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TRAVOPROST PHARMATHEN 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST / TRAVOPROST

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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
your 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
1. WHAT TRAVOPROST IS AND WHAT IT IS
USED FOR
Travoprost eye drops are used to treat high pressure in
the eye. This pressure can lead to an illness called
glaucoma.
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.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
TRAVOPROST
Do not use Travoprost
• if you are allergic to travoprost or any of the other
ingredients of this medicine (listed in section 6)
Warnings and precautions
• If
 you are under 18. Travoprost is not to be used by
people under 18 years of age.
Travoprost may:
• increase the length, thickness, colour and/or number
of your eyelashes and may cause unusual hair growth
on your eyelids.
• change the colour of your iris (the coloured part of
your eye). This change may be permanent.
• rarely cause breathlessness or wheezing or increase
the symptoms of asthma. If you are concerned
about changes in your breathing pattern when
using this medicine talk to your doctor as soon as
possible.
• 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, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

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 this medicine.
Do not use Travoprost if you are breast-feeding.
This medicine may pass into your milk.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, 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
If you wear soft contact lenses. Do not use the drops
with your lenses in. Wait 15 minutes after using the drops
before putting your lenses back in. There is a
preservative in this medicine (benzalkonium chloride) that
can discolour soft lenses.
This preservative may cause also eye irritation or
disruption to the surface of the eye.
Travoprost contains macrogol glycerol hydroxy
stearate 40
This medicine contains macrogol glycerol hydroxy
stearate 40, which may cause skin reactions.
3. HOW TO USE TRAVOPROST
Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure.
Only use Travoprost for dropping in your eyes.
The recommended dose
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. Use this medicine for as long as your doctor
told you to.
• Immediately before using a bottle for the first
time, tear-off the overwrap pouch (picture 1).
Take out the bottle and write the date of
opening on the label in the space provided.

• Get the medicine bottle and a mirror
1
• 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
2
will go in here (picture 2).
• Bring the bottle tip close to the eye. Use the
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 squeeze the bottle to release one drop
of medicine at a time (picture 3).
3
• After using the medicine, press a finger into
the corner of your eye, by the nose (picture
4). This helps to stop the medicine getting
into the rest of the body.
• If you use drops in both eyes, repeat these
same steps for your other eye.
• Close the bottle cap firmly immediately after
use.
4
• Only use one bottle of medicine at a time.
Do not open the pouch until you need to use
the bottle.
• You must throw away the bottle 4
weeks after you first opened it, to
prevent infections, and use a new bottle.
If a drop misses your eye, try again.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects
although not everybody gets them.
If you experience side effects, you can usually carry on
taking the drops, unless the effects are serious. If you
are worried, talk to your doctor or pharmacist. Do not
stop taking Travoprost without speaking to your doctor.
Very common (may affect more than 1 in 10 people)
• Redness of the eye,
• Changes in the colour of the iris (coloured part of
the eye).
Common (may affect up to 1 in 10 people)
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
Effects in the body:
• headache
• skin darkening around the eyes.
Uncommon (may affect up to 1 in 100 people)
Effects in the eye:
• inflammation or infection of the conjunctiva (thin
membrane that covers the inner surface of the eyelid
and the white part of the eyeball) or cornea
• halo vision
• corneal disorder
• eye allergy
• tired eyes.
• increase in pupil size
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
• dry mouth
• constipation

• skin inflammation, redness or itching
• shoulder pain
• bad taste.
Additional side effects that have been
reported include:
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 (a protein produced by the
prostate gland).
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 (website: 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 bottle and the box after ‘Exp’. The expiry
date refers to the last day of the month.
Do not use this medicine if you notice that the tamper
evident seal has been broken or damaged before you first
open it.
Before opening, keep bottle in overwrap pouch in order
to protect from moisture.
After first opening, 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 the bottle 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.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Travoprost contains
• The active substance is travoprost. This medicine
contains 40 micrograms/ml of travoprost.
• The other ingredients are benzalkonium chloride,
macrogol glycerol hydroxy stearate 40, trometamol,
disodium edetate, boric acid, mannitol, sodium
hydroxide for pH adjustment and water for injection.
What Travoprost looks like and the contents of
the pack
Travoprost is a clear, colourless solution supplied in packs
containing translucent polypropylene 5ml bottle(s) with
transparent low density polyethylene (LDPE) dropper and
white high density polyethylene (HPDE) tamper-proof
screw cap packaged in overwrap pouch. Each bottle
contains 2.5ml solution.
The product is available in the following pack sizes:
Cartons containing 1 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder
Distributor:
Pharmathen S.A.
Aspire Pharma Limited
Dervenakion 6
Bellamy House, Winton Road
Pallini 15351
Petersfield, Hampshire
Attiki, Greece,
GU32 3HA, United Kingdom
Manufacturer
Pharmathen S.A. and BALKANPHARMA-RAZGRAD AD
Dervenakion 6
68 Aprilsko vastanie Blvd
Pallini 15351
Razgrad 7200
Attiki,
Greece
Bulgaria

This leaflet was last revised in 03/2014.

XXXXXXX-P1.4

If you use more Travoprost than you should
Rinse all medicine out of your eye with warm water.
Do not put in any more drops until it is time for your next
regular dose.
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.
If you stop using Travoprost
Do not stop using this medicine without speaking to your
doctor. This is because 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 your doctor or pharmacist.

Artwork for:
Aspire Pharma Limited
Product name:
Travoprost 40 micrograms/ml Eye Drops
Size:
PL/PA no:
Type: Leaflet
Artwork dimensions: 240mm x 160mm
Profile supplied: Yes
Date of first artwork: 17 March 2014
Reason for request: Artwork in User Tested style: add numerals to pics
Version no: 1.4
Date of revision:
19 March 2014
Colours:
As swatch(es)
Font(s):
8pt Tahoma
Artwork software:
InDesign CS6
BAC ref: R610

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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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