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TOBRADEX EYE DROPS

Active substance(s): DEXAMETHASONE / TOBRAMYCIN

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Assessed against UK PIL dated August 2017

Package Leaflet – Information for the User
Tobradex® Eye Drops
MOCK-UP
(tobramycin and dexamethasone)

By rajeevkumarj at

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.
The name of your medicine is Tobradex Eye Drops, but will be
referred to as Tobradex throughout the leaflet.
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. Content of the pack and other information

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.
Especially tell your doctor if you are using topical NSAIDs. If you
use topical steroids and topical NSAIDs together, it may increase
corneal healing problems. Tell your doctor if you are using
ritonavir or cobicistat, as this may increase the amount of
dexamethasone in the blood.
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 breastfeeding a baby, talk to your doctor before you use Tobradex.
Tobradex is not recommended during pregnancy or
breastfeeding.

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.

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.

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.

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.

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, and may delay the
healing of your eye wound. Topical non-steroidal antiinflammatory drugs (NSAIDs) are also known to slow or
delay healing. If you use topical NSAIDs and corticosteroids
together, it may increase the potential for healing problems.

If you experience allergic reactions with Tobradex,
discontinue use and consult your doctor. Allergic reactions
may vary from localized itching or skin redness to severe
allergic reactions (anaphylactic reaction) or serious skin
reactions. These allergic reactions may occur with other
topical or systemic antibiotics of the same family
(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.

Contact your doctor if you experience blurred vision or other
visual disturbances.

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.

Talk to your doctor if you experience swelling and weight
gain around the trunk and in the face as these are usually
the first manifestations of a syndrome called Cushing’s
syndrome. Suppression of the adrenal gland function may
develop after stopping a long-term or intensive treatment
with Tobradex. Talk to your doctor before stopping the
treatment by yourself. These risks are especially important
in children and patients treated with a drug called ritonavir or
cobicistat.

Signs and symptoms of adrenal suppression include fatigue;
light-headedness upon standing or difficulty standing,
muscle weakness, fever, weight loss, anxiety, nausea,
vomiting, diarrhoea, headache, sweating, changes in mood
or personality, and joint and muscle pains.

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. Only
use Tobradex for dropping in your eye(s).
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.



After using Tobradex, keep the eyelid
closed, while simultaneously applying
gentle pressure with a finger to the
corner of your eye, by the nose for at
least 1 minute (picture 3). This helps
to limit the amount of medicine that
will get into the rest of the body.

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
If you notice any of the following possible side effects, stop using
this medicine and seek urgent medical advice immediately:

itchy rash or hives

swelling of the face, lips, tongue or other parts of the body

shortness of breath/wheezing

severe skin reactions such as blistering which may be
accompanied by sore throat, fever or headache
The following side effects have also occurred with Tobradex:
Uncommon side effects
(may affect up to 1 in 100 people)
Effects in the eye: increased pressure in your eye (s), 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, eyelid
swelling, increased tear production.
General side effects: dizziness, nausea, abdominal discomfort,
rash, swelling of the face, itching.
Hormone problems: growth of extra body hair (particularly in
women), muscle weakness and wasting, purple stretch marks on
body skin, increased blood pressure, irregular or missing
periods, changes in the levels of protein and calcium in your
body, stunted growth in children and teenagers and swelling and
weight gain of the body and face (called ‘Cushing’s syndrome’)
(see section 2, “Warnings and precautions”).
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 Yellow Card
Scheme. Website: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Tobradex
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
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.

6. Contents of the pack and other information
Tobradex contains two active ingredients tobramycin 0.3% w/v
and dexamethasone 0.1% w/v.
Also contains benzalkonium chloride 0.01% w/v, disodium
edetate, tyloxapol, sodium chloride, sodium sulphate,
hydroxyethylcellulose, sulphuric acid and/or sodium hydroxide
(for pH adjustment) and purified water.
Tobradex is a white suspension, packed in a white 5ml plastic
dropper bottle with a plastic screw cap and a tamper evident
closure.
PL 20774/0968 Tobradex Eye Drops

POM

Manufactured by: Alcon Cusi S.A. Camil Fabra 58, 08320 El
Masnou, Barcelona, Spain. Procured from within the EU.
Product Licence Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
th

Leaflet revision date: 8 November 2017
Tobradex is a registered trademark of Alcon Inc.

Blind or partially sighted? Is
this leaflet hard to see or
read?
Contact Quadrant
Pharmaceuticals Ltd –
01204 473081
PP5/0968/V3

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