PREDNEFRIN FORTE phenylephrine hydrochloride/prednisolone acetate eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenylephrine hydrochloride, Quantity: 1.2 mg/mL; prednisolone acetate, Quantity: 10 mg/mL

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Eye Drops, suspension

Composition:

Excipient Ingredients: benzalkonium chloride; sodium metabisulfite; sodium citrate dihydrate; sodium chloride; boric acid; hypromellose; disodium edetate; phenazone; polysorbate 80; purified water; hydrochloric acid; sodium hydroxide

Administration route:

Ophthalmic

Units in package:

10mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Severe inflammation (non-infectious) of the eye, such as acute iritis, iridocyclitis, scleritis, episcleritis, uveitis, resistant ocular allergy and inflammation following surgery (where no infectious aetiology is suspected), particularly where unusually rapid control of the inflammation is required.

Product summary:

Visual Identification: Milky suspension; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-14

Patient Information leaflet

PREDNEFRIN
®
FORTE
Eye Drops CMI V4.0 PI v5.0
Page 1 of 4
PREDNEFRIN
® FORTE EYE DROPS_ _
_(prednisolone acetate and phenylephrine hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PREDNEFRIN
®
FORTE
eye
drops, (including how to use the
eye drops). It does not contain all
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
PREDNEFRIN
®
FORTE
eye
drops against the benefits they
expect it will have for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read
it again.
WHAT PREDNEFRIN
®
FORTE
EYE DROPS ARE USED
FOR
PREDNEFRIN
®
FORTE
eye
drops are used for the immediate
treatment of severe non infectious
pain, swelling and redness
(inflammation) of the eye,
inflammation of the coloured part
of the eye (iris), inflammation of
the iris and ciliary body,
inflammation of the white part of
the eye and persistent allergy of
the eye. PREDNEFRIN
®
FORTE
eye drops can also be used for the
treatment of non infectious
inflammation following surgery.
_MECHANISM OF ACTION: _
The first active ingredient in
PREDNEFRIN
®
FORTE
eye
drops, prednisolone acetate,
belongs to a chemical group called
the glucocorticoids, which reduce
pain, swelling and redness. The
second active ingredient,
phenylephrine hydrochloride, is
responsible for reducing swollen
blood vessels in the eye and lid.
Your doctor may have prescribed
PREDNEFRIN
®
FORTE
eye
drops for another reason. Ask your
doctor if you have any questions
about why PREDNEFRIN
®
FORTE
eye drops have been
prescribed for you.
BEFORE YOU USE
PREDNEFRIN
® FORTE
EYE
DROPS
_ _
_WHEN YOU MUST NOT USE IT _
Do not use PREDNEFRIN
®
FORTE
eye drops if you have:
1.
an allergy to PREDNEFRIN
®
FORTE
eye drops or any of
the ingredients listed at the
end of this leaflet.
2.
a severe untreated pus
for

Summary of Product characteristics

PREDNEFRIN
®
FORTE Eye Drops PI v4 CCDS v5.0
1
AUSTRALIAN PRODUCT INFORMATION - PREDNEFRIN
® FORTE
(PREDNISOLONE ACETATE AND PHENYLEPHRINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Phenylephrine hydrochloride and prednisolone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREDNEFRIN
®
FORTE eye drops contains prednisolone acetate (microfine suspension)
10 mg
(1%) and phenylephrine hydrochloride 1.2 mg (0.12%).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PREDNEFRIN
®
FORTE eye drops is a s
terile ophthalmic suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe inflammation (non-infectious) of the eye, such as acute iritis,
iridocyclitis, scleritis,
episcleritis, uveitis, resistant ocular allergy and inflammation
following surgery (where no
infectious aetiology is suspected), particularly where unusually rapid
control of the inflammation is
desired.
4.2
DOSE AND METHOD OF ADMINISTRATION
1 to 2 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. The
physician may choose the
dosage which affords optimal therapeutic effect in each case.
In order to minimise systemic absorption of PREDNEFRIN
®
FORTE eye drops, apply pressure to
the tear duct immediately following administration of the drug.
Care should be taken not to discontinue therapy prematurely.
4.3
CONTRAINDICATIONS
PREDNEFRIN
®
FORTE eye drops is contraindicated in:
•
Acute untreated purulent infections, such as superficial (or
epithelial) Herpes simplex keratitis
(dendritic keratitis), vaccinia, varicella and most other viral
diseases of the cornea and
conjunctiva
•
Ocular tuberculosis and fungal infections of the ocular structures of
the eye
PREDNEFRIN
®
FORTE Eye Drops PI v4 CCDS v5.0
2
•
Mycobacterial infection of the eye
•
Narrow angle glaucoma
•
Hypersensitivity to prednisolone acetate, phenylephrine hydrochloride,
benzalkonium chloride
or any of the other constituents.
4.