Loceryl 5% w/v Medicated Nail Lacquer

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amorolfine

Available from:

IMED Healthcare 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:

2013-10-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCERYL 5% W/V MEDICATED NAIL LACQUER
amorolfine (as amorolfine hydrochloride)
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

Summary of Product characteristics

Health Products Regulatory Authority
05 July 2023
CRN00DNYR
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:
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 150,000
Triacetin
Butyl acetate
Ethyl acetate
Ethanol anhydrous
Solvent (on the tissue): isopropyl alcohol 70%.
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.
After first opening the bottle with spatula incorporated in screw cap
use within 3 months.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30 °C. Protect from heat. Keep the bottle tightly closed
after use.
Health Products Regulatory Authority
05 July 2023
CRN00DNYR
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle with screw thread and plastic screw closure.
Packs contain cleansing swabs, nail files and spatula integrated in
the cap.
Pack size: 5 ml (1 x 5 ml)
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
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/081/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
October 2013
10 DATE OF REVISION OF THE TEXT
July 2023