Amorolfine Lacquer medicated nail laquer

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

amorolfine (amorolfine hydrochloride)

Доступно од:

Chanelle Medical

АТЦ код:

D01AE16

INN (Међународно име):

amorolfine (amorolfine hydrochloride)

Дозирање:

50mg/ml

Фармацеутски облик:

medicated nail laquer

Јединице у пакету:

2,5ml glass vial, (10) spatulas, (30) nail files, (30) cleansing swabs

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2022-06-10

Информативни летак

Page1 of 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOROLFINE LACQUER
MEDICATED NAIL LACQUER 5% W/V
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 antifungals. 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 w

Карактеристике производа

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amorolfine 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 pale yellow solution.
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 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 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 children owing to the
lack of clinical
experience available to date.
4.3
CONTRAINDICATIONS
Hypersensitivity to the activ