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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

In this Patient Information leaflet you will find information about
4. Possible side effects
1. What Tobradex is and what it is used for
5. How to store Tobradex
2. What you need to know before you use Tobradex
3. How to use Tobradex
6. Content of the pack and other information
1. WHAT TOBRADEX IS AND WHAT IT IS USED
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.

WARNING!

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
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.

DATE:

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

19/11/14

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.

TVT CHECKED

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.

UK PIL DATED MARCH 2014
REPORTING OF SIDE EFFECTS

6464/2312A
CODE:

DT

ARTWORKER:
Tobradex eye drops
PRODUCT:

DATE OF PROOF:

05-0440
PRE-PRESS NO.:
CUSTOMER: Waymade

Intraocular pressure should be checked frequently, this is especially important in children below 6
years of age receiving dexamethasone-containing products.



Q.A.
APPROVED:



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.

Colour
Swatch

Black

WARNING!

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.

DATE:

CUSTOMER
APPROVED:

If any of these apply ask your doctor for advice.

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.

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

Notes:

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

PROOF HISTORY:
v.1 - waymade - 19/11/14

Leaflet Flat Size = 148 x 317
07/12

27mm

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

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





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.
1
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).
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)

WARNING!

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)

General side effects: bad taste.

DATE:

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.

19/11/14

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 MARCH 2014
REPORTING OF SIDE EFFECTS

TVT CHECKED
6464/2312A
CODE:

DATE OF PROOF:

Tobradex eye drops

ARTWORKER:

DT

DATE:

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

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

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.

6. CONTENTS OF THE PACK AND OTHER 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.) 19.11.2014
Tobradex is a registered trademark of Alcon.

Colour
Swatch

Black

WARNING!

CUSTOMER
APPROVED:

Effects in the eye: redness, blurred vision, dry eye, eye allergy, eye surface inflammation.

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:




PROOF HISTORY:
v.1 - waymade - 19/11/14

Leaflet Flat Size = 148 x 317
07/12

27mm








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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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