Fucithalmic

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Fusidic acid 1%{relative}

Disponible desde:

AFT Pharmaceuticals Ltd

Designación común internacional (DCI):

Fusidic acid 1% w/w

Dosis:

1% w/w

formulario farmacéutico:

Eye drops, solution

Composición:

Active: Fusidic acid 1%{relative} Excipient: Benzalkonium chloride Carbomer Disodium edetate dihydrate Mannitol Sodium hydroxide Water for injection

Unidades en paquete:

Tube, 5 g

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Leo Pharma A/S

indicaciones terapéuticas:

Fucithalmic® is indicated for the topical treatment of bacterial eye infections where the organism is sensitive to the antibiotic. These may include: bacterial conjunctivitis, blepharitis, sty, and keratitis.

Resumen del producto:

Package - Contents - Shelf Life: Tube, - 5 g - 28 days opened stored at or below 25°C 36 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1988-09-08

Información para el usuario

NEW ZEALAND CONSUMER MEDICINE INFORMATION
FUCITHALMIC
®
FUSIDIC ACID EYE DROPS 1% (10 MG/G)
WHAT IS IN THIS LEAFLET
This leaflet contains information about Fucithalmic
®
Eye Drops. Please read it carefully before you start
to take your medicine. Keep it, as you may want to read it again. The
information in this leaflet answers
some common questions. Your doctor or pharmacist has more information.
This leaflet is not intended
to take the place of discussion with your doctor.
Talk to your doctor or pharmacist if there is anything that is
worrying you or you do not understand.
WHAT IS FUCITHALMIC
® USED FOR?
Fucithalmic
®
eye drops contain an antibiotic (called “fusidic acid”). This
antibiotic is used to treat
infections on the surface of the eye.
Examples of such infections are:
▪
Inflammation of the white of the eye, caused by bacteria (called
“conjunctivitis” or “red eye”).
▪
Sty (infection of a hair follicle in the eyelid)
▪
Inflammation of the eyelid (called “blepharitis”)
▪
Inflammation of the cornea, which is the clear area in the centre of
the eye. This is called “keratitis”
and causes discomfort in the eye.
Fucithalmic
®
is effective only against those bacteria which fusidic acid can kill.
Do not use Fucithalmic
®
for other eye conditions, unless your doctor has told you to.
Fucithalmic
®
eye drops contain the active ingredient, fusidic acid, (which is a
very mild acid) in a gel.
This gel gradually releases the fusidic acid. Fucithalmic
®
gel becomes clear liquid in the tear fluid of
your eye. This clear liquid helps prevent blurring of your vision.
This medicine is available only with a doctor’s prescription.
BEFORE YOU USE FUCITHALMIC
® EYE DROPS
_DO NOT USE FUCITHALMIC_
_®_
_ IF: _
▪
You are wearing contact lenses. Contact lenses must NOT be worn during
treatment with
Fucithalmic
®
. Also, do not wear contact lenses until 24 hours after the end of
your Fucithalmic
®
treatment. If you wear contact lenses, ingredients in Fucithalmic
®
eye drops may scratch your

Ficha técnica

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 4
1 FUCITHALMIC®
Fucithalmic 1% w/w Viscous Eye Drops
Fucithalmic® is an antimicrobial agent that inhibits bacterial
protein synthesis. Fucithalmic® kills a
wide range of gram-positive organisms. It is used to treat bacterial
eye infections. Each gram
contains fusidic acid anhydrous 10 mg, as fusidic acid hemihydrate.
Ph.Eur.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains fusidic acid, hemihydrate 10mg.
Excipient with known effect: 0.01% w/w benzalkonium chloride
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sterile viscous eye drops of 1% aqueous sustained release formulation
of fusidic acid
(microcrystalline suspension) in a carbomer gel. Fucithalmic®
liquefies and becomes clear on
contact with the electrolytes of the tear fluid, and therefore causes
less blurring of vision than eye
ointment. The viscosity of the carbomer allows easy administration and
gives rise to prolonged
concentrations of fusidic acid in the tear fluid.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fucithalmic® is indicated for the topical treatment of bacterial eye
infections where the organism is
sensitive to the antibiotic. These may include: bacterial
conjunctivitis, blepharitis, sty, and keratitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
For all ages: One Fucithalmic® drop to be instilled into the eye
twice daily. Treatment should be
continued for at least 48 hours after the eye returns to normal.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of its components.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact lenses should not be worn/used when Fucithalmic® is used. The
microcrystalline fusidic acid
may cause scratches in the contact lens or cornea. Fucithalmic® eye
drops contain benzalkonium
chloride, which is known to discolour soft contact lenses.
Fucithalmic® eye drops are preserved with benzalkonium chloride.
Benzalkonium chloride may
cause eye irritation.
Bacterial resistance has been reported to occur with the use of