Loceryl 5% medicated nail lacquer

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amorolfine hydrochloride

Available from:

Waymade Healthcare Plc

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

Patient Information leaflet

P23205-8
A M O R O L
F I
N 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
Product code: P23205-8
Product description: LOCERYL 5 SOL 5
Market: GBR
Article: Leaflet
Flat size: 107x340 - Fold size: 107x51
Font size: 8 pt
PMS BLUE 072U
GRADIENT LOCERYL
DIELINES
Artwork approved by:
Date:
Signature:
This approval applies to
WHOLE TEXT
, including barcodes,
pre-printed mentions and legal or special labelling constraints.
PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_LAUNCHING DEPARTMENT - Z.I. Galderma - 74540 ALBY-SUR-CHERAN -
FRANCE_
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCERYL 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.
- 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 (see section 6
for other ingredients).
WARNINGS AND PRECAUTIONS
This medicine can cause allergic react

Summary of Product characteristics

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
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
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. Twice weekly
application may prove beneficial in some cases.
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).
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 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.
_Caution:_ When working with organic solven