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MAXITROL OINTMENT

Active substance: POLYMYXIN B SULPHATE

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616071 MAXITROL 3.5G UK_616071 MAXITROL 3.5G UK 02/09/14 07:43 Página 1

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.
• 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 Ointment is
and what it is used for
2. Before you use MAXITROL
Ointment
3. How to use MAXITROL
Ointment

1

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.

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.

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.

Pregnancy and breast-feeding
MAXITROL Ointment is not
recommended during pregnancy
or breast-feeding. If you are pregnant

3

5. How to store MAXITROL
Ointment
6. Further information

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.

2

4. Possible side effects

or might get pregnant, or if you are
breastfeeding a baby, talk to your
doctor before you use MAXITROL
Ointment.

Driving and using machines
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.

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.

HOW TO USE MAXITROL® OINTMENT

The usual dose
The usual dose is to apply MAXITROL
Ointment 3 - 4 times daily.

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

The ointment may also be used at
bedtime while other eye drops are
used during the day.

How to use

• Do not touch your eye or
eyelid, surrounding areas or other
surfaces with the tip of the tube. It
could infect the ointment.

• Wash your hands
before you start.
• Remove the cap
from the tube.
• Tilt your head back.
• Pull down your
lower eyelid with a
finger, until there is
a 'pocket' between
the eyelid and your
eye. The ointment
will go in here
(picture 1).

1

• 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.

2

• If you use ointment in both eyes,
repeat the steps for your other eye.
Replace and tightly close the cap
on the tube.

• Bring the ointment tube close to
the eye. Do this in front of a mirror
if it helps.

• If 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.

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

616071 MAXITROL 3.5G UK_616071 MAXITROL 3.5G UK 02/09/14 07:43 Página 2

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, blurred vision,
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.
Thinning of the surface of the eye has
also been reported. It is not known
how many users may have experienced
this side effect.

5

You may also experience effects
in other parts of your body:
Hypersensitivity or general allergy to
MAXITROL and headache have also
been reported. 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® 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 :
Alcon Laboratories (UK) Ltd.
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR,
United Kingdom.

© 2008, 2014 Novartis

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 Cusí, S.A.
08320 El Masnou - Barcelona,
Spain.
This leaflet was last revised in
August 2014.

616071

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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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