Curanail 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 percent weight/volume

Pharmaceutical form:

Medicated nail lacquer

Therapeutic area:

Other antifungals for topical use; amorolfine

Authorization status:

Marketed

Authorization date:

2012-03-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CURANAIL 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.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet, you may need to read it again.
-
Ask your pharmacist, if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if your
symptoms worsen or do not improve
within 3 months.
WHAT IS IN THIS LEAFLET
1.
What Curanail 5% w/v Medicated Nail Lacquer IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE Curanail 5% w/v Medicated Nail
Lacquer
3.
HOW TO USE Curanail 5% w/v Medicated Nail Lacquer
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE Curanail 5% w/v Medicated Nail Lacquer
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CURANAIL 5% W/V MEDICATED NAIL LACQUER
IS AND WHAT IT IS USED FOR
CURANAIL 5% is an antifungal medicated nail lacquer (
_medicine for treatment of infections caused _
_by a microscopic fungus_
).
CURANAIL 5% is used to treat
NAIL MYCOSES
(
_infections caused by a fungus_
) affecting
UP TO 2 NAILS
in adults. A mycosis generally results in nail discolouration (white,
yellow or brown) and thickening,
although the appearance may vary considerably.
If the infection is limited to the upper part of the nail as in photo
1 below, follow the advice of your
PHARMACIST
. If the infection appears to be more like photos no. 2 or 3, you
should
SEE YOUR DOCTOR
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
CURANAIL 5% W/V MEDICATED NAIL LACQUER
_ _
DO NOT USE CURANAIL:
2
-
if you are allergic (hypersensitive) to the active ingredient
(amorolfine) or to one of the other
ingredients of CURANAIL,
-
if you are under 18 years old.
WARNINGS AND PRECAUTIONS
•
Do not apply CURANAIL on the sk

Summary of Product characteristics

Health Products Regulatory Authority
15 February 2023
CRN00D7XM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Curanail 5% w/v medicated nail lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Curanail nail lacquer contains 5% w/v (50 mg/ml) amorolfine in the
form of amorolfine hydrochloride.
This medicine contains 0.552 g alcohol (ethanol) per 1 g, 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
Treatment of mild cases of distal and lateral subungual onychomycoses
caused by dermatophytes, yeasts and moulds limited
up to 2 nails, in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply CURANAIL to the affected nails once a week.
Method of administration
TO APPLY THE NAIL LACQUER, COMPLY CAREFULLY WITH THE FOLLOWING
RECOMMENDATIONS:
A. Before the first application of CURANAIL, clean the nails
thoroughly. Remove any former varnish layers with a nail varnish
remover; then using a nail file, file the surface of the nail
(particularly the affected nail surface) as thoroughly as possible. Be
careful not to file the periungual skin.
B. The surface of the nail should be cleansed and degreased using one
of the cleaning swabs (supplied).
C. Apply the nail lacquer to the whole surface of the nail with one of
the reusable applicators supplied. Between each nail
application, clean the applicator with the cleaning swab supplied,
thus avoiding any contamination of the nail lacquer. Do not
wipe the applicator off on the edge of the bottle.
D. The applicator must be carefully cleaned with one of the swabs
supplied after each application before treating another nail
so as to avoid contamination of the lacquer.
E. If some nail lacquer has been put on the exterior of the stopper,
please make sure to clean it with one of the cleaning swab
supplied to avoid any contact with the skin.
F. Keep the bottle tightly clo