Amorolfine 5% medicated nail lacquer

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amorolfine hydrochloride

Available from:

Teva 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: 5017007012078

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% w/v Medicated Nail Lacquer
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml 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
Onychomycoses caused by dermatophytes, yeasts and moulds without nail
matrix involvement.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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 Amorolfine 5% w/v Medicated Nail
Lacquer, 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 5% w/v Medicated Nail Lacquer, 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. Allow the nail lacquer to
dry for
3-5 minutes. 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, it is