Perlid

Package Leaflet: Information for the User

Perlid, 50 mg/ml, Nail Lacquer, Medicinal

Amorolfine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Perlid and what is it used for

The active substance of Perlid is amorolfine (as amorolfine hydrochloride), which belongs to the group of antifungal medicines. It has a fungicidal effect on various species of fungi that cause nail infections. Perlid is used to treat fungal nail infections.

2. Important information before using Perlid

When not to use Perlid

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

Warnings and precautions

Before starting to use Perlid, discuss it with your doctor or pharmacist.

• Avoid contact of the lacquer with eyes, ears, and mucous membranes.
• Do not use nail files used for infected nails on healthy nails.
• Do not use artificial nails during the treatment with Perlid.
• After applying Perlid, wait at least 10 minutes before applying any cosmetic nail lacquer. Before reapplying Perlid, carefully remove the cosmetic nail lacquer.
• When in contact with organic solvents (thinners, nail polish remover, etc.), wear impermeable gloves to protect the Perlid applied to the nails.

Children and adolescents

Do not use Perlid in children and adolescents under 18 years of age.

Perlid and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. No studies on the interaction of Perlid with other medicines have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Due to the fact that after local application of Perlid, systemic exposure to amorolfine is negligible, no effect on pregnancy, the newborn, or the breastfed infant is expected. No effect on fertility is expected, as systemic exposure to amorolfine is minimal.

3. How to use Perlid

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults (over 18 years)

Perlid should be applied to the nails of the hands once or twice a week, and to the nails of the feet once a week, as advised by your doctor. It is important not to stop using Perlid until the infection is cured and healthy nails have grown out. This usually takes 6 months for the treatment of fingernails and 9 to 12 months for the treatment of toenails. Your doctor will probably check the progress of the treatment every 3 months.

Instructions for use

• 1. File the nail

Using the nail file (supplied with some packs of Perlid), carefully file the infected areas of the nail and the entire surface.

WARNING

Do not use nail files used for infected nails on healthy nails, as this may spread the infection. To prevent the spread of infection, ensure that no one else uses the nail files from the set used for treatment.

• 2. Clean the nail

Using the cotton swab (soaked in nail cleanser) supplied with the pack, clean the surface of the nail. The steps described in points 1 and 2 should be repeated for each infected nail.

• 3. Take some lacquer from the bottle

Dip one of the reusable applicators into the bottle of nail lacquer. Before applying the lacquer, do not wipe the applicator on the edge of the bottle.

• 4. Apply the lacquer

Apply the lacquer evenly to the entire surface of the nail. The steps described in points 3 and 4 should be repeated for each infected nail.

• 5. Let it dry

Let the treated nails dry for about 10 minutes.

• 6. Clean the applicator

The applicators supplied with the medicine are reusable. However, it is important to clean them thoroughly after each treatment using the same cotton swab used to clean the nail. Avoid touching the cotton swab to the freshly lacquered nails. Close the bottle of nail lacquer tightly. Dispose of the cotton swab carefully, as it is flammable. After applying Perlid, wait at least 10 minutes before applying any cosmetic nail lacquer. Before reusing Perlid, first remove the old lacquer using a cotton swab, and then file the nails if necessary. Reapply the lacquer as described above. Water and soap do not affect the dried nail lacquer, so you can wash your hands and feet as usual. If you need to use chemicals such as paint thinners or nail polish remover, wear rubber or other impermeable gloves to protect the lacquer on your nails.

Important

• If Perlid gets into your eye or ear, rinse immediately with water and consult a doctor, pharmacist, or the nearest hospital.
• Avoid contact of the lacquer with mucous membranes (e.g., mouth or nose).

Do not inhale.

Using more than the recommended dose of Perlid

If the lacquer is accidentally ingested by the patient or others, consult a doctor, pharmacist, or the nearest hospital.

Stopping the use of Perlid

It is important not to stop using Perlid until the infection is cured and healthy nails have grown out. If the treatment is stopped too early, the infection may not be fully cured. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Rare (may affect up to 1 in 1,000 people):

• nails may become discolored, loosened, or start to separate from the nail bed,
• brittle nails,
• fragile nails.

Very rare (may affect up to 1 in 10,000 people):

• a burning sensation may occur in the area of the nail.

Frequency not known (cannot be estimated from the available data):

• redness of the skin, itching of the skin, contact dermatitis, hives, or blisters may occur in the area of the nail.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49 21 301, Fax: 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 Perlid

Keep this medicine out of the sight and reach of children. Store the bottle tightly closed. Shelf-life after first opening: 6 months. 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 the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. 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 Perlid contains

• The active substance is amorolfine 50 mg/ml, as amorolfine hydrochloride.
• The other ingredients are: ammonio methacrylate copolymer (Type A), triacetin, butyl acetate, ethyl acetate, and ethanol.

What Perlid looks like and contents of the pack

Perlid is a medicinal nail lacquer. The pack sizes are:

• a bottle containing 2.5 ml of medicinal nail lacquer with 10 applicators.
• a bottle containing 2.5 ml of medicinal nail lacquer with 10 applicators, 30 cotton swabs, and 30 nail files.
• a bottle containing 5 ml of medicinal nail lacquer with 10 applicators, 30 cotton swabs, and 30 nail files. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

P.W. Beyvers GmbH, Schaffhausener Strasse. 26–34, D-12099 Berlin, Germany

Date of last revision of the leaflet: