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

Active substance: RIMEXOLONE

View full screen / Print PDF » Download PDF ⇩

Transcript
KAPVORM

PMS ZWART
à 100 %

44773-5

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,
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. What VEXOL is and what it is used for

4. Possible side effects

2. What you need to know before you
use Vexol

5. How to store VEXOL

3. How to use VEXOL

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
a
)
portion inside the eye (  nterior segment .

2

6. Contents of the pack and other
information

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...

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 of this medicine ( isted in
l
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

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 (  enzalkonium chloride 
b
)
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 (  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

KAPVORM

3

PMS ZWART
à 100 % - 20 %

How to use VEXOL® (  ontinued 
c
)

How to 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 there is a
‘pocket’ between the eyelid
2
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

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

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 carton. The
m
)
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.

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) :
a
):
Common (  ffect 1 to 10 people in 100    Blurred
vision, discharge, discomfort.
a
):
Uncommon (  ffect 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 (  to 10 users in 10,000    Swelling of the
1
):
back of the eye, eyelid swelling, sensitivity to
light, crusting on the eyelids or scarring or other
disorders.
c
Not known (  annot be estimated from the
available data    Reduced vision.
):
• You may also experience effects in other
areas of your body including  
:
Uncommon (  ffect 1 in 10 people in 1000   
a
):
Headache, redness or soreness of the throat, bad
or unusual taste.
1
):
Rare (  in 10 users in 10,000    Allergy, low blood
pressure, runny nose.
Not known (  annot be estimated from the
c
available data    Chest pain.
):

5

• 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.

• 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
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 purified
t
)
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 2014.

®

© 2011, 2012, 2013, 2014 Novartis
09-2014

44773-5

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
(web2)