Skip to Content

BIMATOPROST PHARMATHEN 0.3 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST / BIMATOPROST / BIMATOPROST

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Bimatoprost 0.3mg/ml, eye drops,
solution
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 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

Bimatoprost is an antiglaucoma preparation.
It belongs to a group of medicines called
prostamides.
Bimatoprost eye drops are 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
Do not use Bimatoprost:
- 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.
Talk to your doctor:
- if you have any breathing problems;
- if you have liver or kidney problems;
- if you have had a cataract surgery in the past;
- if you have dry eye;
- if you have or have had any problems with
your cornea (front transparent part of the eye);
- if you wear contact lenses (see ‘Bimatoprost
contains benzalkonium chloride’);
- if you have or have had low blood pressure or
low heart rate;
- if 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.
Children and adolescents
This medicine 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.

If you use Bimatoprost with another eye
medicine, wait at least five minutes between
using Bimatoprost and the other eye medicine.
Pregnancy and breast-feeding
If you are pregnant or breast feeding, think you
might be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before using this medicine.
You should not breast-feed while using
Bimatoprost as this medicine may get into
breast milk.
Driving and using machines
Your sight may become blurred for a short
time just after using this medicine. You should
not drive or use machines until your sight is
clear again.
Bimatoprost 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.
Known to discolour soft contact lenses.

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.
This medicine 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.
• Take the container (picture 1) out of the
carton box.

1
• W
 ash your hands. Tilt your head back and
look at the ceiling (picture 2).

2

3

4

5

• G
 ently pull down the lower eyelid until there is
a small pocket (picture 3).
• Turn the bottle upside down and squeeze it to
release one drop into each eye that needs
treatment (picture 4).
• Let go of the lower lid, and close your eye for
30 seconds (picture 5).
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 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.
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.
Very common: 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)
Common: 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
Affecting the body:
• Headaches
• An increase in blood-test results that show
how your liver is working
• Increased blood pressure
Uncommon: may affect up to 1 in 100 people
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 shrinking, moving away from surface
of the eye
• Skin redness around the eye
Affecting the body:
• Nausea
• Dizziness
• Weakness
• Hair growth around the eye
Not known: frequency cannot be estimated
from the available data
Affecting the eye:
• Eyes appear sunken
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)
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.

After first opening of the container, the product
may be stored for 4 weeks. 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 use this medicine if you notice the
tamper-proof seal on the bottle neck is broken
before you first use it.
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 0.3 mg bimatoprost.
- The other ingredients are benzalkonium
chloride (preservative), sodium chloride,
sodium phosphate dibasic heptahydrate, citric
acid monohydrate and water for injection.
Small amounts of hydrochloric acid or sodium
hydroxide may be added to keep the level of
acid (pH levels) normal.
What Bimatoprost looks like and
contents of the pack
Bimatoprost is a clear, colourless solution free
from visible particles in a white opaque low
density polyethylene vial for eye drops
containing 3ml of the ophthalmic solution sealed
with a white opaque LDPE plug applicator and a
white HDPE/LDPE cap with a tamper-proof seal.
The following pack sizes are available: cartons
containing 1 or 3 bottles of 3ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Pharmathen S.A.
6 Dervenakion Street
Pallini 15351 Athens, Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749
Email: info@pharmathen.com
Manufacturer:
BALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd., Razgrad,
7200 Bulgaria
Telephone: +359 84 613 318
Fax: +359 84 634 272
E-Mail: office@antibiotic.bg
or
Pharmathen S.A.
6 Dervenakion Street
Pallini 15351 Athens, Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749
Email: info@pharmathen.com
This leaflet was last revised in Oct 2016

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 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.
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.
This medicinal product does not require any
special storage conditions.

XXXXXXX-P1.3

5. How to store Bimatoprost

Artwork for:
Product name:
Size:
PL/PA no:
Type:
Artwork dimensions:
Profile supplied:
Date of first artwork:
Reason for request:
Version no:
Date of revision:
Colours:
Font(s):
Artwork software:
BAC ref:

Aspire Pharma Limited
Bimatoprost
PL 17277/0351
Leaflet
320mm x 160mm
Yes
20 October 2016
Artwork in User Tested style: text edits
1.3
26 October 2016
As swatch(es)
9pt Tahoma
InDesign CC
T957

Black

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.

Hide