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BONDULC 40MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST / TRAVOPROST / TRAVOPROST

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Package leaflet:
Information for the user

Bondulc 40micrograms/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 Bondulc is and what it is used for
2 What you need to know before you use Bondulc
3 How to use Bondulc
4 Possible side effects
5 How to store Bondulc
6 Contents of the pack and other information
1 What Bondulc is and what it is used for

Bondulc 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. betablockers, which also reduce pressure.

Driving and using machines
You may find that your vision is blurred for a time just after you use
Bondulc. Do not drive or use machines until this has worn off.
Bondulc contains benzalkonium chloride
May cause eye irritation. Avoid contact with soft contact lenses.
Remove contact lenses prior to application and wait at least 15
minutes before reinsertion. Know to discolour soft contact lenses.
Bondulc contains macrogol glycerol hydroxy stearate 40
This medicine contains macrogol glycerol hydroxy stearate 40,
which may cause skin reactions.

3 How to use Bondulc

Always use this medicine exactly as your doctor or the doctor
treating your child has told you. 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 Bondulc 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 Bondulc for dropping in your or your child’s eyes.

1

• 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
• Wash your hands.
• Twist off the cap.

Bondulc is used to reduce high pressure in the eye in adults,
adolescents and children from 2 months old onward. This pressure
can lead to an illness called glaucoma.

2 What you need to know before you use Bondulc

Do not use Bonculc
• If you are allergic to travoprost or any of the other ingredients of
this medicine (listed in section 6).

2

• 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
the mirror if it helps.

Ask your doctor for advice if this applies to you.
Warnings and precautions
• Bondulc may increase the length, thickness, colour and/or
number of your eyelashes. Changes in the eyelids including
unusual hair growth or in the tissue around the eye have also
been observed.
• Bondulc 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 Bondulc.
• If you have current or previous history of an eye inflammation
(iritis and uveitis), talk to your doctor before you use Bondulc.
• Bondulc may 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.
• Bondulc 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
Bondulc can be used in children from 2 months to <18 years at the
same dose as for adults. Use of Bondulc is not recommended to
those children under 2 months of age.
Other medicines and Bondulc
Tell your doctor or pharmacist if you are using, have recently used
or might use any other medicines.
Pregnancy, breast-feeding and fertility
Do not use Bondulc 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 Bondulc if you are breast-feeding. Bondulc may get
into your milk.
Ask your doctor for advice before taking any medicine.
Continued top of next column

3

• 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 medicine at a time (picture 3).
• After using the medicine, 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 the medicine getting into the
rest of the body.

4

• If you use drops in both eyes, repeat these
same steps for the other eye.
• Close the bottle cap firmly immediately
after use.
• Only use one bottle of medicine at a time.
Do not open the pouch until you need to
use the bottle.
If a drop misses your 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 Bondulc and the other eye preparations.
If you or your child receive more Bondulc than you should
Rinse all the medicine out with warm water. Do not put in any
more drops until it is time for your next regular dose.
If you forget to use Bondulc
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 Bondulc
Do not stop using this medicine 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.
Continued over page

Travoprost 40 micrograms/ml 2.5ml Eye Drops PIL - UK
item no: AAAI9970

dimensions: 160 x 320

print proof no: 06

pharmacode:

origination date: 04-05-2016

min pt size: 8.5 pts

1. Black
2.
3.
4.
5.
6.

originated by: NM
approved for print/date

colours/plates:

revision date: 30-06-2016

Technical Approval

revised by: NM

date sent: 04-05-2016 28-06-2016

supplier: Pharmathen

technically app. date: 28-06-2016

Non Printing Colours
1.
2.
3.

If you have any further questions on the use of this medicine,
ask your doctor, the doctor treating your child or pharmacist.

4 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 are worried, talk to your doctor or pharmacist. Do
not stop taking Bondulc without speaking to your doctor.
The following side effects have been seen with Bondulc.
Very common side effects: may affect more than 1 in 10 people
Effects in the eye
• eye redness.
Common side effects: 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 side effects: 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
• irregular heartbeat
• shortness of breath
• asthma
• stuffy nose
• throat irritation
• darkening of skin around the eye(s)
• skin darkening
• abnormal hair texture
• excessive hair growth.
Rare side effects: may affect up to 1 in 1,000 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
• breathing problems
• sore throat.

Not known: frequency cannot be estimated from the available
data
Effects in the eye:
• inflammation 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
• increase in heart rate.
In children and adolescents, the most common side effects seen
with Bondulc 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 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 Bondulc

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 Bondulc contains
• The active substance is travoprost. Each ml of solution contains
40micrograms of travoprost.
• The other ingredients are benzalkonium chloride solution,
macrogol glycerol hydroxy stearate 40, trometamol, disodium
edetate, boric acid (E284), mannitol (E421), sodium hydroxide for
pH adjustment and water for injection.
What Bondulc looks like and the contents of the pack
Bondulc Eye Drop, Solution 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.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Manufacturer
Pharmathen S.A.
6 Dervenakion str., 15351 Pallini, Attiki, Greece
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd., Razgrad, 7200, Bulgaria
This leaflet was last revised in May 2016.

Continued top of next column
AAAI9970

Actavis, Barnstaple, EX32 8NS, UK

Travoprost 40 micrograms/ml 2.5ml Eye Drops PIL - UK
item no: AAAI9970

dimensions: 160 x 320

print proof no: 06

pharmacode:

origination date: 04-05-2016

min pt size: 8.5 pts

1. Black
2.
3.
4.
5.
6.

originated by: NM
approved for print/date

colours/plates:

revision date: 30-06-2016

Technical Approval

revised by: NM

date sent: 04-05-2016 28-06-2016

supplier: Pharmathen

technically app. date: 28-06-2016

Non Printing Colours
1.
2.
3.

Expand Transcript

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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