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LOCERYL MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE

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3.

PACKAGE LEAFLET: INFORMATION FOR THE USER

LOCERYL® MEDICATED NAIL LACQUER
AMOROLFINE 5% MEDICATED NAIL LACQUER
(amorolfine hydrochloride)

Instructions for use

Step 1. File the nail
Before the first application, file down the infected areas of nail,
including the nail surface, as much as possible using the nail
file provided.
CAUTION: Do not use nail files used for infected nails on
healthy nails, otherwise you may spread the infection.
To prevent the spread of infection take care that no one else
uses the files from your kit.

Your medicine is available using one of the above names, but will be referred to as Loceryl
throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

Step 2. Clean the nail
Use one of the swabs provided to clean the nail surface.
Repeat steps 1 and 2 for each affected nail.

What is in this leaflet
1. What Loceryl is and what it is used for
2. What you need to know before you use Loceryl
3. How to use Loceryl
4. Possible side effects
5. How to store Loceryl
6. Contents of the pack and other information
1.

Step 3. Take some lacquer from the bottle
Dip the applicator into the bottle of nail lacquer. The lacquer
must not be wiped off on the edge of the bottle before it is
applied.

WHAT LOCERYL IS AND WHAT IT IS USED FOR

Loceryl is used to treat fungal infections of the nails.
Loceryl contains the active ingredient amorolfine (as the hydrochloride), which belongs to a
group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail
infections.

2.

HOW TO USE LOCERYL

Always use this medicine exactly as your doctor had told you. Check with your doctor or
pharmacist if you are not sure.
Loceryl should be applied to the affected finger or toe nails once or twice a week exactly as
directed by your doctor.

Step 4. Apply the lacquer
Apply the nail lacquer evenly over the entire surface of the nail.
Repeat steps 3 and 4 for each affected nail.

WHAT YOU NEED TO KNOW BEFORE YOU USE LOCERYL

Do not use Loceryl if you are:


Allergic (hypersensitive) to amorolfine or any of the other ingredients of Loceryl (see section
6 for other ingredients).

Warnings and precautions

Step 5. Allow to dry
Let the treated nail(s) dry for approximately 3 minutes.

Using other medicines

Step 6. Clean the applicator
The applicator provided is re-usable. However, it is important
to clean it thoroughly after completing each treatment
procedure, using the same swab you used for nail cleansing.
Avoid touching newly treated nails with the swab.
Close the nail lacquer bottle tightly. Dispose of the swab
carefully as it is inflammable.

Talk to your doctor or pharmacist before using Loceryl.
• Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g.
mouth and nostrils).
• Do not inhale.
• Wear impermeable gloves when using organic solvents to stop the nail lacquer from being
removed.
There are no known interactions with other medicines.

Using other nail products

Nail varnish or artificial nails should not be used while using Loceryl.

Pregnancy and breast-feeding

You should not use Loceryl and tell your doctor if you are pregnant, planning to become
pregnant or are breast-feeding. Your doctor will then decide whether you should use Loceryl.
Ask your doctor or pharmacist for advice before taking any medicine.

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Before using Loceryl again, first remove the old lacquer from your nails using a swab, then
file down the nails again if necessary.
• Re-apply the lacquer as described above.
• When dry the nail lacquer is unaffected by soap and water, so you may wash your hands
and feet as normal. If you need to use chemicals such as paint thinners or white spirit,
rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on
your fingernails.
• It is important to carry on using Loceryl until the infection has cleared and healthy nails
have grown back. This usually takes 6 months for finger nails and 9 to 12 months for toe
nails.
Your doctor will probably check how your treatment is progressing every 3 months or so.


5.







If you get Loceryl in your eyes or ears

If you get Loceryl in your eyes or ears wash out with water immediately and contact your
doctor, pharmacist or nearest hospital straight away.

If you accidentally swallow Loceryl

If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or
nearest hospital straight away.

If you forget to use Loceryl

Don’t worry if you forget to use Loceryl at the right time. When you remember, start using the
product again, in the same way as before.

If you stop using Loceryl

Do not stop using Loceryl before your doctor tells you to or your infection could come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In addition to the beneficial effects of Loceryl, it is possible that unwanted effects will occur
during treatment, even when it is used as directed.

Rare side effects (occurring in less than 1 in 1000 people)
Your nail may become discoloured, broken or brittle.

Very rare side effects (occurring in less than 1 in 10, 000 people)
A burning sensation may occur in the area around the nail.

Unknown frequency of occurrence

Redness, itching, hives, blisters and allergic skin reaction (contact dermatitis).

6.

HOW TO STORE LOCERYL

This medicine must not be used after the expiry date (EXP) printed on the pack. The expiry
date refers to the last day of that month. Return any left over medicine to your pharmacist
for safe disposal. Only keep it if your doctor tells you to.
Do not store above 30°C, protect from heat. Keep the bottle tightly closed after use.
Keep this medicine out of the sight and reach of children.
If your doctor tells you to stop using this medicine, please take it back to your pharmacist to
be destroyed. Only keep it if the doctor tells you to.
If the medicine becomes discoloured or show any signs of deterioration, you should seek the
advice of your doctor or pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Loceryl contains

Loceryl contains the active ingredient amorolfine (as the hydrochloride), which belongs to a
group of medicines know as antifungals. Loceryl contains 50 mg/ml (5%) of the active
ingredient amorolfine and the other ingredients are methacrylic acid copolymer, triacetin,
butyl acetate, ethyl acetate and ethanol.

What Loceryl looks like and contents of the pack

Each pack contains 1 amber glass bottle with screw thread and plastic screw closure, filled with
5 ml of Loceryl together with cleansing swabs, spatulas and nail files.

Manufacturer

This medicine is made by Produits Roche S.A., 94120 Fontenay-sous-Bois, France
Or
LABORATOIRES GALDERMA, Alby-sur-Chéran, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0392

POM

Leaflet revision and issue date (Ref): 18.07.16
Loceryl® is a registered trademark of Galderma S.A.

Reporting of side effects

P18751

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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