VEXOL 1% EYE DROPS

Active substance: RIMEXOLONE

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Vexol ® 1% Eye Drops

Ref: 0544/070114/1/F

(rimexolone)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or your pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Vexol 1% Eye Drops,
throughout the remainder of this leaflet it will be
referred to as Vexol
In this leaflet
1 What Vexol is and what it is used for
2 Before you use Vexol
3 How to use Vexol
4 Possible side effects
5 How to store Vexol

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.
Using other medicines
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.

6 Further information

1

What Vexol is and what it is used for

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.

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

Before you use Vexol

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 listed in section 6.

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.

Ask your doctor for advice.

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.

Vexol is not for use in CHILDREN.

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.

Remove the loose collar from the cap when the
bottle is first opened.



You may still be able to use Vexol, but discuss it
with your doctor first.

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

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).
• 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).
• 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.

Rare (1 in 10 users in 10,000): Allergy.
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.

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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you help provide more
information on the safety of this medicine.

5

How to store Vexol

EXPIRY DATE
Do not use this medicine after date shown on the
carton label on or bottle. Only keep this medicine if
your doctor tells you to. If your eye drops become
discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you
what to do.
HOW TO STORE VEXOL
• Do not store above 30°C.
• Do not freeze.
• KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
• Once the bottle has been opened then the eye
drops must be discarded one month after first
opening.

If you have any further questions on the use of
Vexol, ask your doctor or pharmacist.
6 Further Information

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, pain, a feeling
of something in your eye, increased pressure in the
eye.
Uncommon (affect 1 to 10 people in 1000):
Redness of the eye or inside the eyelid, itching, dry
eyes, swelling, watery eyes, sensitivity to light,
irritation, crusting on the eyelids, serious infections,
eye surface inflammation, scarring or other
disorders.

What Vexol contains
Vexol contains 10mg/ml of rimexolone as the active
ingredient. Vexol also contains benzalkonium
chloride, mannitol, carbomer, polysorbate 80,
sodium chloride, disodium edetate, sodium
hydroxide, hydrochloric acid, purified water.
What Vexol looks like and contents of the pack
Vexol is a white to off-white suspension in a plastic
dropper bottle.
Vexol is available in bottles of 5ml of solution.
Manufacturer and Licence Holder
Vexol is manufactured by Alcon Cusi, S.A C/Camil
Fabra 58, 08320 EI Masnou-Barcelona, Spain and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

POM
Rare (1 to 10 users in 10,000) :
Swelling of the back of the eye, eyelid swelling.
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, low blood pressure, runny nose, redness
or soreness of the throat, bad or unusual taste.

PL 15184/0544

Leaflet revision date: 07/01/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 0544/070114/1/B

Ref: 0544/070114/1/F

Rimexolone 1% Eye Drops
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or your pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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 Rimexolone.
Driving and using machines
If your vision is blurred or your sight is affected in
any way following the use of Rimexolone, you
should not drive or operate machinery until your
vision is clear.

Your medicine is called Rimexolone 1% Eye Drops,
throughout the remainder of this leaflet it will be
referred to as Rimexolone

Using other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.

In this leaflet
1 What Rimexolone is and what it is used for

If you are using more than one eye preparation,
wait 15 minutes between each application.

2 Before you use Rimexolone
3 How to use Rimexolone
4 Possible side effects
5 How to store Rimexolone

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.

6 Further information

1 What Rimexolone is and what it is used

for

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 Rimexolone(benzalkonium chloride) that can
discolour soft contact lenses and may cause eye
irritation.

Rimexolone 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

Before you use Rimexolone

Do not use Rimexolone...
• 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 listed in section 6.

3 How to use Rimexolone
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.

Ask your doctor for advice.

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.

Rimexolone is not for use in CHILDREN.

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.

Remove the loose collar from the cap when the
bottle is first opened.



You may still be able to use Rimexolone, but
discuss it with your doctor first.

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

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).
• 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).
• 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 Rimexolone, 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 Rimexolone than you should,
it can be washed out with luke warm water.
• If treatment with Rimexolone 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.

Rare (1 in 10 users in 10,000): Allergy.
Not known (cannot be estimated from the available
data): Chest pain.



If Rimexolone 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.

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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you help provide more
information on the safety of this medicine.

5 How to store Rimexolone
EXPIRY DATE
Do not use this medicine after date shown on the
carton label on or bottle. Only keep this medicine if
your doctor tells you to. If your eye drops become
discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you
what to do.
HOW TO STORE VEXOL
• Do not store above 30°C.
• Do not freeze.
• KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
• Once the bottle has been opened then the eye
drops must be discarded one month after first
opening.

If you have any further questions on the use of
Rimexolone, ask your doctor or pharmacist.
6 Further Information
4 Possible side effects
Like all medicines, Rimexolone 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, pain, a feeling
of something in your eye, increased pressure in the
eye.
Uncommon (affect 1 to 10 people in 1000):
Redness of the eye or inside the eyelid, itching, dry
eyes, swelling, watery eyes, sensitivity to light,
irritation, crusting on the eyelids, serious infections,
eye surface inflammation, scarring or other
disorders.
Rare (1 to 10 users in 10,000) :
Swelling of the back of the eye, eyelid swelling.

What Rimexolone contains
Rimexolone contains 10mg/ml of rimexolone as the
active ingredient. Rimexolone also contains
benzalkonium chloride, mannitol, carbomer,
polysorbate 80, sodium chloride, disodium edetate,
sodium hydroxide, hydrochloric acid, purified water.
What Rimexolone looks like and contents of the
pack
Rimexolone is a white to off-white suspension in a
plastic dropper bottle.
Rimexolone is available in bottles of 5ml of solution.
Manufacturer and Licence Holder
Rimexolone is manufactured by Alcon Cusi, S.A
C/Camil Fabra 58, 08320 EI Masnou- Barcelona,
Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0544

Leaflet revision date: 07/01/14
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, low blood pressure, runny nose, redness
or soreness of the throat, bad or unusual taste.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 0544/070114/1/B

Expand view ⇕

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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