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BIMATOPROST 0.1 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST

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TEVA UK Ref:

231-30-30213-B LEA BIMATOPROST TEVA 0.1 mg/ml 3ml EYE DROP SOL TUK
BIMATOPROST 0.1 mg/ml
EYE DROPS, SOLUTION
Package leaflet:
Information for the user

Version:

2

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.

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.

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.

What is in this leaflet:

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.

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

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.

3

How to use Bimatoprost

Always use this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.

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

2

What you need to know
before you use Bimatoprost

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

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.

8 December 2015

TEVA UK Ref:

231-30-30213-B LEA BIMATOPROST TEVA 0.1 mg/ml 3ml EYE DROP SOL TUK
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.

Version:

2

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.

Reporting of side effects
If you get any side effects, talk to your
If you get any side effects, talk to your doctor or pharmacist. This includes any
doctor or pharmacist. This includes any possible side effects not listed in this
possible side effects not listed in this
leaflet. You can also report side effects
leaflet.
directly via the Yellow Card Scheme at:
Very common: may affect more than 1 www.mhra.gov.uk/yellowcard
By reporting side effects you can help
in 10 people
provide more information on the
Affecting the eye:
• slight redness (up to 29% of people). safety of this medicine.
Common: may affect up to 1 in 10
people
Affecting the eye:
• small breaks in the surface of the
eye, with or without inflammation
• irritation
• itchy eyes
• longer eyelashes
• irritation, when drop is put in the eye
• eye pain.
Affecting the skin:
• red and itchy eyelids
• darker skin colour around the eye
• hair growth around the eye.
Uncommon: may affect up to 1 in 100
people
Affecting the eye:
• tired eye
• swelling of the surface of the eye
• blurred vision
• loss of eye lashes.
Affecting the skin:
• dry skin
• crusting on the edge of the eyelid
• swelling of the eyelid
• itching.
Affecting the body:
• headache
• feeling of sickness.

5

How to store Bimatoprost

Keep this medicine out of the sight and
reach of children.
Store below 30°C.
Do not use this medicine after the
expiry date which is stated on the
bottle label and the carton after EXP.
The expiry date refers to the last day of
that month.
You must throw away the bottle at the
latest four weeks after you first
opened it, even if there are still some
drops left. This will prevent infections.
To help you remember, write down the
date you opened it in the space on the
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 Bimatoprost contains
• The active substance is bimatoprost.
One ml of solution contains 0.1 mg
Not known: frequency cannot be
bimatoprost.
estimated from the available data
• The other ingredients are
Affecting the eye:
benzalkonium chloride (preservative),
• darker skin colour around the eye
sodium chloride, disodium
• darker iris colour
phosphate, anhydrous (E339), citric
• eyes appear sunken
acid anhydrous (E330) and water for
• cystoid macular oedema (swelling of
injections. Small amounts of
the retina within the eye leading to
hydrochloric acid or sodium
worsening vision)
hydroxide may be added to keep the
• eye dryness.
level of acid (pH levels) normal.
Affecting the body:
What Bimatoprost looks like and
• symptoms of allergic reaction
contents of the pack
(swelling, redness and rash of the
Bimatoprost is a clear/colourless to
skin and eye)
slightly yellow eye drop solution in a
• asthma
pack
containing either 1 plastic bottle or
• worsening of asthma
• worsening of the lung disease called 3 plastic bottles each with a screw cap.
Each bottle is approximately half full
chronic obstructive pulmonary
and contains 3 millilitres of eye drops
disease (COPD)
solution. This is enough for 4 weeks
• shortness of breath.
usage. Not all pack sizes may be
marketed.
In addition to the side effects for
Bimatoprost, the following side effects
have been seen with another medicine Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
containing a higher strength of
BN22 9AG, UK
bimatoprost (0.3 mg/ml):
• dizziness
Manufacturer
• ocular burning
Teva Pharmaceutical Works Private
• an allergic reaction in the eye
Limited Company
• inflamed eyelids
Táncsics Mihály út 82.
• difficulty in seeing clearly
H-2100 Gödöllő,
• worsening of vision
Hungary
• swelling of the see-through layer
that covers the eye
This leaflet was last revised in 12/2015.
• a feeling that something is in your
eye
PL 00289/1884
• 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.

30213-B

140 x 420
x-xxxxxxxx/x

8 December 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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