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OMICUR 5% W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Omicur 5% w/v
Medicated Nail Lacquer
Amorolfine
Read this entire leaflet carefully before you
start taking this medicine.
! 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 symptoms are the same as yours.
! If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Omicur is and what it is used for
2. Before you use Omicur
3. How to take Omicur
4. Possible side effects
5. How to store Omicur
6. Further information
1. WHAT OMICUR IS AND WHAT IT IS USED
FOR
Omicur 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. BEFORE YOU USE OMICUR
Do not use Omicur
If you are allergic (hypersensitive) to amorolfine
or any of the other ingredients of Omicur
! You should check with your doctor or
pharmacist if you are not sure.

!

Take special care with Omicur
Omicur is not recommended for use in children.
You should check with your doctor or
pharmacist if you are not sure.

!
!

Using other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Pregnancy and breast-feeding
No effects during pregnancy and lactation are
anticipated, since systemic exposure to amorolfine
is negligible.
Omicur can be used during pregnancy and
lactation. Ask your doctor or pharmacist for advice
before taking any medicine.
3. HOW TO USE OMICUR
Always use Omicur exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
Omicur should be applied to to the affected finger or
toe nails once or twice a week exactly as directed
by your doctor.
Instructions for use: for the packaging without
cleansing swabs and nail files
The patient should apply the Omicur as follows:
a) Before the first application, it is essential that
the infected areas of nail (particularly the nail

surfaces) are filed down as thoroughly as
possible. Be careful to not file down the
periungual skin (skin around the nail).
b) The surface of the nail should then be cleansed
and degreased using a cleaning pad or a
cleansing swab tinctured with a nail varnish
remover.
c) With one of the reusable spatulas supplied,
apply the nail lacquer to the entire surface of the
affected nail. Clean the reusable spatula
between each nail to be treated, to avoid the
infection of the lacquer. Don't wipe off any of the
lacquer on the bottle neck.
d) Clean the spatula after use with a cleaning pad
or a cleansing swab tinctured with a nail varnish
remover. Keep the bottle tightly closed.
e) Repeat the process above for each affected
nail.
f) Treatment should be continued without
interruption until the nail is regenerated and the
affected areas are finally cured.
The required duration of treatment is usually six
months for the finger nails and nine months for the
toe nails (depending essentially on the intensity, the
localisation of the infection and the infected area of
nail).
Cautions:
Nail files used for treatment must not be reused
for the care of healthy nails.
! Before repeat application of Omicur the
affected nails should be cleansed with a
cleansing pad or a cleansing swab impregnated
with a nail varnish remover to remove any
remaining lacquer then filed down again as
necessary.
! When working with organic solvents (thinners,
white spirit, etc.) wear impermeable gloves in
order to protect the Omicur lacquer on the nails.
! Avoid contact of the lacquer with eyes, ears and
mucous membranes.

!

Instructions for use: for the packaging with
cleansing swabs and nail files
The patient should apply the Omicur as follows:
a) Before the first application, it is essential that
the infected areas of nail (particularly the nail
surfaces) are filed down as thoroughly as
possible. Be careful to not file down the
periungual skin (skin around the nail).
b) The surface of the nail should then be cleansed
and degreased using a cleaning pad (as
supplied).
c) With one of the reusable spatulas supplied,
apply the nail lacquer to the entire surface of the
affected nail. Clean the reusable spatula
between each nail to be treated, to avoid the
infection of the lacquer. Don't wipe off any of the
lacquer on the bottle neck.
d) After use, clean the spatula with the same
cleaning pad used before for nail cleaning.
Keep the bottle tightly closed.
e) Repeat the process above for each affected
nail.
f) Treatment should be continued without
interruption until the nail is regenerated and the
affected areas are finally cured.

The required duration of treatment is usually six
months for the finger nails and nine months for the
toe nails (depending essentially on the intensity, the
localisation of the infection and the infected area of
nail).

medicines should also not be disposed of via
wastewater. These measures will help to protect
the environment.

Cautions:
Nail files used for treatment must not be reused
for the care of healthy nails.
! Before repeat application of Omicur the
affected nails should be cleansed with a
cleansing pad (as supplied) to remove any
remaining lacquer then filed down again as
necessary.
! When working with organic solvents (thinners,
white spirit, etc.) wear impermeable gloves in
order to protect the Omicur lacquer on the nails.
! Avoid contact of the lacquer with eyes, ears and
mucous membranes.

What Omicur contains
The active substance is:
Amorolfine hydrochloride
Equivalent to Amorolfine base
For 100 ml

!

It is important to carry on using Omicur until the
infection has cleared and healthy nails have grown
back. This usually takes around six months for the
finger nails and nine months for the toe nails.
If you use more Omicur than you should
Please immediatly contact your doctor or
pharmacist.
If you forget to use Omicur
Don't worry if you forget to use Omicur at the right
time. When you remember, start using the product
again at the correct time.
If you have any further questions on the use of this
product, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omicur can cause side effects,
although not everybody gets them.
Rare side effects (occurring in less than 1 in 1000
people)
Your nail may become discoloured or it may
become loose and start to separate from the nail
bed.
Very rare side effects (occurring in less than 1 in 10
000 people)
A burning sensation of allergic skin reaction
(contact dermatitis) may occur in the area around
the nail.
If any side effect becomes serious or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE OMICUR
Keep out of the reach and sight of children.
Do not use Omicur after the expiry date which is
stated on the bottle and carton after EXP. The
expiry date refers to the last day of that month.
Once the bottle has been opened, the product
should be discarded after 6 months.
The pack should be stored away from heat.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. Waste material contaminated with

6. FURTHER INFORMATION

5.574 g
5.000 g

The other ingredients are:
Ammonio methacrylate copolymer (Eudragit RL
100), triacetin, butyl acetate, ethyl acetate, ethanol
absolute.
What Omicur looks like and contents of the
pack
Omicur 5% is a medicated nail lacquer, filled in
amber glass bottles with white screw caps.
Omicur 5% is available in packs of:
! 2.5 mL* bottle and 10 spatulas.
! 2.5 mL* bottle and 20 spatulas.
! 2.5 mL* bottle, cleansing swabs, nail files and
spatulas.
! 2.5 mL* bottle, 30 cleansing swabs, 30 nail files
and 10 spatulas.
! 2.5 mL* bottle, 30 cleansing swabs, 30 nail files
and 30 spatulas.
! 5 mL bottles (2.5 mL & 2.5 mL), 10 spatulas.
! 5 mL bottles (2.5 mL & 2.5 mL), 60 cleansing
swabs, 30 nail files and 10 spatulas.
! 5 mL bottles (2.5 mL & 2.5 mL), 60 cleansing
swabs, 30 nail files and 30 spatulas.
! 5 mL bottles (2.5 mL & 2.5 mL), cleansing
swabs, nail files and spatulas.
*: Nominal volume is 2.5 ml and the filling volume is
3 ml.
Not all packaging sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA
U.K
Manufacturer
laboratoire chemineau
93, route de Monnaie
B.P.16
37210 vouvray - france
This leaflet was last approved in September
2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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