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TOBRADEX EYE DROPS SUSPENSION

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

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PACKAGE LEAFLET – INFORMATION FOR THE USER

TOBRADEX® EYE DROPS, SUSPENSION
(tobramycin / dexamethasone)
This product is available as the above but will be referred to as Tobradex throughout the
remainder of this 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. 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.
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.
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 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)
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 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
• Keep out of the sight and reach of children.
• Do not store above 25°C. Do not freeze. 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.
• If eye drops becomes discoloured or show any signs of deterioration, you should consult
your pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tobradex contains
• Each ml of suspension contains 1 mg of dexamethasone and 3 mg of tobramycin as the
active ingredients.
• The other ingredients are: benzalkonium chloride, disodium edetate, sodium chloride,
sodium sulfate anhydrous (E514), tyloxapol, hydroxyethylcellulose, sulfuric acid / sodium
hydroxide (to adjust pH) 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 tamper evident screw cap.
PL No: 15814/1082

Tobradex® Eye Drops, Suspension

POM

Tobradex is manufactured by S.A. Alcon-Couvreur N.V., Puurs, Belgium.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 12.06.2017.
Tobradex is a registered trademark of Novartis AG, Switzerland.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

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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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