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

Active substance(s): DEXAMETHASONE / TOBRAMYCIN

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T07083

Tobradex® 3 mg/ml / 1 mg/ml Eye Drops, Suspension
(tobramycin and dexamethasone)
Patient Information Leaflet

The name of your medicine is Tobradex
3 mg/ml / 1 mg/ml Eye Drops, Suspension but
will be referred to as Tobradex throughout the
patient information leaflet.
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
2. What you need to know before you use
Tobradex
3. How to use Tobradex
4. Possible side effects
5. How to store Tobradex
6. Contents of the pack and other
information

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.
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.

2. 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 non-steroidal
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 breast-feeding.
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.

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• 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 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.
• After using Tobradex, keep 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.
• 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.
• 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.

4. 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.
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.

5. How to store Tobradex
• Keep out of the sight and reach 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.
• 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. Contents of the pack and other
information
What Tobradex contains
• Each ml contains 3 mg/ml tobramycin and 1
mg/ml dexamethasone.
• The other ingredients are benzalkonium
chloride,
edetate
disodium,
sodium
chloride,
sodium
sulfate,
tyloxapol,
hydroxyethylcellulose, sulfuric acid and/or
sodium hydroxide and purified water.
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 and Product Licence Holder
This product is manufactured by Alcon Cusi,
S.A., c/ Camil Fabra, 58, 08320 El Masnou,
Barcelona, Spain. It is procured from within the
EU by the Product Licence Holder:
Swinghope Ltd, and repackaged by YMD
Pharma Ltd both at Commerce Way,
Edenbridge, TN8 6ED, UK.
POM
PL No: 10380/1607
Leaflet revision date: 20/02/2018
®

Tobradex is a registered trademark of Novartis
AG, Switzerland.

Blind or partially
sighted?
Is this leaflet hard to see
or read?
Call 02030969700 to
obtain the leaflet in a
format suitable for you.

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
Yellow
Card
Scheme,
Website
www.mhra.gov.uk/yellowcard or search MHRA
Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help
provide more information on the safety of this
medicine.

T07083

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