Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using PREDNEFRIN® FORTE?
PREDNEFRIN® FORTE eye drops contain the active ingredients phenylephrine hydrochloride
and prednisolone acetate. PREDNEFRIN® FORTE is used to treat severe inflammation
(pain, swelling and redness) of the eye that is NOT caused by an infection and persistent
allergy of the eye.
2. What should I know before I use PREDNEFRIN® FORTE?
Check the list of ingredients at the end of the CMI. Do not use PREDNEFRIN® FORTE
if you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not aware that you have
any other medical conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with PREDNEFRIN® FORTE and affect how it works, or PREDNEFRIN®
FORTE may interfere with other medicines and affect how they work.
4. How do I use PREDNEFRIN® FORTE?
Your doctor will tell you the number of drops to use, when to use PREDNEFRIN® FORTE
and how long to use it.
5. What should I know while using PREDNEFRIN® FORTE
|
Things you should do
|
Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using
PREDNEFRIN® FORTE®.
Follow all your doctor's instructions carefully.
Keep all your follow-up appointments so your condition can be closely checked.
|
|
Things you should not do
|
Do not stop using this medicine suddenly.
Do not to touch the dropper tip against your eye, eye lid or any surface.
Do not use PREDNEFRIN® FORTE while you are wearing contact lenses.
|
|
Driving or using machines
|
Wait for your vision to clear after using PREDNEFRIN® FORTE before you drive or use
machines.
|
|
Drinking alcohol
|
There is no information on the effects of using PREDNEFRIN® FORTE with alcohol.
|
|
Looking after your medicine
|
Follow all instructions on the carton and bottle label.
Store upright in a cool dry place, below 25°C, away from moisture, heat, or sunlight.
Do not freeze.
|
6. Are there any side effects?
Increased pressure in the eye, eye irritation, dilation (widening) of the pupil, dry
eye, eye discharge, eye infection, eye pain, foreign body sensation, itchy eye, watery
eye(s), eye redness, blurry vision or changes in vision, headache, changes to taste,
itchy, red skin rash, severe allergic reaction.
Active ingredients:
[phenylephrine hydrochloride & prednisolone acetate] (fen-nil-ef-rin hi-dro-chlor-ride & pred-nis-so-lone as-see-tate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PREDNEFRIN® FORTE eye drops.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using PREDNEFRIN® FORTE.
Where to find information in this leaflet:
1. Why am I using PREDNEFRIN® FORTE?
PREDNEFRIN® FORTE contains the active ingredients phenylephrine hydrochloride and
prednisolone acetate.
PREDNEFRIN® FORTE is used to treat severe inflammation (pain, swelling and redness)
of the eye that is NOT caused by an infection.
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.
2. What should I know before I use PREDNEFRIN® FORTE?
Warnings
Do not use PREDNEFRIN® FORTE if:
you are allergic to phenylephrine hydrochloride, prednisolone acetate, or any of the
ingredients listed at the end of this leaflet.
you have any infection in or around the eye (bacterial, viral or fungal)
you have an open sore on the front layer of the eyeball
you have glaucoma (increased pressure in the eye).
Check with your doctor if you:
have any condition which might cause thinning of the front layer of the eyeball
have thickening of the walls of blood vessels (arteriosclerosis)
have or have had high blood pressure
have an overactive thyroid
have an enlarged prostate
have diabetes
are susceptible to allergies
have or have had adrenal suppression (body doesn't make enough hormones, which can
make you feel tired and weak)
have or have had asthma
take any medicines for any other condition.
The use of steroids after cataract surgery may delay healing.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Make sure your doctor is aware that you are pregnant or plan to become pregnant or
are breastfeeding or intend to breastfeed.
Use in children
Use of PREDNEFRIN® FORTE is not recommended in children or adolescents younger than
18 years of age.
3. What if I am taking other medicines?
Tell your doctor, pharmacist or optical practitioner if you are using any other medicines,
including any medicines, vitamins, or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Some medicines may interfere with PREDNEFRIN® FORTE and affect how it works; while
PREDNEFRIN® FORTE may affect how other medicines work.
Do not use PREDNEFRIN® FORTE if:
you are taking specific medicines to treat depression called "monoamine oxidase (MAO)
inhibitors," tricyclic antidepressants, or you have taken them in the last 14 days.
There is a small chance that taking certain CYP3A inhibitor medicines, like some antibiotics,
antifungal, and antiretroviral drugs, could increase your risk of having side effects.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are using and if these affect
PREDNEFRIN® FORTE.
4. How do I use PREDNEFRIN® FORTE?
How much to use
use one to two drops in the affected eye(s), according to your doctor's instructions.
When to use PREDNEFRIN® FORTE
Use PREDNEFRIN® FORTE as instructed by your doctor.
Make sure you understand how frequently you should use it and when to start using
it and when to finish using it.
In some instances, PREDNEFRIN® FORTE needs to be used with other eye drops. Your
doctor will let you know which drops, how to use them and how long to use them.
Wait at least 5 to 10 minutes after using PREDNEFRIN® FORTE before using other eye
drops.
How to use PREDNEFRIN® FORTE
1. If you wear contact lenses, remove them before using PREDNEFRIN® FORTE.
2. Wash your hands well with soap and water.
3. Shake the bottle well.
4. Tear off the protective seal on any new bottle and throw the seal away. Remove the
lid/cap.
5. Hold the bottle upside down in one hand between your thumb and index finger.
6. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
7. Tilt your head back and look up. This might be easier if you are sitting or lying
down.
8. Put the tip of the bottle close to your lower eyelid. Do not let the tip touch your
eye or eyelid.
9. Release one drop into the pouch or pocket formed between your eye and eyelid by gently
squeezing the bottle.
10. If a drop misses your eye, try again, and wipe off any excess that runs down your
cheek.
11. Close your eye. Do not blink or rub your eye or eyelid.
12. While your eye is closed, place your index finger against the inside corner of your
eye and press against your nose for about two minutes. This will help to stop the
medicine from draining through the tear duct to the nose and throat, from where it
can be absorbed into other parts of your body.
13. Replace the lid/cap, sealing it tightly.
14. Wash your hands again with soap and water.
15. If you wear contacts, wait 15 minutes before replacing your contact lenses.
If you forget to use PREDNEFRIN® FORTE
It is important that you use PREDNEFRIN® FORTE according to your doctor's instructions.
If you forget to use PREDNEFRIN® FORTE and it is almost time for your next dose, skip
the dose you missed and use your next dose when you are meant to.
Otherwise, use the drops as soon as you remember, and then go back to using/taking
them as you would normally.
Do not use double the number of drops to make up for the dose you missed.
If you use too much PREDNEFRIN® FORTE
Immediately rinse your eyes with warm water.
If PREDNEFRIN® FORTE is accidentally swallowed, you should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appears to be no signs of discomfort or poisoning.
5. What should I know while using PREDNEFRIN® FORTE?
Things you should do
Follow all of your doctor's instructions carefully.
If you wear soft contact lenses, remove them before using PREDNEFRIN® FORTE, and wait
at least 15 minutes before inserting them again. The preservative in PREDNEFRIN® FORTE
eye drops (benzalkonium chloride) may be absorbed and cause discolouration of soft
contact lenses.
Keep all your follow-up appointments with your doctor so your eye(s) can be checked.
Use all the medication prescribed to treat your eye condition.
Keep the bottle tightly sealed to avoid contaminating the eye drops.
Call your doctor straight away if:
you develop an eye infection, receive an eye injury, or have eye surgery
you develop blurred vision or you notice any changes in your vision
you become pregnant while using PREDNEFRIN® FORTE
your eye(s) seem(s) to be getting worse or is/are not improving.
Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using
PREDNEFRIN® FORTE.
Things you should not do
Do not touch the dropper tip against your eye, eyelid, or anything else, to avoid
contaminating the eye drops. PREDNEFRIN® FORTE eye drops contain a corticosteroid.
Corticosteroid eye drops should not be used for more than 10 days, except under strict
supervision by your doctor.
Do not stop using this medicine suddenly without checking with your doctor.
Driving or using machines
Wait for your vision to clear after using PREDNEFRIN® FORTE before you drive or use
machines.
Looking after your medicine
Follow the instructions on the carton and bottle label on how to take care of your
medicine properly.
Store PREDNEFRIN® FORTE upright.
Store it in a cool dry place away from moisture, heat or sunlight; for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on window sills.
Do not freeze the eye drops.
Keep it where young children cannot reach it.
When to discard your medicine
Discard the bottle 4 weeks after first opening it.
Getting rid of any unwanted medicine
If your doctor advises that you no longer need to use this medicine or it is out of
date, take it to any pharmacy for safe disposal.
Do not open a new bottle to use it if the expiry date has passed.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most
of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Effects on the eye:
increased pressure in the eye
eye irritation
dilation (widening) of the pupil
dry eye
eye discharge
eye pain
foreign body sensation
itchy eye
watery eye(s)
eye redness
droopy eye lid
Effects on the body as a whole:
headache
changes to taste
itchy, red skin rash.
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety
of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
using any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What PREDNEFRIN® FORTE contains
|
Active ingredients
(main ingredients)
|
phenylephrine hydrochloride
prednisolone acetate
|
|
Other ingredients
(inactive ingredients)
|
boric acid
disodium edetate
hydrochloric acid
hypromellose
phenazone
polysorbate 80
purified water
sodium chloride
sodium citrate dihydrate
sodium hydroxide
sodium metabisulfite
|
|
Potential allergens
|
benzalkonium chloride
|
Do not use this medicine if you are allergic to any of these ingredients.
What PREDNEFRIN® FORTE looks like
PREDNEFRIN® FORTE is a milky suspension. It is supplied in a plastic dropper bottle
containing 10 mL of liquid. (Aust R 23235).
Who distributes PREDNEFRIN® FORTE?
PREDNEFRIN® FORTE is distributed in Australia by:
AbbVie Pty Ltd
Mascot NSW 2020
Australia
Toll-free:1800 252 224
This leaflet was prepared in July 2025
Version 1
© 2025 AbbVie. All rights reserved.
PREDNEFRIN® FORTE and its design are trademarks of Allergan Inc., an AbbVie company.