FUNGILAK 50 mg /Ml Medykament Na Paznokcie

Treść ulotki

1. FUNGILAK 50 mg/ml medicated nail lacquer
   1. What is FUNGILAK and what is it used for
   2. What you need to know before using FUNGILAK
   3. How to use FUNGILAK
   4. Possible side effects
   5. How to store FUNGILAK
   6. Contents of the pack and other information

FUNGILAK 50 mg/ml medicated nail lacquer

amorolfine

Read this leaflet carefully before using this medicine as it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your pharmacist has told you.
• 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 pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 3 months.

Contents of this leaflet

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

1. What is FUNGILAK and what is it used for

FUNGILAK is a medicine (broad-spectrum antifungal agent) for the local treatment of fungal infections (mycoses) of the nails (which do not present involvement of the nail matrix, e.g. superficial white fungi, fungi under the nail, which affect less than 50% of the nail surface and less than three nails).
FUNGILAK contains the active ingredient amorolfine, an antifungal agent that kills a wide range of fungi responsible for nail infections.
The amorolfine-based medicated nail polish is used for the treatment of fungal infections of the nails (caused by dermatophytes and yeasts) when up to 50% of the nail is infected (especially the most exposed area).

2. What you need to know before using FUNGILAK

Do not use FUNGILAK

• if you are allergic to the active ingredient amorolfine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using FUNGILAK.
Nail files used for infected nails must not be used for healthy nails.
FUNGILAK must not be applied to the skin around the infected nail.
Avoid any contact of the medicated nail polish with eyes, ears and mucous membranes.
The use of artificial nails should be avoided during treatment.
Users who work with organic solvents (thinners, petroleum ether etc.) must wear
waterproof gloves to protect the layer of FUNGILAK present on the nails of the hand. Otherwise
FUNGILAK will be removed.
All medicines can trigger allergic reactions and although they are usually mild, in some
cases they can be severe. If this happens, stop using the
product immediately, remove the product with a nail polish remover or with the cleansing wipes provided in the
package and consult your doctor. The product should not be reapplied.
If you experience any of the following symptoms, consult your doctor urgently:

• difficulty breathing
• swelling of the face, lips, tongue or throat
• severe skin rashes

Information is not yet available in patients with inflammatory changes around
the nail, diabetes, impaired blood circulation, malnutrition and alcoholism.
The product is flammable! Keep the solution away from fire and flames.

Paediatric population
No information is yet available in infants, children and adolescents. Therefore,
patients under 18 years of age should not be treated with FUNGILAK.

Other medicines and FUNGILAK
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
No known interactions with other medicines are reported for FUNGILAK. You can use FUNGILAK
together with other medicines.
For the simultaneous use with a cosmetic nail polish, see section 3.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Since systemic exposure to amorolfine is negligible after topical administration of
FUNGILAK, no risks are expected during pregnancy or in the newborn/breastfed
infant.

Driving and using machines
FUNGILAK does not or negligibly alters the ability to drive vehicles and use
machinery.

FUNGILAK contains ethanol
FUNGILAK contains ethanol (alcohol) and may cause a burning sensation on damaged skin
if it accidentally comes into contact with the skin surrounding the nail.

3. How to use FUNGILAK

Use this medicine following exactly the instructions described in this leaflet or as your
pharmacist has told you. If you have doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, FUNGILAK is applied as follows:

Route of administration:
For application on the nails
Apply FUNGILAK to the affected nail of the hand or foot once a week.
Continue treatment until healthy nails have regrown (nails with a normal
appearance).
When using the medicated nail polish, always observe the following instructions:
When using the nail polish for the first time,the infected sections of the
nail surfaces should be filed down as much as possible. When
the nail polish is applied again, file the nails again if necessary (e.g. if the nails have thickened). The package
contains disposable files.

To clean the nail surface, always use one of the alcohol-soaked wipes
included. This will also remove any nail polish residue.

Apply the medicated nail polish with one of the reusable spatulas
provided. The package contains a spatula holder to facilitate
the application of the medicated nail polish. The reusable spatulas
must be inserted into the spatula holder.

Take the nail polish using one of the reusable spatulas
provided. The spatula with the perforated surface must be re-immersed for each nail to be treated, avoiding rubbing it on the neck of the
bottle (risk of the screw cap sticking to the bottle).

Using the spatula, FUNGILAK should be applied to the entire
surface of the infected nail.

The particular shape of the spatula holder prevents the spatula from coming into contact with the
surface (fungal spores remain on the spatula). The spatula can be
put aside without worrying that fungal spores can spread.

The bottle must be closed tightly immediately after each use, to
prevent the solution from evaporating. You must wait 10 minutes for the
treated nails to dry.

To reuse it, the spatula must be cleaned with a cleaning wipe
after use.
After applying FUNGILAK, you must wait for FUNGILAK to dry (at least 10
minutes) before using any cosmetic nail polish.
Before reusing FUNGILAK, you must carefully remove the cosmetic nail polish. In the
meantime, however, the use of a nail polish remover should be avoided.

What else should be considered during the treatment of nail fungus
Nail files used for treatment must no longer be usedfor the care of healthy nails
because healthy nails could become infected in turn. Use the disposable filesprovided for
treating infected nails.
The layer of FUNGILAK on the nails of the hand can be eroded or removed when handling
organic solvents (nitro diluents, white spirit, etc.). Consequently, you must wear waterproof gloves
when working with these substances, to protect the medicated nail polish layer.
Additional tips to support treatment
Towels should be washed as often as possible at a minimum temperature of
60 degrees.
Keep shoes well ventilated and let them dry.
Elderly: No specific dosages are recommended for elderly users.

Duration of treatment
Fungal infections are often very persistent. For this reason, you must continue treatment
once a week (as described above) until the healthy nail has completely regrown
completely. To achieve this, a period of six months (for fingernails) and nine to twelve months (for toenails) is generally necessary, considering that the extent of the infection
plays an important role. Nails grow at a rate of about 1 or 2 millimeters per month.
A review of the treatment is recommended approximately at intervals of three months.
Important note:
If you, or someone else, accidentally ingests the nail polish, contact your doctor, pharmacist or the emergency room of the nearest hospital.
Contact your doctor or pharmacist if you feel that the effect of FUNGILAK is too strong or
too weak.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
Rare (may affect up to 1 in 1,000 people):
Nail disorders (e.g. discoloration, brittle or split nails)
This reaction may also be due to the fungal infection itself.
Very rare (may affect up to 1 in 10,000 people):
Mild and transient tingling in the area surrounding the treated nail (periungual burning)
Not known (frequency cannot be estimated based on available data):
Severe allergic reactions have been reported which may be associated with swelling of the face, lips,
tongue or throat, difficulty breathing and/or severe skin rashes, allergic skin reactions
(contact dermatitis*, at the application site or also extending beyond the application site), itching*, erythema*, urticaria*, blisters*.
*Information obtained in the post-marketing period.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store FUNGILAK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the package after
“Exp.” The expiry date refers to the last day of that month.
Do not store above 30 °C.

Notes on the period of validity after opening:
After first opening, use the bottle within 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FUNGILAK contains
The active ingredient is:
Amorolfine
1 ml of medicated nail lacquer contains 55.74 mg of amorolfine hydrochloride (equivalent to 50 mg
of amorolfine).
The other ingredients are:
Ethanol; ethyl acetate; ammonium methacrylate copolymer (Type A); butyl acetate; triacetin.

Description of the appearance of FUNGILAK and contents of the pack
FUNGILAK is a clear and colourless solution with a characteristic odour, contained in an amber glass
bottle with a white HDPE screw cap.
FUNGILAK is available in packs of 3 ml and 6 ml (2 x 3 ml) of medicated nail lacquer.
Each pack includes 10 reusable spatulas, a spatula holder as an application device,
30 nail files and 30 cleaning wipes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
mibe pharma Italia S.r.l.
via Leonardo Da Vinci 20/B
39100 Bolzano

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
__________________________________________________________________________________

Instructions for nail files and cleaning wipes
Distributor: Dermapharm AG, 82031 Grünwald, Germany

Read the instructions for use carefully

Do not reuse

For external use only