Skip to Content

BRIMONIDINE TARTRATE 2 MG/ML EYE DROPS SOLUTION

Active substance(s): BRIMONIDINE TARTRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

231-30-40219-A LEA BRIMONIDINE TARTRATE 2mg /ml EYE DROPS 5ml TUK Dimensions:
Length:
Width:
Depth:

Version:

Colours Used:

4

26 April 2016
Template

465 mm
135 mm
-

PANTONE® GREEN C
BLACK

Pharmacode
459

322K011970116

Pharmacode
459

Fold
Package leaflet: Information for the user

BRIMONIDINE TARTRATE
2 mg/ml EYE DROPS,
SOLUTION

Text area
119 x 425 mm

medicines, including medicines
obtained without a prescription.

Tell your doctor if you are taking
any of the following medicines:
• monoamine oxidase (MAO)
inhibitors and certain other
Read all of this leaflet carefully
antidepressants
before you start using this

painkillers,
sedatives, opiates,
medicine because it contains
barbiturates or are regularly
important information for you.
consuming
alcohol
• Keep this leaflet. You may need
• anaesthetics
to read it again.

that
can
affect
the metabolism
• If you have any further
like chlorpromazine,
questions, ask your doctor or
methylphenidate and reserpine
pharmacist.
• to treat a heart condition or to
• This medicine has been
lower blood pressure
prescribed for you only. Do not
pass it on to others. It may harm • which work on the same receptor
as Brimonidine, for example
them, even if their signs of
isoprenaline and prazosin.
illness are the same as yours.
• If you get any side effects, talk to
Pregnancy and breast-feeding
your doctor or pharmacist. This
If you are pregnant or
includes any possible side
breast-feeding, think you may be
effects not listed in this leaflet.
pregnant or are planning to have a
See section 4.
baby, ask your doctor or
What is in this leaflet:
pharmacist for advice before
taking this medicine.
1. What Brimonidine is and what it
This medicine should not be used
is used for
during pregnancy unless your
2.What you need to know before
doctor still recommends it.
you use Brimonidine
This medicine should not be used
3.How to use Brimonidine
if you are breast-feeding.
4.Possible side effects
5.How to store Brimonidine
Driving and using machines
6.Contents of the pack and other
This medicine may cause
information
drowsiness, tiredness or blurred
vision in some patients. Do not
1 What Brimonidine is and drive or use machinery until the
what it is used for
symptoms have cleared. If you
This medicine is an eye drop that experience any problems, talk to
your doctor.
is used to control glaucoma. It
contains brimonidine which
reduces high pressure in the eye
and belongs to a group of
medicines called alpha-2
adrenergic receptor agonists.
Brimonidine is prescribed to
reduce high pressure in the eye
when beta-blocker eye drops can't
be used or when a second medicine
is required to reduce the pressure
in the eye to the desired level.
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. Brimonidine
works by reducing the production
of liquid and increasing the
amount of liquid that is drained.
This reduces the pressure inside
the eye whilst still continuing to
feed the eye.

2 What you need to know
before you use
Brimonidine

Do not use Brimonidine:
• if you are allergic to brimonidine
or any of the other ingredients of
this medicine (listed in section 6)
• if the patient is less than 2 years
old
• if you are taking monoamine
oxidase (MAO) inhibitors or
certain other antidepressant drugs.

Brimonidine contains
benzalkonium chloride
This medicine contains 0.05 mg/ml
benzalkonium chloride.
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. Benzalkonium chloride
is known to discolour soft contact
lenses.

3 How to use Brimonidine
Always use this medicine exactly
as your doctor has told you. Check
with your doctor or pharmacist if
you are not sure.
Ocular use.
The recommended dose is one
drop of this medicine, twice a day
about 12 hours apart. Do not
change the dose or stop taking it
without speaking to your doctor.
If you use this medicine together
with other eye drops, leave at least
five minutes between putting in
brimonidine and the other drops.
Instructions for use
You must not use the bottle if the
tamper-proof seal on the bottle
neck is broken before you first
begin to use it.
Wash your hands before opening
the bottle.
Tilt your head back and look at the
ceiling.

Warnings and precautions
Talk to your doctor or pharmacist 1. Gently pull down the
lower eyelid until
before using Brimonidine
there is a small pocket.
• if you have now or have had in
the past
• depression or other psychiatric
problems
• heart or blood pressure
2. Turn the bottle upside
problems
down and squeeze it
• reduced or altered blood
to release one drop
supply affecting the brain, legs
into each eye that
or arms
needs treatment.
• kidney or liver problems
• if you wear contact lenses. You
can still use Brimonidine but
3. Let go of the lower lid,
follow the instructions for
and close your eye.
contact lens wearers in section
“Brimonidine contains
benzalkonium chloride”.
Children
Brimonidine is not recommended 4.Keep the eye closed
for use in children aged 2-12 years. and press your finger
against the corner of
Other medicines and Brimonidine
your eye (the side
Please tell your doctor or
where your eye meets
pharmacist if you are taking or
your nose) for one
have recently taken any other
minute.

TEVA UK Ref:

Version:

231-30-40219-A LEA BRIMONIDINE TARTRATE 2mg /ml EYE DROPS 5ml TUK Dimensions:
Length:
Width:
Depth:

Colours Used:

4

26 April 2016
Template

465 mm
135 mm
-

PANTONE® GREEN C
BLACK

Fold

Text area
119 x 425 mm

If a drop misses your eye, try again.
To help prevent infection, do not
let the tip of the bottle touch your
eye or anything else. Put the
screw-cap back on to close the
bottle, straight after you have used
it.
Use in children
Brimonidine is not recommended
for use in patients below 12 years
of age and must not be used in
babies and children under 2 years
of age.

• Sleeplessness
• Fainting
• High or low blood pressure.
Not known (the frequency cannot
be estimated from the available
data)
• Itching of eyelids
• Skin reactions including redness,
face swelling, itching, rash and
widening of blood vessels.

Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
If you use more Brimonidine than includes any possible side effects
not listed in this leaflet.
you should
You can also report side effects
Adults
directly via the Yellow Card
If you use more of this medicine
Scheme at:
than you should, it is unlikely to
www.mhra.gov.uk/yellowcard
cause you any harm. Put your next By reporting side effects you can
drop in at the usual time. If you are help provide more information on
worried, talk to your doctor or
the safety of this medicine.
pharmacist. If this medicine is
swallowed then you should
5 How to store Brimonidine
contact your doctor.
Adults who accidentally
Keep this medicine out of the
swallowed Brimonidine
sight and reach of children.
experienced decrease in blood
Do not use this medicine after the
pressure, which in some patients
expiry date which is stated on the
was followed by the increase in
carton and on the bottle. The
blood pressure.
expiry date refers to the last day of
Babies
A few incidences of overdose have
been reported in babies (up to 4
weeks old) using brimonidine.
Signs include sleepiness,
floppiness, low body temperature,
paleness and breathing difficulties.
If any of these occur, contact your
doctor immediately.

that month.
Do not store above 25°C.
Do not refrigerate or freeze.
Throw the bottle away 28 days
after opening, even if there is
solution remaining.

unless your doctor tells you to.

• The other ingredients are
benzalkonium chloride solution
50%, polyvinyl alcohol, sodium
citrate, citric acid monohydrate,
sodium chloride, water for
injection and sodium hydroxide
or hydrochloric acid to adjust pH.

Do not throw away any medicines
via wastewater or household
waste. Ask your pharmacist how to
throw away medicines you no
If you forget to use Brimonidine
If you forget to use your medicine, longer use. These measures will
use a single drop in each eye that help protect the environment.
needs treatment as soon as you
6 Contents of the pack and
remember, and then go back to
other information
your regular routine. Do not take a
double dose to make up for a
What Brimonidine contains
forgotten dose.
• The active substance is
brimonidine tartrate. One ml
If you stop using Brimonidine
solution contains 2.0 mg
Brimonidine should be used every
brimonidine tartrate, equivalent
day to work properly.
to 1.3 mg brimonidine.
Do not stop using your medicine
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):
• Eye irritation (eye redness,
burning, stinging, itching, a
feeling of something in the eye,
white spots under the eyelid),
blurred vision, an allergic
reaction in the eye
• Headache, drowsiness
• Dry mouth
• Tiredness.

What Brimonidine looks like and
contents of the pack
Eye drop, solution
Clear, greenish-yellow solution in
a 5 ml plastic bottle with a screw
cap.
Pack sizes: 1, 3 and 6 bottles. Not
all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation holder:
TEVA UK Limited, Brampton Road,
Hampden Park, Eastbourne, East
Sussex, BN22 9AG, United
Kingdom.
Company responsible for
manufacture: Pharmachemie B.V.,
Swensweg 5, Postbus 552, 2003
RN Haarlem, The Netherlands.

Common (may affect up to 1 in 10
people):
• Irritation around the eye,
swelling, redness and
inflammation of or under the
eyelid, sticky or painful eyes,
tears, sensitivity to light, small
breaks in the surface of the eye, This leaflet was revised in: April 2016
dryness of the eye, whiteness
PL 00289/1034
under the eyelid, sight problems.
• Dizziness, taste disturbance
• Cold-like symptoms
• Digestive problems
• Weakness.
Uncommon (may affect up to 1 in
100 people):
• General allergic reactions
• Depression
• Palpitations, effects on the heart
beat
• Dry nose.
Rare (may affect up to 1 in 1,000
people):
• Shortness of breath.
Very rare (may affect up to 1 in
10,000 people):
• Eye inflammation or a reduction
in pupil size
40219-A

Expand view ⇕

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