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LOCERYL 5% W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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Loceryl

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

®

amorolfine

5% w/v Medicated Nail Lacquer
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.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Loceryl 5% w/v Medicated Nail Lacquer
Amorolfine

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

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.

1. What Loceryl is and what it is used for

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.

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.

If you stop using Loceryl
Do not stop using Loceryl before your doctor tells you to or your infection could come back.

2. What you need to know before you use Loceryl

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

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).

4. Possible side effects

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.

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.

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

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

Using other nail products
Nail varnish or artificial nails should not be used while using Loceryl.

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

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.

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.

3. How to use Loceryl

5. How to store 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.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
• Keep the pack away from heat (store below 30°C) and keep the bottle tightly closed after use.
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.

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.

6. Contents of the pack and other information
What Loceryl contains
The active substance is amorolfine. Loceryl contains 50 mg/ml (5%) of amorolfine (equivalent
to 6.4% amorolfine hydrochloride).
The other ingredients are: ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl
acetate and ethanol.

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 Loceryl looks like and contents of the pack
The pack is available in sizes of 2.5 ml, 5 ml, 7.5 ml and 10 ml bottles.
Each 2.5 ml and 5 ml pack consists of 1 bottle filled with Loceryl nail lacquer together with
cleansing swabs, nail files and spatula integrated in the cap or separate spatulas.
Each 7.5 ml and 10 ml pack consists of 2 bottles filled with Loceryl nail lacquer together with
cleansing swabs, nail files, and spatula integrated in the cap or separate spatulas.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder is Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road,
Watford, Herts, WD17 1DS, United Kingdom. (PL 10590/0042)
Manufacturer: Laboratoires Galderma, ZI-Montdésir, 74540 Alby-sur-Chéran, France.

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.

You can get more information on Loceryl Nail Lacquer from your doctor or pharmacist.
This leaflet was last revised in 06/2015.

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.

Product code: MOCK-UP
Product description: LOCERYL 5 SOL 5
Market: GBR
Article: Leaflet
Flat size: 107x340 - Fold size: 107x51
Font size: 8 pt
Specification n° MT.09.MPS.1388
LAUNCHING DEPARTMENT - Z.I. Galderma
74540 ALBY-SUR-CHERAN - FRANCE

PMS BLUE 072U
GRADIENT LOCERYL

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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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