CURANAIL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMOROLFINE HYDROCHLORIDE

Available from:

Galderma (UK) Ltd

ATC code:

D01AE16

INN (International Name):

AMOROLFINE HYDROCHLORIDE

Dosage:

5 %w/v

Pharmaceutical form:

Medicated Nail Lacquer

Prescription type:

Product not subject to medical prescription

Therapeutic area:

amorolfine

Authorization status:

Marketed

Authorization date:

2012-03-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_Medicinal product name _
CURANAIL 5%, MEDICATED NAIL LACQUER
AMOROLFINE
_Outline _
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.
_Leaflet contents _
WHAT IS IN THIS LEAFLET:
1. WHAT CURANAIL 5%, medicated nail lacquer IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CURANAIL 5%, medicated nail
lacquer
3. HOW TO USE CURANAIL 5%, medicated nail lacquer
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CURANAIL 5%, medicated nail lacquer
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CURANAIL 5%, MEDICATED NAIL LACQUER IS AND WHAT IT IS USED FOR
_Invented name, active substance and pharmacotherapeutic group _
CURANAIL 5% is an antifungal medicated nail lacquer (_medicine for
treatment of infections caused _
_by a microscopic fungus_).
_Therapeutic indications _
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
nb1 below, follow the advice of your
PHARMACIST. If the infection appears to be more like photos nb 2 or 3,
you SHOULD see your DOCTOR.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CURANAIL 5%, MEDICATED NAIL
LACQUER
_Contra-indications _
DO NOT USE CURANAIL:
o
if you are allergic (hypersensitive) to the active ingredient
(amorolf

Summary of Product characteristics

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.
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 closed.
Repeat the same process for each affected nail.
After each application of CURANAIL, it is important to wash your
hands. However, when applying on fingernails,
wait