PERLID

Package leaflet: Information for the user

Perlid, 50 mg/ml, nail lacquer, medicinal
Amorolfinum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What is Perlid and what is it used for
2. Important information before using Perlid
3. How to use Perlid
4. Possible adverse reactions
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 in Perlid is amorolfine (in the form of amorolfine hydrochloride), which belongs to
the group of antifungal medicines. It acts fungicidally against various species of fungi causing
nail infections.
Perlid is used in the treatment of fungal nail infections.

2. Important information before using Perlid

When not to use Perlid

• if the patient is 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 this with your doctor or pharmacist.
• Avoid contact of the nail lacquer with eyes, ears, and mucous membranes.
• Nail files used on infected nails must not be used on healthy nails.
• Artificial nails should not be used during treatment with Perlid.
• After applying Perlid, wait at least 10 minutes before applying any cosmetic nail polish. Before reapplying Perlid, carefully remove any cosmetic nail polish.
• When handling organic solvents (paint thinners, gasoline, etc.), wear impermeable gloves to protect the Perlid applied to the nail.

Children and adolescents
Perlid should not be used in children and adolescents under 18 years of age.
Perlid and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
No studies on interactions between Perlid and other medicines have been conducted.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Since systemic exposure to amorolfine after topical application of Perlid is negligible, an effect of amorolfine on pregnancy or on the newborn or breastfed infant is not expected.
An effect of the medicine on fertility is not expected, due to negligible systemic exposure to amorolfine.

3. How to use Perlid

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults (over 18 years of age)
Perlid should be applied to fingernails once or twice weekly, and to toenails once weekly, as directed by your doctor.

It is important not to interrupt treatment with Perlid until the infection has cleared and healthy nails have regrown. This usually takes about 6 months when treating fingernails and 9 to 12 months when treating toenails. Your doctor will likely monitor your treatment approximately every 3 months.

Instructions for use

1. File the nail

Using the nail file (included in some Perlid packages),

thoroughly file the infected areas and the entire surface of the nail.
WARNING
Do not use nail files used on infected nails on healthy nails, as this may spread the infection. To prevent transmission of infection, ensure that no one else uses the files from the treatment set.

2. Clean the nail

Using a swab (moistened with nail cleanser) included in the package,

clean the surface of the nail. Repeat steps 1 and 2 for each infected nail.

3. Draw up some of the lacquer from the bottle

Dip one of the reusable spatulas into the bottle containing the nail lacquer.

Do not wipe the spatula against the neck of the bottle before applying the lacquer.

4. Apply the lacquer

Evenly apply the lacquer over the entire surface of the nail.

Repeat steps 3 and 4 for each infected nail.

5. Allow to dry
   Leave the treated nails to dry for about 10 minutes.

6. Clean the spatula

The spatulas supplied with the medicine are reusable. However, it is important to clean them thoroughly after each treatment using the same swab used to clean the nail. Avoid touching freshly lacquered nails with the swab. Tightly close the bottle containing the nail lacquer. The swab should be disposed of carefully, as it is flammable.

After applying Perlid, wait at least 10 minutes before applying any cosmetic nail polish.

Before reapplying Perlid, remove the old lacquer first using a swab, and if necessary, file the nail. Then reapply the lacquer as described above.

Water and soap do not affect the dried nail lacquer, so hands and feet may be washed as usual. However, if chemical agents such as paint thinners or lacquer thinner are to be used, wear rubber or other impermeable gloves to protect the lacquered nails.

Important

• If Perlid gets into the eye or ear, immediately rinse thoroughly with water and contact your doctor, pharmacist, or nearest hospital.
• Avoid contact of the lacquer with mucous membranes (e.g. mouth or nose). Do not inhale.
  Use of more than the recommended dose of Perlid
  In case of accidental ingestion by the patient or any other person, contact your doctor, pharmacist, or nearest hospital immediately.

Discontinuation of Perlid treatment

It is important not to stop using Perlid until the infection has cleared and healthy nails have regrown. If treatment is stopped too early, the infection may not be fully cured.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare (may occur in not more than 1 in 1,000 patients):

• nails may become discolored, loosen, or start separating from the nail bed,
• brittle nails,
• fragile nails.

Very rare (may occur in not more than 1 in 10,000 patients):

• burning sensation around the nail may occur.

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

• redness of the skin around the nail, itching, contact dermatitis, urticaria, or blisters may occur.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Perlid

Keep the medicine out of sight and reach of children.
Keep the bottle tightly closed.
Shelf life after first opening the bottle: 6 months.
Do not use this medicine after the expiry date stated on the carton and bottle following: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Perlid contains

• The active substance is amorolfine 50 mg/ml, in the form of 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.
Packaging:

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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