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BIMATOPROST SANDOZ 300 MCG/ML EYE DROPS

Active substance(s): BIMATOPROST

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bimatoprost 300 mcg/ml Eye Drops

Bimatoprost

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 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

pharmacist for advice
before taking any
medicine.

What Bimatoprost
is and what it is
used for

Bimatoprost may get into
breast milk so you should
not breast-feed while you
are using Bimatoprost.

Bimatoprost is an
antiglaucoma preparation.
It belongs to a group of
medicines called
prostamides.

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 is used to
reduce high pressure in
the eye. This medicine
may be used on its own or
with other drops called
beta-blockers which also
reduce pressure.

Important information
about some of the
ingredients of
Bimatoprost
Bimatoprost contains
benzalkonium chloride, a
preservative which may
cause eye irritation and
which can discolour soft
contact lenses. Avoid
contact with 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.

Your eye contains a clear,
watery liquid that feeds the
inside of the eye. Liquid is
constantly being drained
out of the eye and new
liquid is made to replace
this. If the liquid cannot
drain out quickly enough,
the pressure inside the
eye builds up. This
medicine works by
increasing the amount of
liquid that is drained. This
reduces the pressure
inside the eye. If the high
pressure is not reduced, it
could lead to a disease
called glaucoma and
eventually damage your
sight.

2

How to use
3 Bimatoprost

What you need to
know before you
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.

Do not use Bimatoprost:
• if you are allergic
(hypersensitive) to
bimatoprost or any of
the other ingredients of
this medicine (listed in
section 6).
• if you have had to stop
using eye drops in the
past because of a side
effect of the preservative
benzalkonium chloride.

Bimatoprost should only
be applied to the eye. The
recommended dose is one
drop of Bimatoprost in the
evening, once daily in
each eye that needs
treatment.

If you use Bimatoprost
with another eye medicine,
wait at least five minutes
between using
Bimatoprost and the other
eye medicine.

Warnings and
precautions
Talk to your doctor or
pharmacist before using
Bimatoprost.

Do not use more than
once a day as the
effectiveness of treatment
may be reduced.

Talk to your doctor, if:
• You have any breathing
problems.
• You have liver or kidney
problems.
• You have had a cataract
surgery in the past.
• You have dry eye.
• You have or have had
any problems with your
cornea (front transparent
part of the eye).
• You wear contact lenses
(see “Important
information about some
of the ingredients of
Bimatoprost”).
• You have or have had
low blood pressure or
low heart rate.
• You have had a viral
infection or inflammation
of the eye.

Instructions for use:

You must not use the
bottle if the tamper-proof
seal on the bottle neck is
broken before you first use
it.
1. Wash your hands. Tilt
your head back and look
at the ceiling.

Bimatoprost may cause
your eyelashes to darken
and grow, and cause the
skin around the eyelid to
darken too. The colour of
your iris may also go
darker over time. These
changes may be permanent.
The change may be more
noticeable if you are only
treating one eye.
Children and adolescents
Bimatoprost has not been
tested in children under
the age of 18 and
therefore Bimatoprost
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.

3. Turn the bottle upside
down and squeeze it to
release one drop into each
eye that needs treatment.

4. Let go of the lower lid,
and close your eye for 30
seconds.

Pregnancy, breast-feeding
and fertility
If you are pregnant or
breast-feeding, think you
might be pregnant or are
planning to have a baby,
ask your doctor or

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2. Gently pull down the
lower eyelid until there is a
small pocket.

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Wipe off any excess that
runs down the cheek.

Side effects where the
frequency is unknown

To help prevent infections,
do not let the tip of the
bottle touch your eye or
anything else. Put the cap
back on and close the
bottle straight after you
have used it.

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
(www.mhra.gov.uk/
yellowcard). By reporting
side effects you can help
provide more information
on the safety of this
medicine.

If a drop misses your eye,
try again.

Affecting the eye
• Eyes appear sunken

If you use more
Bimatoprost than you
should
If you use more
Bimatoprost than you
should, it is unlikely to
cause you any serious
harm. Put your next dose
in at the usual time. If you
are worried, talk to your
doctor or pharmacist.

to store
5 How
Bimatoprost

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 use a
double dose to make up
for a forgotten dose.

Keep this medicine out of
the sight and reach of
children.
This medicine does not
require any special
storage conditions.

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.

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.

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.

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

side
4 Possible
effects

Medicines should not be
disposed of via
wastewater or household
waste. Ask your
pharmacist how to dispose
of medicines no longer
required. These measures
will help to protect the
environment.

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

6

Very common side
effects (may affect more
than 1 in 10 people)

Affecting the eye
• Longer eyelashes (up to
45% of people)
• Slight redness (up to
44% of people)
• Itchiness (up to 14% of
people)

Contents of the
pack and other
information

What Bimatoprost
contains
• The active substance is
bimatoprost. One ml of
solution contains 0.3 mg
bimatoprost. One drop
contains approximately
7.5 micrograms
bimatoprost.
• The other ingredients
are benzalkonium
chloride (preservative),
citric acid monohydrate,
disodium phosphate
heptahydrate, sodium
chloride, purified water
and sodium hydroxide or
hydrochloric acid.

Common side effects
(may affect up to 1 in 10
people)

Affecting the eye
• An allergic reaction in
the eye
• Tired eyes
• Sensitivity to light
• Darker skin colour
around the eye
• Darker eyelashes
• Pain
• A feeling that something
is in your eye
• Sticky eyes
• Darker iris colour
• Difficulty in seeing
clearly
• Irritation
• Burning
• Inflamed, red and itchy
eyelids
• Tears
• Dryness
• Worsening of vision
• Blurred vision
• Swelling of the
see-through layer which
covers the surface of the
eye
• Small breaks in the
surface of the eye, with
or without inflammation

What Bimatoprost looks
like and contents of the
pack
Bimatoprost is a clear,
colourless solution,
practically free from
particles in a pack
containing either 1 plastic
bottle or 3 plastic bottles
each with a screw cap.
Each bottle is
approximately half full and
contains either 2.5
millilitres or 3 millilitres of
solution. This is enough for
4 weeksʼ usage.

Not all pack sizes may be
marketed.

Marketing Authorisation
Holder and Manufacturer

Affecting the body
• Headaches
• An increase in blood-test
results that show how
your liver is working
• Increased blood
pressure

Marketing Authorisation
Holder:
Sandoz Limited
Frimley Business Park,
Frimley, Camberley,
Surrey,
GU16 7SR
United Kingdom

Uncommon side effects
(may affect up to 1 in 100
people)

Manufacturer:
S.C. Rompharm Company
s.r.l.
Eroilor Street, no. 1A
Otopeni 075100, Ilfov.
Romania

Affecting the eye
• Cystoid macular
oedema (swelling of the
retina within the eye
leading to worsening
vision)
• Inflammation within the
eye
• Retinal bleeding
• Swollen eyelids
• Eyelid twitching
• Eyelid has moved away
from surface of eye
• Skin redness around the
eye

or

Aeropharm GmbH
Francois-Mitterrand-Allee
1
D-07407 Rudolstadt
Germany
or

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Affecting the body
• Nausea
• Dizziness
• Weakness
• Hair growth around the
eye

This leaflet was last
revised in 05/2014.

Very rare side effects
(may affect up to 1 in
10,000 people)

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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.

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Artwork Proof Box
Ref: V001: Addition of Lek Ljubljana as Batch Release site
Proof no.
002.0

Date prepared:
29/05/2014

Colours:
Black
Dimensions: 100 x 630 mm

Font size:
9pt
Fonts:
Helvetica

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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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