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

Active substance(s): DEXAMETHASONE / TOBRAMYCIN

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T06073

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.
2.
3.
4.
5.
6.

What Tobradex is and what it is used
for
What you need to know before you use
Tobradex
How to use Tobradex
Possible side effects
How to store Tobradex
Content 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.
• If you experience allergic reactions such as
eyelid itching, swelling or, redness of the
eye with Tobradex, discontinue use and
consult your doctor. This allergic sensitivity
may occur with other topical or systemic
antibiotic of 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 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.
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.
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.
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.
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.
• 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).

BACK PAGE
6. Content of
information

the

pack

and

other

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.
• Do not squeeze the bottle, only a gentle
press on the bottom is needed.
• 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
Uncommon side effects
(may affect up to 1 in 100 people)

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, Brandon House, Marlowe Way,
Croydon CR0 4XS UK

POM
PL No: 10380/1607
Leaflet revision date: 17/03/2016
Tobradex® is a registered trademark of Novartis
AG, Switzerland.

Effects in the eye: increased pressure in your
eye (s), eyelid redness, eyelid swelling, 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, increased tear production, eye surface
inflammation.
General side effects: allergy (hypersensitivity),
dizziness, nausea, abdominal discomfort, rash,
swelling of the face, itching.
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme via: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

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.

T06073

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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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