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RIMEXOLONE 1% EYE DROPS SUSPENSION

Active substance(s): RIMEXOLONE

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Package Leaflet - Information for the User

Vexol® 1% (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 your pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their symptoms 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

1

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

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).

2

It helps to relieve the symptoms of inflammation such as
redness, soreness and swelling.

What you need to know before you use Vexol

Do not use Vexol…

Driving and using machines

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.

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.

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.

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.

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.

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.

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.

3 How 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 ( picture1).

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.

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.

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.
Not known ( cannot be estimated from the
available data ) : Reduced vision.
Your may also expirence effects in ither areas of
your body including:
Uncommon ( affect 1 in 10 people in 1000):
Headache ,redness or soreness of the the throat, bad or
unusal 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.
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.

5 How to store Vexol
Do not use after the expiry date printed on the carton
or bottle label. The expiry date refers to the last day of
that month.
Do not store above 25°C, Do not freeze.
You should discard any unused suspension 28 days
after first opening the bottle. The bottle should be
discarded four weeks after first opening, to prevent
infections.
Keep out of the sight and reach of children.

If your doctor tells you to stop taking this medicine,
return any unused tablets to your pharmacist for safe
disposal. Only keep this medicine if your doctor tells
you to.
If your suspension become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
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.

6 Contents of the pack and other information
What Vexol Contains
Vexol contains 10mg of the active ingredient, Rimexolone
in every millilitre of white to off-white suspension.
The Other ingredients are benzalkonium chloride (as
preservative), mannitol, carbomer 934P, polysorbate 80,
disodium edetate, sodium chloride and purified water.
Sodium hydroxide and/or hydrochloric acid may also be
included in very small quantities to adjust the acidity and
alkalinity of the product to ensure comfort of the product in
the eye.

How Vexol looks like and contents of the pack
Vexol is avalbel in 5 ml plastic bottle with a white plastic
dropper cap with a tamper evident seal.
Manufactured by: Alcon Cusi S.A., E-08320 EI Masnou,
Barcelona, Spain.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Vexo 10mg/ml eye drops, suspension
POM
PL No: 18799/2537
Leaflet date: 23.07.2015

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 your pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their symptoms 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

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).

2

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

It helps to relieve the symptoms of inflammation such as
redness, soreness and swelling.

What you need to know before you use Rimexolone

Do not use Rimexolone…

Driving and using machines

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.

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.

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.

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
This will depend on the reason for use.

Inflammation after eye surgery

Inflammation (red, painful eye )

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.

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.

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.

3 How 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 ( picture1).

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.

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.

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.
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.
Not known ( cannot be estimated from the
available data ) : Reduced vision.
Your may also expirence effects in ither areas of
your body including:
Uncommon ( affect 1 in 10 people in 1000):
Headache ,redness or soreness of the the throat, bad or
unusal 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 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.
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.

5 How to store Rimexolone
Do not use after the expiry date printed on the carton
or bottle label. The expiry date refers to the last day of
that month.
Do not store above 25°C, Do not freeze.
You should discard any unused suspension 28 days
after first opening the bottle. The bottle should be
discarded four weeks after first opening, to prevent
infections.
Keep out of the sight and reach of children.

If your doctor tells you to stop taking this medicine,
return any unused tablets to your pharmacist for safe
disposal. Only keep this medicine if your doctor tells
you to.
If your suspension become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
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.

6 Contents of the pack and other information
What Rimexolone Contains
Rimexolone contains 10mg of the active ingredient,
Rimexolone in every millilitre of white to off-white
suspension.
The Other ingredients are benzalkonium chloride (as
preservative), mannitol, carbomer 934P, polysorbate 80,
disodium edetate, sodium chloride and purified water.
Sodium hydroxide and/or hydrochloric acid may also be
included in very small quantities to adjust the acidity and
alkalinity of the product to ensure comfort of the product in
the eye.

How Rimexolone looks like and contents of the
pack
Rimexolone is available in 5ml plastic bottle with a
white plastic dropper cap with a tamper evident seal.
Manufactured by: Alcon Cusi S.A., E-08320 EI Masnou,
Barcelona, Spain.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Rimexolone10mg/ml eye drops, suspension
PL No: 18799/2537
POM
Leaflet date: 23.07.2015

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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