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TOBRADEX EYE DROPS

Active substance(s): DEXAMETHASONE / TOBRAMYCIN / DEXAMETHASONE / TOBRAMYCIN

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Ref: 0921/140717/1/F

®

Tobradex Eye Drops
(tobramycin/dexamethasone)

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.
Your medicine is called Tobradex Eye Drops but will be referred to as
Tobradex throughout this leaflet.
In this leaflet:
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 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.

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.
Tell your doctor if you are using topical NSAIDs. Concomitant use of topical
steroids and topical NSAIDs may increase corneal healing problems.
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.

If any of these apply ask your doctor for advice.
Remove the loose collar from the cap when the bottle is first opened.
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.
Topical non-steroidal anti-inflammatory drugs ( NSAIDs ) are also known to
slow or delay healing.
* 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 diabetic please consult your doctor. The risk of
corticosteroid-induced increase intraocular pressure and / or cataract
formation is increased in diabetic patients.
* 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.

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

Ref:0921/140717/1/B

Tobradex ®Eye Drops
(tobramycin/dexamethasone)

Patient Information Leaflet (continued)
How to use
* Wash your hands before you start.
* Shake the bottle well.
* Twist off the bottle cap.
* 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.
* 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 ).
* 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 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)
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.

How to store Tobradex

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C. Do not refrigerate or freeze.
* Do not use after 4 weeks of opening the bottle.
* Do not use this medicine after the expiry date shown on the carton label or

*
*
*

bottle label. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist (chemist) for safe disposal. Only keep
this medicine, if your doctor tells you to. If your medicine becomes
discoloured or shows any other signs of deterioration, consult your
pharmacist (chemist) who will tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
This leaflet does not tell you everything about your medicine. If you have
any questions or are not sure about anything, ask your doctor or
pharmacist (chemist). He/she will have additional information about this
medicine and will be able to advise you.

6

Content of the pack and other information

WHAT IS IN YOUR MEDICINE
Each ml contains 3mg of tobramycin and 1mg of dexamethasone as the
active ingredients.
Inactive ingredients: disodium edetate, hydroxyethylcellulose, preservative:
benzalkonium chloride (0.01%), purified water, sodium chloride, sodium
sulphate, sulphuric acid and/or sodium hydroxide and tyloxapol.
WHAT THIS MEDICINE LOOKS LIKE AND CONTENTS OF THE PACK
Tobradex is a clear eye drop solution, in a 5ml opaque plastic dropper bottle.
WHO MANUFACTURED YOUR MEDICINE?
Tobradex is manufactured by Alcon Cusi, S.A., Camil Fabra 58,08320 EI
Masnou, Barcelona, Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0921

Tobradex Eye drops

Tobradex is a registered trademark of Novartis AG.
Revision date: 14/07/17

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 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

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

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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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