Maxitrol

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MAXITROL™ Eye Drops

Dexamethasone, Neomycin and Polymyxin B

CONSUMER MEDICINE INFORMATION

What is in this leaflet If you have any concerns about There is no evidence that
using this medicine, ask your Maxitrol Eye Drops are
doctor or pharmacist. addictive.
Read this leaflet carefully
before you start to use Keep this leaflet with your
medicine.
Use in children
Maxitrol Eye Drops.
This leaflet answers some You may need to read it again. Maxitrol Eye Drops are not
common questions about recommended for use in children
Maxitrol Eye Drops. It does not What Maxitrol Eye as the safety and effectiveness in
contain all the available Drops is used for children has not been
information. It does not take the established.
place of talking to your doctor or Maxitrol Eye Drops is a sterile
pharmacist. eye drop that contains the active Before you use Maxitrol
ingredients dexamethasone, Eye Drops
The information in this leaflet
neomycin and polymyxin B.
was last updated on the date
Both neomycin and polymyxin When you must not use it
listed on the final page. More
B are antibiotic agents.
recent information on the
Dexamethasone is a type of Do not use Maxitrol Eye Drops
medicine may be available.
cortisone and belongs to the if you have an allergy to:
You should ensure that you group of medicines called
speak to your pharmacist or corticosteroids. • neomycin or other
doctor to obtain the most up to aminoglycoside antibiotics
date information on the Maxitrol Eye Drops are used to • polymyxin B or other
medicine. treat inflammation and bacterial polymyxin antibiotics
infections in the external part of
You can also download the most • dexamethasone or any other
the eye.
up to date leaflet from corticosteroid medicine
www.medsafe.govt.nz. Before prescribing Maxitrol Eye
• any of the ingredients in
The updates may contain Drops, your doctor will have
Maxitrol Eye Drops listed
important information about the examined your eye(s) and
under Product Description
medicine and its use of which decided that Maxitrol Eye Drops
at the end of this leaflet
you should be aware. is the right medicine for you.
• other similar medicines.
All medicines have risks and Ask your doctor if you have
benefits. Your doctor has any questions about why this Some of the symptoms of an
weighed the risks of you using medicine has been prescribed allergic reaction may include:
Maxitrol against the expected for you.
benefits it will have for you. • shortness of breath

The information in this leaflet Your doctor may have • wheezing or difficulty
applies to Maxitrol Eye Drops prescribed Maxitrol Eye Drops breathing
only. This information does not for another reason.
apply to similar products, even if • swelling of the face, lips,
they contain the same This medicine is only available
tongue or other parts of the
ingredients. with a doctor’s prescription
body

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• rash, itching or hives on the Tell your doctor if you are How to use Maxitrol
skin. pregnant or plan to become
pregnant. Eye Drops
Do not use Maxitrol Eye Drops
if: Your doctor can discuss with Use Maxitrol Eye Drops only as
you the risks and benefits prescribed by your doctor.
• the safety seal around the involved. Follow all directions given to
closure and neck area is you by your doctor carefully.
broken Tell your doctor if you are
breast-feeding. They may differ from the
• the bottle/packaging shows information contained in this
signs of tampering leaflet.
Your doctor can discuss with
• the expiry date on the you the risks and benefits If you do not understand the
bottle/carton has passed. involved. instructions on the box ask
If you use this medicine after the your doctor or pharmacist for
If you have not told your help.
expiry date has passed, it may
doctor about any of the above,
not work. How much to use
tell them before you use
Contact lens wear is not Maxitrol Eye Drops.
recommended during treatment The usual dose is 1 to 2 drops in
of an eye infection. Using other medicines the affected eye(s) up to 4 to 6
times daily. Your doctor may
The preservative in Maxitrol Eye Tell your doctor or pharmacist increase the dose to 1 to 2 drops
Drops, benzalkonium chloride, if you are taking any other in the affected eye(s) every hour
may cause eye irritation and is medicines, including other eye depending on your condition.
known to discolour contact drops or ointments, and any
lenses. other medicines that you get Your doctor will tell you how
without a prescription from a much you need to use each
Maxitrol Eye Drops is not to pharmacy, supermarket or day. These dosing instructions
be used if you have an ocular health food shop. will be printed on the label your
viral or fungal infection or pharmacist puts on the bottle or
have had a foreign body Some medicines and Maxitrol carton.
removed from the outside of Eye Drops may interfere with
the eye. each other. These medicines How to use it
may be affected by Maxitrol Eye
If you are not sure whether Drops, or may affect how well it It is important to use Maxitrol
you should start using works. You may need different Eye Drops exactly as your
Maxitrol Eye Drops, talk to amounts of your medicines, or doctor or pharmacist has told
your doctor. you may need to take different you. If you use it less often than
medicines. you should, it may not work as
Before you start to use it well and the eye problem may
Tell your doctor or pharmacist not improve. Using it more
Tell your doctor if you have if often than you should may not
had an allergy to any other improve the eye problem any
medicines or any other • you are using non-steroidal faster and may cause increased
substances, such as foods, anti-inflammatory (NSAIDs) side effects.
preservatives or dyes. medicines in your eyes
Follow these steps to use the eye
Tell your doctor if you have or • you are using medicines to drops:
have had any medical treat viral infections e,g.
conditions including: ritonavir or cobicistat 1. Wash your hands
thoroughly with soap and
• disease(s) that causes Your doctor or pharmacist has water.
thinning of the cornea (the more information on medicines
front layer of the eye ball) or to be careful with or avoid while 2. Immediately before using a
sclera (the white outer layer using this medicine. bottle for the first time,
of the eyeball). break the safety seal around

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the neck area and throw the 9. Close your eye. Do not How long to use it
loose plastic ring away. blink or rub your eye.
Your doctor or pharmacist will
3. Remove the cap from the 10. While your eye is closed, tell you how long to use
bottle. place your index finger Maxitrol Eye Drops.
against the inside corner of
4. Hold the bottle upside down your eye and press against Do not use Maxitrol Eye Drops
in one hand between your your nose for about two for longer than your doctor
thumb and middle finger minutes. This will help to tells you.
(see Diagram 1). stop the medicine from
draining through the tear If you use Maxitrol Eye Drops
duct to the nose and throat, for longer than your doctor or
from where it can be pharmacist tells you, the chance
absorbed into other parts of of side effects may increase.
your body. This will also
reduce the unpleasant taste If you are not sure how long to
Diagram 1
sensation that some people use Maxitrol Eye Drops, talk
5. While tilting your head experience when using to your doctor or pharmacist.
back, gently pull down the these drops.
lower eyelid of your eye to If you forget to use it
form a pouch / pocket. 11. If necessary, repeat the
above steps for the other If it is almost time for your
6. Place the tip of the bottle eye. next dose, skip the dose you
close to your eye. Do not missed and use your next dose
let it touch your eye. 12. Your eyelids can only hold when you are meant to.
less than one drop at a time,
7. Release one drop into the so it is normal for a small Otherwise, use the eye drops
pouch / pocket formed amount of the eye drop to as soon as you remember, and
between your eye and spill onto your cheek. You then go back to using them as
eyelid by gently tapping or should wipe away any you would normally.
pressing the base of the spillage with a tissue.
bottle with your forefinger Do not use a double dose to
(see Diagrams 2 and 3). Do 13. Replace the cap on the make up for the eye drops that
not squeeze the bottle. bottle, closing it tightly. you missed. This may increase
the chance of you getting an
8. 14. Wash your hands again unwanted side effect.
with soap and water to
remove any residue. If you are not sure what to do,
ask your doctor or pharmacist.
You may feel a slight burning
sensation in the eye shortly after If you have trouble
using Maxitrol Eye Drops. If remembering to use your
this persists, or is very medicine, ask your pharmacist
Diagram 2 uncomfortable, contact your for some hints.
doctor or pharmacist.
If you use too much
Be careful not to touch the tip (overdose)
of the bottle against your
fingers or the eye, or anything If you accidentally put too many
else. This will help prevent the eye drops in your eye(s)
eye drops becoming dirty or immediately rinse your eye(s)
contaminated. with lukewarm water.

After using Maxitrol Eye Drops, If you think that you or


wait at least 5 minutes before someone else has swallowed
putting any other eye drops in Maxitrol Eye Drops,
your eye(s). immediately telephone your
Diagram 3

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doctor or the National Poisons medicine containing ritonavir or possible if you do not feel well
Centre on 0800 POISON or cobicistat. while you are using Maxitrol
0800 764 766 for advice, or go Eye Drops.
to Accident and Emergency at Tell your doctor immediately
if you become pregnant while Maxitrol Eye Drops help most
your nearest hospital.
using Maxitrol Eye Drops. people with inflammation and
bacterial infections but it may
Do this even if there are no
Keep all your doctor’s have unwanted side effects in a
signs of discomfort or
appointments so that your doctor few people. All medicines can
poisoning.
can check on your progress. have side effects. Sometimes
Your doctor may need to check they are serious, most of the time
While you are using they are not. You may need
your eye pressure whilst you are
Maxitrol Eye Drops using Maxitrol Eye Drops. medical treatment if you get
some of the side effects.
Things you must do Things you must not do Ask your doctor or pharmacist
to answer any questions you
If you feel that Maxitrol Eye Do not let children handle may have.
Drops is not helping your Maxitrol Eye Drops.
condition, tell your doctor (or Do not be alarmed by the
pharmacist). If your Do not use Maxitrol Eye Drops following list of possible side
symptoms do not improve to treat any other complaints effects. You may not
within a few days, or if they unless your doctor tells you to. experience any of them.
become worse, tell your
doctor. Do not give Maxitrol Eye Tell your doctor or pharmacist
Drops to anyone else, even if if you notice any of the
If you are about to start taking they have the same condition following and they worry you:
any new medicine, tell your as you.
doctor and pharmacist that • Eye irritation,
you are using Maxitrol Eye Do not stop using Maxitrol Eye discomfort or feeling of
Drops. Drops or lower the dosage having something in the
because you are feeling better, eye
Tell all the doctors, dentists unless advised by your doctor.
and pharmacists who are • Eye pain
treating you that you are using Ask your doctor or pharmacist if
Maxitrol Eye Drops. you are concerned about the • Inflammation of the
length of time you have been cornea (clear front
Tell your doctor if, for any using Maxitrol Eye Drops. portion of your eye)
reason, you have not used (keratitis)
Maxitrol Eye Drops exactly as Things to be careful of
prescribed. Otherwise your • Swollen, itchy eyes or
doctor may think that it was not Be careful driving or operating eyelids
effective and change the machinery until you know how
treatment unnecessarily. Maxitrol Eye Drops affect you • Eye redness
Tell your doctor if you and your vision.
• Increased tearing
experience swelling and weight
As with any eye medicine,
gain around the trunk and in the • Blurred vision
temporary blurred vision or
face, it may be symptoms of a other visual disturbances may
hormonal imbalance known as affect the ability to drive or use • Drooping eyelid
Cushing’s syndrome. Talk to machines. If blurred vision
your doctor before stopping the occurs at instillation, wait until • Dilated pupil
treatment by yourself. Stopping your vision is clear before
long term or intensive treatment driving or using machinery. • Increased sensitivity to
with Maxitrol may cause your sunlight
adrenal glands to not work
Side effects
properly. These risks are • Secondary eye infection
especially important in children
Tell your doctor as soon as
and patients treated with

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• Raised pressure in the Store Maxitrol Eye Drops in a Ingredients
eye which may lead to cool dry place where the
headaches and temperature stays below 25°C. Active ingredients:
disturbances of vision. Do not freeze.
• dexamethasone 1 mg in 1
• Delayed healing of any Do not store Maxitrol Eye mL
eye wounds. Drops or any other medicine in
the bathroom or near a sink. • neomycin sulfate 3500 IU in
In some rare cases, the Do not leave it on a window sill 1 mL
development of glaucoma (a or in the car.
condition of the eye in which the • polymyxin B sulfate 6000
pressure of fluid in the eye may Heat and dampness can destroy IU in 1 mL.
be high, however some people some medicines.
with glaucoma may have normal It also contains:
pressure) with optic nerve Keep it where children cannot
damage (the nerve that connects reach it. • benzalkonium chloride (0.04
the eye to the brain) has been mg/mL) as preservative
reported. A locked cupboard at least one-
and a half meters above the • hypromellose
If any of the following happen, ground is a good place to store
stop using Maxitrol Eye Drops medicines. • polysorbate 20
and call your doctor
immediately or go to Accident Disposal • sodium chloride
and Emergency at your
nearest hospital: Write the date on the bottle • sodium hydroxide and/or
when you first open the eye hydrochloric acid (to adjust
• skin rash drops and throw out any pH)
remaining drops after four
• swelling of the face (lips,
mouth, tongue, throat),
weeks. • purified water.
hands or feet Maxitrol Eye Drops contains a Supplier
• wheezing, difficulty in preservative which helps prevent
breathing germs growing in the suspension Maxitrol Eye Drops are supplied
for the first four weeks after in New Zealand by:
• severe and sudden onset of opening the bottle. After this
pinkish, itchy swellings on time there is a greater risk that
the skin, also called hives or Novartis New Zealand Limited
the suspension may become
nettlerash contaminated and cause an eye Newmarket
• shortness of breath, chest infection. A new bottle should
pain, dizziness, light- be opened. Auckland 1149
headedness.
If your doctor tells you to stop New Zealand.
These hypersensitivity reactions using Maxitrol Eye Drops or
can be very serious side effects. the expiry date has passed, ask Free Phone: 0800 354 335.
You may need urgent medical your pharmacist what to do
attention or hospitalisation. with any medicine that is left Date of preparation
These side effects are very rare. over.
This leaflet was prepared in July
Other side effects not listed Product description 2020.
above may also occur in some
people. What it looks like TM
trademark.
Maxitrol Eye Drops comes in a 5
After using Maxitrol mL Drop-Tainer with screw cap.
Eye Drops
Tamper evidence is provided
Storage with a safety seal around the
neck area of the bottle.

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