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TOBRADEX EYE DROPS SUSPENSION

Active substance(s): DEXAMETHASONE / TOBRAMYCIN

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Tobradex® Eye Drops, Suspension
(Tobramycin and Dexamethasone)
This product is available using the above name but will be referred to as
Tobradex throughout this leaflet.
Patient Information Leaflet

• 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.

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.

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 dexamethasonecontaining products.
• Do not give Tobradex to children below 2 years old because the safety
and efficacy in this population has not been established.

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.
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.

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).
• 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 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

5) How to store Tobradex

If you have any further questions on the use of Tobradex, ask your
doctor or pharmacist.

• Keep out of the sight and reach of children.
• Do not store above 25°C. Do not refrigerate or freeze.
• Do not use this medicine after the expiry date (shown as "EXP" on the
bottle and carton).
• Once the bottle has been opened then this medicine must be thrown
away four weeks after opening.
• Any leftover or out of date drops should be returned to your pharmacist
who will dispose of them safely for you.
• If the eye drops become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist.
• 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.
• Do not pass this medicine on to others. It may harm them, even if their
symptoms are the same as yours.

4) Possible side effects

6) Further information

Like all medicines, Tobradex can cause side effects, although not
everybody gets them.

What Tobradex contains
Each ml of Tobradex Eye Drops, Suspension contains 1mg of
dexamethasone and 3mg of tobramycin as the active ingredients.

• 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.

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.
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.

They also contain benzalkonium chloride, disodium edetate, tyloxapol,
sodium chloride, sodium sulphate, hydroxyethylcellulose and purified water.
Tiny amounts of sulphuric acid or sodium hydroxide are sometimes added
to keep acidity levels (pH levels) normal.
What Tobradex looks like and contents of the pack
Tobradex Eye Drops is an eye drop suspension packaged in a 5-ml white
low density plastic bottle, with a dispensing nozzle and a white tamper
evident polypropylene closure.
PL 10383/1805

®

Tobradex Eye Drops, Suspension

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Alcon Cusi S.A. Camil Fabra 58, El
Masnou, Barcelona Spain. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 31.03.2015
Tobradex is a registered trademark of Novartis AG, Basle, Switzerland.

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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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