Consumer Medicine Information

LOCERYL^®

amorolfine 5%
Nail Lacquer

Please read the following information carefully before you start using Loceryl

This leaflet answers some common questions about LOCERYL nail lacquer. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using LOCERYL nail lacquer against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

What is LOCERYL and what is it used for

LOCERYL contains the active ingredient amorolfine. It is used to treat fungal infections of the nails. LOCERYL belongs to a family of medicines called anti-fungal drugs. These medicines work by killing a wide variety of fungi that can cause nail infections.

This medicine is available from a pharmacist. A doctor's prescription is not required.

When you must not use LOCERYL

Do not use LOCERYL if:

1. you have had an allergic reaction to LOCERYL or any ingredients listed at the end of this leaflet.
2. the package is torn or shows signs of tampering.
3. the expiry date (EXP) printed on the pack has passed.
4. you are pregnant or you are breast-feeding or intend to breast-feed. The safety of LOCERYL in pregnancy and breast-feeding has not been established.

If you are not sure if you should start using LOCERYL, talk to your doctor or pharmacist.

Use in children.

The safety and effectiveness of LOCERYL in children have not been established.

Before you start to use LOCERYL

Tell your doctor or pharmacist if:

• you are allergic to any other medicines, foods, dyes or preservatives.
• you have any other health problems.
• you are taking any other medicines.

How to use LOCERYL

LOCERYL is intended for external use only. LOCERYL should not be swallowed.

Carefully follow the steps below before using LOCERYL:

1. Place everything you need for the LOCERYL treatment within easy reach:
   • LOCERYL nail lacquer.
   • nail file (supplied).
   • cleaning pad (supplied).
   • reusable spatula (supplied).
2. Before painting with LOCERYL nail lacquer, file down the infected areas of the nail (particularly the nail surfaces) as thoroughly as possible using the nail file.
   CAUTION: Nail files used on an infected nail must not be used on healthy nails.
3. Clean the surface of the infected nail with a cleaning pad.
4. Dip one of the reusable spatulas into the lacquer. Do not wipe it on the neck of the bottle.
   Note: the spatula provides a measured dose of LOCERYL.
5. Using the spatula, paint LOCERYL nail lacquer over the entire surface of the infected nail.
6. Close the bottle tightly immediately after painting the infected nail.
7. Repeat steps 2, 3, 4 and 5 for each nail.
8. Allow time for the nails to dry (3 to 5 minutes).
9. When you have finished treating all of your infected nails clean the spatula and the neck of the bottle with the same cleaning pad that was used during the treatment.

NOTE: Follow these steps each time you use Loceryl.

How often to apply LOCERYL

Paint LOCERYL once or twice weekly on the infected fingernails or toenails or as otherwise directed by your doctor or pharmacist.

If you forget to paint on the LOCERYL nail lacquer, use it as soon as you remember. Then go back to using LOCERYL as you would normally.

How long LOCERYL should be used

Treatment should be continued until the infected nails are completely cured and re-grown.

Usually, treatment of fungal infections of the nails takes around six months for the fingernails and nine to twelve months for the toenails.

Don't be discouraged if after several weeks of therapy no improvement is visible. A healthy nail only grows by approximately 2mm per month.

In case of accidental swallowing

Immediately telephone your doctor or Poisons Information Centre for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have swallowed LOCERYL, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using LOCERYL

Things you must do

If you are about to be started on a new medicine, tell your doctor and pharmacist that you are using LOCERYL.

If you work with solvents (eg paint thinner, turpentine substitute, petrol, paraffin etc), wear

gloves to protect the coat of nail lacquer on your fingernails.

Things you must not do

Do not use nail files for infected nails on healthy nails.

Do not use artificial nails during treatment with LOCERYL.

Do not apply cosmetic nail varnish or other medication(s) on the nail(s) being treated.

Do not give LOCERYL to anyone else to use, even if they have the same condition as you.

Do not use LOCERYL to treat other complaints unless your doctor says to.

Things to be careful of

Take care that LOCERYL does not come into contact with the skin.

Side effects

All medicines can have side effects. LOCERYL helps most people with fungal infections of the nails but it may have unwanted side effects in a few people.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• burning feeling in the area surrounding the treated nail(s). This is usually mild and short-lasting.
• itching or redness of the skin.

Do not be alarmed by these possible side effects. You may not experience any of them.

After using LOCERYL

Storage

Screw the bottle top of the LOCERYL nail lacquer tightly immediately after use.

Keep LOCERYL in a cool dry place where the temperature stays below 30°C. Heat and

dampness can destroy some medicines.

Do not store it, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Keep LOCERYL where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Product description

Availability

LOCERYL nail lacquer comes in one strength, 5% amorolfine (50 mg/ mL) in an amber glass bottle.

LOCERYL comes in a pack containing 1 bottle of 5 mL nail lacquer, 10 spatulas, 30 cleaning pads saturated with 70% isopropyl alcohol in foil packets and 30 nail files.

Ingredients

Active ingredient- amorolfine

Each 2.5 mL bottle contains 250mg of amorolfine as the hydrochloride.

Inactive ingredients

Each 2.5 mL bottle also contains: methacrylic acid copolymer, glycerol triacetate, butyl acetate, ethyl acetate, absolute ethanol.

Sponsor

Galderma Australia Pty Ltd
9 Rodborough Road
Frenchs Forest NSW 2086

Distributed in New Zealand by:

Pacific Pharmaceuticals
76 Leonard Road,
Mt Wellington. Auckland

Australian Registration Number: AUST R 57051

This leaflet was prepared in December 1999.