Loceryl 5% w/v Medicated Nail Lacquer

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amorolfine

Available from:

Imbat Limited

ATC code:

D01AE; D01AE16

INN (International Name):

Amorolfine

Dosage:

5 percent weight/volume

Pharmaceutical form:

Medicated nail lacquer

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antifungals for topical use; amorolfine

Authorization status:

Authorised

Authorization date:

2013-12-20

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCERYL 5% W/V MEDICATED NAIL LACQUER
amorolfine
Your medicine is available using the above name 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.
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.
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. Please
check by reading the list of ingredients in section 6. If you answer
yes, you must inform
your doctor before starting treatment.
Please seek immediate medical attention if you experience symptoms of
an allergic reaction.
Signs or symptoms of a severe allergic reaction may include a rash,
with or without itching,
swelling of the face, eyelids or lips and difficulty in breathing.
WARNINGS AND PRECAUTIONS
This medicine can cause allergic reactions; some can be serious. If
this happens, stop applying
the product, immediately remove the product with a nail varnish
remover

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loceryl 5% w/v Medicated Nail Lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Loceryl nail lacquer contains 5% w/v amorolfine in the form of
amorolfine hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated Nail Lacquer.
_Product imported from_ The UK
A clear colourless to almost colourless liquid.
4 CLINICAL PARTICULARS
As per PA0590/018/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0590/018/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Ammonio methacrylate copolymer A
Triacetin
Butyl acetate
Ethyl acetate
Ethanol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer carton of the product as marketed
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30
o
C.
Protect from heat.
Keep bottle tightly closed after use.
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6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle with screw thread amd plastic screw closure. All
packs contain cleaning swabs, spatulas and nail
files.
Or
Amber glass bottle with screw thread and plastic screw closure with
integrated applicator. All packs contain cleansing
swabs and nail files.
Pack size: 5.0 ml (1 x 5.0 ml)
Not all pack sizes may be mark