Omicur 5% medicated nail lacquer
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-04-2020
Summary of Product characteristics
(SPC)
29-05-2020
Active ingredient:
Amorolfine hydrochloride
Available from:
Morningside Healthcare 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: 5055132712630 5055132712715
Patient Information leaflet
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
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.
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.
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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omicur 5% w/v Medicated Nail Lacquer
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amorolfine hydrochloride
5.574 g
Equivalent to Amorolfine base
5.000 g
For 100 ml
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Medicated nail lacquer.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
First line treatment of onychomycoses without matrix affection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To be applied to the affected finger or toe nails once or twice
weekly.
_ _
Method of administration
_For the packaging without cleansing swabs and nail files _
The patient should apply the Omicur 5% 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). However
if there
isn’t improvement, a review of the treatment is recommended at
intervals of
approximately three months.
Co-existent tinea pedis should be treated w
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