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Active substance(s): RIMEXOLONE

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Package Leaflet - Information for the User
VEXOL10 mg/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 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. 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


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.


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.
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. Simultanous use of topical NSAIDs and topical
steroids may increase the potential for healing problems.

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 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.
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.
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.

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 (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
 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.

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

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 the
national reporting system (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:
+353 1 6762517. Website:; E-mail:
United Kingdom
Yellow card scheme


How to store

Keep out of the reach and sight of children.
Do not freeze or store above 30C.
Stop using the bottle 4 weeks after first opening, to prevent infections.
Do not use the drops after the expiry date (marked 'Exp') on the bottle and the carton.
The expiry date refers to the last day of that month.
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.
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
 The active substance is rimexolone. One ml of suspension contains 10 mg of
 The other ingredients are benzalkonium chloride, mannitol (E421), carbomer,
polysorbate 80(E433), disodium edetate, sodium chloride, hydrochloric acid and/or
sodium hydroxide (to adjust pH) and purified water.
What VEXOL looks like and contents of the pack
VEXOL is a white to off-white suspension supplied in a pack containing a 3 ml, 5 ml or
10 ml plastic bottle with a screw cap.
Marketing authorisation holder:
Alcon Laboratories (UK) Ltd.
Frimley Business Park
Surrey, GU16 7SR
United Kingdom

SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
Alcon Cusi S.A., Camil Fabra 58,
08320 El Masnou, Barcelona, Spain.
This medicinal product is authorized in the Member States of the EEA under the
following names:
Austria, Finland, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, UK: VEXOL
This leaflet was last revised in May 2016
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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.