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MAXITROL EYE DROPS

Active substance(s): DEXAMETHASONE / NEOMYCIN SULPHATE / POLYMYXIN B SULPHATE / DEXAMETHASONE / NEOMYCIN SULPHATE / POLYMYXIN B SULPHATE / DEXAMETHASONE / NEOMYCIN SULPHATE / POLYMYXIN B SULPHATE

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75609-1

Package Leaflet - Information for the User

MAXITROL*

eye drops, suspension
Dexamethasone, Neomycin sulphate, Polymyxin B sulphate
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 MAXITROL is and what it is
used for
2. Before you use MAXITROL

5. How to store MAXITROL
6. Further information

3. How to use MAXITROL

1

4. Possible side effects

WHAT MAXITROL* IS AND WHAT IT IS USED FOR

MAXITROL contains a steroid, dexamethasone
and two antibiotics, neomycin sulphate and
polymyxin B sulphate.

It is used for the short term treatment of
inflammation of the eye, where administration of
an antibiotic is also required to prevent an eye
infection.

2
BEFORE YOU USE MAXITROL
MAXITROL. Talk to your doctor before stopping
Do not use MAXITROL...
• 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 neomycin or to any of the
other ingredients listed in section 6.
Ask your doctor for advice.

Take special care...
• Do not inject or swallow this medicine.
• Consult your doctor or pharmacist before using
this medicine if you have a disorder causing a
thinning of the eye tissues.
• You should have your eye pressure checked
regularly while using this medicine. This is
especially important for children.
• The risk of increase in eye pressure and / or
cataract formation is higher in susceptible
patients ( e.g. patients with diabetes ) using
steroids.
• Consult your doctor or pharmacist if your eye
pain, redness, swelling, or irritation gets worse
or persists.
• Steroids applied to the eye may delay the
healing of your eye wound. Topical NSAIDs
( Non-Steroidal Anti Inflammatory DrugsMedications ) are also known to slow or delay
healing. Simultaneous use of topical NSAIDs
and topical steroids may increase the potential
for healing problems.
• As with any antibiotic, use of MAXITROL for a
long time may lead to other infections. If your
symptoms get worse or suddenly return tell
your doctor.
• 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 treatment with

3

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.

Pregnancy and breast-feeding
MAXITROL is not recommended during
pregnancy or 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
MAXITROL.

Driving and using machines
You may experience blurred vision after using
MAXITROL. Do not drive or use any machines
unless your vision is normal.

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. Taking MAXITROL with other
medicines may increase the seriousness of the
side effects. 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.

Important information if you wear
Contact Lenses
Wearing contact lenses is not advisable during
the treatment of an eye infection, as they may
make your condition worse.
If you do continue to wear your lenses, you must
remove them before using MAXITROL and wait at
least 15 minutes after use before putting your
lenses back in.
There is a preservative in MAXITROL
( benzalkonium chloride ) that can discolour soft
contact lenses.

HOW TO USE MAXITROL

The usual dose
The usual dose is 1 or 2 drops into the space
between your eyelid and eye 6 times daily, or
more frequently if required.
Remove the loose collar from the cap when
the bottle is first opened.

Always use MAXITROL exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
MAXITROL should not be used for a long period
of time unless advised by your doctor.

Continued over

756091_GB_p3_LFT.indd 1

25/07/2017 11:39

The Maltings

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

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Live Text:
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WO:
1609502
Comp. Description: Leaflet_Maxitrol eye drops_LDMO_5ml/10ml_GB

Production Site:
ACC:
Printing Colours:

Comp. Number New: 756091 GB
Comp. Number Old: 756090 GB
Format/Dimension: 140x335_140x22 mm
Tech. Drawing No.: TECH_INS_140x335_140x22_001

Technical Colours: Cutting

Alcon Puurs
Sels, Pascale
Black

Minimum Font Size: 6.0pt
Font Type: Helvetica Neue LT Pro
Proof Number: 3
Braille:

25/07/2017

Sara Kruger

! P LEASE TU R N OV E R P R I N T I N G O N !
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3

HOW TO USE MAXITROL* ( 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 ).
• If a drop misses your eye, try again.
• If you forget to take MAXITROL, do not
worry, just take it as soon as possible.
Do not take a double dose to make up.
• If you use more MAXITROL than you
should it can be washed out of your eye with
warm water.

4

You may experience some or all of the
following effects in your eyes  :
Uncommon ( affect 1 to 10 users in 1000 )  :
eye surface inflammation, increased pressure in
eye, sensitivity to light, change in pupil size,
drooping of eye lid, eye pain, swelling or redness,
eye irritation, itching or discomfort, abnormal eye
sensation, increased tear production.
Not known (cannot be estimated from the
available data): blurred vision.
Thinning of the surface of the eye has also been
reported. It is not known how many users may
have experienced this side effect.
You may also experience effects in other
parts of your body  :
Hypersensitivity or general allergy to MAXITROL
and headache have been reported. Hormone
problems: growth of extra body hair (particularly







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

in women), muscle weakness and wasting, purple
stretch marks on body skin, 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”). It is not known how
many users may have experienced these side
effects.

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 MAXITROL

Keep out of the reach and sight of children.
Do not refrigerate or store above 25  °C.
Keep the bottle tightly closed.
Keep away from direct sunlight.
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.

6

• If you are using other eye drops, wait at
least 5 minutes after putting in MAXITROL
before using the other eye drops. Eye
ointments should be administered last.

POSSIBLE SIDE EFFECTS

Like all medicines, MAXITROL can cause side
effects, although not everybody gets them.

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.
• If you use drops in both eyes, repeat the steps
for your other eye. Put the bottle cap firmly
back on immediately after use.

• Stop using the bottle 4 weeks after first
opening, to prevent infections.
• 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 MAXITROL contains
• The active substances are dexamethasone
1 mg / ml, neomycin sulphate 3500 IU / ml,
polymyxin B sulphate 6000 IU / ml.
• The other ingredients are sodium chloride,
polysorbate 20, hypromellose, benzalkonium
chloride, hydrochloric acid and / or sodium
hydroxide ( to adjust pH ) and purified water.

Marketing authorisation holder  :
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom.

What MAXITROL looks like and
contents of the pack
MAXITROL Eye Drops is a cloudy, white liquid
supplied in a pack containing a 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 07/2017

* a trademark of Novartis
© 2010, 2013, 2014 Novartis
75609-1

756091_GB_p3_LFT.indd 2

25/07/2017 11:39

The Maltings

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

x Yes
Live Text:
/
No
/
Both
WO:
1609502
Comp. Description: Leaflet_Maxitrol eye drops_LDMO_5ml/10ml_GB

Production Site:
ACC:
Printing Colours:

Comp. Number New: 756091 GB
Comp. Number Old: 756090 GB
Format/Dimension: 140x335_140x22 mm
Tech. Drawing No.: TECH_INS_140x335_140x22_001

Technical Colours: Cutting

Alcon Puurs
Sels, Pascale
Black

Minimum Font Size: 6.0pt
Font Type: Helvetica Neue LT Pro
Proof Number: 3
Braille:

25/07/2017

Sara Kruger

! P LEASE TU R N OV E R P R I N T I N G O N !
5134139_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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