Loceril

Package Leaflet: Information for the Patient

Loceryl, 50 mg/ml, Nail Lacquer, Medicinal

Amorolfine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Loceryl and what is it used for

Loceryl is an antifungal medicine in the form of a nail lacquer for topical use. The active substance of the medicine, amorolfine, acts on various types of fungi that cause nail fungus. The indication for the use of Loceryl is nail fungus caused by dermatophytes, yeasts, and molds. Loceryl is indicated for the treatment of nail fungus that does not involve the nail matrix (the area where the nail plate is formed) and is limited to 2 nail plates. The medicine can be used when, as a result of fungal infection of the nail plate, there has been a change in the color of the nail plate (discoloration of white, yellow, or brown) or thickening of the nail plate. Loceryl is indicated for use in cases of fungal infections that affect only the upper part of the nail plate - as shown in the example in picture 1.If the fungal change affects a larger part of the nail plate (e.g., as shown in picture 2 or 3), you should consult a doctor.

2. Important information before using Loceryl

When not to use Loceryl:

Warnings and precautions

The medicine is intended for application only to the nail plate. Do not apply the Loceryl medicinal lacquer to the skin around the nails. During treatment with the medicine, do not use artificial nails. After applying the Loceryl medicinal lacquer, a break of at least 10 minutes should be maintained before applying any cosmetic nail lacquer. Before reapplying the Loceryl medicinal lacquer, the cosmetic nail lacquer should be carefully removed. You should use impermeable protective gloves if you come into contact with solvents, as this will protect the applied Loceryl lacquer from dissolving. If Loceryl gets into your eye or ear, rinse the area with plenty of water and contact a doctor or the nearest hospital. You should avoid contact of the lacquer with mucous membranes (mouth or nose). Do not inhale the lacquer.

Children and adolescents

Do not use Loceryl, as there is insufficient data on its use in children.

Loceryl and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take. There is no data available. No studies have been conducted on the interaction of Loceryl with other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. Do not use Loceryl in pregnant or breastfeeding women unless your doctor considers it necessary.

Driving and using machines

No effect of Loceryl on the ability to drive and use machines has been observed.

Loceryl contains ethanol

This medicine contains 552.0 mg of alcohol (ethanol) per gram, which is equivalent to 55.2% w/w. Ethanol is a flammable substance, so do not use the medicine near an open flame, lit cigarette, or certain appliances (e.g., hair dryers). The medicine may cause burning of damaged skin.

3. How to use Loceryl

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Before starting treatment

Mark the infected area on the diagram below. This will help assess the treatment results. Every month, mark the area that reflects the infected area until a healthy nail plate appears. In the case of 2 infected nail plates, to assess the treatment results, choose the one that is more severely infected.

Before treatment month 1 month 2 month 3 month 6

Dosage

Loceryl lacquer should be applied to the infected nail once a week. Treatment should be continued until a fully healthy nail plate appears, which usually occurs after about 6 months in the case of fingernails and from 9 to 12 months in the case of toenails. Nail growth is a slow process, so the first signs of improvement in the nail plate are usually visible after 2 to 3 months of treatment.

If the appearance of the nail plate does not improve, contact your doctor.

Apply the Loceryl lacquer to the nail as described below.

• 1.Before the first application of Loceryl, remove any previously applied layers of lacquer (e.g., cosmetic lacquers). The infected nail (especially its surface) should be carefully filed using the enclosed nail file. Note: Do not use the same nail file for infected and healthy nails to avoid infecting healthy nails.

• 2.Then, clean and degrease the nail surface with the enclosed swab soaked in isopropyl alcohol. The soaked swab can also be used later to remove lacquer from the spatula. Before reapplying the lacquer, prepare the nail as described above and always clean it first to remove any remaining lacquer using the enclosed files and swabs.

• 3.Use spatulas for multiple uses. Dip the spatula into the lacquer (without wiping the lacquer off the edge of the bottle). Apply the lacquer to the entire nail surface and let it dry for 3 to 5 minutes.

If 2 nail plates are being treated, repeat the entire procedure on the second infected nail. Before reapplying the Loceryl medicinal lacquer, remove the previously applied layer of Loceryl lacquer and apply a new one. Clean the nail using a soaked swab and apply the lacquer as described above. Cosmetic nail lacquer can be applied after at least 10 minutes from the application of the Loceryl medicinal lacquer. Before reapplying the Loceryl medicinal lacquer, the cosmetic lacquer should be carefully removed.

After each application of Loceryl lacquer:

• Carefully clean the spatula using a soaked swab. The spatula can be used multiple times if it is cleaned after each procedure. The same swab used to clean the nail can be used to clean the spatula.
• Remove any lacquer residue from the cap using a swab.
• After applying the lacquer, close the bottle tightly as soon as possible.
• Be careful when disposing of the swab, as it is flammable.
• After applying the lacquer, wash your hands after the lacquer has completely dried.

When in contact with organic solvents, wear impermeable gloves to protect the Loceryl lacquer layer on the nails. Do not use nail files used for infected nails on healthy nails.

Using more than the recommended dose of Loceryl

The medicine is intended for application only to the nail plate. If you swallow Loceryl, contact a doctor, pharmacist, or the nearest hospital.

Missing a dose of Loceryl

Do not use a double dose to make up for a missed dose. If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Loceryl can cause side effects, although not everybody gets them.

The following side effects are listed by frequency of occurrence:

Very common (occurring in more than 1 in 10 people)
Common (occurring in less than 1 in 10 people)
Uncommon (occurring in less than 1 in 100 people)
Rare (occurring in less than 1 in 1000 people)
Very rare (occurring in less than 1 in 10,000 people)
Frequency not known (cannot be estimated from the available data).
Rare:
nail plate disorders, nail brittleness, nail plate discoloration, excessive nail fragility with splitting.
Very rare:
skin redness.
Frequency not known:
flushing (severe skin redness), itching, contact dermatitis, hives, blister on the skin, generalized allergic reaction (severe allergic reaction that may cause swelling of the face, tongue, or throat, difficulty breathing, and severe skin rash).
If you experience a severe allergic reaction, contact a doctor or the nearest hospital immediately.
Side effects may also be caused by the development of nail fungus.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al Jerozolimskie 181C, 02-222 Warsaw, Poland, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loceryl

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Store in a temperature not exceeding 30°C. Medicines should not be disposed of 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 pack and other information

What Loceryl contains

• The active substance of the medicine is amorolfine. One milliliter of lacquer contains 50 mg of amorolfine.
• The other ingredients of the medicine are: methacrylic acid copolymer (type A), triacetin, butyl acetate, ethyl acetate, anhydrous ethanol.

What Loceryl looks like and contents of the pack

Loceryl is a medicinal nail lacquer. The pack contains: an orange glass bottle with an HDPE cap and an LDPE spatula containing 2.5 ml of nail lacquer, 30 swabs soaked in 70% isopropanol, 30 nail files, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Galderma Poland Sp. z o.o., ul. Puławska 145, 02-715 Warsaw, Poland, tel.: 22 331 21 80

Manufacturer:

Laboratoires Galderma, Z.I. Montdésir, 74540 Alby-sur-Chéran, France

Date of last revision of the leaflet:

ADVICE AND RECOMMENDATIONS FOR TREATMENT

Fungal nail infections (onychomycosis): what are the risk factors?

Toenails:

• Recurring micro-damage to the nail, improper alignment of the toe
• Wearing tight shoes or shoes made of plastic or synthetic fibers that accumulate moisture.
• Professions that require wearing protective shoes, which can cause increased sweating of the feet.
• Sports activities that increase the risk of infection (marathon), especially sports where athletes have bare feet: swimming, judo.

Fingernails:

• Fungal infections of the feet (dermatophytosis).
• Excessive contact with water (may cause candidiasis).
• Nail plate damage caused by:
• recurring micro-damage (gardening work);
• manual work using detergents (liquids or powders for washing or other corrosive substances).
• Certain professions with increased risk (hairdresser, people performing manicures, podiatrist).

Fungal infections: how to prevent and avoid infections

• Disinfect shoes and socks. Ask your pharmacist for help if needed.
• Treat skin changes involving the spaces between the toes and foot skin as soon as possible.
• Use only your own towel to avoid infecting others.
• Dry the spaces between the toes and the entire foot thoroughly after bathing to avoid infecting other nails or skin.