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TRAVOPROST 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST

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TEVA UK Ref:

231-30-90227-E LEA TRAVOPROST 40mcg/ml EYE DROPS 2.5ml TUK Dimensions:
Length:
Width:
Depth:

300 mm
160 mm
-

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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. 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

WHAT TRAVOPROST IS AND WHAT IT IS
USED FOR

Travoprost contains travoprost, one of a group of
medicines called prostaglandin analogues. It works
by reducing the pressure in the eye. It may be used
on its own or with other drops e.g. beta-blockers,
which also reduce pressure.
Travoprost eye drops are used to treat high pressure
in the eye in adults, adolescents and children from 2
months onward. This pressure can lead to an illness
called glaucoma.

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Colours Used:

TRAVOPROST 40 micrograms/ml
EYE DROPS, SOLUTION

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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).
Ask your doctor for advice if this applies to you.
Warnings and precautions
• Travoprost may increase the length, thickness,
colour and/or number of your eyelashes. Changes
in the eyelids including unusual hair growth or in
the tissues around the eye have also been
observed
• Travoprost may change the colour of your iris (the
coloured part of your eye). This change may be
permanent. A change in the colour of the skin
around the eye may also occur
• If you have had cataract surgery, talk to your
doctor before you use travoprost
• If you have current or previous history of an eye
inflammation (iritis and uveitis), talk to your doctor
before you use travoprost
• 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. If
any of the medicinal product comes into contact
with the skin, it should be washed off straight
away. This is especially important in women who
are pregnant or are attempting to become
pregnant
• If you wear soft contact lenses, do not use the
drops with your lenses in. After using the drops
wait 15 minutes before putting your lenses back in.
Children and adolescents
Travoprost can be used in children from 2 months to
< 18 years at the same dose as for adults. Use of
Travoprost is not recommended to those children
under 2 months of age.

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Other medicines and Travoprost
Tell your doctor or pharmacist if you are taking or
have recently taken or used any other medicines.
Pregnancy, breast-feeding and fertility
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.
Do not use travoprost if you are breast-feeding,
travoprost may get into your milk.
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 Travoprost (benzalkonium chloride)
that can discolour soft lenses.
This product contains benzalkonium chloride.
Patients who can not tolerate benzalkonium chloride
may use other travoprost eye drops, containing
different preservative agent. Benzalkonium chloride
may cause small breaks in the surface of the eye.
Travoprost contains macrogol glycerol hydroxy
stearate
This may cause skin reactions.

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HOW TO USE TRAVOPROST

Always use this medicine exactly as your doctor or
the doctor treating your child has told you. You
should check with your doctor, the doctor treating
your child or pharmacist if you are not sure.
The recommended dose is
One drop in the affected eye or eyes, once a day-in
the evening.
Only use travoprost in both eyes if your doctor told
you to. Use it for as long as your doctor or the doctor
treating your child told you to.
Only use travoprost for dropping in your or your
child’s eye(s).

Picture 1

Picture 2

Picture 3

Picture 4

• Immediately before using a bottle for the first time,
tear open the overwrap pouch, take the bottle out
(Picture 1) and write the date of opening on the
label in the space provided
• Wash your hands
• Twist off the cap
• Hold the bottle, pointing down, between your
thumb and fingers
• Tilt your head or your child’s head gently back. Pull
down the eyelid with a clean finger, until there is a
‘pocket’ between the eyelid and the eye. The drop
will go in here (Picture 2)
• Bring the bottle tip close to the eye. Use a mirror if
it helps
• Do not touch the 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, keep the eyelid closed,
apply gentle pressure by pressing a finger into the
corner of the eye, by the nose (Picture 4) for at
least 1 minute. This helps to stop travoprost getting
into the rest of the body

TEVA UK Ref:

231-30-90227-E LEA TRAVOPROST 40mcg/ml EYE DROPS 2.5ml TUK Dimensions:
Length:
Width:
Depth:

300 mm
160 mm
-

1

Colours Used:

• If you use drops in both eyes, repeat the steps for
the 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 the eye, try again.
If you or your child are using other eye preparations
such as eye drop or eye ointment, wait for at least 5
minutes between putting in travoprost and the other
eye preparations.
If you or your child receive more Travoprost than you
should
Rinse all the medicine out with warm water. Don’t put
in any more drops until it’s 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. Never
use more than one drop in the affected eye(s) in a
single day.
If you stop using Travoprost
Do not stop using Travoprost without first speaking to
your doctor or the doctor treating your child, the
pressure in your eye or your child’s eye will not be
controlled which could lead to loss of sight.
If you have any further questions on the use of this
product, ask your doctor, the doctor treating your
child or pharmacist.

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POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects although not everybody gets them.
You can usually carry on using the drops, unless the
side effects are serious. If you’re worried, talk to a
doctor or pharmacist. Do not stop taking travoprost
without speaking to your doctor.
The following side effects have been seen with
travoprost
Very common: may affect more than 1 in 10 people
Effects in the eye: eye redness.
Common: may affect up to 1 in 10 people
Effects in the eye: changes in the colour of the iris
(coloured part of the eye), eye pain, eye discomfort,
dry eye, itchy eye, eye irritation.
Uncommon: may affect up to 1 in 100 people
Effects in the eye: corneal disorder, eye
inflammation, iris inflammation, inflammation inside
the eye, eye surface inflammation with/out surface
damage, sensitivity to light, eye discharge, eyelid
inflammation, eyelid redness, swelling around the
eye, eyelid itching, reduced vision, blurred vision,
increased tear production, infection or inflammation
of the conjunctiva (conjunctivitis), abnormal turning
outward of the lower eyelid, clouding of the eye,
eyelid crusting, growth of eyelashes, discolouration
of the eyelashes, tired eyes.
General side effects: increased allergic symptoms,
headache, dizziness, feeling your heart beat,
shortness of breath, asthma, stuffy nose, throat
irritation, darkening of skin around the eye(s), skin
darkening, abnormal hair texture, excessive hair
growth, visual field defect.
Rare: may affect up to 1 in 1000 people
Effects in the eye: perception of flashing lights,
eczema of the eyelids, eye swelling, halo vision,
decreased eye sensation, inflammation of the glands
of the eyelids, pigmentation inside the eye, increase
in pupil size, change in the texture of the eyelashes.
General side effects: eye viral infection, bad taste,
irregular or decreased heart rate, increased or
decreased blood pressure, cough, voice changes,
gastrointestinal discomfort or ulcer, constipation, dry
mouth, redness or itching of the skin, rash, hair
colour change, loss of eyelashes, musculoskeletal
pain, generalised weakness, herpes infection, pain in
the throat, problems breathing.

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Not known: frequency cannot be estimated from the
available data
Effects in the eye: swelling of the back of the eye,
eyes appear more inset.
General side effects: depression, anxiety, sensation
of false movement, ringing in ears, chest pain,
worsening of asthma, diarrhoea, abdominal pain,
nausea, itching, abnormal hair growth, joint pain,
painful or involuntary urination, increase in prostate
cancer marker, very slow or fast heart beat.
In children and adolescents, the most common side
effects seen with travoprost are eye redness and
growth of eyelashes. Both side effects were
observed with a higher incidence in children and
adolescents compared to adults.
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.

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HOW TO STORE TRAVOPROST

Keep this medicine out of the sight and reach of
children.
Do not use Travoprost 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.
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.
Do not use this medicine if you notice that the tamper
evident seal has been broken or damaged before you
first open it.
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.

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CONTENTS OF THE PACK AND OTHER
INFORMATION

What Travoprost contains
The active substance is travoprost 40 micrograms/ml.
The other ingredients are: benzalkonium chloride,
macrogol glycerol hydroxy stearate (cremophor
RH40), trometamol, disodium edetate, boric acid
(E284), mannitol (E421), sodium hydroxide (for pH
adjustment), water for injection.
What Travoprost looks like and the contents of the
pack
Travoprost is a liquid (a clear, colourless solution)
supplied in a pack containing a 5 ml plastic bottle
with a screw cap or in a pack containing one, three
or six 5 ml plastic bottles with screw caps. Each
bottle contains 2.5 ml solution. Each bottle is placed
in a pouch. Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturers
Pharmathen S.A, Dervenakion 6, Pallini 15351, Attikis,
Greece
This leaflet was last revised in 04/2016.
PL 00289/1785

90227-E

300 x 160
269221.02-GB

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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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