Loceryl 5% w/v Medicated Nail Lacquer

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amorolfine

Available from:

PCO Manufacturing Ltd.

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:

2009-08-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCERYL
® 5% W/V
MEDICATED NAIL LACQUER
amorolfine
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
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 t

Summary of Product characteristics

Health Products Regulatory Authority
30 August 2023
CRN00DS2J
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.
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 150,000
Triacetin
Butyl acetate
Ethyl acetate
Ethanol Anhydrous
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 package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30 ˚C.
Protect from heat.
Keep bottle tightly closed after use.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle with screw thread and plastic screw closure.
All packs contain cleansing swabs, spatulas and nail files.
Health Products Regulatory Authority
30 August 2023
CRN00DS2J
Page 2 of 2
Pack size: 5.0 ml (1 x 5.0ml)
Not all pack sizes may be marketed.
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/234/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
August 2009
10 DATE OF REVISION OF THE TEXT
August 2023