Amorolfine 5% medicated nail lacquer

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amorolfine hydrochloride

Available from:

Zentiva Pharma 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: 5000283655671

Patient Information leaflet

4 COLOUR: CMYK
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOROLFINE 5% W/V MEDICATED NAIL LACQUER
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 your symptoms worsen or do not improve
within 3 months.
WHAT IS IN THIS LEAFLET:
1. What Amorolfine 5% w/v is and what it is used for
2. What you need to know before you use Amorolfine 5% w/v
3. How to use Amorolfine 5% w/v
4. Possible side effects
5. How to store Amorolfine 5% w/v
6. Contents of the pack and other information 1. WHAT AMOROLFINE 5% W/V IS AND WHAT IT IS USED FOR
Amorolfine 5% w/v is used to treat:
•
Fungal infections of the nails without involvement of the nail root
(nail matrix)
•
Fungal infections affecting up to 2 nails and affecting the upper half
or sides of the nail (as shown in the first picture below). If the
infection
appears to be more like pictures 2 or 3, you should consult your
doctor.
•
The active substance in Amorolfine 5% w/v is amorolfine (as the
hydrochloride) which belongs to a group of medicines known as
antifungals.
•
Amorolfine 5% w/v kills a wide variety of fungi that can cause nail
infections. A fungal nail infection is likely to result in discoloured
(white,
yellow or brown), thick or brittle nails, although their appearance
can vary considerably as the following pictures show:
Picture 1
Picture 2
Picture 3 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE 5% W/V
DO NOT USE AMOROLFINE 5% W/V IF YOU ARE:
•
Allergic to amorolfine or any of the other ingredients of this
medicine (listed in section 6).
•
Under the age of 18.
Warning and precaut

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amorolfine 5% Medicated nail lacquer
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amorolfine contains 5% w/v amorolfine in the form of hydrochloride. 1
ml solution
contains 55.74 mg amorolfine hydrochloride (equivalent to 50 mg
amorolfine).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Medicated nail lacquer.
Clear, colourless to pale yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild cases of distal and lateral subungual onychomycoses
caused by
dermatophytes, yeasts and moulds; treatment is limited to 2 nails.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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 amorolfine, 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 an alcohol cleaning pad. Before repeat application of
amorolfine, 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.
Treatment should be continued without interruption until the nail is
regenerated and
the affected areas are finally cured. The required frequency and
duration of treatment
depends essentially on intensity and localisation of the infection. In
general, i