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TOBRAVISC 3.0 MG/ML EYE DROPS SOLUTION

Active substance(s): TOBRAMYCIN

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KAPVORM

PMS ZWART
à 100 %

45802-1

Package Leaflet - Information for the User
®

TOBRAVISC

3.0 mg/ml eye drops, solution

Tobramycin

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 further questions, ask your doctor or 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 TOBRAVISC is and what
it is used for

4. Possible side effects
5. How to store TOBRAVISC

2. Before you use TOBRAVISC
3. How to use TOBRAVISC

1

6. Further information

WHAT TOBRAVISC IS AND WHAT IT IS USED FOR
®

TOBRAVISC belongs to a group of medicines
known as aminoglycoside antibiotics.

2

It is used for the treatment of bacterial
infections of the surface of the eye and eyelids,
such as conjunctivitis and blepharitis.

BEFORE YOU USE TOBRAVISC

®

Do not use TOBRAVISC...

Using other medicines

• If you are allergic to tobramycin, or any of
the other ingredients listed in section 6.
• In CHILDREN under the age of 1 year.

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, wait at
least 5-10 minutes after putting in TOBRAVISC
before using the other drops. Put all your eye
drops in before using any eye ointment.

Ask your doctor for advice.
Only use TOBRAVISC for dropping in your
eye(s).

Take special care...
• If you suffer from liver or kidney disease.
Tell your doctor if you are taking any
other antibiotic medicines by mouth or by
injection.
• As with any antibiotic, use of TOBRAVISC
for a long time may lead to other
infections. If your symptoms get worse or
suddenly return tell your doctor.

Pregnancy and breast-feeding

Important Information if you wear
Contact Lenses
Wearing contact lenses is not advisable
during the treatment of an eye infection, as
they may make your condition worse.
Do not use the drops while wearing contact
lenses. Wait at least 15 minutes after using
the eye drops before putting your lenses back
in. There is a preservative in TOBRAVISC
(benzododecinium bromide) that can affect soft
contact lenses.

If you are pregnant or might get pregnant, or if
you are breast-feeding a baby, talk to your
doctor before you use TOBRAVISC.

Driving and using machines
You may find that your vision is blurred for a
time just after you use TOBRAVISC. Do not
drive or use any machines unless your
vision is clear.

3

HOW TO USE TOBRAVISC

®

Do not stop using TOBRAVISC before your
doctor advises, even if your symptoms
improve.
Remove the loose collar from the cap when
the bottle is first opened.

The usual dose
The usual dose in adults and children
1 year and older is 1 drop in your eye(s),
twice a day–morning and evening for 7 days.
In severe infections, this may be increased to
1 drop 4 times a day for the first day, followed
by 1 drop twice a day for 6 days.

Always use TOBRAVISC exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.

Continued over

Quark 7

Tobravisc 5 ml

recto-verso

GB

AANTAL KLEUREN : 1

WS

16-10-2013

Local
Graphics

140 x 335 / 140 x 22 mm

-DRAFT-

Approval

BELGIUM 45802-1

BESOP-00326

Affiliates

V1

Ready for sending:

as is.

new proof.

Final release:

as is.

new proof.

With approval in Catalyst you confirm that this proof contains an accurate translation of the
English Corporate Standard text, and is in compliance with the registered information and
the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if
mentioned, storage conditions and trademarks.

KAPVORM

PMS ZWART
à 100 % - 20 %

HOW TO USE TOBRAVISC (continued)
®



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



1




2

• If a drop misses your eye, try again.
• If you forget to use TOBRAVISC, do not
worry, just use it as soon as possible.
However, if it is almost time for your next
dose, skip the missed dose and go back to
your normal dosing schedule. Do not take
a double dose to make up.

4

The following side effects are common and are
experienced by up to 1 in 10 people using
TOBRAVISC: eye redness, eye discomfort, eye
allergy, itchy eyelids.
The following uncommon side effects have
been reported by up to 1 in 100 people using
TOBRAVISC :
• headache, hypersensitivity reactions
• inflammation, scratching or other problems
with the surface of the eye such as swelling
• impaired or blurred vision
• redness or swelling of the eyelid
• eye discharge, eye pain, dry eyes, itchy
eyes, watery eye(s)

If you have any further questions on the
use of TOBRAVISC, ask your doctor or
pharmacist.

• problems with the skin such as abnormal
sensations, inflammation of the skin, itchy
or dry skin
• the appearance of patches on the skin
• loss of eye brows or eye lashes
The following side effects have also been
reported but it is not known how many people
have been affected:
• skin rash or redness, eye irritation.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

HOW TO STORE TOBRAVISC

• Keep out of the reach and sight of children.
• Keep the bottle tightly closed.
• Do not use the drops after the expiry date
(marked ‘Exp’) on the bottle and the carton.
The expiry date refers to the last day of that
month.
• Stop using the bottle 4 weeks after
first opening, to prevent infections.

6

• If you use more TOBRAVISC than you
should, it can be, rinsed out with warm
water.

POSSIBLE SIDE EFFECTS

Like all medicines, TOBRAVISC can cause side
effects, although not everybody gets them.

5

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).
Don’t 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.

®

• 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.

FURTHER INFORMATION

What TOBRAVISC contains

What TOBRAVISC looks like and
contents of the pack

• The active substance is tobramycin
3 mg/ml.
• The other ingredients are xanthan gum,
benzododecinium bromide, mannitol,
trometamol, boric acid, polysorbate 80,
sulphuric acid and/or sodium hydroxide
(to adjust pH) and purified water.

TOBRAVISC is a clear solution supplied in a
pack containing a 5 ml plastic bottle with a
screw cap.

Marketing authorisation holder :
Alcon Laboratories (UK) Ltd.
Pentagon Park, Boundary Way,
Hemel Hempstead, Herts, HP2 7UD.
United Kingdom.

Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
Date of last revision October 2013.

© 2009, 2013 Novartis
10-2013

45802-1

Quark 7

Tobravisc 5 ml

recto-verso

GB

AANTAL KLEUREN : 1

WS

16-10-2013

Local
Graphics

140 x 335 / 140 x 22 mm

-DRAFT-

Approval

BELGIUM 45802-1

BESOP-00326

Affiliates

V1

Ready for sending:

as is.

new proof.

Final release:

as is.

new proof.

With approval in Catalyst you confirm that this proof contains an accurate translation of the
English Corporate Standard text, and is in compliance with the registered information and
the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if
mentioned, storage conditions and trademarks.

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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