TOBRADEX EYE DROPS

Active substance: TOBRAMYCIN

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

TOBRADEX® EYE DROPS
(Dexamethasone and Tobramycin)
Patient Information Leaflet

27mm

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Read all of this leaflet carefully before you start using this medicine
- 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What Tobradex is and what it is used for
2. Before you use Tobradex
3. How to use Tobradex

It is used to prevent and treat inflammation and possible infection of the eye after cataract surgery in adults
and children 2 years and older.

DATE OF PROOF:

28/06/13

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
Benzalkonium chloride, used as a preservative in Tobradex, may cause eye irritation and discolour soft
contact lenses.

UK PIL DATED FRBRUARY 2013

6464/2312A

If you wear soft contact lenses remove them before using Tobradex and wait at least 15 minutes before
putting them back in.

CODE:

PRODUCT:

Tobradex eye drops

ARTWORKER:

DT

DATE:

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.

3. HOW TO USE TOBRADEX
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.

Colour
Swatch

Black

WARNING!

Using other medicines
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 also using other eye drops, wait at least 10 minutes between using each one.

Q.A.
APPROVED:
05-0440

Intraocular pressure should be checked frequently, especially 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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

You may still be able to use Tobradex, but discuss it with your doctor first.



PRE-PRESS NO.:

WARNING!

Take special care
• 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.

DATE:

CUSTOMER
APPROVED:

2. 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.



CUSTOMER: Waymade

4. Possible side effects
5. How to store Tobradex
6. Further 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.

PROOF HISTORY:
v.2 - waymade - 28/06/13

Notes:

Leaflet Flat Size = 148 x 317
07/12

This product is known by the above name but will be referred to as Tobradex in this leaflet.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

How to use
• Wash your hands before you start.
27mm

• Shake the bottle well.
• Twist off the bottle cap.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

• 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.

2

• 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.

WARNING!

• 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

• You may experience some or all of the following effects in your eye(s):
Uncommon (affect 1 to 10 people in 1000):
Irritation, pain, itching, redness, watery eyes, discomfort, feeling of something in your eye, blurred vision, dry
eye, raised pressure in your eye, which may lead to headaches and disturbances of vision.
Swelling and redness of the eyelid and sensitivity to light may also occur.
• You may also experience effects in other areas of your body including:
Uncommon: Headache, runny nose, tightness of the throat.
If Tobradex is used for more than 24 days, it may make you more likely to get an infection and the healing
of your wound may also be delayed.

28/06/13

DT

DATE:

5. HOW TO STORE TOBRADEX
• Keep all medicines out of the sight and reach of children.
• Do not use after the expiry date printed on the bottle or carton label after EXP. The expiry date refers to the
last day of that month.
• Tobradex eye drops should not be stored above 25°C. Do not refrigerate or freeze. The bottle should be
discarded four weeks after first opening, to prevent infections.
• If your doctor tells you to stop using the drops, please take them back to the pharmacist for safe disposal.
Only keep the medicine if your doctor tells you to.
• If the drops become discoloured or show any other signs of deterioration, you should seek the advice of
your pharmacist before using them.
• 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.

UK PIL DATED FRBRUARY 2013

CODE:

6464/2312A

DATE OF PROOF:

ARTWORKER:
Tobradex eye drops
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

6. FURTHER INFORMATION
Each ml contains 1mg of dexamethasone and 3mg of tobramycin.
A white plastic dropper bottle, with a white plastic screw-cap and tamper evident ring. The bottle contains a
whitish suspension.
Tobradex eye drops also contain the following:
Benzalkonium chloride, disodium edetate, sodium chloride, tyloxapol, sodium sulphate, hydroxyethylcellulose
and purified water. Tiny amounts of sodium hydroxide and sulphuric acid are sometimes added to keep
acidity levels (pH) normal.
Tobradex eye drops are available as plastic dropper bottles of 5mls of suspension.
POM

PL No: 6464/2312

This product is manufactured by Alcon Cusi SA, c/ Camil Fabra, 58, 08320 El Masnou-Barcelona, Spain and
is procured from within the EU and repackaged by the Product Licence holder who is:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 27.6.2013
Tobradex is a registered trademark of Alcon.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

4. POSSIBLE SIDE EFFECTS
Like all medicines, Tobradex can cause side effects, although not everybody gets them.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

1

• Tilt your head back.

PROOF HISTORY:
v.2 - waymade - 28/06/13

Leaflet Flat Size = 148 x 317
07/12

• Hold the bottle pointing down, between your thumb and fingers.

Expand view ⇕

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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