Mikocare
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mikocare 5% medicated nail lacquer
Amorolfine
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because 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.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you notice worsening of symptoms after 3 months.
Contents of this leaflet:
- What Mikocare is and what it is used for
- What you need to know before using Mikocare
- How to use Mikocare
- Possible side effects
- How to store Mikocare
- Contents of the pack and other information
1. WHAT MIKOCARE IS AND WHAT IT IS USED FOR
Mikocare contains the active substance amorolfine (in the form of hydrochloride), which belongs to a group of
medicines known as antifungals. It kills a wide range of fungi that can cause nail infections.
Mikocare is used to treat fungal infections of the nails.
2. WHAT YOU NEED TO KNOW BEFORE USING MIKOCARE
Do not take Mikocare
- if you are allergic to amorolfine or to 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 such a case,
discontinue use of this medicine immediately, remove it promptly using a nail polish remover or the alcohol-soaked wipes provided in the package, and consult a doctor. The medicine must not be reapplied. If you experience any of the following symptoms, seek medical advice immediately:
- 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
Talk to your doctor or pharmacist before using Mikocare.
After applying Mikocare, a 10-minute interval must be observed before applying any cosmetic nail polish. Before reapplying Mikocare, any cosmetic nail polish must be removed.
Given the supply conditions of this medicine (a non-prescription medicine available exclusively from pharmacies), the medicine should not be dispensed in the following situations, unless otherwise directed by a physician:
if you have diabetes,
if you are being treated for immune system disorders (conditions causing reduced body defenses),
if you have circulatory problems in the hands or feet,
if you have a history of nail injuries, skin disorders 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 severely damaged (more than two-thirds of the nail surface affected) or infected. In such cases, the doctor may prescribe oral therapy in addition to the application of Mikocare medicated nail lacquer,
if you are pregnant or breastfeeding,
if you have nail dystrophy and/or destroyed nail plate.
Special recommendations:
- Avoid contact of the nail lacquer with eyes, ears or mucous membranes.
- Mikocare is not recommended for children under 18 years of age.
- The nail file used for infected 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 must not be applied to the skin surrounding the nail. Local or systemic allergic reactions may occur after using this medicine. In such a case, treatment must be stopped immediately and a doctor should be consulted. Carefully remove the medicine using a nail polish remover. The medicine must not be reapplied.
Other medicines and Mikocare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No studies on interactions between Mikocare and other medicines are available. Inform your doctor or pharmacist if you notice any adverse effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Clinical experience with the use of amorolfine during pregnancy and/or breastfeeding is limited.
Mikocare must not be used during pregnancy and/or breastfeeding unless clearly necessary.
This medicine contains alcohol (ethanol). Ethanol is flammable, and Mikocare must not be used near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
3. HOW TO USE MIKOCARE
Use this medicine exactly as instructed by 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,
during follow-up visits, how the nail looked before starting treatment. Every 3 months, update the
diagram to show the appearance of the affected area until the infected nail has completely regrown. If
more than one nail is infected, select the most severely damaged one for this exercise.
Bring this Patient Information Leaflet to your doctor or pharmacist during follow-up visits to inform them
about the progress of your treatment so far.
Before treatment 3 months 6 months 9 months
Mikocare should be applied to infected fingernails once or twice weekly, or to infected toenails once weekly,
according to your doctor's instructions (usually once a week is sufficient).
- Filing the nail
File as deeply as possible the infected area of the nail, including the surface, using the nail file provided.
WARNING: Do not use the nail file used on infected nails on healthy nails, as this could spread the infection. To prevent spreading the infection, ensure that no one else uses the file from your kit.
- Cleaning the nail
Use one of the wipes provided to clean the nail surface.
Keep the wipe or cotton pad to clean the spatula later.
Repeat steps 1 and 2 for each infected nail.
- Collecting the medicinal nail lacquer from the bottle
Dip one of the reusable spatulas into the nail lacquer bottle.
Do not rub the spatula against the edge of the bottle before application.
- Applying the nail lacquer
Apply the lacquer evenly over the entire nail surface. Clean the reusable spatula between applications to different nails to avoid contaminating the lacquer.
Repeat steps 3 and 4 for each infected nail. Immediately close the bottle after each use.
- Allow to dry
Leave to dry for approximately 3 minutes.
- Cleaning the spatula
The spatulas provided are reusable. However, it is important to clean them thoroughly after each treatment procedure, using the same wipe used to clean the nail. Avoid touching the treated nails with the wipe. Close the nail lacquer bottle tightly. Dispose of the wipe carefully as it is flammable.
Before reapplying Mikocare, remove the old lacquer from the nails using a wipe, and if necessary, file the nails again. Reapply the lacquer as described above.
Once the lacquer is dry, it is not damaged by soap or water, so you may wash your hands and feet as usual. However, if you need to use chemical products such as solvents or turpentine, wear rubber or other waterproof gloves to protect the medicinal nail lacquer.
Average duration of treatment
Treatment must continue uninterrupted until a completely healthy nail has regrown and the affected areas have healed. The duration of treatment mainly depends on the severity and location of the infection, as well as the nail's natural growth rate. In general, treatment takes about 6 months for fingernails and 9 to 12 months for toenails.
If you do not observe any improvement after 3 months of treatment, consult your doctor.
Important
Wait until the medicinal nail lacquer is completely dry before washing your hands or feet.
If Mikocare comes into contact with the eyes or ears, rinse immediately with water and contact your doctor, pharmacist, or nearest hospital immediately.
Do not use artificial nails during treatment with Mikocare.
Avoid contact of the nail lacquer with mucous membranes (e.g., mouth and nostrils).
Do not inhale.
Wear waterproof gloves when using solvents or thinners (e.g., turpentine) to avoid removing the medicinal nail lacquer.
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 medicinal nail lacquer.
If you or anyone else accidentally swallows the nail lacquer, contact your doctor, pharmacist, or nearest hospital immediately.
Cosmetic nail polishes based on nitrocellulose (cellulose nitrate) may be applied (check the list of ingredients; most cosmetic nail polishes contain nitrocellulose). You must wait at least 10 minutes after applying Mikocare before applying cosmetic nail polish. Before reapplying Mikocare, thoroughly remove any cosmetic nail polish. Until the next application of Mikocare, the use of cosmetic nail polish removers should be avoided.
If you stop treatment with Mikocare
It is important to continue using Mikocare until the infection has healed and healthy nails have fully regrown. This typically takes about 6 months for fingernails and 9 to 12 months for toenails. Your doctor will likely monitor your treatment progress approximately every 3 months.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The adverse reactions with 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 around the nail area may occur.
Frequency not known (cannot be estimated based on available data): systemic allergic reaction (a severe allergic reaction which 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, urticaria or blisters may occur around the nail area.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. HOW TO STORE MIKOCARE
Keep this medicine out of the sight and reach of children.
Store 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 stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Mikocare contains
The active substance is Amorolfine hydrochloride.
The other components are methacrylic acid-ammonium methacrylate copolymer (type A), triacetin, n-butyl acetate, ethyl acetate, anhydrous ethanol.
Description of the appearance of Mikocare and contents of the package
Mikocare is a clear solution ranging from colourless to pale yellow.
Mikocare is available in amber glass bottles containing 2.5 ml or 5 ml of medicated 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 European Economic Area (EEA) Member States under the following names:
ES Amorolfina Bluefish 50mg/ml medicated nail lacquer
IT Mikocare 5% medicated nail lacquer
PT Amorolfina Bluefish 5% medicated nail varnish
This leaflet was last revised on