FUCITHALMIC VISCOUS EYE-DROPS

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

FUSIDIC ACID

Beschikbaar vanaf:

DKSH MALAYSIA SDN BHD

INN (Algemene Internationale Benaming):

FUSIDIC ACID

Eenheden in pakket:

5 gm

Geproduceerd door:

LEO LABS LTD

Bijsluiter

FUCITHALMIC
® VISCOUS EYE-DROPS
Fusidic acid (10mg/g)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Fucithalmic_
_®_
is used for
2.
How
_Fucithalmic_
_®_
works
3.
Before you use
_Fucithalmic_
_®_
4.
How to use
_Fucithalmic_
_®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Fucithalmic_
_®_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _FUCITHALMIC_
_®_ IS USED FOR
_Fucithalmic_
_®_
is
indicated
for
bacterial
eye
infections
caused
by
susceptible
organisms
in
conjunctivitis
(inflammation of the white of the eye, or
called
as
“red
eye”),
blepharitis
(inflammation of the eyelid), sty (a lump
on the edge of the upper or lower eyelid),
keratitis
(inflammation
of
the
cornea,
which is the clear area in the centre of
the eye), dacryocystitis (inflammation of
the
tear
sac)
and
in
connection
with
removal of foreign bodies.
HOW _FUCITHALMIC_
_®_ WORKS
_Fucithalmic_
_®_
works
by
killing
germs
(bacteria) that cause infections.
BEFORE YOU USE _FUCITHALMIC_
_®_
-
_When you must not use it _
Do not use
_Fucithalmic_
_®_
• If you are allergic (hypersensitive) to
fusidic
acid,
or
any
of
the
other
ingredients in your medicine. You can
find a list of these ingredients in section
of product description of this leaflet.
_ _
-
_Before you start use it _
_Pregnancy and breast-feeding _
Please ask your doctor or pharmacist for
advice before using
_Fucithalmic_
_®_
:
• If you are pregnant, or think you are
pregnant.
• If you are breast-feeding.
-
_Taking other medicines _
Please tell your doctor or pharmacist if
you are taking, or have recently taken
any other medicines. This includes any
medicines
which
you
have
bought
without a prescription.
HOW TO USE _FUCITHALMIC_
_®_
-
_How much to use _
Always use
_Fucithalmic_
_®_
exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
This medicine is only for use in your
eyes. Do not swallow the drops. Do not
pu

Productkenmerken

Fucithalmic ® is a sterile 1% aqueous sustained-release formulation of fusidic
acid, preserved with benzalkonium chloride.
Product Description:
Viscous, white to off-white aqueous suspension.
Properties:
Fucithalmic
® is active against Staphylococci, Streptococci, Neisseria,
Haemophilus, Moraxella and Corynebacteria.
The sustained-release formulation of Fucithalmic
® ensures a prolonged
contact with the conjunctival sac. A twice-daily application provides sufficient
concentrations in all relevant tissues of the eye. Fucithalmic
® penetrates well
into the aqueous humour.
Indications:
Bacterial eye infections caused by susceptible organisms inconjunctivitis,
blepharitis, sty, keratitis, dacryocystitis and in connection with removal of
foreign bodies.
Dosage:
One drop to be instilled into the eye twice daily. Treatment should be
continued for at least two days after the eye appears normal.
Contra-indications:
Hypersensitivity to any component.
Precautions:
Should not be used when contact lenses are being worn.
Pregnancy and lactation:
There is inadequate evidence of safety in human pregnancy.
Animal studies and many years of clinical experience have suggested that\
fusidic acid is devoid of teratogenic effects. Safety in nursing mothers has not
been established.
Side-effects:
Transient stinging may occur. Fucithalmic
® has a very low allergenic potential.
Drug interaction:
Not relevant.
Incompatibilities:
Fucithalmic
® is a ready-for-use preparation and should, therefore not be
mixed with other ingredients or preparations.
Storage:
Store below 30°C.
Discard after 28 days from opening.
Dosage form: Viscous Eye-Drops
Packaging: 5g tube
Manufactured by:
LEO Laboratories, Dublin, Ireland
Date of revision of PI: November 2018.
MAH:
Amdipharm Limited, Temple Chambers,
3 Burlington road, Dublin 4, Ireland
Fucithalmic ®
Fusidic acid 10 mg/g
Viscous eye-drops
P A GE 1 OF 2
Dimension: 145 x 280 mm
C ommodit y No.: N/A
Pharma Code: N/A
Core Spec Ref.: N/A
Print Colours: Black
Non-Print Colours: Cutter
Min. Font Size: 1