LOCERYL

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

AMOROLFINE

Saadav alates:

Galderma (UK) Ltd

ATC kood:

D01AE16

INN (Rahvusvaheline Nimetus):

AMOROLFINE

Annus:

5.0 %w/v

Ravimvorm:

Medicated Nail Lacquer

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

amorolfine

Volitamisolek:

Marketed

Loa andmise kuupäev:

1993-03-25

Infovoldik

A M O R O L
F I
N E
(
A S
A M O R O L
F I
N E
H Y D R O C H L
O R I
D E )
L O C E R Y L 5 % W / V M E D I C A T E D N A I L L A C Q U E R
P2XXXX-X
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
This medicine can cause allergic reactions, some can be serious. If
this happens, stop applying
the product, immediatel

Toote omadused

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.
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 for use in elderly
patients.
PAEDIATRIC POPULATION
There are no specific dosage recommendations for children owing to the
lack of clinical experience available to date.
H
E
A
L
T
H
P
R
O
D
U
C
T