Amorolak

Patient Information Leaflet

Amorolak, 50 mg/ml, medicinal nail lacquer
Amorolfinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 months of treatment, or if your condition worsens, contact your doctor.

Leaflet Contents

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

1. What Amorolak is and what it is used for

Amorolak is an antifungal medicine with a broad spectrum of activity, used topically for the treatment of fungal infections (mycoses) of the nails [without involvement of the nail matrix (the area where the nail grows from), such as superficial white onychomycosis, subungual onychomycosis, when nail infection affects less than 50% of the nail surface and involves fewer than three nails]. Amorolak contains the active substance amorolfine, which has antifungal properties and kills various types of fungi that may cause nail infections.
Amorolak is used in the treatment of fungal nail infections (caused by dermatophytes and yeasts) when the infection affects up to 50% of the nail surface (especially the distal part).

2. Important information before using Amorolak medicine

When not to use Amorolak
If the patient is allergic to the active substance - amorolfine, or to any of the other
components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Amorolak, consult a doctor or pharmacist.
Nail files used during treatment must not be used for caring for healthy nails.
Amorolak medicine should not be applied to the skin around the infected nail.
Avoid any contact of the medicine with eyes, ears, and mucous membranes.
Avoid using artificial nails during treatment.
Patients who are exposed to organic solvents at work (e.g. thinners, petroleum ether, etc.) should wear impermeable gloves to protect the Amorolak varnish layer. Otherwise, the Amorolak varnish may be removed from the nail surface.
Like all medicines, this product may cause allergic reactions, which are usually mild, but some may be severe. In such a case, discontinue use of the varnish immediately, remove the varnish with nail polish remover or the swabs provided in the package, and contact a doctor. Do not reapply the varnish. Contact a doctor or the nearest hospital immediately if the patient experiences any of the following symptoms:

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

There is no experience with the use of the medicine in patients with inflammatory changes around the nail, diabetes, circulatory disorders, malnutrition, or alcohol abuse.

Children and adolescents
There is no experience with the use of this medicine in infants, children, and adolescents. Therefore, Amorolak should not be used in patients under 18 years of age.

Amorolak and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No interactions between Amorolak and other medicines are known. Amorolak may be used while taking other medicines.
Information regarding concomitant use of the medicine with cosmetic nail polish is provided in section 3.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Since systemic exposure to amorolfine after topical application of Amorolak is negligible, no effect of amorolfine on pregnancy or on the newborn or breastfed infant is expected.

Driving and operating machinery
Amorolak has no effect or has a negligible effect on the ability to drive and operate machinery.

Amorolak contains ethanol
1 g of this medicine contains 0.552 g of alcohol (ethanol), equivalent to 55.2% w/w.
Amorolak contains ethanol and may cause a stinging sensation on damaged skin if accidentally applied to the skin surrounding the nail.
Amorolak is flammable. It contains ethanol, which is a flammable substance, and should not be used near open flames, lit cigarettes, or certain devices such as hair dryers.

3. How to use Amorolak

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Unless otherwise advised by your doctor, Amorolak should be applied as described below.
Method of administration:
For topical use on the nail.
Amorolak should be applied once weekly to infected fingernails and toenails. Treatment should be continued until the nail plate has fully regenerated (i.e. healthy nail has regrown).
When applying the nail lacquer, always follow the instructions below.

1. Before the first application of the lacquer, file down as much as possible of the diseased nail surface. Before subsequent applications, if necessary, re-file the nails (e.g. if they have thickened). The package contains single-use nail files.

2. To clean the nail surface, always use one of the alcohol-soaked swabs provided in the package. This will also remove any residual lacquer.

The medicinal nail lacquer should be applied using one of the reusable spatulas provided. The package contains a spatula holder to facilitate application of the nail lacquer. The reusable spatula should be inserted into the spatula holder.

3. Take the lacquer using one of the provided reusable spatulas. To apply the lacquer to each infected nail, dip the spatula (with its uneven surface) into the bottle each time, without wiping it against the neck of the bottle (to avoid the risk of the cap sticking to the bottle).

4. Apply Amorolak lacquer evenly over the entire surface of the affected nail using the spatula.

The special shape of the spatula holder prevents the spatula from contacting any surface (ensuring fungal spores remain on the spatula). The spatula can be temporarily placed down without risk of transferring fungal spores.

5. Immediately after each use, close the bottle tightly to prevent the solution from drying out. Leave the treated nails to dry for 10 minutes.

6. To reuse the spatula, clean it after use with an alcohol-soaked swab.

After applying Amorolak, cosmetic nail polish may be applied immediately after the Amorolak layer has dried (after 10 minutes).
Before reapplying Amorolak, carefully remove the cosmetic nail polish. However, avoid using nail polish remover.
Additional considerations during treatment of onychomycosis
Nail files used during treatment must not be used for the care of healthy nails, as this could lead to infection of healthy nails. For treatment of affected nails, use only the single-use nail files provided in the package.
The Amorolak lacquer layer on fingernails may be worn off or damaged by contact with organic solvents (cellulose thinners, turpentine derivatives, etc.).
Therefore, wear impermeable gloves when handling such substances to protect the lacquer layer.
Additional advice during treatment
Wash towels as frequently as possible at a minimum temperature of 60°C.
Ensure shoes are well aired and dried.
Elderly patients
No special dosage recommendations for elderly patients.
Duration of treatment
Fungal infections are often long-lasting. Therefore, the medicine should be used once weekly continuously (as described above) until the nails are completely healed. This usually requires treatment for approximately six months (for fingernails) and nine to twelve months (for toenails), depending on the severity of the infection.
Nails regrow at a rate of approximately 1 to 2 mm per month.
Regular treatment evaluation every approximately three months is recommended.
Important warning:
If the lacquer is accidentally swallowed, contact your doctor, pharmacist, or nearest hospital immediately.
If you feel that the effect of Amorolak is too strong or too weak, consult your doctor or pharmacist.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions
Rare (may occur in no more than 1 in 1,000 people):
Nail-related changes (e.g. discoloration, brittleness or fragility of nails).
These symptoms may also be caused by the fungal infection itself.
Very rare (may occur in no more than 1 in 10,000 people):
Mild, transient burning sensation on the skin surrounding the treated nail.
Frequency not known (cannot be estimated from the available data):
Severe allergic reactions have been reported, which may involve swelling of the face,
lips, tongue or throat, difficulty breathing, and (or) severe rash, allergic skin reaction
(dermatitis* at the site of application or spreading beyond the area where the nail lacquer was applied),
itching*, redness*, urticaria*, and skin blisters*.
*information obtained post-marketing
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amorolak

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Information on shelf life after first opening
Shelf life after first opening of the bottle: 6 months.
Medicines must not be disposed of via the sewage system 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 Amorolak contains
The active substance is amorolfine.
1 ml of medicinal nail lacquer contains 55.74 mg of amorolfine hydrochloride, equivalent to
50 mg of amorolfine.
The other components are:
anhydrous ethanol, ethyl acetate, ammonium methacrylate copolymer (type A), butyl acetate, triacetin.

What Amorolak looks like and contents of the pack
Amorolak is a transparent, colourless solution with a characteristic odour.
The medicine is supplied in a brown glass bottle with a white HDPE screw cap, presented in a cardboard box.
Each package also contains: 10 reusable spatulas and a spatula holder as an application device, 30 nail files, and 30 alcohol-impregnated swabs.
Amorolak is available in packs containing 3 ml or 6 ml (2 x 3 ml) of medicinal nail lacquer.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Amorocutan 50 mg/ml wirkstoffhaltiger Nagellack
Austria: Amorocutan 50 mg/ml wirkstoffhaltiger Nagellack
Poland: Amorolak

Instructions for use of nail files and alcohol-impregnated swabs
Distributor: SUN-FARM Sp. z o.o., 05-092 Łomianki, Poland

Follow the instructions provided in the patient leaflet.

Single-use nail files.

For external use only.