Amorolfine 5% w/v medicated nail lacquer

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Amorolfine

Inapatikana kutoka:

Chanelle Medical

ATC kanuni:

D01AE16

INN (Jina la Kimataifa):

Amorolfine

Kipimo:

5 percent weight/volume

Dawa fomu:

Medicated nail lacquer

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

amorolfine

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2013-06-21

Taarifa za kipeperushi

Page1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOROLFINE 5% W/V MEDICATED NAIL LACQUER
amorolfine (as hydrochloride)
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. 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 Amorolfine Lacquer is and what it is used for
2.
What you need to know before you use Amorolfine Lacquer
3.
How to use Amorolfine Lacquer
4.
Possible side effects
5.
How to store Amorolfine Lacquer
6.
Contents of the pack and other information
1.
WHAT AMOROLFINE LACQUER IS AND WHAT IT IS USED FOR

Amorolfine Lacquer is used to treat fungal infections of the nails.

Amorolfine Lacquer contains the active ingredient amorolfine (as the
hydrochloride) which
belongs to a group of medicines known as anti fungals. It kills a wide
variety of fungi that can
cause nail infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE LACQUER
DO NOT USE AMOROLFINE LACQUER IF YOU ARE:

Allergic (hypersensitive) to amorolfine or any of the other
ingredients of Amorolfine Lacquer.
Please check by reading the list of ingredients in section 6. If you
answer yes, you must inform
your doctor before starting treatment.
Please seek immediate medical attention if you experience symptoms of
an allergic reaction.
Signs or symptoms of a severe allergic reaction may include a rash,
with or without itching,
swelling of the face, eyelids or lips and difficulty in breathing.
WARNINGS AND PRECAUTIONS:
This medicine can cause allergic reactions, some can be serious. If
this happens, stop applying the
product, immediately remove the product with a n

Tabia za bidhaa

Health Products Regulatory Authority
01 April 2019
CRN008P19
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amorolfine 5% w/v medicated nail lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 50mg amorolfine (as hydrochloride).
For a 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
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.
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 spatulas 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 spatula with the
same cleaning pad used before for nail cleaning. Keep the
bottle tightly closed.
For each nail to be treated, dip the spatula into the nail lacquer
without wiping off any of the lacquer on the bottle neck.
The required duration of treatment depends essentially on intensity
and localisation of the infection. In general, it is six months
(finger nails) and nine to twelve months (toe nails).
Elderly
There are no specific dosage recommendations for use in elderly
patients.
Children
There are no specific dosage recommendations for