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VEXOL 1% EYE DROPS SUSPENSION

Active substance(s): RIMEXOLONE

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Package Leaflet - Information for the User
Vexol® 1% Eye Drops, Suspension
(rimexolone)
Your medicine is known as the above but will be referred to as
Vexol throughout the remainder of this leaflet.
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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
1.

What Vexol is and what it is used for
What you need to know before you use Vexol
How to use Vexol
Possible side effects
How to store Vexol
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). It helps to relieve
the symptoms of inflammation such as redness, soreness and
swelling.
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.
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.
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.
3.

How to use Vexol

 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.

The usual dose
This will depend on the reason for use.

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

Inflammation (red, painful eye)
Apply 1 drop in the affected eye 4 times a day or more often, if
advised by your doctor.

4.

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 (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.

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.
 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 Yellow card scheme Website: www.mhra.gov.uk/
yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5.
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6.

How to store Vexol
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date shown as
“EXP” on the bottle and carton.
Stop using the bottle 4 weeks after first opening, to
prevent infections.
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.
If you notice signs of your medicine deteriorating, consult
your pharmacist.
Do not pass this medicine on to others. It may harm
them, even if their symptoms are the same as yours.
Contents of the pack and other information

What Vexol contains
1 ml of suspension contains 10 mg of rimexolone.
Also contains benzalkonium chloride, mannitol, carbomer,
polysorbate 80, sodium chloride, sodium edetate,
hydrochloric acid and/or sodium hydroxide and purified
water.




What Vexol looks like and contents of the pack
A 5ml translucent plastic dropper bottle with white plastic screw
cap incorporating tamper-evident seal containing a white to offwhite suspension.
Manufacturer
This product is manufactured by: S.A. Alcon-Couvreur NV,
Puurs, Belgium.
or
ALCON CUSI, S.A., Camil Fabra, 58 08320 El Masnou,
Barcelona, Spain.
It is procured within the EU and re-packaged by the Product
Licence holder: G Pharma Ltd, Dakota Avenue, Salford
M50 2PU.
POM

PL No. 16369/1655
Leaflet revision date: 09/12/2015
Vexol is a registered trademark of N.V. Organon

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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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