(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 forming eye infection.
3. Herpes simplex of the eye.
4. an ulcer on the front layer of the eyeball.
5. viral diseases of the eye.
6. Tuberculosis (mycobacterial infection) of the eye.
7. fungal infections of the eye.
Check with your doctor if:
1. you have a condition in which the pressure of fluid in the eye may be high (glaucoma).
2. you have a disease which causes thinning of the front layer of the eyeball.
3. you have a disease of the artery walls (arteriosclerosis).
4. you have high blood pressure (hypertension).
5. you have a condition where your thyroid gland is overactive (hyperthyroidism).
6. you have an enlarged prostate.
7. you have a condition where your blood sugar levels are too high (diabetes).
8. you have received monoamine oxidase (MAO) inhibitor therapy or you are within 14 days
of stopping such treatment.
9. you are susceptible to allergies or you are an asthmatic.
10. you are pregnant or have the intention of becoming pregnant. Like most medicines,
PREDNEFRIN® FORTE eye drops are not recommended during pregnancy unless the benefits outweigh
the risks.
11. you are breastfeeding or planning to start breastfeeding. It is not known whether
your baby may absorb this medicine from breast milk and therefore there is a possibility
of harm to the baby.
Do not use PREDNEFRIN® FORTE eye drops if:
the seal around the cap is broken,
the bottle/packaging shows signs of tampering,
the expiry date on the bottle or carton has passed.
If you use this medicine after the expiry date has passed, it may not work.
Do not put the eye drops into your eye(s) while you are wearing soft contact lenses.
The preservative in PREDNEFRIN® FORTE eye drops (benzalkonium chloride) may be deposited in soft contact lenses.
You can put your soft contact lenses back into your eyes 15 minutes after you have
used PREDNEFRIN® FORTE eye drops.
It is not known if PREDNEFRIN® FORTE eye drops are safe and useful for children and adolescents under 18 years.
It is not recommended to be used in children and adolescents under 18 years.
These drops are for topical use only.
If you are not sure whether you should start using PREDNEFRIN® FORTE eye drops, talk to your doctor.
Before you start to use it
Tell your doctor if:
1. you have had an allergy to any other medicines or any other substances, such as foods,
preservatives or dyes.
2. you have or have had any medical conditions, especially a bacterial, viral or fungal
disease.
If you have not told your doctor about any of the above, tell them before you use
PREDNEFRIN® FORTE eye drops.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
There are no known drug interactions with PREDNEFRIN® FORTE eye drops.
How to use PREDNEFRIN® FORTE eye drops
How much to use
The usual dosage of PREDNEFRIN® FORTE eye drops is one to two drops in the eye(s) two to four times daily. During
the initial 24 to 48 hours your doctor may increase the dosage to two drops every
hour.
Do not stop using PREDNEFRIN® FORTE eye drops even if you feel well unless instructed by your doctor.
Your doctor will tell you how many drops you need to use each day. Use PREDNEFRIN® FORTE eye drops only as prescribed by your doctor.
Follow all directions given to you by your doctor carefully. They may differ from
the information contained in this leaflet.
Use PREDNEFRIN® FORTE eye drops every day, at about the same time each day, unless your doctor tells
you otherwise. Using your eye drops at the same time each day will have the best effect
on your condition. It will also help you remember when to use the eye drops.
If you are using more than one eye drop product, wait 5 minutes before using the second
product.
If you are being changed from one eye drop to another, follow your doctor’s instructions
carefully as to when to stop the old drops and when to start the new drops.
How to use it
You may find it easier to put drops in your eye while you are sitting or lying down.
If you are wearing soft contact lenses, remove them before putting the drops in your
eye.
To open a new bottle of PREDNEFRIN® FORTE eye drops, first tear off the protective seal from the bottle. The seal will
break and you can pull it off and then throw it away.
1. Wash your hands well with soap and water.
2. Shake the bottle gently.
4. Hold the bottle upside down in one hand between your thumb and forefinger or index
finger.
5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
6. Tilt your head back and look up.
7. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
8. Release one drop into the pouch or pocket formed between your eye and eyelid by gently
squeezing the bottle.
9. Close your eye. Do not blink or rub your eye.
10. 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. Ask your doctor for more specific instructions
on this technique.
11. Replace the cap, sealing it tightly.
12. Wash your hands again with soap and water to remove any residue.
Wait 15 minutes before replacing your contact lenses.
Be careful not to touch the dropper tip against your eye, eyelid or anything else
to avoid contaminating the eye drops.
Contaminated eye drops may give you an eye infection.
How long to use it
Continue using PREDNEFRIN® FORTE eye drops for as long as your doctor prescribes.
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.
If you forget to use it
If 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.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not use double the amount to make up for the dose that you missed.
If you use too much (overdose)
If you accidentally put several drops in your eye(s), immediately rinse your eye(s)
with warm water.
If you think that you or anyone else may have swallowed any or all of the contents
of a bottle of PREDNEFRIN® FORTE eye drops, drink fluids to dilute and immediately telephone your doctor or
Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your
nearest hospital. Do this even if there are no signs of discomfort or poisoning.
While you are using PREDNEFRIN® FORTE eye drops
Things you must do
If you develop an eye infection, receive an eye injury, or have eye surgery tell your
doctor.
Your doctor may tell you to use a new container of PREDNEFRIN® FORTE eye drops because of possible contamination of the old one, or may advise
you to stop your treatment with PREDNEFRIN® FORTE eye drops.
If you become pregnant while using PREDNEFRIN® FORTE eye drops tell your doctor immediately.
If you wear soft contact lenses, remove them before using PREDNEFRIN® FORTE eye drops. Leave your lenses out for at least 15 minutes after putting in the
eye drops.
Tell your doctor if your condition gets worse or does not get better while using PREDNEFRIN® FORTE eye drops.
If you are about to be started on any new medicine tell your doctor and pharmacist
that you are using PREDNEFRIN® FORTE eye drops.
Things you must not do
Do not give PREDNEFRIN® FORTE eye drops to anyone else, even if they have the same condition as you.
Do not stop using PREDNEFRIN® FORTE eye drops without first talking to your doctor.
Things to be careful of
Your vision may blur for a short time after you put in your PREDNEFRIN® FORTE eye drops. If this happens you should wait until you can see well again before
you drive or use machinery.
PREDNEFRIN® FORTE eye drops may cause the pupils to get dilated (get bigger) or transient blurring
of vision which may impair the ability to drive a car or operate machinery. Wait until
your vision has cleared. Be careful driving or operating machinery until you know
how PREDNEFRIN® FORTE eye drops affect you.
Use of PREDNEFRIN® FORTE eye drops after cataract surgery may delay healing and increase the likelihood
of blister formation on the eye.
If you experience blurred vision or other visual disturbances while using PREDNEFRIN® FORTE eye drops, tell your doctor immediately.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using PREDNEFRIN® FORTE eye drops. PREDNEFRIN® FORTE eye drops help most people with severe inflammation of the eye, but it may
have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them. Ask your doctor or pharmacist to answer any questions you may have.
Some side effects of PREDNEFRIN® FORTE eye drops are:
increased pressure in the eye
formation of cataract, i.e. blurred vision
viral, bacterial or fungal infections of the eye
perforation of the tissues of the eye
eye irritation
vision blurred/vision disturbances
dilation of the pupil
dry eye
eye discharge
eye pain
foreign body sensation
eye pruritus (itchy eye)
increased flow of tears
ocular hyperemia (red eye)
droopy eyelid (ptosis)
There can also be effects on the body as a whole such as allergy, rash, headache,
altered taste and itching.
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice any other effects and they worry you.
After using PREDNEFRIN® FORTE eye drops
Storage
Keep your eye drops in a cool place where the temperature stays below 25°C. Store
upright. Do not freeze the eye drops.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave
it in the car or on window sills. Do not carry the eye drops in pockets of your clothes.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.
Do not leave the top/lid off the bottle for any length of time to avoid contaminating
the eye drops.
Disposal
Write the date on the bottle when you open the eye drops and throw out any remaining
solution after four weeks.
Eye drops contain a preservative which helps prevent germs growing in the solution
for the first four weeks after opening the bottle. After this time there is a greater
risk that the drops may become contaminated and cause an eye infection. A new bottle
should be opened.
If your doctor tells you to stop using the eye drops or they have passed their expiry
date, ask your pharmacist what to do with any remaining solution.
Product description
What it looks like
The eye drops come in a 10 mL sterile plastic bottle.
Ingredients
Active ingredients: Prednisolone acetate 10 mg/mL (1%) and phenylephrine hydrochloride
1.2 mg/mL (0.12%).
Inactive ingredients: benzalkonium chloride 0.04 mg/mL (0.004%), phenazone, polysorbate
80, boric acid, sodium citrate, sodium chloride, sodium metabisulfite, disodium edetate,
hypromellose, and purified water.
Manufacturer/Supplier
AbbVie Pty Ltd
Mascot NSW 2020
AUSTRALIA
ARTG number: AUST R 23235
Date of preparation:
May 2023
© 2023 AbbVie. All rights reserved.
PREDNEFRIN FORTE and its design are trademarks of Allergan, Inc., an AbbVie company.