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MAXIDEX 0.1% W/V EYE DROPS SUSPENSION

Active substance(s): DEXAMETHASONE / DEXAMETHASONE / DEXAMETHASONE

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75610-2

Package Leaflet - Information for the User

MAXIDEX

®

eye drops, suspension

Dexamethasone
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
4. Possible side effects

1. What MAXIDEX is and
what it is used for
2. Before you use MAXIDEX
3. How to use MAXIDEX

1.

5. How to store MAXIDEX
6. Further information

WHAT MAXIDEX IS AND WHAT IT IS USED FOR

MAXIDEX belongs to a group of medicines
known as corticosteroids.
It is used to treat inflammation of the eye
surface and the front portion inside the eye

2.

( anterior segment ) and to prevent or treat
inflammation following surgery to the eye.
It helps to relieve the symptoms of inflammation
such as redness, soreness and swelling.

BEFORE YOU USE MAXIDEX

Do not use MAXIDEX...
• If you think that you have any type of
infection, including viral and fungal infections
and tuberculosis of the eye.
• If you are allergic to dexamethasone or any
of the other ingredients listed in section 6.
If any of these apply, ask your doctor for advice.

Take special care...
• Only use MAXIDEX in your eye ( s ).
MAXIDEX should be used with caution in
children under 2 years of age.
• Use of MAXIDEX for long periods of time,
may cause increased pressure in your eye ( s )
and / or the development of cataracts.
MAXIDEX should not be used for more than
one week, unless advised by your doctor. The
risk of increase in eye pressure and/or cataract
formation is higher in susceptible patients (e.g.
patients with diabetes) using steroids.
• If you already have high pressure in your eye ( s )
or an eye disease such as glaucoma, you
should have your eye pressure checked
regularly whilst using MAXIDEX.
This is especially important in paediatric
patients, as the risk of corticosteroid-induced
ocular hypertension may be greater in children
and may occur earlier than in adults. Ask your
doctor for advice especially in children.
• Use of steroids may make eye infections
worse and delay healing of an eye wound.
If you have an infection, your doctor will
prescribe another medicine to treat it. Topical
NSAIDs (Non-Steroidal Anti Inflammatory
Drugs-Medications) are also known to slow or
delay healing. Simultaneous use of topical
NSAIDs and topical steroids may increase the
potential for healing problems.
• If you have a disorder causing a thinning of
the eye tissues. Steroids may cause further
thinning and possible perforation.
• Talk to your doctor if you experience swelling
and weight gain around the trunk and in the face
as these are usually the first manifestations of a
syndrome called Cushing’s syndrome.
Suppression of the adrenal gland function may
develop after stopping a long-term or intensive

3.
HOW TO USE MAXIDEX
The usual dose
The usual dose is 1 drop in the affected eye ( s )
every 4 hours.
However, in severe inflammations the dose may be
increased to 1 to 2 drops every 30 to 60 minutes
until a satisfactory response is obtained, when the
dose may gradually be reduced.
Use MAXIDEX with caution in children below
2 years of age.

treatment with Maxidex. Talk to your doctor
before stopping the treatment by yourself. These
risks are especially important in children and
patients treated with a drug called ritonavir or
cobicistat.
• Contact your doctor if you experience blurred
vision or other visual disturbances.
If any of these apply, you may still be able to use
MAXIDEX, 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 MAXIDEX.
MAXIDEX should not be used during pregnancy
or breast-feeding.

Driving and using machines
MAXIDEX may cause your vision to be blurred for
some time after use. Do not drive or use any
machines unless your vision is clear.

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.
Tell your doctor if you are using topical NSAIDs.
Simultaneous use of topical steroids and topical
NSAIDs may increase healing problems in your eye.
Tell your doctor if you are using ritonavir or
cobicistat, as this may increase the amount of
dexamethasone in the blood.
If you are using more than one type of eye
medicine, the medicines must be used at least
5 minutes apart. Eye ointments should be used
last.

Important information if you wear
Contact Lenses
Wearing contact lenses is not recommended
while your eye is inflamed.
If you continue to wear your lenses, remove
them before using MAXIDEX and wait at least
15 minutes before putting your lenses back in.
There is a preservative in MAXIDEX ( benzalkonium
chloride ) that can discolour soft contact lenses.

If your symptoms get worse or suddenly
return, please consult your doctor. You may be
more likely to develop eye infections while using
MAXIDEX.
Remove the loose collar from the cap when
the bottle is first opened.
Always use MAXIDEX exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

Continued over

756102_GB_p3_LFT.indd 1

01/06/2017 08:45

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

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01/06/2017

Rachel Smith

! P LE ASE TU R N OVE R P R I N T I N G O N !
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3.

HOW TO USE MAXIDEX ( continued )

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 ).

1

2

3

• If a drop misses your eye, try again.
• If you forget to take MAXIDEX, do not
worry, just take it as soon as possible.
However, if it is nearly 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.

4.

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

increased blood pressure, irregular or missing
periods, changes in the levels of protein and
calcium in your body, stunted growth in children
and teenagers and swelling and weight gain of
the body and face (called ‘Cushing’s syndrome’)
(see section 2, “Warnings and precautions”).
In very rare cases, some patients with severe
damage to the clear layer at the front of the eye
(the cornea) have developed cloudy patches on
the cornea due to calcium build-up during
treatment.
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.
United Kingdom
Yellow Card Scheme
Website : www.mhra.gov.uk /yellowcard

HOW TO STORE MAXIDEX







Keep out of the reach and sight of children.
Do not refrigerate, freeze or store above 25° C.
Keep the bottle tightly closed.
Store in the original package.
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.
• Stop using the bottle 4 weeks after first
opening, to prevent infections.

6.

• If you use more MAXIDEX than you
should it can be washed out of your eye
with warm water.

POSSIBLE SIDE EFFECTS

Like all medicines, MAXIDEX can cause side
effects, although not everybody gets them.
• You may experience some or all of the
following effects in your eye ( s ) :
Common ( affects 1 to 10 users in 100 )  :
discomfort.
Uncommon ( affects 1 to 10 users in 1,000 )  :
swelling, dry eyes, sensitivity to light, blurred
vision, abnormal sensation, increased tear
production, eyelid crusting, itching, irritation
or redness.
Not known ( cannot be estimated from the
available data )  : increased pressure in your eye ( s ),
reduced vision, corneal disorder, drooping of
eyelid, pain or increase in pupil size.
• You may experience effects in other areas
of your body including :
Uncommon : bad taste.
Not known : allergy, dizziness or headache,
hormone problems: growth of extra body hair
(particularly in women), muscle weakness and
wasting, purple stretch marks on body skin,

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 ( picture 2 ).
• Do not squeeze the bottle, only a gentle
press on the bottom is needed.
• After using MAXIDEX, press a finger into the
corner of your eye by the nose ( picture 3 ). This
helps to stop the medicine getting into the rest
of the body.
• 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.

FURTHER INFORMATION

What MAXIDEX contains
• The active substance is dexamethasone
1 mg  / ml.
• The other ingredients are sodium chloride,
disodium phosphate anhydrous, citric acid,
polysorbate 80, hypromellose, benzalkonium
chloride, purified water and disodium edetate.

What MAXIDEX looks like and
contents of the pack
MAXIDEX is a white to off-white suspension
supplied in a pack containing a 5 ml or 10 ml
plastic bottle with a screw cap.

Marketing authorisation holder :

Manufacturer :

Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR,
United Kingdom

SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in 05/2017.

®
© 2010, 2013, 2014 Novartis
05-2017

75610-2

756102_GB_p3_LFT.indd 2

01/06/2017 08:45

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1607544
Comp. Description: Leaflet_Maxidex_LDMO_0.1% 5/10ml_GB
Comp. Number New: 756102 GB
Comp. Number Old: 756101 GB
Format/Dimension: 140x335_140x22 mm
Tech. Drawing No.: TECH_INS_140x335_140x22_001

Both

Production Site:
ACC:
Printing Colours:

Alcon Puurs
Sels, Pascale
Black

Technical Colours: Cutting

Minimum Font Size: 7.5pt
Font Type: Helvetica Neue LT Pro
Proof Number: 3
Braille:

01/06/2017

Rachel Smith

! P LE ASE TU R N OVE R P R I N T I N G O N !
5130111_0

Expand Transcript

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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