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VEXOL 10 MG/ML EYE DROPS SUSPENSION

Active substance(s): RIMEXOLONE

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T05555

VEXOL® 10 mg/ml Eye Drops, Suspension
(rimexolone)

Patient Information Leaflet
Your medicine is called VEXOL® 10 mg/ml Eye
Drops, Suspension but will be referred to as
Vexol throughout the following:
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 of the side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

3. How to use Vexol
The usual dose
This will depend on the reason for use.
Inflammation (red, painful eye)
Apply 1 drop in the affected eye 4 times a day or
more often, if advised by your doctor.
Inflammation of the inside of the eye
(Uveitis)
1st week - Apply 1 drop in the affected eye
every hour while awake.
2nd week - Apply 1 drop every 2 hours while
awake.
3rd week - Apply 1 drop 4 times a day.
4th week - Apply 1 drop twice daily for the first 4
days and then apply 1 drop once daily for the
last 3 days.

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

Inflammation after eye surgery
Apply 1 drop in the affected eye 4 times a day,
beginning 24 hours after your operation and
continuing for the first 2 weeks afterwards.

1. What Vexol® is and what it is used for

Always use Vexol exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

Vexol belongs to a group of medicines known
as corticosteroids.
It is used to prevent or treat eye inflammation
following surgery of the eye and to treat
inflammation of the eye surface and the front
portion inside the eye (anterior segment).
It helps to relieve the symptoms of inflammation
such as redness, soreness and swelling.

2. What you need to know before you
use Vexol

Not for use in CHILDREN.
Remove the loose collar from the cap when
the bottle is first opened.

How to use
• Wash your hands before you start.
• Shake the bottle well.
• Twist off the bottle cap.
• Hold the bottle pointing down, between
your thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with a finger,
until there is a ‘pocket’ between the eyelid
and your eye.
The drop will go in here (picture 1).

Do not use Vexol...
• If you have any type of infection of the eye
that is not being treated. Use of steroids
may make infections worse.
• If you have a red eye that has not been
seen by a doctor.
• If you are allergic to rimexolone or any of
the other ingredients of this medicine (listed
in section 6).
Ask your doctor for advice.
Vexol is not for use in CHILDREN.
Take special care...
• If you have a disorder causing a thinning
of the eye tissues, such as rheumatoid
arthritis, Fuch’s dystrophy or following a
corneal transplant. Steroids may cause
further thinning and possible perforation.
• Steroids applied to the eye may delay the
healing of your eye wound.

• Bring the bottle tip close to the eye.
Do this in front of a mirror if it helps.
• Do not touch your eye or eyelid,
surrounding areas or other surfaces with the
dropper. It could infect the drops.
• Gently press on the base of the bottle to
release one drop at a time (picture 2).

You may still be able to use Vexol, but discuss
it with your doctor first.
Pregnancy and breast-feeding
If you are pregnant or might get
pregnant, or if you are breast-feeding a baby,
talk to your doctor before you use Vexol.
Driving and using machines
If your vision is blurred or your sight is affected
in any way following the use of Vexol, you
should not drive or operate machinery until
your vision is clear.
Other medicines and Vexol
Tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
If you are using more than one eye
preparation, wait 15 minutes between each
application.
Important information if you wear Contact
Lenses
Wearing contact lenses is not advisable during
treatment of an eye inflammation as it may
make your condition worse.
Do not use the drops while wearing contact
lenses. Wait at least 15 minutes after use
before putting your lenses back in. There is a
preservative in Vexol (benzalkonium chloride)
that can discolour soft contact lenses and may
cause eye irritation.

• Do not squeeze the bottle, only a gentle
press on the bottom is needed.
• If you use drops in both eyes, repeat the
steps for your other eye. Put the bottle cap
firmly back on immediately after use.
• If a drop misses your eye, try again.
• If you forget to use Vexol, just use it as
soon as possible. However, if it is almost
time for your next dose, skip the missed
dose and go back to your normal dosing
schedule. Do not take a double dose to
make up.
• If you use more Vexol than you should, it
can be washed out with luke warm water.
• If treatment with Vexol is stopped…
A flare-up of inflammation may occur if
treatment is discontinued early. Do not
suddenly stop using the product without
your doctor’s advice. Your doctor may want
to gradually reduce the amount you use to
reduce the chance of unwanted effects.
If you have any further questions on the use
of Vexol, ask your doctor or pharmacist.

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4. Possible side effects
Like all medicines, Vexol can cause side effects,
although not everybody gets them.
• You may experience some or all of the
following effects in your eye(s):
Common (affect 1 to 10 people in 100): Blurred
vision, discharge, discomfort.
Uncommon (affect 1 to 10 people in 1000):
Redness of the eye or inside the eyelid, pain,
itching, dry eyes, swelling, watery eyes, eye
staining, irritation, serious infections, increased
pressure in the eye, eye surface inflammation
or other disorders.
Rare (1 to 10 users in 10,000): Swelling of the
back of the eye, eyelid swelling, sensitivity to
light, crusting on the eyelids or scarring or other
disorders.

Manufacturer and Product Licence Holder:
This product is manufactured by SA
Alcon-Couvreur NV, Rijksweg 14, B-2870
Puurs, Belgium. It is procured from within the
EU by the Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS and repackaged by Interport
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS.
POM
PL No: 10380/1579
Leaflet revision date: 21/07/2015
Vexol® is registered trademark of Novartis AG,
Switzerland.

Not known (cannot be estimated from the
available data): Reduced vision.
• You may also experience effects in other
areas of your body including:
Uncommon (affect 1 in 10 people in 1000):
Headache, redness or soreness of the throat,
bad or unusual taste.
Rare (1 in 10 users in 10,000): Allergy, low
blood pressure, runny nose.
Not known (cannot be estimated from the
available data): Chest pain.
If Vexol is used for a long time this can lead to
an increase in pressure inside the eye or the
formation of cataracts, both of which can lead to
decreased vision. It can also lead to infections,
as your natural resistance to these is reduced.
The risk of Vexol induced increased pressure
inside the eye may be greater in children and
may occur earlier than in adults. Vexol is not
approved for use in children.
If any of the side effects get serious, or you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
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
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 Vexol
• Keep out of the sight and reach of children.
• Do not freeze. Do not store above 25° C.
• Stop using the bottle 4 weeks after first
opening, to prevent infections.
• Do not use the drops after the expiry date
(marked ‘Exp’) on the bottle and the carton.
The expiry date refers to the last day of that
month.
• Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
• Do not pass this medicine on to others. It
may harm them, even if their symptoms are
the same as yours.
• If the medicine becomes discoloured or
shows any other signs of deterioration, you
should seek the advice of your pharmacist
who will tell you what to do.

6. Contents of the pack and other
information
What Vexol contains
• Each 1 ml contains 10 mg of rimexolone.
• The other ingredients are benzalkonium
chloride, mannitol, carbomer,
polysorbate 80, disodium edetate,
sodium chloride, hydrochloric acid and / or
sodium hydroxide (to adjust pH) and
purified water.
What Vexol looks like and contents of the
pack
Vexol is a white to off-white suspension.
supplied in a pack containing a 5 ml plastic
bottle with a screw cap.

T05555

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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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