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BIMATOPROST 0.1 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST

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BIMATOPROST 0.1 mg/ml
EYE DROPS, SOLUTION
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 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 Bimatoprost is and what it is
used for
2. What you need to know before you
use Bimatoprost
3. How to use Bimatoprost
4. Possible side effects
5. How to store Bimatoprost
6. Contents of the pack and other
information

1

What Bimatoprost is and
what it is used for

Other medicines and Bimatoprost
Tell your doctor or pharmacist if you
are taking, have recently taken, or
might take any other medicines.
Bimatoprost can affect or be affected
by other medicines you are using,
including other eye drops for the
treatment of glaucoma (for example a
prostaglandin analogue). Talk to your
doctor as they may need to monitor
the pressure in your eye(s) during
treatment.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
Bimatoprost may get into breast milk
so you should not breast-feed while
you are taking Bimatoprost.
Driving and using machines
Your sight may become blurred for a
short time just after using Bimatoprost.
You should not drive or use machines
until your sight is clear again.
Bimatoprost contains benzalkonium
A preservative in Bimatoprost called
benzalkonium chloride may cause eye
irritation and can discolour soft contact
lenses. Do not use the drops when you
are wearing your lenses. Wait
15 minutes after using the drops
before you put your lenses back in.

Bimatoprost Eye Drops, Solution
3 How to use Bimatoprost
contains bimatoprost. Bimatoprost is
an antiglaucoma preparation. It
belongs to a group of medicines called Always use this medicine exactly as
your doctor or pharmacist has told
prostamides.
you. Check with your doctor or
pharmacist if you are not sure.
Bimatoprost eye drops are used to
reduce high pressure in the eye in
Bimatoprost should only be applied to
adults. This medicine may be used on
the eye. The recommended dose is one
its own or with other drops called
drop of Bimatoprost in the evening,
beta-blockers which also reduce
once daily in each eye that needs
pressure.
treatment.
How Bimatoprost works
Your eye contains a clear, watery liquid If you use Bimatoprost with another
that feeds the inside of the eye. Liquid eye medicine, wait at least five
minutes between using Bimatoprost
is constantly being drained out of the
eye and new liquid is made to replace and the other eye medicine.
this. If the liquid cannot drain out
Do not use more than once a day as
quickly enough, the pressure inside the
the effectiveness of treatment may be
eye builds up. This medicine works by
reduced.
increasing the amount of liquid that is
drained. This reduces the pressure
Instructions for use:
inside the eye. If the high pressure is
You must not use the bottle if the
not reduced, it could lead to a disease tamper-proof seal on the bottle neck is
called glaucoma and eventually
broken before you first use it.
damage your sight.

2

What you need to know
before you use Bimatoprost

Do not use Bimatoprost if you:
• are allergic (hypersensitive) to
bimatoprost or any of the other
1. Wash your hands. Tilt your head back
ingredients of this medicine (listed in
and look at the ceiling.
section 6)
• have had to stop using eye drops in 2. Gently pull down the lower eyelid
the past because of a side effect of
until there is a small pocket.
the preservative benzalkonium
chloride.
3. Turn the bottle upside down and
squeeze it to release one drop into
Warnings and precautions
each eye that needs treatment.
Talk to your doctor or pharmacist
before using Bimatoprost if you:
4. Let go of the lower lid, and close
• have any breathing problems
your eye.
• have liver or kidney problems
5. Whilst keeping your eye closed,
• have had a cataract surgery in the
press a finger against the corner of
past
the affected eye by the nose and
• have dry eye
hold for 1 minute.
• have or have had any problems with
your cornea (front transparent part
Wipe off any excess that runs down
of the eye)
the cheek.
• wear contact lenses (see section
“Bimatoprost contains
If a drop misses your eye, try again.
benzalkonium” below)
• have or have had low blood pressure To help prevent infections and avoid
or low heart rate
eye injury, do not let the tip of the
• have had a viral infection or
bottle touch your eye or anything else.
inflammation of the eye.
Put the cap back on and close the
bottle straight after you have used it.
Bimatoprost may cause your eyelashes
to darken and grow, and cause the skin If you use more Bimatoprost than you
around the eyelid to darken too. The
should
colour of your iris may also go darker If you use more Bimatoprost than you
over time. These changes may be
should, it is unlikely to cause you any
permanent. The change may be more
serious harm. Put your next dose in at
noticeable if you are only treating one the usual time. If you are worried, talk
eye.
to your doctor or pharmacist.
Children and adolescents
Bimatoprost has not been tested in
children under the age of 18 and
therefore should not be used by
patients under 18 years.

If you forget to use Bimatoprost
If you forget to use Bimatoprost, use a
single drop as soon as you remember,
and then go back to your regular
routine. Do not take a double dose to
make up for a forgotten dose.

If you stop using Bimatoprost
Bimatoprost should be used every day
to work properly. If you stop using
Bimatoprost the pressure inside your
eye may go up, therefore talk to your
doctor before stopping this treatment.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

4

Possible side effects

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

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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.

5

How to store Bimatoprost

Keep this medicine out of the sight and
reach of children.

Store below 30°C.
If you get any side effects, talk to your
doctor or pharmacist. This includes any Do not use this medicine after the
possible side effects not listed in this
expiry date which is stated on the
leaflet.
bottle label and the carton after EXP.
The expiry date refers to the last day of
Very common side effects (may affect that month.
more than 1 in 10 people)
Affecting the eye:
You must throw away the bottle at the
• slight redness (up to 29% of people). latest four weeks after you first
opened it, even if there are still some
Common side effects (may affect up to drops left. This will prevent infections.
1 in 10 people)
To help you remember, write down the
Affecting the eye:
date you opened it in the space on the
• small breaks in the surface of the
box.
eye, with or without inflammation
• irritation
Do not throw away any medicines via
• itchy eyes
wastewater or household waste. Ask
• longer eyelashes
your pharmacist how to throw away
• irritation, when drop is put in the eye medicines you no longer use. These
• eye pain.
measures will help protect the
environment.
Affecting the skin:
• red and itchy eyelids
of the pack and
6 Contents
• darker skin colour around the eye
other
information
• hair growth around the eye.
What Bimatoprost contains
Uncommon side effects (may affect up
• The active substance is bimatoprost.
to 1 in 100 people)
One ml of solution contains 0.1 mg
Affecting the eye:
bimatoprost.
• darker iris colour
• The other ingredients are
• tired eye
benzalkonium chloride
• swelling of the surface of the eye
(preservative), sodium chloride,
• blurred vision
disodium phosphate, anhydrous
• loss of eye lashes.
(E339), citric acid anhydrous (E330)
and water for injections. Small
Affecting the skin:
amounts of hydrochloric acid or
• dry skin
sodium hydroxide may be added to
• crusting on the edge of the eyelid
keep the level of acid (pH levels)
• swelling of the eyelid
normal.
• itching.
What Bimatoprost looks like and
contents of the pack
Bimatoprost is a clear/colourless to
slightly yellow eye drop solution in a
Side effects where the frequency is not pack containing either 1 plastic bottle
or 3 plastic bottles each with a screw
known
cap. Each bottle is approximately half
Affecting the body:
full and contains 3 millilitres of eye
• asthma
drops solution. This is enough for
• worsening of asthma
• worsening of the lung disease called 4 weeks usage. Not all pack sizes may
be marketed.
chronic obstructive pulmonary
disease (COPD)
Marketing Authorisation Holder
• shortness of breath.
TEVA UK Limited, Eastbourne,
BN22 9AG, UK
In addition to the side effects for
Bimatoprost, the following side effects
have been seen with another medicine Manufacturer
Teva Pharmaceutical Works Private
containing a higher strength of
Limited Company
bimatoprost (0.3 mg/ml):
Táncsics Mihály út 82.
• dizziness
H-2100 Gödöllő,
• ocular burning
Hungary
• an allergic reaction in the eye
• inflamed eyelids
This leaflet was last revised in 05/2015.
• difficulty in seeing clearly
• worsening of vision
PL 00289/1884
• swelling of the see-through layer
that covers the eye
• a feeling that something is in your
eye
• eye dryness
• sensitivity to light
• tears
• sticky eyes
• darker eyelashes
• retinal bleeding
• inflammation within the eye
• cystoid macular oedema (swelling of
the retina within the eye leading to
worsening vision)
• eyelid twitching
• eyelid shrinking, moving away from
surface of the eye
• eyes appear sunken
• skin redness around the eye
• increased blood pressure
• weakness
• an increase in blood-test results that
show how your liver is working.
Affecting the body:
• headache
• feeling of sickness.

Other side effects reported with eye
drops containing phosphates
In very rare cases, some patients with
severe damage to the clear layer at the
front of the eye (the cornea) have
developed cloudy patches on the
cornea due to calcium build-up during
treatment.

30213-A

140 x 420
3-xxxxxxxx/A

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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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