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BIMATOPROST MYLAN 0.1 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST / BIMATOPROST

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Package leaflet:
Information for the user

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

1. What Bimatoprost
0.1 mg/ml is and what
it is used for
Bimatoprost is an antiglaucoma
preparation. It belongs to a
group of medicines called
prostamides.
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.
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. What you need to
know before you use
Bimatoprost 0.1 mg/ml
Do not use Bimatoprost
0.1 mg/ml:
• if you are allergic 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.
Warnings and precautions
Talk to your doctor or
pharmacist before using
Bimatoprost 0.1 mg/ml.
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 “Bimatoprost
0.1 mg/ml contains
benzalkonium chloride”)
• you have or have had low
blood pressure or low
heart rate
• you have had a viral infection
or inflammation of the eye.
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.

Description Bimatoprost 0.1 mg_1 ml_1 x 3 ml
Component Type Leaflet
Affiliate Item Code 1183985
Superceded Affiliate Item Code N/A
TrackWise PR No. 1183985
MA No. PL 04569/1684
Packing Site/Printer

Rompharm Company,
Romania

Supplier Code PR1183985

Pharma Code 2054
SAP No. N/A
Vendor Job No. 476772
Trackwise Proof No. 2
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. leafelt+150+x+640+mm
Barcode Info N/A

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 or have recently
taken or might take any other
medicines.
Pregnancy, breast-feeding
and fertility
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
0.1mg/ml contains
benzalkonium chloride
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. A preservative
in Bimatoprost called
benzalkonium chloride may
cause eye irritation and can
discolour soft contact lenses.

3. How to use Bimatoprost
0.1 mg/ml
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 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.
Do not use more than once
a day as the effectiveness of
treatment may be reduced.
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.

2.

3.

4.

1. Wash your hands. Tilt your
head back and look at the
ceiling.
2. G
 ently pull down the lower
eyelid until there is a small
pocket.
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.
Wipe off any excess that runs
down the cheek.
If a drop misses your eye, try
again.
To help prevent infections and
avoid eye injury, 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.
If you use more Bimatoprost
0.1 mg/ml 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.

Date: 16 Jun 17
No. of colours
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1

Time: 17:18
Page Count

1/2

Black

Non-Print
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Equate CMYK
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Dimensions

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150 x 640 mm

Body Text Size 13 pt
Min Text Size used 13 pt

Sign-offs

v1/May 2015

If you forget to use
Bimatoprost 0.1 mg/ml
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
0.1 mg/ml
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.
Very common side effects
(may affect more than
1 in 10 people)
Affecting the eye:
• slight redness (up to 29 %
of people).
Common side effects (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 side effects (may
affect up to 1 in 100 people)
Affecting the eye:
• darker iris colour
• tired eye
• swelling of the surface of
the eye
• blurred vision
• loss of eye lashes.
Affecting the skin:
• dry skin
• crusting of on the edge of
the eyelid
• swelling of the eyelid
• itching.
Affecting the body:
• headache
• feeling of sickness.
Not known (frequency
cannot be estimated from the
available data)
Affecting the eye:
• macular oedema (swelling
of the retina at the back of
the eye which may lead to
worsening vision)
• darker eyelid colour
• eyes appear sunken
• eye dryness.
Affecting the body:
• asthma
• worsening of asthma
• worsening of the lung disease
called chronic obstructive
pulmonary disease (COPD)
• shortness of breath
• symptoms of allergic reaction
(swelling, redness of the eye
and rash of the skin).
In addition to the side effects
for Bimatoprost 0.1 mg/ml, the
following side effects have been
seen with another medicine
containing a higher strength of
bimatoprost (0.3 mg/ml):
• dizziness
• ocular burning
• an allergic reaction in the eye
• inflamed eyelids
• difficulty in seeing clearly
• worsening of vision
• 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.
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 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 0.1 mg/ml
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 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 to
protect the environment.

6. Contents of the pack
and other information
What Bimatoprost 0.1 mg/ml
contains:
• The active substance is
bimatoprost. One ml of
solution contains 0.1 mg
bimatoprost. One drop
contains approximately
2.5 micrograms bimatoprost.
• The other ingredients are
benzalkonium chloride
(preservative), sodium
chloride, disodium phosphate
heptahydrate, citric acid
monohydrate, sodium
hydroxide or hydrochloric
acid (for pH-adjustment) and
purified water.
What Bimatoprost 0.1 mg/ml
looks like and contents of
the pack
Bimatoprost is a clear, colourless
solution 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 weeks usage.
Not all pack sizes may be
marketed.
Marketing Authorisation
Holder
Mylan, Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
S.C. ROMPHARM COMPANY
S.R.L., Eroilor Street, no. 1A,
Otopeni 075100, Ilfov, Romania.
This leaflet was last revised in
06/2017

1183985
PR1183985
3024335A10

Description Bimatoprost 0.1 mg_1 ml_1 x 3 ml
Component Type Leaflet
Affiliate Item Code 1183985
Superceded Affiliate Item Code N/A
TrackWise PR No. 1183985
MA No. PL 04569/1684
Packing Site/Printer

Rompharm Company,
Romania

Supplier Code PR1183985

Pharma Code 2054
SAP No. N/A
Vendor Job No. 476772
Trackwise Proof No. 2
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. leafelt+150+x+640+mm
Barcode Info N/A

Date: 16 Jun 17
No. of colours
Colours

1

Time: 17:18
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font
Dimensions

Myriad Pro
150 x 640 mm

Body Text Size 13 pt
Min Text Size used 13 pt

Sign-offs

v1/May 2015

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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