Flucon

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

fluorometholone

Доступно од:

Novartis Pharmaceuticals Australia Pty Ltd

Класа:

Medicine Registered

Статус ауторизације:

Registered

Информативни летак

FLUCON EYE DROPS 0.1%
1
FLUCON EYE DROPS
0.1%
_Fluorometholone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU USE ANY FLUCON EYE
DROPS.
This leaflet answers some common
questions about FLUCON Eye
Drops. It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
FLUCON Eye Drops against the
risks this medicine could have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUCON IS USED
FOR
FLUCON Eye Drops are used to treat
the redness, swelling, and other
symptoms of eye inflammation.
FLUCON Eye Drops contain the
active ingredient fluorometholone
acetate. Fluorometholone belongs to
a class of medicines known as
"steroids" or "corticosteroids" which
reduce inflammation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
_USE IN CHILDREN _
This medicine is not recommended in
children.
The safety and effectiveness of
FLUCON Eye Drops has not been
established in children.
BEFORE YOU USE
FLUCON
_WHEN YOU MUST NOT USE IT _
Do not use this medicine if you have
an allergy to:

Fluorometholone

Any other similar medicines
containing other types of
"steroids"

An

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION – FLUCON
(FLUOROMETHOLONE) EYE DROPS SUSPENSION
1
NAME OF THE MEDICINE
Fluorometholone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of FLUCON contains fluorometholone 1.0 mg
List of excipients with known effect: benzalkonium chloride 0.1 mg as
preservative
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye drops, suspension. It is a sterile ophthalmic suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and anterior
segment of the globe.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Shake well before use.
One or two drops instilled into the conjunctival sac two to four times
daily. During the initial 24 to
48 hours the dosage may be safely increased to 2 drops every hour.
Care should be taken not to
discontinue therapy prematurely.
4.3
C
ONTRAINDICATIONS
−
Acute, untreated bacterial infections.
−
Herpes simplex keratitis.
−
Fungal diseases of ocular structures.
−
Vaccinia, varicella and most other viral diseases of the cornea and
conjunctiva.
−
Tuberculosis of the eye.
−
Hypersensitivity to the constituents of this medication.
−
Mycobacterial ocular infections.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Employment of steroid medication in the treatment of stromal keratitis
or uveitis caused by herpes
simplex requires great caution; frequent slit lamp microscopy is
mandatory. Prolonged use may
result in ocular hypertension and/or glaucoma, damage to the optic
nerve, defects in visual acuity
2
and visual field, posterior subcapsular cataract formation.
Corticosteroids may reduce resistance to
and aid in the establishment of bacterial, viral or fungal secondary
ocular infection from pathogens
liberated from ocular tissue. In those diseases causing thinning of
the cornea, or sclera, perforation
has been known to occur with the use of topical steroids. Acute
untreated infection may be masked
or enhanced by s