LOCERYL NAIL LACQUER

Active substance: AMOROLFINE HYDROCHLORIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

LOCERYL® NAIL LACQUER
(amorolfine hydrochloride)
Patient Information Leaflet

This medicine is known by the above name but will be referred to as Loceryl in this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
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SERETIDE 6464/2342 6464/2343

4. Possible side effects
5. How to store Loceryl
6. Contents of the pack and other information

1. 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. 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).

WARNING!

Warnings and precautions
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.

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.

DATE:
12/05/14
TVT CHECKED

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.
Step 3. Take some lacquer from the bottle
Dip one of the re-usable applicators into the bottle of nail lacquer. The lacquer
must not be wiped off on the edge of the bottle before it is applied.
UK PIL DATED JULY 2013
REPORTING OF SIDE EFFECTS

DATE OF PROOF:

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.

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Instructions for use

CODE:

Q.A.
APPROVED:
05-0440

CUSTOMER: Waymade
PRODUCT: Loceryl Nail Lacquer

PRE-PRESS NO.:

3. HOW TO USE LOCERYL
Always use this medicine exactly as your doctor has 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.
Step 5. Allow to dry
Let the treated nail(s) dry for approximately 3 minutes.

Step 6. Clean the applicator
The applicators provided are re-usable. However, it is important to clean them
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.

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WARNING!

DATE:

CUSTOMER
APPROVED:

Using other medicines
There are no known interactions with other medicines.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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.
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

PROOF HISTORY:
v.1 - waymade - 12/05/14

Leaflet Flat Size = 148 x 317
11/10

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.

WARNING!

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Loceryl nail lacquer. It contains 50mg of the active ingredient, amorolfine (as the
hydrochloride) in each millilitre of clear colourless solution.
Loceryl nail lacquer also contains the following:
Methacrylic acid copolymer 150000, triacetin, butyl acetate, ethyl acetate and absolute ethanol.
The cleansing swabs contain 0.5ml of 70%v/v isopropanol.

UK PIL DATED JULY 2013
REPORTING OF SIDE EFFECTS

6464/0907A
CODE:

CUSTOMER: Waymade
PRODUCT: Loceryl Nail Lacquer

Each pack contains one amber glass bottle containing 5ml of nail lacquer with a tamper-evident screw cap
together with 30 cleansing swabs, application spatulas and 30 nail files.
POM

PL No: 6464/0907

This product is manufactured by Laboratoires Galderma, 74540 Alby-Sur-Chéran, France and is procured
from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 12.05.2014
LOCERYL is a registered trademark of GALDERMA S.A.

Colour
Swatch

Black

WARNING!

12/05/14
DATE OF PROOF:

5. HOW TO STORE LOCERYL
• Do not use after the expiry date printed on the carton or bottle label. The expiry date refers to the last day of
that month.
• If it becomes out of date during use, return it to your pharmacist for safe disposal.
• Loceryl nail lacquer should be stored below 30°C. The cap should be replaced after use.
• Loceryl nail lacquer is flammable and should be stored away from naked flames and heat.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop using the solution, please take it back to the pharmacist for safe disposal.
Only keep the solution if your doctor tells you to.
• If the solution becomes discoloured or shows any other sign of deterioration, you should ask your
pharmacist for advice.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

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DATE:

Reporting of side effects
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.

TVT CHECKED

Q.A.
APPROVED:
PRE-PRESS NO.:

05-0440

CUSTOMER
APPROVED:

Unknown frequency of occurrence
Redness, itching, hives, blisters and allergic skin reaction (contact dermatitis).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 12/05/14

Leaflet Flat Size = 148 x 317
11/10

27mm

• 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.

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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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