Loceryl 5% w/v Medicated Nail Lacquer

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amorolfine

Available from:

Galderma International

ATC code:

D01AE; D01AE16

INN (International Name):

Amorolfine

Dosage:

5.0 percent weight/volume

Pharmaceutical form:

Medicated nail lacquer

Therapeutic area:

Other antifungals for topical use; amorolfine

Authorization status:

Marketed

Authorization date:

1993-03-25

Patient Information leaflet

1
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

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2023
CRN00D3YJ
Page 1 of 4
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 contains 0.552 g alcohol (ethanol) which is
equivalent to 55.2 % w/w.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated Nail Lacquer.
A clear colourless to almost colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Onychomycoses caused by dermatophytes, yeasts and moulds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The nail lacquer should be applied to the affected finger or toe nails
once weekly.
The patient should apply the nail lacquer as follows:
1.Before the first application of Loceryl, it is essential that the
affected areas of nail (particularly the nail surfaces) should be
filed down as thoroughly as possible using the nail file supplied. The
surface of the nail should then be cleansed and degreased
using a cleaning pad (as supplied). Before repeat application of
Loceryl, the affected nails should be filed down again as
required, following cleansing with a cleaning pad to remove any
remaining lacquer.
_Caution:_ Nail files used for affected nails must not be used for
healthy nails.
2.With one of the reusable applicators supplied, apply the nail
lacquer to the entire surface of the affected nails and allow it to
dry. After use, clean the applicator with the same cleaning pad used
before for nail cleaning. Keep the bottle tightly closed.
For each nail to be treated, dip the applicator into the nail lacquer
without wiping off any of the lacquer on the bottle neck.
The required duration of treatment depends essentially on intensity
and localisation of the infection. In general, it is six
months (finger nails) and nine to twelve months (toe nails).
OLDER PEOPLE
There are no specific dosage recommendations f