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RIMEXOLONE 1% EYE DROPS SUSPENSION

Active substance(s): RIMEXOLONE / RIMEXOLONE / 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 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.
The name of your medicine is Vexol 1% (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 the pack and other information

1. What Vexol is and what it is used for
Vexol belongs to a group of medicines known as
corticosteroids.

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

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. 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).

Pregnancy and breast-feeding
If you are pregnant or might get pregnant, or if you are breastfeeding a baby, talk to your doctor before you use Vexol.

Ask your doctor for advice.

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.

Vexol is not for use in CHILDREN.

Other medicines and Vexol

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.
 If you are diabetic, have a family history of glaucoma, or
are very near - sighted please consult your doctor. The risk
of developing an increase in eye pressure and/or cataract
formation is higher in susceptible patients using steroids.
 Steroids applied to the eye may delay the healing of your
eye wound Topical NSAIDs (non-steroidal anti
inflammatory drug- medications-( type of painkillers )) are
also known to slow or delay healing. Simultaneous use of
topical NSAIDs and topical steroids may increase the
potential for healing problems.

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

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

Tell your doctor if you are using topical NSAIDs. Simultaneous
use of topical steroids and topical NSAIDs may increase
corneal healing problems.
If more than one topical ophthalmic medicinal product is being
used, the medicines must be administered at least 5 minutes
apart. Eye ointments should be administered last.

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.

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.
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.

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.
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) .









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).
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.




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):

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

Common (affect 1 to 10 people in 100): Blurred vision,
discharge, discomfort



Not known (cannot be estimated from the available data):
Chest pain.

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.


You may also experience effects in other areas of your
body including:

Uncommon (affect 1 to 10 people in 1000): Headache, redness
or soreness of the throat, bad or unusual taste.

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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report any 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





Keep out of the sight and reach of children.
Do not use the drops after the expiry date which is stated
on the carton or bottle label after 'Éxp'. The expiry date
refers to the last day of that month.
Do not store above 25°C. Do not freeze.
Discard contents 28 days after first opening the bottle.






Remember if your doctor tells you to stop taking this
medicine, return any unused medicine 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 to
protect 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 available in 5 ml plastic bottle with a white plastic
dropper cap with a tamper evident seal.
Manufactured by: Alcon Cusi S.A., Camil Fabra 58, 08320
EL Masnou, Barcelona, Spain.
OR S.A. Alcon-Couvreur NV, 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.
POM
Vexol® 1% (10mg/ml) Eye Drops, Suspension;
PL 18799/2537
Leaflet date: 20.03.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

Package Leaflet - Information for the User

Rimexolone 1% 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 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 1% 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 the pack and other information

1. What Rimexolone is and what it is used for
Rimexolone belongs to a group of medicines known as
corticosteroids.

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

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. 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.
 If you are diabetic, have a family history of glaucoma, or
are very near - sighted please consult your doctor. The risk
of developing an increase in eye pressure and/or cataract
formation is higher in susceptible patients using steroids.
 Steroids applied to the eye may delay the healing of your
eye wound Topical NSAIDs (non-steroidal anti
inflammatory drug- medications-( type of painkillers )) are
also known to slow or delay healing. Simultaneous use of
topical NSAIDs and topical steroids may increase the
potential for healing problems.
You may still be able to use Rimexolone, but discuss it with
your doctor first.

Pregnancy and breast-feeding
If you are pregnant or might get pregnant, or if you are breastfeeding 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.

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.
Tell your doctor if you are using topical NSAIDs. Simultaneous
use of topical steroids and topical NSAIDs may increase
corneal healing problems.
If more than one topical ophthalmic medicinal product is being
used, the medicines must be administered at least 5 minutes
apart. Eye ointments should be administered last.

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.

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

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.
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) .
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.
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.





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):

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

Common (affect 1 to 10 people in 100): Blurred vision,
discharge, discomfort



Not known (cannot be estimated from the available data):
Chest pain.

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.


You may also experience effects in other areas of your
body including:

Uncommon (affect 1 to 10 people in 1000): Headache, redness
or soreness of the throat, bad or unusual taste.

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.

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 any 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





Keep out of the sight and reach of children.
Do not use the drops after the expiry date which is stated
on the carton or bottle label after 'Éxp'. The expiry date
refers to the last day of that month.
Do not store above 25°C. Do not freeze.
Discard contents 28 days after first opening the bottle.






Remember if your doctor tells you to stop taking this
medicine, return any unused medicine 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 to
protect 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 5 ml plastic bottle with a white
plastic dropper cap with a tamper evident seal.
Manufactured by: Alcon Cusi S.A., Camil Fabra 58, 08320
EL Masnou, Barcelona, Spain.
OR S.A. Alcon-Couvreur NV, 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.
POM
Rimexolone 1% Eye Drops, Suspension;
PL 18799/2537
Leaflet date: 20.03.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

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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