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MAXITROL OINTMENT

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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Package Leaflet - Information for the User

MAXITROL® OINTMENT, eye ointment
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.
• I f 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.
• I f 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 Ointment is 4. Possible side effects
and what it is used for
5. H ow to store MAXITROL
2. B efore you use MAXITROL
Ointment
Ointment
6. Further information
3. H ow to use MAXITROL
Ointment

®
1. WHAT MAXITROL OINTMENT IS AND
WHAT IT IS USED FOR

MAXITROL Ointment 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, when it is also considered that a
bacterial eye infection could develop.

2. BEFORE YOU USE MAXITROL® OINTMENT
Do not use MAXITROL
Ointment...
• 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 sticky discharge from
your eye.
• If you are allergic to neomycin or
any of the other ingredients listed in
section 6.
Ask your doctor for advice.

• Contact your doctor if you experience
blurred vision or other visual
disturbances.

Pregnancy and breastfeeding
MAXITROL Ointment is not
recommended during pregnancy or
breast-feeding. If you are pregnant
or might get pregnant, or if you are
breastfeeding a baby, talk to your
doctor before you use MAXITROL
Ointment.

Driving and using machines

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 cataract formation is
increased in patients with some
conditions such as diabetes.
• 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 Drugs-Medications) are
also known to slow or delay healing.
Concomitant use of topical NSAIDs
and topical steroids may increase the
potential for healing problems.
• As with any antibiotic, use of
MAXITROL Ointment 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 MAXITROL.
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.

MAXITROL Ointment may cause brief
blurring of vision on instillation. If your
sight is affected in any way you should
not drive or operate machinery.

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 Ointment with
other medicines may increase the
seriousness of any side effects.
Tell your doctor if you are using topical
NSAIDs. Concomitant use of topical
steroids and topical NSAIDs may
increase corneal healing problems.
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 the
condition worse.
If you do continue to wear your lenses,
you must remove them before using
MAXITROL Ointment and wait at least
15 minutes after use before putting your
lenses back in.

Important information about
some of the ingredients in
MAXITROL Ointment
MAXITROL Ointment contains lanolin
which may cause local skin reactions
(e.g. contact dermatitis).
MAXITROL Ointment contains
parahydroxybenzoates which can cause
allergic reactions, possibly delayed.

3. HOW TO USE MAXITROL® OINTMENT
The usual dose

The usual dose is to apply MAXITROL
Ointment 3 - 4 times daily.
The ointment may also be used at
bedtime while other eye drops are used
during the day.

How to use
• Wash your hands
before you start.
• Remove the cap
from the tube.
• Tilt your head back.
• Pull down your
1
lower eyelid with a
finger, until there is
a 'pocket' between
the eyelid and your
eye. The ointment
will go in here
(picture 1).
2
• Bring the ointment
tube close to the eye. Do this in front
of a mirror if it helps.
• I f you miss a dose do not worry,
just apply the next dose when it is
due. Do not use a double dose to
make up.
• If you use more MAXITROL
Ointment than you should do not
worry, it is not likely to do any harm.
• 
If this medicine is accidentally
swallowed it is not likely to cause
any serious problems.

Always use MAXITROL Ointment
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.

• 
Do not touch your eye or eyelid,
surrounding areas or other surfaces
with the tip of the tube. It could infect
the ointment.
• Gently squeeze a small ribbon of
ointment into the pocket formed
between your lower eyelid and your
eye (picture 2).
• Release the lower eyelid and blink a
few times.
• If you use ointment in both eyes,
repeat the steps for your other eye.
Replace and tightly close the cap on
the tube.

If you are also using other eye drops
or eye ointment wait at least 5 minutes
after putting in the other medicine
before applying MAXITROL Ointment.
If you have any further questions on
the use of MAXITROL Ointment, ask
your doctor or pharmacist.

Continued over>
616074 GB

Telephone +353 (0)1 440 3222
novartis@perigord-as.com
www.perigord-as.com

Comp. No. New:
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Date: 05 Jul 2017

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Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15

El Masnou
Anacka, Olga
Black

Cutting

J.N.: 311134

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4. POSSIBLE SIDE EFFECTS
Like all medicines, MAXITROL Ointment
can cause side effects, although not
everybody gets them.

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 eyelid,
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 also
been reported. Hormone problems:

growth of extra body hair (particularly
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

5. HOW TO STORE MAXITROL® OINTMENT
• Keep out of the reach and sight of
children.
• Do not refrigerate or store above
25°C.
• Keep the tube tightly closed and keep
out of direct sunlight.
• Do not use the ointment after the
expiry date (marked 'Exp') on the
tube and the carton. The expiry date
refers to the last day of that month.
• Stop using the tube 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.

6. FURTHER INFORMATION
What MAXITROL Ointment
contains
• The active substances are
Dexamethasone 1 mg/g, Neomycin
sulphate (as base) 3500 IU/g,
Polymyxin B sulphate 6000 IU/g.
• The other ingredients are methyl
parahydroxybenzoate, propyl
parahydroxybenzoate, liquid lanolin
and white soft paraffin.
Marketing authorisation holder:
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR,
United Kingdom.

What MAXITROL Ointment
looks like and contents of the
pack
MAXITROL Ointment is a white to very
pale yellow ointment supplied in a pack
containing a 3.5 g metal tube with a
screw cap.

Manufacturer:
Alcon Cusi, S.A.
08320 El Masnou - Barcelona, Spain.
This leaflet was last revised in 07/2017

616074 GB

Telephone +353 (0)1 440 3222
novartis@perigord-as.com
www.perigord-as.com

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

Both Production Site:
CTM:
Printing Colours:
LFT_OTHER AI/COMBO_
OINO_6000IU/G/3_ALU_3.5G_GB
616074 GB
616073 GB
125 X 500 mm
MT0114-2
Technical Colours:

Min. Font Size Text:
Font Type:
Version No.: 4

8 pt
Helvetica
Date: 05 Jul 2017

 Yes /
1607988

Live Text:
WO:
Comp. Description:

Braille:



No /



Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15

El Masnou
Anacka, Olga
Black

Cutting

J.N.: 311134

N/A

! PLEASE TURN OVERPRINTING ON !
2 of 2

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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