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TRAVOPROST SANDOZ 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST

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KAPVORM

PMS ZWART
à 100   % - 20  %

64926-0

PACKAGE LEAFLET  : INFORMATION FOR THE USER

Travoprost 40 micrograms / ml
eye drops, solution
travoprost
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 pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness 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.
What is in this leaflet
1. What Travoprost is and what it is used for
2. What you need to know before you use
Travoprost
3. How to use Travoprost
4. Possible side effects
5. How to store Travoprost
6. Contents of the pack and other information

3 How to use Travoprost

Travoprost is and what it is
used for
1 What
Travoprost eye drops are used to treat high
pressure in the eye. This pressure can lead to an
illness called glaucoma.

Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

High pressure in the eye  : Your eyeballs contain a
clear, watery liquid which feeds the inside of the
eye. Liquid is always emptying out of the eye, and
more liquid is always being produced. If the eye
fills up faster than it empties, the pressure inside
the eye builds up. If it gets too high, it can
damage your sight.

The recommended dose is  :

Travoprost is one of a group of medicines for
glaucoma called prostaglandin analogues. It
works by increasing the outflow of liquid, which
lowers the pressure in the eye. It may be used on
its own or with other drops e.g. beta-blockers,
which also reduce pressure.

Only use Travoprost for dropping in your eyes.

Adults  : 1 drop in the eye or eyes, once a day in
the evening.
Only use Travoprost in both eyes if your doctor
told you to. Take it for as long as your doctor told
you to.

Instruction for use  :

you need to know before you
use Travoprost
2 What

1

2

3

4

Do not use Travoprost

if you are allergic to travoprost or any of the
other ingredients of this medicine ( listed in
section 6 ).
Ask your doctor for advice if this applies to you.
Warnings and precautions
Talk to your doctor or pharmacist before using
Travoprost.
Travoprost may increase the length, thickness,
colour and / or number of your eyelashes and
may cause unusual hair growth on your
eyelids.



Travoprost may change the colour of your iris
( the coloured part of your eye ). This change
may be permanent.



Travoprost may rarely cause breathlessness or
wheezing or increase the symptoms of
asthma. If you are concerned about changes
in your breathing pattern when using
Travoprost advise your doctor as soon as
possible.



Travoprost may be absorbed through the skin
and therefore should not be used by women
who are pregnant or are attempting to become
pregnant. If any of the product comes into
contact with the skin then it should be washed
off straight away.



Children and adolescents
Travoprost is not to be used by people under
18 years of age.
Other medicines and Travoprost
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines.

Immediately before using a bottle for the first
time, tear-off the overwrap pouch take it out
( picture 1 ) and write the date of opening on the
label in the space provided.

Get the Travoprost bottle and a mirror.

Wash your hands.

Twist off the cap.

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

Tilt your head back. Pull down your eyelid with
a clean finger, until there is a ‘pocket’ between
the eyelid and your eye. The drop will go in
here ( picture 2 ).

Bring the bottle tip close to the eye. Use the
mirror if it helps.

Don’t touch your eye or eyelid, surrounding
areas or other surfaces with the dropper. It
could infect the drops.

Gently squeeze the bottle to release one drop
of Travoprost at a time ( picture 3 ).

After using Travoprost, press a finger into the
corner of your eye, by the nose ( picture 4 ).
This helps to stop Travoprost getting into the
rest of the body.

If you take drops in both eyes, repeat the
steps for your other eye.

Close the bottle cap firmly immediately after
use.

Only use one bottle at a time. Do not open the
pouch until you need to use the bottle.


If a drop misses your eye, try again.

Pregnancy and breast-feeding
Do not use Travoprost if you are pregnant. If you
think that you may be pregnant speak with your
doctor right away. If you could become pregnant
you must use adequate contraception whilst you
use Travoprost.

If you use more Travoprost than you should
Rinse it all out with warm water. Don’t put in any
more drops until it’s time for your next regular
dose.

Do not use Travoprost if you are breast-feeding,
Travoprost may get into your milk.

If you forget to use Travoprost
Continue with the next dose as planned. Do not
use a double dose to make up for a forgotten
dose. The dose should not exceed one drop in
the affected eye( s ) daily.

Ask your doctor for advice before taking any
medicine.
Driving and using machines
You may find that your vision is blurred for a time
just after you use Travoprost. Do not drive or use
machines until this has worn off.
Travoprost contains

benzalkonium chloride  : This may cause eye
irritation. Avoid contact with soft contact
lenses. Remove contact lenses prior to
application and wait at least 15 minutes before
reinsertion. Benzalkonium chloride is known to
discolour soft contact lenses.

macrogolglycerol hydroxystearate 40  : This
may cause skin reactions.

If you stop using Travoprost
Without speaking to your doctor, the pressure in
your eye will not be controlled which could lead to
loss of sight.
If you are using other eye drops, leave at least
5 minutes between putting in Travoprost and the
other drops.
If you have any further questions on the use of
this medicine ask a doctor or pharmacist.

Continued on the next page >>

InDesign CS4

-DRAFT-

140 x 504  /  140 x 22 mm

Travoprost 0.004%
2.5 ml / 3 x 2.5 ml

recto-verso

GB

AANTAL KLEUREN   : 1

HVR

Local
Ready for sending:
Graphics

Approval

BELGIUM 64926-0

22-06-2014
BESOP-00326

V1

Affiliates

as is.

new proof.

The undersigned:
confirms 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.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.

Local
Final release:
Graphics

as is.

new proof.

KAPVORM

PMS ZWART
à 100  % - 20  %

of the pack and other
information
6 Contents

4 Possible side effects

What Travoprost contains

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



You can usually carry on taking the drops, unless
the effects are serious. If you’re worried, talk to a
doctor or pharmacist. Do not stop taking
Travoprost without speaking to your doctor.
Very common side effects, affects more than
1 per 10 users
Redness of the eye, changes in the colour of the
iris ( coloured part of the eye  ; this may affect up to
23  % of the patients )
Common side effects, affects 1 to 10 per
100 users



The active substance is travoprost. Each ml
of solution contains 40 micrograms travoprost.
The other ingredients are  : Benzalkonium
chloride solution, macrogolglycerol
hydroxystearate 40, trometamol, disodium
edetate, boric acid, mannitol and purified
water. Tiny amounts of hydrochloric acid or
sodium hydroxide are added to keep acidity
levels ( pH levels ) normal.

What Travoprost looks like and contents of the
pack
Travoprost is a clear, colourless eye drop solution,
supplied in a pack containing 1, 3 or 6 plastic
dropper container( s ) of 2.5 ml, each with a screw
cap. Each dropper container is placed in a pouch.
Not all pack sizes may be marketed.

Effects in the eye  :

inflammation inside the eye

eye pain or swelling

eye irritation

eye discharge

sensitivity to light

blurred

reduced or abnormal vision

dry eye, itchy eye

increased tear production

abnormal or decreased eye sensation

eyelid abnormality, irritation, itching, redness,
pain, swelling or crusting

discolouration of the eyelashes, increased or
decreased growth or number of eyelashes

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder  :
Sandoz Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey,
GU16 7SR
United Kingdom
Manufacturer  :

Effects in the body  :

headache

skin darkening around the eyes

Alcon-Couvreur N.V
Rijksweg 14, B-2870 Puurs
Belgium

Uncommon side effects, affects 1 to 10 per
1000 users

Or

Effects in the eye  :
inflammation or infection of the conjunctiva
or cornea

halo vision

corneal disorder

eye allergy

tired eyes

increase in pupil size

Alcon Cusí S.A
Camil Fabra 58, 08320 El Masnou, Barcelona
Spain



Or
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia

Effects in the body  :

asthma, shortness of breath

increased or decreased blood pressure

irregular, increased, or decreased heart rate

dizziness

viral infection

cough

generalised weakness

increased allergic symptoms

throat irritation

stuffy nose

voice changes

gastrointestinal discomfort or ulcer

constipation

redness or itching

shoulder pain

bad taste

dry mouth

Or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
Or
Aeropharm GmbH
Francois-mitterrand-allee 1, 07407 Rudolstadt
Germany
This leaflet was last revised in 08 / 2014.

Frequency unknown, according to the available
data  :
Effects in the eye  :
inflammation of the back of the eye

sunken eyes


Effects in the body  :
worsening of asthma

ringing in ears

increased prostate antigen


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 ( www.mhra.gov.uk / yellowcard ). By
reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Travoprost
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton, the pouch and the
bottle label after ‘EXP’. The expiry date refers to
the last day of that month.
This medicine does not require any special
storage conditions.
You must throw away the bottle 4 weeks after you
first opened it, to prevent infections, and use a
new bottle. Write down the date you opened it in
the space on each bottle label and box.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

Sandoz and
Novartis.

are registered trademarks of

05-2014

64926-0

InDesign CS4

-DRAFT-

140 x 504  /  140 x 22 mm

Travoprost 0.004%
2.5 ml / 3 x 2.5 ml

recto-verso

GB

AANTAL KLEUREN   : 1

HVR

Local
Ready for sending:
Graphics

Approval

BELGIUM 64926-0

22-06-2014
BESOP-00326

V1

Affiliates

as is.

new proof.

The undersigned:
confirms 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.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.

Local
Final release:
Graphics

as is.

new proof.

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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