Medication Guide App

VEXOL 1% (10MG/ML) EYE DROPS SUSPENSION

Active substance: RIMEXOLONE

View full screen / Print PDF » Download PDF ⇩

Transcript
KAPVORM

PMS ZWART
à 100 %

44773-4

Package Leaflet - Information for the User

VEXOL 10 mg    l eye drops, suspension
/m
®

Rimexolone
Read all of this leaflet carefully before you start using this medicine
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET
1. What VEXOL is and what it is used for

4. Possible side effects

2. Before you use VEXOL

5. How to store VEXOL

3. How to use VEXOL

6. Further 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

2

surface and the front portion inside the eye
(  nterior segment .
a
)
It helps to relieve the symptoms of
inflammation such as redness, soreness
and swelling.

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 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.

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

Using other medicines
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
(  enzalkonium chloride  that can discolour
b
)
soft contact lenses and may cause eye
irritation.

HOW TO USE VEXOL®

The usual dose
This will depend on the reason for use.
Inflammation (  ed, painful eye 
r
)
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
(  veitis 
U
)
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.

Continued over

InDesign CS4

V2

Local
Ready for sending:
Graphics

BELGIUM 44773-4
Vexol 3 ml - 5 ml - 10 ml

recto-verso

GBI

AANTAL KLEUREN   1
:

HB

Approval

140 x 335     140 x 22 mm
/

BESOP-00326

22-07-2013

Affiliates

as is.

new proof.

The undersigned:
confirms that this proof contains an accurate translation of the English Corporate
Standard text, and is in compliance with the registered information and the legal
rules. Please also carefully check: local barcodes if any, formula,
shelflife if mentioned, storage conditions and trademarks.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.

Local
Final release:
Graphics

as is.

new proof.

KAPVORM

3

PMS ZWART
à 100% - 20%

HOW TO USE VEXOL® (  ontinued 
c
)

How to use

• 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 (  icture 2 .
p
)
• 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.

• Wash your hands before
you start.
• Shake the bottle well.
• Twist off the bottle cap.
1
• Hold the bottle pointing
down, between your
thumb and fingers.
• Tilt your head back.
• Pull down your lower
eyelid with a finger, until
2
there is a ‘pocket’
between the eyelid and your eye.
The drop will go in here (  icture 1 .
p
)
• 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.

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 (  ffect 1 to 10 people in 100   
a
):
Blurred vision, discharge, discomfort, pain,
a feeling of something in your eye,
increased pressure in the eye.
Uncommon (  ffect 1 to 10 people in 1000   
a
):
Redness of the eye or inside the eyelid,
itching, dry eyes, swelling, watery eyes,
sensitivity to light, irritation, crusting on the
eyelids, serious infections, eye surface
inflammation, scarring or other disorders.
Rare (  to 10 users in 10,000    Swelling of
1
):
the back of the eye, eyelid swelling.
Not known (  annot be estimated from the
c
available data    Reduced vision.
):

5

• You may also experience effects in
other areas of your body including  
:
Uncommon (  ffect 1 in 10 people in 1000   
a
):
Headache, low blood pressure, runny nose,
redness or soreness of the throat, bad or
unusual taste.
Rare (  in 10 users in 10,000    Allergy.
1
):
Not known (  annot be estimated from the
c
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.
If any of the side effects get serious, or
you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist.

HOW TO STORE VEXOL®

• 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
(  arked ‘Exp’  on the bottle and the
m
)
carton. The expiry date refers to the last
day of that month.

6

• 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.

• 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.

FURTHER INFORMATION

What VEXOL contains
• The active substance is rimexolone.
One ml of suspension contains 10 mg of
rimexolone.
• The other ingredients are benzalkonium
chloride, mannitol (  421 , carbomer,
E
)
polysorbate 80 (  433 , disodium edetate,
E
)
sodium chloride, hydrochloric acid and    r
/o
Marketing authorisation holder  
:
Alcon Laboratories (  K  Ltd.
U )
Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.
This medicinal product is authorised in the Member
States of the EEA under the following names  
:
Austria, Finland, Germany, Greece, Ireland, Italy,
Portugal, Spain, Sweden, UK   VEXOL
:

sodium hydroxide (  o adjust pH  and
t
)
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.
Manufacturer  
:
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in August 2013

®

© 2011, 2012, 2013 Novartis
07-2013

44773-4

InDesign CS4

V2

Local
Ready for sending:
Graphics

BELGIUM 44773-4
Vexol 3 ml - 5 ml - 10 ml

recto-verso

GBI

AANTAL KLEUREN   1
:

HB

Approval

140 x 335     140 x 22 mm
/

BESOP-00326

22-07-2013

Affiliates

as is.

new proof.

The undersigned:
confirms that this proof contains an accurate translation of the English Corporate
Standard text, and is in compliance with the registered information and the legal
rules. Please also carefully check: local barcodes if any, formula,
shelflife if mentioned, storage conditions and trademarks.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.

Local
Final release:
Graphics

as is.

new proof.

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.

Hide
(web1)