Skip to Content

BIMATOPROST/TIMOLOL 0.3 MG/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): BIMATOPROST / TIMOLOL MALEATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user

SZ00000LT000

Bimatoprost/Timolol 0.3 mg/ml
+ 5 mg/ml eye drops, solution
Bimatoprost/Timolol
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, please 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/Timolol
is and what it is used for
2. What you need to know
before you use
Bimatoprost/Timolol
3. How to use Bimatoprost/
Timolol
4. Possible side effects
5. How to store Bimatoprost/
Timolol
6. Contents of the pack and
other information

1

What Bimatoprost
/Timolol is and
what it is used for

Bimatoprost/Timolol contains
two different active
substances (bimatoprost and
timolol) that both reduce
pressure in the eye.
Bimatoprost belongs to a
group of medicines called
prostamides, a prostaglandin
analogue. Timolol belongs to
a group of medicines called
beta-blockers.
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 and could
eventually damage your sight
(an illness called glaucoma).
Bimatoprost/Timolol works
by reducing the production
of liquid and also increasing
the amount of liquid that is
drained. This reduces the
pressure inside the eye.
Bimatoprost/Timolol eye
drops are used to treat high
pressure in the eye in adults,
including the elderly. This
high pressure can lead to
glaucoma. Your doctor will
prescribe you Bimatoprost/
Timolol when other eye drops
containing beta-blockers or
prostaglandin analogues
have not worked sufficiently
on their own.

2

What you need to
know before you
use Bimatoprost/
Timolol

Do not use Bimatoprost/
Timolol eye drops, solution
• if you are allergic to
bimatoprost, timolol,
beta-blockers or any of
the other ingredients of this
medicine (listed in section 6).
• if you have now or have
had in past respiratory
problems such as asthma,
severe chronic
obstructive bronchitis
(severe lung disease which
may cause wheeziness,
difficulty in breathing and/
or long-standing cough).
• if you have heart problems
such as low heart rate,
heart block, or heart failure.
Warnings and precautions
Talk to your doctor or
pharmacist before using
Bimatoprost/Timolol, if you
have now or have had in the
past
• coronary heart disease
(symptoms can include
chest pain or tightness,
breathlessness or choking),
heart failure, low blood
pressure,
• disturbances of heart rate
such as slow heartbeat,
• breathing problems,
asthma or chronic
obstructive pulmonary
disease,
• poor blood circulation
disease (such as
Raynaud’s disease or
Raynaud’s syndrome),
• overactivity of the thyroid
gland as timolol may mask
signs and symptoms of
thyroid disease,
• diabetes as timolol may
mask signs and symptoms
of low blood sugar,
• severe allergic reactions,
• liver or kidney problems,
• eye surface problems,
• separation of one of the
layers within the eyeball
after surgery to reduce the
pressure in the eye,
• known risk factors for
macular oedema (swelling
of the retina within the eye
leading to worsening
vision), for example,
cataract surgery.
Tell your doctor before
surgical anaesthesia that you
are using Bimatoprost/Timolol
as timolol may change effects
of some medicines used
during anaesthesia.
Bimatoprost/Timolol 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.
Bimatoprost/Timolol may
cause hair growth when in
contact with the skin surface.
Children and adolescents
Bimatoprost/Timolol should
not be used in children and
teenagers under 18.
Other medicines and
Bimatoprost/Timolol
Bimatoprost/Timolol can
affect or be affected by other
medicines you are using,
including other eye drops for

the treatment of glaucoma.
Please tell your doctor or
pharmacist if you are taking,
have recently taken or might
take any other medicines. Tell
your doctor if you are using
or intend to use medicines to
lower blood pressure, heart
medicine, medicines to treat
diabetes, quinidine (used to
treat heart conditions and
some types of malaria) or
medicines to treat depression
known as fluoxetine and
paroxetine.
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. Do not use
Bimatoprost/Timolol if you are
pregnant unless your doctor
still recommends it.
Do not use
Bimatoprost/Timolol if you are
breast-feeding. Timolol may
get into your breast milk. Ask
your doctor for advice before
taking any medicine during
breast-feeding.
Driving and using machines
Bimatoprost/Timolol may
cause blurred vision in some
patients. Do not drive or use
machines until the symptoms
have cleared.
Bimatoprost/Timolol contains
Benzalkonium chloride
Bimatoprost/Timolol contains
a preservative called
benzalkonium chloride.
Benzalkonium chloride may
cause eye irritation and is
also known to discolour soft
contact lenses. Do not use
the drops while your contact
lenses are in your eyes. Wait
at least 15 minutes after
using the eye drops before
putting your lenses back in
your eyes.

3

How to use
Bimatoprost/
Timolol

Always use Bimatoprost/
Timolol exactly as your doctor
or pharmacist has told you.
Check with your doctor or
pharmacist if you are not sure.
The usual dose is one drop
once a day, either in the
morning or in the evening in
each eye that needs treatment.
Use at the same time each day.
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.

5.

1. Wash your hands. Tilt your
head back and look at the
ceiling.
2. Gently 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.
Continued on the next page >>

4. Let go of the lower lid, and
close your eye.
5. Whilst keeping the eye
closed, press your finger
against the corner of the
closed eye (the site where
the eye meets the nose)
and hold for 2 minutes.
This helps to stop
Bimatoprost/Timolol getting
into the rest of the body.
If a drop misses your eye,
try again.
To avoid contamination, 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 Bimatoprost/Timolol
with another eye medicine,
leave at least 5 minutes
between putting in
Bimatoprost/Timolol and the
other medicine. Use any eye
ointment or eye gel last.
If you use more Bimatoprost/
Timolol than you should
If you use more Bimatoprost/
Timolol 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/Timolol
If you forget to use
Bimatoprost/Timolol, 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.
If you stop using
Bimatoprost/Timolol
Bimatoprost/Timolol should
be used every day to work
properly.
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. You
can usually carry on taking
the drops, unless the effects
are serious. If you’re worried,
talk to a doctor or pharmacist.
Do not stop using Bimatoprost/
Timolol without speaking to
your doctor.The following
side effects may be seen with
Bimatoprost/Timolol:
Very common side effects
(may affect more than 1 in 10
people)
Affecting the eye
• redness.
Common side effects (may
affect up to 1 in 10 people)
Affecting the eye
• burning,
• itching,
• stinging,
• irritation of the conjunctiva
(see-through layer of the
eye),
• sensitivity to light,
• eye pain, sticky eyes, dry
eyes, a feeling of
something in the eye,
• small breaks in the surface
of the eye with or without
inflammation,
• difficulty in seeing clearly,
• redness and itching of the
eyelids,
• hair growing around the
eye,
• darkening of the eyelids,
• darker skin colour around
the eyes,
• longer eyelashes,
• eye irritation,
• watery eyes,
• swollen eyelids,
• reduced vision.
Affecting other parts of the
body
• runny nose,
• dizziness,
• headache.
Uncommon side effects
(may affect up to 1 in 100
people)
Affecting the eye
• abnormal sensation in the
eye,
• iris inflammation,
• swollen conjunctiva (seethrough layer of the eye),
• painful eyelids,
• tired eyes,
• in-growing eyelashes,
• darkening of iris colour,
• eyes appear sunken,
• eyelid has moved away
from the surface of the eye
• darkening of eyelashes.
Affecting other parts of the
body
• shortness of breath.
Side effects where the
frequency is not known
(frequency cannot be estimated
from the available data)
Affecting the eye
• cystoid macular oedema
(swelling of the retina
within the eye leading to
worsening vision),
• eye swelling,
• blurred vision.
Affecting other parts of the
body
• difficulty breathing/
wheezing,
• symptoms of allergic reaction
(swelling, redness of the
eye and rash of the skin),
• changes in your taste
sensation,
• slowing of heart rate,
• difficulty sleeping,
• nightmare,
• asthma,
• hair loss,
• tiredness.
Additional side effects have
been seen in patients using
eye drops containing Timolol
or bimatoprost and so may
possibly be seen with
Bimatoprost/Timolol. Like other
medicines applied into eyes,
timolol is absorbed into the
blood. This may cause similar
side effects as seen with
”intravenous” and /or “oral”
beta-blocking agents. The
chance of having side effects
after using eye drops is lower

than when medicines are for
example, taken by mouth or
injected. Listed side effects
include reactions seen within
bimatoprost and timolol when
used for treating eye
conditions:
• severe allergic reactions
with swelling and difficulty
breathing which could be
life-threatening;
• low blood sugar,
• depression; memory loss,
• fainting; stroke; decreased
blood flow to the brain;
worsening of myasthenia
gravis (increased muscle
weakness); tingling
sensation,
• decreased sensation of your
eye surface; double vision;
drooping eyelid; separation
of one of the layers within
the eyeball after surgery to
reduce the pressure in the
eye; inflammation of the
surface of the eye, bleeding
in the back of the eye
(retinal bleeding),
inflammation within the
eye, increased blinking,
• heart failure; irregularity
or stopping of the heart
beat; slow or fast heart
beat; too much fluid, mainly
water, accumulating in the
body; chest pain,
• low blood pressure; high
blood pressure; swelling
or coldness of your hands,
feet and extremities,
caused by constriction of
your blood vessels,
• cough, worsening of
asthma, worsening of the
lung disease called chronic
obstructive pulmonary
disease (COPD),
• diarrhoea; stomach pain;
feeling and being sick;
indigestion; dry mouth,
• red scaly patches on skin;
skin rash,
• muscle pain,
• reduced sexual urge;
sexual dysfunction
• 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 (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/
Timolol

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 medicine does not
require any special storage
conditions.
Once opened, solutions may
become contaminated, which
can cause eye infections.
Therefore, you must throw
away the bottle 4 weeks after
you first opened it, even if
some solution is left. To help
you remember, write down
the date that you opened it in
the space on the carton.
Do not throw away any
medicines via wastewater
. 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/Timolol
contains
• The active substances are
bimatoprost 0.3 mg/ml and
timolol 5 mg/ml
corresponding to timolol
maleate 6.8 mg/ml.
• The other ingredients are
benzalkonium chloride
(a preservative), sodium
chloride, disodium
phosphate heptahydrate,
citric acid monohydrate and
purified water. Small
amounts of hydrochloric
acid or sodium hydroxide
may be added to bring the
solution to the correct pH
(acidity) level.
What Bimatoprost/Timolol
looks like and contents of
the pack
Bimatoprost/Timolol is a
colourless to slightly yellow
solution in a plastic bottle.
Each pack contains either
1 plastic bottle or 3 plastic
bottles each with a screw-cap.
Each bottle is about half full
and contains 3 milliliters of
solution. This is enough for
4 weeks’ usage. Not all pack
sizes may be marketed.
Marketing Authorisation
Holder and Manufacturer
Marketing Authorisation
Holder
Sandoz Limited, Frimley
Business Park, Frimley,
Camberley,Surrey,GU16 7SR,
UK
Manufacturer
S.C. ROMPHARM
COMPANY S.R.L.
Eroilor Street no. 1A
Otopeni, Ilfov
075100
Romania
This leaflet was last revised
in 06/2017
00000000
SZ00000LT000

draft: 44075631, 44075640
laetus code: supplier to add
mat.no.: supplier to add

Artwork Proof Box
Ref: Licence application
Proof no.
001.0

Date prepared:
12/06/2017

Colours:
Black
Dimensions: 100 x 630 mm

Font size:
8pt
Fonts:
Helvetica

+ 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