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VEXOL 10MG/ML EYE DROPS SUSPENSION

Active substance(s): RIMEXOLONE

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Package Leaflet - Information for the User

Vexol® 10mg/ml eye drops, suspension
(rimexolone)
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.
The name of your medicine is Vexol 10mg/ml eye drops, suspension but will be referred to as Vexol throughout
this leaflet.

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 pack and other information

1. 1 What Vexol is and what it is used for
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. 2 What you need to know 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 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.
You may still be able to use Vexol, but discuss it with
your doctor first.

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.

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

.

3.

How to use Vexol

The usual dose

Inflammation after eye surgery

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.

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.

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.

Not for use in CHILDREN.
Remove the loose collar from the cap when the
bottle is first opened.
Always use Vexol exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.
Continued over

3. 3How to use Vexol (continued)
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).

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.

4.

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 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.

Possible side effects

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

Rare (1 in 10 users in 10,000): Allergy, low blood
pressure, runny nose.

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.

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.

Rare (1 to 10 users in 10,00 ): Swelling of the back of
the eye, eyelid swelling, sensitivity to light, crusting on
the eyelids or scarring or other disorders.

If any of the side effects get serious, or you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.

Not known (cannot be estimated from the
available data): Reduced vision.

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 can help provide more
information on the safety of this medicine.

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.

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.

5.

How to store Vexol
Do not store above 25°C. Do not freeze.
Unopened Vexol: Do not use your eye drops after
the expiry date which is stated on the carton/bottle
label after ‘Exp’. The expiry date refers to the last
day of that month.
Discard 28 days after first opening.

6.

Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help in the protection
of the environment.

Contents of the pack and other information

What Vexol Contains
The active ingredient is rimexolone. Each ml of
suspension contains 10mg rimexolone.
The other ingredients are benzalkonium chloride,
mannitol, carbomer, polysorbate 80, disodium
edetate, sodium chloride and sodium hydroxide
and/or hydrochloric acid to adjust the pH, purified
water.

Manufactured by: SA Alcon-Couvreur NV,
Rijksweg 14, B-2870 Puurs, Belgium.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

What Vexol looks like and contents of the
pack

Vexol® 10mg/ml eye drops, suspension;
PL 18799/2489

Vexol is white to off-white suspension. It comes in a
plastic dropper bottle (Droptainer) with dropper and a
white screw cap containing 5ml suspension.

Leaflet date: 30.11.2015

POM

Package Leaflet - Information for the User

Rimexolone 10mg/ml eye drops, suspension
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.
The name of your medicine is Rimexolone 10mg/ml eye drops, suspension but will be referred to as Rimexolone
throughout this leaflet.

What is in this leaflet
1. What Rimexolone is and what it is used for
2. What you need to know before you use
Rimexolone
3. How to use Rimexolone

4. Possible side effects
5. How to store Rimexolone
6. Contents of pack and other information

1. 1 What Rimexolone is and what it is used for
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. 2 What you need to know 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 of this medicine (listed in section 6).
Ask your doctor for advice.
Rimexolone 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.
You may still be able to use Rimexolone, but discuss it
with your doctor first.

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.

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

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

.

3.

How to use Rimexolone

The usual dose

Inflammation after eye surgery

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.

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.

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.

Not for use in CHILDREN.
Remove the loose collar from the cap when the
bottle is first opened.
Always use Rimexolone exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

Continued over

3. 3How to use Rimexolone (continued)
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).

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.

4.

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 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.
If you have any further questions on the use of
RIMEXOLONE, ask your doctor or pharmacist.

Possible side effects

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

Rare (1 in 10 users in 10,000): Allergy, low blood
pressure, runny nose.

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.

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. The risk of Rimexolone
induced increased pressure inside the eye may be
greater in children and may occur earlier than in adults.
Rimexolone is not approved for use in children.

Rare (1 to 10 users in 10,00 ): Swelling of the back of
the eye, eyelid swelling, sensitivity to light, crusting on
the eyelids or scarring or other disorders.

If any of the side effects get serious, or you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.

Not known (cannot be estimated from the
available data): Reduced vision.

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 can help provide more
information on the safety of this medicine.

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.

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.

5.

How to store Rimexolone
Do not store above 25°C. Do not freeze.
Unopened Rimexolone: Do not use your eye drops
after the expiry date which is stated on the
carton/bottle label after ‘Exp’. The expiry date refers
to the last day of that month.
Discard 28 days after first opening.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help in the protection
of the environment.

theand
pack
and
other information
6. KeepContents
out of the of
sight
reach
of children.
What Rimexolone Contains
The active ingredient is rimexolone. Each ml of
suspension contains 10mg rimexolone.
The other ingredients are benzalkonium chloride,
mannitol, carbomer, polysorbate 80, disodium
edetate, sodium chloride and sodium hydroxide
and/or hydrochloric acid to adjust the pH, purified
water.

What Rimexolone looks like and contents of
the pack
Rimexolone is white to off-white suspension. It comes in
a plastic dropper bottle (Droptainer) with dropper and a
white screw cap containing 5ml suspension.

Manufactured by: SA Alcon-Couvreur NV,
Rijksweg 14, B-2870 Puurs, Belgium.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Rimexolone 10mg/ml eye drops, suspension;
PL 18799/2489
Leaflet date: 30.11.2015

POM

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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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