Curanail 5% medicated nail lacquer

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amorolfine hydrochloride

Available from:

Galderma (UK) Ltd

ATC code:

D01AE16

INN (International Name):

Amorolfine hydrochloride

Dosage:

50mg/1ml

Pharmaceutical form:

Medicated nail lacquer

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5020465200284

Summary of Product characteristics

OBJECT 1
LOCERYL CURANAIL 5% W/V MEDICATED NAIL
LACQUER
Summary of Product Characteristics Updated 13-Feb-2018 | Galderma
(U.K) Ltd
1. Name of the medicinal product
Loceryl Curanail 5% w/v Medicated Nail Lacquer
2. Qualitative and quantitative composition
Loceryl Curanail 5% nail lacquer contains 5% w/v amorolfine in the
form of hydrochloride. Amorolfine
is chemically described as
_cis_-4-[(RS)-3[4-(1,1-Dimethylpropyl)phenyl]-2-methylpropyl]-2,6-
dimethylmorpholine.
Amorolfine hydrochloride HSE 6.40 %w/w
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Medicated Nail Lacquer.
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.
4.2 Posology and method of administration
_ADULTS AND ELDERLY_
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 Curanail 5% nail lacquer,
it is essential that the affected areas of
nail (particularly the nail surfaces) should be filed down as
thoroughly as possible using a nail file, as
supplied. The surface of the nail should then be cleansed and
degreased using an alcohol cleaning pad, as
supplied.
Cosmetic nail lacquer may be applied at least 10 min after amorolfine
5% nail lacquer application.
Before repeat application of amorolfine 5% nail lacquer, any remaining
nail lacquer, and cosmetic nail
lacquer if any, should be removed carefully, then the affected nails
should be filed down again as
required, and at any rate be cleansed with an alcohol soaked swab 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