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PRED FORTE 1%W/V EYE DROPS

Active substance(s): PREDNISOLONE ACETATE / PREDNISOLONE ACETATE / PREDNISOLONE ACETATE

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Part Number: 72064MD012J
Drawing Number: 0106901

Do not use PRED FORTE
■■ If you are allergic to
prednisolone acetate,
benzalkonium chloride or
any of the other ingredients
of this medicine (listed in
section 6)
■■ If you suffer from viral, fungal
or bacterial eye infections
■■ If you suffer from tuberculosis
of the eye
■■ If you have injuries to or
ulcers on the cornea

2. What you need to
know before you use
PRED FORTE

It reduces the irritation,
burning, redness and swelling
of eye inflammation caused
by chemicals, heat, radiation,
allergy, or foreign objects in
the eye.

PRED FORTE belongs to a
group of medicines known as
steroidal anti-inflammatory
drugs. PRED FORTE is used
in adults for the short-term
treatment of eye inflammation.

1. What PRED FORTE is
and what it is used for

What is in this leaflet:
1. What PRED FORTE is and
what it is used for
2. What you need to know
before you use PRED FORTE
3. How to use PRED FORTE
4. Possible side effects
5. How to store PRED FORTE
6. Contents of the pack and
other information

Package leaflet:
Information for the user
If you have previously had
herpes simplex

Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be

Some medicines may increase
the effects of PRED FORTE
and your doctor may wish to
monitor you carefully if you
are taking these medicines
(including some medicines for
HIV: ritonavir, cobicistat).

Other medicines and
PRED FORTE
Please tell your doctor if you
are taking or have recently
taken any other medicines,
including medicines obtained
without a prescription.

Tell your doctor before using
PRED FORTE, if you are:
Using or have used other
steroid eye drops, as frequent
or long-term use of steroids can
result in additional side effects.

Warnings and precautions
Talk to your doctor before using
PRED FORTE if you suffer from,
or have in the past suffered from:
■■ Eye ulcers or have had a
disease or treatment to the
eye that caused the tissue
to become thin
■■ You have glaucoma or are
being treated for raised
pressure within the eye
■■ You have had surgery for
cataracts
■■ Bacterial, viral or fungal eye
infections

■■

The recommended dose is
1 or 2 drops into the affected
eye(s) 2 to 4 times a day.
During the first two days of
treatment you may be asked
to apply the drops as often as
every hour.

Always use this medicine
exactly as your doctor has
told you. Check with your
doctor or pharmacist if you
are not sure.

3. How to use PRED FORTE

PRED FORTE contains
benzalkonium chloride
Contact lenses
• Do not use the drops while
your contact lenses are in
your eyes. Wait at least 15
minutes after using the eye
drops before putting your
lenses back in your eyes.
• A preservative in
PRED FORTE (benzalkonium
chloride) may cause eye
irritation. PRED FORTE
should not be used whilst soft
contact lenses are in place,
as it may discolour them.

Driving and using
machines
PRED FORTE may cause
temporary blurred vision. Do
not drive or use machinery until
the symptoms have cleared.

pregnant or are planning to
have a baby, ask your doctor
or pharmacist for advice before
taking this medicine as steroids
may be harmful to the baby.

1% w/v Eye Drops, Suspension
Prednisolone acetate

PRED FORTE®

Let go of the
lower lid, and
close your eye.
Press your finger
against the
corner of your eye
(the side where
your eye meets
your nose) for
one minute.

Turn the bottle
upside down
and squeeze it
to release one
or two drops into
each eye that
needs treatment.

Gently pull the
lower eyelid down
until there is a
small pocket.

If a drop misses your eye,
try again.

4.

3.

2.

1.

Wash your hands.
Shake the bottle
well before use.
Tilt your head
back and look at
the ceiling.

Apply your eye drops in the
following way:

Instructions for use
You must not use the bottle if
the tamper-proof seal on the
bottle neck is broken before
you first use it.

Turn over

If you use this medicine for more
than 10 days, your doctor may
ask you to have check-ups.
These are to make sure that your
medicine is working properly and

To avoid eye injury and
contamination, do not let the tip
of the dropper touch your eye or
anything else.
Replace and tighten the cap
straight after use.
Wipe off any excess liquid from
your cheek with a clean tissue.

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

Insert - Pred Forte® - United Kingdom - MoH Submission

Package leaflet:
Information for the user

PRED FORTE®

1% w/v Eye Drops, Suspension
Prednisolone acetate

that the dose you are taking
is right for you. Your doctor
will check your eyes for:
• an increase in pressure
• cataracts
• infection
The proper application of your
eye drops is very important. If
you have any questions ask
your doctor or pharmacist.

If you use more PRED FORTE
than you should
Putting too many drops in
your eye(s) is unlikely to lead
to unwanted side effects. If
you have placed too many
drops in your eye(s), wash
your eye(s) with clean water.
Apply your next dose at the
normal time.

If, by accident, anyone drinks
this medicine, contact your
doctor straight away.
If you forget to use
PRED FORTE
If you forget a dose apply it as
soon as you remember, unless
it is almost time for your next
dose, in which case you should
miss out the forgotten dose.
Then apply your next dose as
usual and continue with your
normal routine.
Do not take a double dose to
make up for a forgotten dose.

If you stop using
PRED FORTE
PRED FORTE should be used
as advised by your doctor. Do
not stop using PRED FORTE
until your doctor has told you to.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. Possible Side Effects

Like all medicines, this
medicine can cause side
effects, although not
everybody gets them.

You should see your
doctor immediately if you
experience:
■■ ulcers on the surface
of the eye
severe pain in the eye

■■

You should see your doctor
if any of the following
effects prove troublesome
or if they are long-lasting:
■■ allergic reaction
■■ headache
■■ increased pressure
within the eye
■■ centre of the eye becomes
cloudy (cataracts)
a feeling that something is
in your eye
■■

■■

■■
■■
■■
■■
■■
■■

eye infections (bacterial,
fungal or viral)
mild stinging or irritation
red eye
blurred or poor vision
pupil dilation
change in sense of taste
rash or itching

Reporting of side effects
If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible
side effects not listed in this
leaflet. You can also report
side effects directly via:
Yellow Card Scheme
Website:
www.mhra.gov.uk/yellowcard

By reporting side effects you can
help provide more information
on the safety of this medicine.

5. How to store PRED FORTE
Keep this medicine out of the
sight and reach of children.
Discard the bottle 28 days
after opening, even if there is
solution remaining.

Do not use this medicine after
the expiry date which is stated
on the bottle label and the
bottom of the carton after EXP.
The expiry date refers to the
last day of that month for an
unopened bottle.
Do not store above 25°C (room
temperature). Do not freeze.

Do not use this medicine if
you notice the tamper-proof
seal is broken.

Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help
protect the environment.

6. Contents of the pack and
other information

If you would like further
information, please contact
Medical Information
at Allergan Ltd. Tel:
01628 494026 or Email:
uk_medinfo@allergan.com

Manufacturer
Allergan
Pharmaceuticals Ireland
Westport
Co Mayo
Ireland

This leaflet was last revised in
February 2017.

What PRED FORTE contains
• The active substance is
Prednisolone acetate 1.0% w/v.
• The other ingredients are
benzalkonium chloride,
disodium edetate,
hydroxypropylmethylcellulose,
polysorbate 80, boric acid,
sodium citrate, sodium
chloride and purified water.
What PRED FORTE looks like
and contents of the pack
PRED FORTE is a sterile eye drop
suspension in a plastic bottle.
Each carton contains 1 plastic
bottle with a screw cap. Each
bottle is about half full and
contains 5 ml or 10 ml of the
eye drops as written on the front
of the carton.

Marketing
Authorisation Holder
Allergan Limited
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL

72064MD012J

To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free
of charge: 0800 198 5000 (UK only).
Please be ready to give the following
information: Prednisolone 1% reference
number PL 00426/0051. This is a service
provided by the Royal National Institute of
Blind People.
® marks owned by Allergan, Inc.
© 2017 Allergan, Inc., Irvine CA 92612

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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