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BONDULC 40MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): 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.
2.
3.
4.
5.
6.

What Bondulc is and what it is used for
What you need to know before you use Bondulc
How to use Bondulc
Possible side effects
How to store Bondulc
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. beta-blockers, which also reduce pressure.
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)
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.
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.
 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.

2

3

4

 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.
 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.

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, diarrhea, 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.
Not all pack sizes may be marketed.
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 August 2015.

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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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