TOBREX® Eye Drops 0.3%

Tobramycin

What is in this leaflet

This leaflet answers some common questions about TOBREX Eye Drops. It does
not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you
using TOBREX Eye Drops against the expected benefits of using this medicine.

The information in this leaflet applies to TOBREX Eye Drops only. This
information does not apply to similar products, even if they contain the same
ingredients.

If you have any concerns about using this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What TOBREX is used for

TOBREX Eye Drops contain the active ingredient tobramycin. Tobramycin is an
"aminoglycoside" antibiotic.

TOBREX Eye Drops are used to treat bacterial infections of the external part
of the eye.

Before prescribing TOBREX Eye Drops, the doctor will have examined your
eye(s) and decided that TOBREX Eye Drops is the right medicine.

Ask your doctor if you have any questions about why this medicine has been
prescribed for you.

Your doctor may have prescribed TOBREX Eye Drops for another reason.

Before you use TOBREX

When you must not use it

Do not use TOBREX Eye Drops if you have an allergy to:

  • tobramycin, other aminoglycoside antibiotics or any of the ingredients in
    TOBREX Eye Drops listed under Product Description at the end of this
    leaflet
  • any other similar medicines.

Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or
other parts of the body; rash, itching or hives on the skin.

Ask your doctor or pharmacist to be sure you do not have any of these
conditions.

Do not use TOBREX Eye Drops if:

  • the seal around the cap is broken
  • the bottle/packaging shows signs of tampering
  • the expiry date on the bottle/carton has passed.

If you use this medicine after the expiry date has passed, it may not work.

Do not put TOBREX Eye Drops into your eye(s) while you are wearing contact
lenses.

You can put your contact lenses back into your eye 15 minutes after you
have used TOBREX Eye Drops.

If you are not sure whether you should start using TOBREX Eye Drops, talk to
your doctor.

Before you start to use it

Tell your doctor if you have had an allergy to any other medicines or any
other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant or are
breast-feeding.
Your doctor can discuss with you the risks and benefits
involved.

If you have not told your doctor about any of the above, tell them before
you use TOBREX Eye Drops.

Using other medicines

Tell your doctor or pharmacist if you are taking any other medicines,
including other eye drops or ointments, and any other medicines that you get
without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and TOBREX Eye Drops may interfere with each other. These
include:

  • topical beta lactam type antibiotics

These medicines may be affected by TOBREX Eye Drops, or may affect how well
it works. You may need different amounts of your medicines, or you may need to
take different medicines.

Your doctor or pharmacist has more information on medicines to be careful
with or avoid while using this medicine.

How to use TOBREX

Follow all directions given to you by your doctor and pharmacist
carefully.
They may differ from the information contained in this leaflet.

If you are being changed from one medicine to another, follow your doctor's
instructions carefully as to when to stop the medicine and when to start the new
eye drops.

If you do not understand the instructions on the carton / bottle, ask your
doctor or pharmacist for help.

How much to use

Use TOBREX Eye Drops only when prescribed by your doctor.

The usual dose for adults will depend on the type and severity of the
infection that is being treated. For very severe infections your doctor may
recommend that you apply 2 drops in the affected eye(s) every hour;
in mild to moderate infections this will usually be reduced to a 1- 2 drops
in the affected eye(s) every four hours.

Your doctor will tell you how much you need to use each day. These
dosing instructions will be printed on the label your pharmacist puts on the
bottle or carton.

How to use it

It is important to use TOBREX Eye Drops exactly as your doctor or pharmacist
has told you. If you use it less often than you should, it may not work as well
and the eye problem may not improve. Using it more often than you should may not
improve the eye problem any faster and may cause increased side effects.

Follow these steps to use the eye drops:

  1. Wash your hands thoroughly with soap and water.
  2. Remove the cap from the bottle.
  3. Hold the bottle upside down in one hand between your thumb and middle
    finger (see Diagram 1).



    Diagram 1.

    Diagram 1

  4. While tilting your head back, gently pull the lower eyelid of your eye
    down using the forefinger of your other hand.
  5. Place the dropper tip close to, but not touching, your lower eyelid and
    gently tap or press the base of the bottle with your forefinger to release one
    drop (see Diagrams 2 and 3).




    Diagram 2.

    Diagram 2




    Diagram 3.


    Diagram 3

  6. Close your eye gently without blinking
  7. If necessary, repeat the above steps for your other eye.
  8. Place the cap on the bottle and close it tightly.
  9. Wash your hands again with soap and water to remove any residue.

You may feel a slight burning sensation in the eye shortly after using TOBREX
Eye Drops. If this persists, or is very uncomfortable, contact your doctor or
pharmacist.

Be careful not to touch the tip of the bottle against your fingers or the
eye, or anything else. This will help prevent the eye drops becoming dirty or
contaminated.

When to use it

Use TOBREX Eye Drops, at about the same time every day unless your doctor
tells you otherwise.
Using your eye drops at the same time each day will
have the best effect on your eye infection. It will also help you remember when
to use it.

How long to use it

Keep using TOBREX Eye Drops for the full time of treatment, even if you
begin to feel better after a few days.
If you do not complete the full
course prescribed by your doctor, the infection may not clear completely or your
symptoms may return.

Do not use TOBREX Eye Drops longer than your doctor tells you. If you
use it longer than your doctor or pharmacist tells you, the chance of side
effects may increase.

If you are unsure about when or how to stop using TOBREX Eye Drops you
should talk to your doctor or pharmacist.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use
your next dose when you are meant to.

Otherwise, use the eye drops as soon as you remember, and then go back to
using them as you would normally.

Do not use a double dose to make up for the eye drops that you missed.
This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist
for some hints.

If you use too much (overdose)

If you accidentally put too many eye drops in your eye(s) immediately rinse
your eye(s) with lukewarm water.

If you think that you or someone else has swallowed any or all of the
contents of TOBREX Eye Drops, or used too many eye drops, immediately telephone
your doctor or the Poisons Information Centre.

In Australia call 13 1126; in New Zealand call 0800 POISON or 0800 764 766
for advice or go to Accident & Emergency at your nearest hospital. Do this even
if there are no signs of discomfort or poisoning.

While using TOBREX

Things you must do

If the symptoms of your infection do not improve within a few days, or if
they become worse, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and
pharmacist that you are taking TOBREX Eye Drops.

Tell all the doctors, dentists and pharmacists who are treating you that
you are using TOBREX Eye Drops.

Tell your doctor if, for any reason, you have not used TOBREX Eye Drops
exactly as prescribed
. Otherwise your doctor may think that it was not
effective and change the treatment unnecessarily.

If you become pregnant while using TOBREX Eye Drops, tell your doctor.

Things you must not do

Do not use TOBREX Eye Drops to treat any other complaints unless your
doctor tells you to.

Do not give TOBREX Eye Drops to anyone else, even if they have the same
condition as you.

Do not stop using TOBREX Eye Drops or lower the dosage because you are
feeling better, unless advised by your doctor.
If you do not complete the
full course prescribed by your doctor, all of the bacteria causing your
infection may not be killed. These bacteria may continue to grow and multiply so
that your infection may not clear completely or it may return.

Things to be careful of

Be careful driving or operating machinery until you know how TOBREX Eye
Drops affect you and your vision. As with any eye medicine, temporary blurred
vision or other visual disturbances may affect the ability to drive or use
machines. If blurred vision occurs at instillation, wait until your vision is
clear before driving or using machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are using TOBREX Eye Drops.

This medicine helps most people with eye infections, but it may have unwanted
side effects in a few people. All medicines can have side effects. Sometimes
they are serious, most of the time they are not. You may need medical treatment
if you get some of the side effects.

Do not be alarmed by the following list of possible side effects. You may
not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they
worry you:

  • eye irritation or feeling of having something in the eye
  • inflammation of the cornea (clear front portion of your eye) (punctate
    keratitis
    )
  • swollen / itchy eyelids
  • eye redness
  • increased tearing

These are the more common side effects of your medicine. They are usually
mild and short-lived.

If any of the following happen, stop using TOBREX Eye Drops and tell your
doctor immediately or go to Accident & Emergency at your nearest hospital:

  • skin rash (rash)
  • swelling of the face, hands or feet (peripheral oedema)
  • wheezing, difficulty in breathing (bronchospasm, exacerbation of
    asthma, respiratory failure, pulmonary distress
    )
  • severe and sudden onset of pinkish, itchy swellings on the skin, also
    called hives or nettlerash (urticaria)

These hypersensitivity reactions can be very serious side effects. You may
need urgent medical attention or hospitalisation. These side effects are very
rare.

Tell your doctor or pharmacist if you notice anything that is making you
feel unwell.
Other side effects not listed above may also occur in some
people.

After Using TOBREX

Storage

Store TOBREX Eye Drops in a cool dry place where the temperature stays below
25°C. It is not necessary to store TOBREX Eye Drops in the refrigerator. Do
not freeze.

Do not store TOBREX Eye Drops or any other medicine in the bathroom or near a
sink. Do not leave it on a window sill or in the car. Heat and dampness can
destroy some medicines.

Do not carry the eye drops in pockets of your clothes.

Do not leave the cap off the bottle for any length of time to avoid
contaminating the eye drops.

Keep it where children can not reach it. A locked cupboard at least
one-and a half meters above the ground is a good place to store medicines.

Disposal

Write the date on the bottle when you open the eye drops and throw out any
remaining drops after four weeks. TOBREX Eye Drops contains a preservative
which helps prevent germs growing in the solution for the first four weeks after
opening the bottle. After this time there is a greater risk that the solution
may become contaminated and cause an eye infection. A new bottle should be
opened.

If your doctor tells you to stop using TOBREX Eye Drops or the expiry date
has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

TOBREX Eye Drops comes in a 5 mL DROP-TAINER™ with screw cap.

Ingredients

Active ingredients:

  • tobramycin (3.0 mg/mL)

Other ingredients:

It also contains:

  • benzalkonium chloride (0.1 mg/mL) as preservative
  • boric acid
  • sodium sulfate
  • sodium chloride
  • tyloxapol
  • sodium hydroxide and/or sulfuric acid (to adjust pH)
  • purified water

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