Flucon

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluorometholone 0.1%{relative} (+5% overage)

Available from:

Novartis New Zealand Ltd

INN (International Name):

Fluorometholone 0.1% w/v (+5% overage)

Dosage:

0.1% w/v

Pharmaceutical form:

Eye drops, suspension

Composition:

Active: Fluorometholone 0.1%{relative} (+5% overage) Excipient: Benzalkonium chloride Dibasic sodium phosphate Disodium edetate dihydrate Hydrochloric acid Hypromellose Monobasic sodium phosphate monohydrate Polysorbate 80 Polyvinyl alcohol Purified water Sodium chloride Sodium hydroxide

Units in package:

Bottle, dropper, Droptainer, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, Droptainer - 5 mL - 24 months from date of manufacture stored at or below 25°C. Do not freeze

Authorization date:

1982-11-18

Patient Information leaflet

Internal document code
PAGE: 1
Flu200818cNZ
FLUCON EYE DROPS 0.1%_ _
_Fluorometholone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU USE 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.medsafe.govt.nz.
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 against the risks this
medicine could have for you.
The information in this leaflet
applies to Flucon only. This
information does not apply to
similar products, even if they
contain the same ingredients.
IF YOU HAVE ANY CONCERNS ABOUT
USING FLUCON EYE DROPS, 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

Summary of Product characteristics

Internal document code
1
Flu200818iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Flucon
®
fluorometholone 0.1% Eye Drops Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Flucon contains 1.0 mg of fluorometholone (0.1% w/v)
.
Excipient with known effect
Benzalkonium chloride 0.1 mg in 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and
anterior segment of the globe.
4.2.
DOSE AND METHOD OF ADMINISTRATION
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.
CONTRAINDICATIONS

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.

Mycobacterial ocular infections.

Hypersensitivity to
fluorometholone and the other constituents of this medication. (See
Section 6.1. List of excipients).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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 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 steroid medicati