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TOBRADEX 3MG/ML/1MG/ML EYE DROPS SUSPENSION

Active substance(s): DEXAMETHASONE / TOBRAMYCIN

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45030-8

Package Leaflet - Information for the User

TOBRADEX

®

3 mg / ml / 1 mg / ml Eye Drops, Suspension
Tobramycin and Dexamethasone
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• 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 you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

In this Patient Information leaflet you
will find information about
1. What TOBRADEX is and what it is
used for

4. Possible side effects

2. What you need to know before you
use TOBRADEX

5. How to store TOBRADEX

3. How to use TOBRADEX

1

What TOBRADEX® is and what it is used for

TOBRADEX contains dexamethasone
a corticosteroid and tobramycin, an antibiotic
which is active against a wide range of bacteria
that may infect the eye.

2

6. Content of the pack and other
information

It is used to prevent and treat inflammation
and prevent possible infection of the eye after
cataract surgery in adults and children aged
2 years and older.

What you need to know before you use TOBRADEX

Do not use TOBRADEX…
• If you have or think that you have any type of
infection of the eye. Use of corticosteroids
may make infections worse.
• If you have a sticky discharge from your eye.
• If you have a red eye that has not been seen
by a doctor.
• If you are allergic to tobramycin or
dexamethasone or to any of the other
ingredients listed in section 6.
If any of these apply ask your doctor for advice.

Warnings and precautions
• If you have a disorder causing a thinning of the
eye tissues, such as rheumatoid arthritis,
Fuch’s dystrophy or following a corneal
transplant. Corticosteroids may cause further
thinning and possible perforation, and may delay
the healing of your eye wound. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are
also known to slow or delay healing. If you use
topical NSAIDS and corticosteroids together, it
may increase the potential for healing problems.
• If you experience allergic reactions with
TOBRADEX, discontinue use and consult your
doctor. Allergic reactions may vary from localized
itching or skin redness to severe allergic
reactions (anaphylactic reaction) or serious skin
reactions. These allergic reactions may occur
with other topical or systemic antibiotics of the
same family (aminoglycoside type).
• If your symptoms get worse or suddenly return,
please consult your doctor. You may become
more susceptible to eye infections with the use
of this product.
• If you are diabetic please consult your doctor.
The risk of corticosteroid-induced increase
intraocular pressure and / or cataract formation
is increased in diabetic patients.
• Contact your doctor if you experience blurred
vision or other visual disturbances.
• If you are using other antibiotic treatment,
including oral, with TOBRADEX, ask your
doctor for advice.
• If you use TOBRADEX for a long period of time,
you may become more susceptible to eye
infections, have increased pressure in your
eye(s) or develop cataracts.
• 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 TOBRADEX. 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.
• Signs and symptoms of adrenal suppression
include fatigue; light-headedness upon standing
or difficulty standing, muscle weakness, fever,
weight loss, anxiety, nausea, vomiting, diarrhoea,
headache, sweating, changes in mood or
personality, and joint and muscle pains.
You may still be able to use TOBRADEX, but
discuss it with your doctor first.
• Intraocular pressure should be checked
frequently, this is especially important in
children below 6 years of age receiving
dexamethasone-containing products.
• Do not give TOBRADEX to children below
2 years old because the safety and efficacy in
this population has not been established.

Other medicines and TOBRADEX
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Especially tell your doctor if you are using topical
NSAIDs. If you use topical steroids and topical
NSAIDs together, it 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.
If you are using other eye drops or eye
ointments, wait at least 5 minutes between
using each one. Eye ointments should be
administered last.

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 TOBRADEX. TOBRADEX is not
recommended during pregnancy or breastfeeding.

Driving and using machines
If you experience temporary blurred vision after
using TOBRADEX you should not drive or operate
machinery until your vision is clear.

Important information if you wear
Contact Lenses
Contact lens wear is not recommended during
treatment of an ocular infection or inflammation.
Benzalkonium chloride, used as a preservative in
TOBRADEX, may cause eye irritation and
discolour soft contact lenses.
If you wear soft contact lenses remove them
before using TOBRADEX and wait at least
15 minutes before putting them back in.

3

How to use TOBRADEX

Always use this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure. Only use
TOBRADEX for dropping in your eye(s).

The usual dose
The usual dose is 1 drop in the affected eye(s)
every 4 to 6 hours while you are awake. During
the initial 48 hours, your doctor may increase the
dose to 1 drop every 2 hours.
Do not use for more than 24 days.
TOBRADEX may be used in children 2 years of
age and older at the same dose as in adults.
Remove the loose collar from the cap when
the bottle is first opened.
Always use TOBRADEX exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.

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.
• If a drop misses your eye, try again.
• If you forget to take TOBRADEX, do not
worry, just take it as soon as possible. Do not
take a double dose to make up.

4

Not known (frequency cannot be estimated from
available data)
Effects in the eye: increase in pupil size, eyelid
redness, eyelid swelling, increased tear production,.
General side effects: dizziness, nausea, abdominal
discomfort, rash, swelling of the face, itching.
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”).
If TOBRADEX is used for more than 24 days, it
may cause you to get an infection and the healing of
your wound may also be delayed.
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 TOBRADEX

• Keep out of the reach and sight of children.
• This medicinal product does not require any
special temperature storage conditions.
• Keep the bottle tightly closed.
• Do not use the drops after the expiry date which is
stated on the bottle and the carton after ‘Exp:’. 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 TOBRADEX than you
should it can be washed out with warm water.
If you have any further questions on the use
of TOBRADEX, ask your doctor or pharmacist.

Possible side effects

Like all medicines, TOBRADEX can cause side effects,
although not everybody gets them.
The following side effects have been seen with
TOBRADEX
If you notice any of the following possible side effects,
stop using this medicine and seek urgent medical
advice immediately:
• itchy rash or hives
• swelling of the face, lips, tongue or other parts of
the body
• shortness of breath/wheezing
• severe skin reactions such as blistering which may
be accompanied by sore throat, fever or headache
The following side effects have also occurred with
TOBRADEX:
Uncommon side effects
(may affect up to 1 in 100 people)
Effects in the eye: increased pressure in your
eye (s), eye irritation, eye pain, eye itching, watery
eyes, eye discomfort.
General side effects: headache, runny nose,
tightness of the throat.
Rare side effects
(may affect up to 1 in 1000 people)
Effects in the eye: redness, blurred vision, dry eye,
eye allergy, eye surface inflammation.
General side effects: bad taste.

5

• 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).
• Bring the bottle tip close to the
1
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.
2
• 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 TOBRADEX, keep
3
the eyelid closed, while
simultaneously applying gentle pressure with a
finger to the corner of your eye, by the nose for
at least 1 minute (picture 3). This helps to limit
the amount of medicine that will get 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 TOBRADEX contains
• The active substances are tobramycin
3 mg / ml and dexamethasone 1 mg / ml.
• The other ingredients are disodium edetate,
tyloxapol, sodium chloride, sodium sulphate,
hydroxyethylcellulose, benzalkonium chloride,
sulphuric 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 TOBRADEX looks like and
contents of the pack
TOBRADEX is a white to off-white suspension
supplied in a pack containing a 5 ml plastic bottle
with a screw cap.

Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in 08/2017
®

© 2009, 2010, 2012, 2013, 2014 Novartis
09-2017

45030-8

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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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