa Cooper S.p.A.
Via Milano 160,
21042 Caronno Pertusella (Va)
Italy

Manufacturer
Chanelle Medical Unlimited Company
Loughrea
Co. Galway, Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
ES Amorolfina Bluefish 50mg/ml medicinal nail varnish
IT Mikocare 5% medicinal nail lacquer
PT Amorolfina Bluefish 5 % medicinal nail varnish