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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® 10 mg/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 10mg/ml eye drops, suspension, but
will be referred to as Vexol throughout the remainder of the 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 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.
• 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.

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 (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 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.
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.
• 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
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 the 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. How to store Vexol
Keep out of the sight and reach 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.
6. Contents of the pack and other information
Vexol is white to off-white suspension in plastic dropper bottle containing
5ml of solution.
The active ingredient in Vexol is rimexolone 10 mg/ml. Also contains
benzalkonium chloride as a preservative, mannitol, carbomer,
polysorbate 80, disodium edetate, sodium chloride and purified water.
Very small amounts of hydrochloric acid and/or sodium hydroxide may
have been added to regulate the acidity/alkalinity of the product to ensure
comfort in the eye.
This medicine is manufactured by Alcon Cusi, S.A. C/Camil Fabra, 58
08320 EI Masnou Barcelona, Spain. Procured from with in the EU.
Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Vexol 10mg/ml eye drops, suspension

PL 20774/1210

Vexol is a registered trademark of N.V. Organon.
POM
th

Date of preparation 12 April 2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant
Pharmaceuticals
Ltd, Tel: 01204 473081
PP3/1210/V3

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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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