Loceryl 5% w/v Medicated Nail Lacquer

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Amorolfine

Tilgængelig fra:

Lexon Pharmaceuticals (Ireland) Limited

ATC-kode:

D01AE; D01AE16

INN (International Name):

Amorolfine

Dosering:

5 percent weight/volume

Lægemiddelform:

Medicated nail lacquer

Terapeutisk område:

Other antifungals for topical use; amorolfine

Autorisation dato:

2020-10-30

Indlægsseddel

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:
What Loceryl is and what it is used for
What you need to know before you use
Loceryl
How to use Loceryl
Possible side effects
How to store Loceryl
Contents of the pack and other information 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. 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
Talk to your doctor or pharmacist before using
Loceryl.
•
The lacquer should not be applied on the skin
around the nail.
•
Avoid the lacquer coming into contact with the
eyes, ears or mucous membranes (e.g. mouth and
nostrils).
•
Do not inhale.
•
Do not apply to the nail bed as it may cause
localised effects such as contact dermatitis.
•
Wear impermeable gloves when using organic
solvents

Produktets egenskaber

Health Products Regulatory Authority
07 December 2023
CRN00DZLM
Page 1 of 2
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.
Excipient with known effect:
One gram of nail lacquer alcohol (ethanol)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated Nail Lacquer.
_ _
_Product imported from Greece_
A clear colourless to almost colourless liquid.
4 CLINICAL PARTICULARS
As per PA22743/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22743/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Methacrylic acid copolymer
Triacetin
Acetate butyl ester
Ethyl acetate
Absolute alcohol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
Shelf life after first opening: 3 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
Protect from heat.
Keep bottle tightly closed after use.
Health Products Regulatory Authority
07 December 2023
CRN00DZLM
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass type III bottle with screw thread and plastic screw
closure with integrated applicator.
Pack sizes: 5.0ml (1 x 5.0 ml)
All packs contain cleansing swabs and nail files.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/036/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 30
th
October 2020
10 DATE OF REVISION OF THE TEXT
December 2023