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BRINZOLAMIDE 10 MG/ML EYE DROPS SUSPENSION

Active substance(s): BRINZOLAMIDE / BRINZOLAMIDE / BRINZOLAMIDE

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Package leaflet: Information for
the user

Brinzolamide 10 mg/ml eye drops,
suspension
Brinzolamide

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.

vision is blurred for a time just after using
Brinzolamide.
Brinzolamide may impair the ability to perform
tasks requiring mental alertness and/or
physical coordination. If affected, take care
when driving or using machines.
Brinzolamide contains benzalkonium
chloride
Brinzolamide contains a preservative
(benzalkonium chloride) which may cause eye
irritation and is known to discolour soft
contact lenses. Contact with soft contact
lenses should be avoided. If you wear contact
lenses you should remove them prior to the
application of Brinzolamide and wait at least
15 minutes after instillation of the dose before
putting your lenses back in.

3. How to use Brinzolamide

Always use this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
What is in this leaflet
1. What Brinzolamide is and what it is used for Only use Brinzolamide for your eyes.
Do not swallow or inject.
2. What you need to know before you
use Brinzolamide
The recommended dose is
3. How to use Brinzolamide
1 drop in the affected eye or eyes, twice a
4. Possible side effects
day - morning and night.
5. How to store Brinzolamide
6. Contents of the pack and other information Use this much unless your doctor told you to
do something different. Only use Brinzolamide
in both eyes if your doctor told you to. Use it
1. What Brinzolamide is and what
for as long as your doctor told you to.

it is used for

Brinzolamide contains brinzolamide, which
belongs to a group of medicines called
carbonic anhydrase inhibitors. It reduces
pressure within the eye.
Brinzolamide eye drops are used to treat high
pressure in the eye. This pressure can lead to
an illness called glaucoma.
If the pressure in the eye is too high, it can
damage your sight.

How to use


Picture 1

Picture 2

Picture 3

• G
 et the Brinzolamide bottle and a mirror.
• Wash your hands.
• Shake the bottle and twist off the cap.
2. What you need to know before you
After the cap is removed, if tamper evident
use Brinzolamide
snap collar is loose, remove before using
Do not use Brinzolamide
the product.
• Hold the bottle, pointing down, between
- if you have severe kidney problems.
your thumb and middle finger.
- if you are allergic to brinzolamide, or any of
the other ingredients of this medicine (listed • Tilt your head back. Pull down your eyelid
with a clean finger, until there is a ‘pocket’
in section 6).
between the eyelid and your eye. The drop
- if you are allergic to medicines called
will go in here (picture 1).
sulphonamides. Examples include medicines
• Bring the bottle tip close to the eye. Use the
used to treat diabetes and infections and
mirror if it helps.
also diuretics (water tablets). Brinzolamide
• Do not touch your eye or eyelid,
may cause the same allergy.
surrounding areas or other surfaces
- if you have too much acidity in your blood
with the dropper. It could infect the drops.
(a condition called hyperchloraemic
• Gently press on the base of the bottle to
acidosis).
release one drop of Brinzolamide at a time.
If you have further questions, ask your doctor
• Do not squeeze the bottle: it is designed
for advice.
so that a gentle press on the bottom is all
Warnings and precautions
that it needs (picture 2).
Talk to your doctor or pharmacist before using • After using Brinzolamide, press a finger to
Brinzolamide:
the corner of your eye, by the nose
(picture 3) for at least 1 minute. This helps
- if you have kidney or liver problems.
to stop Brinzolamide getting into the rest
- if you have dry eyes or cornea problems.
of the body.
- if you are taking other sulphonamide

I

f you take drops in both eyes, repeat the
medicines.
steps for your other eye.
Children and adolescents
• Put the bottle cap back on firmly
immediately after use.
Brinzolamide is not to be used by infants,
children or adolescents under 18 years of age • Use up one bottle before opening the
unless advised by your doctor.
next bottle.
If
a drop misses your eye, try again.
Other medicines and Brinzolamide
If you are using other eye drops, leave at
Tell your doctor or pharmacist if you are
least 5 minutes between putting in
taking, have recently taken or might take any
Brinzolamide and the other drops. Eye
other medicines.
ointments should be administered last.
If you are taking another carbonic anhydrase
If you use more Brinzolamide than
inhibitor (acetazolamide or dorzolamide, see
section 1 ‘What Brinzolamide is and what it is you should
used for’), talk to your doctor.
If you get too much in your eyes, rinse it all
out with warm water. Do not put in any
Pregnancy and breast-feeding
more drops until it’s time for your next
If you are pregnant or breast-feeding, think
regular dose.
you may be pregnant or are planning to have
If you forget to use Brinzolamide
a baby, ask your doctor or pharmacist for
advice before using this medicine.
Use a single drop as soon as you remember,
and then go back to your regular routine.
Women who may become pregnant are
Do not use a double dose to make up for a
advised to use effective contraception during
forgotten dose.
Brinzolamide treatment. The use of
Brinzolamide is not recommended during
If you stop using Brinzolamide
pregnancy or breast-feeding. Do not use
If you stop using Brinzolamide without
Brinzolamide unless clearly indicated by
speaking to your doctor, the pressure in your
your doctor.
eye will not be controlled which could lead to
Ask your doctor or pharmacist for advice
loss of sight.
before taking any medicine.
If you have any further questions on the use
Driving and using machines
of this medicine, ask your doctor or
pharmacist.
Do not drive or use machines until your
vision is clear. You may find that your

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not everyone
gets them.
The following side effects have been seen
with brinzolamide.
Common side effects
(may affect up to 1 in 10 people)
- Effects in the eye: blurred vision, eye
irritation, eye pain, eye discharge, itchy
eye, dry eye, abnormal eye sensation,
redness of the eye.
- General side effects: bad taste.
Uncommon side effects
(may affect up to 1 in 100 people)
- Effects in the eye: sensitivity to light,
inflammation or infection of the
conjunctiva, eye swelling, eyelid itching,
redness or swelling, growth on surface of
eye, increased pigmentation of the eye,
tired eyes, eyelid crusting, or increased
tear production.
- General side effects: decreased or
reduced heart function, palpitations,
decreased heart rate, difficulty breathing,
shortness of breath, cough, decreased
red blood cell count in blood, increased
chlorine level in blood, dizziness,
drowsiness, difficulty with memory,
depression, nervousness, generalized
weakness, fatigue, feeling abnormal,
pain, shaking, decreased sex drive, male
sexual difficulty, cold symptoms, chest
congestion, sinus infection, throat
irritation, throat pain, abnormal or
decreased sensation in mouth,
inflammation of the lining of the
oesophagus, abdominal pain, nausea,
vomiting, upset stomach, frequent bowel
movements, diarrhoea, intestinal gas,
digestive disorder, kidney pain, muscle
pain, muscle spasms, back pain, nose
bleeds, runny nose, stuffy nose, sneezing,
rash, abnormal skin sensation, itching,
headache, dry mouth.
Rare side effects
(may affect up to 1 in 1,000 people)
- Effects in the eye: corneal swelling,
double or reduced vision, abnormal vision,
decreased eye sensation, swelling around
the eye, increased pressure in eye,
damage to the optic nerve.
- General side effects: memory
impairment, drowsiness, chest pain,
upper respiratory tract congestion,
sinus congestion, nasal congestion, dry
nose, ringing in ears, hair loss,
generalized itching, feeling jittery,
irritability, irregular heart rate, body
weakness, difficulty sleeping.
Not known (frequency cannot be estimated
from the available data):
- Effects in the eye: eyelid abnormality,
visual disturbance, corneal disorder, eye
allergy, decreased growth or number
of eyelashes.
- General side effects: increased allergic
symptoms, decreased sensation, tremor,
loss or decrease in taste, decreased blood
pressure, increased blood pressure,
increased heart rate, joint pain, asthma,
pain in extremity, skin redness,
inflammation, or itching, abnormal liver
blood tests, swelling of the extremities,
frequent urination, decreased appetite.

For a pack containing a single bottle,
write only one date.
Opened (1):
Opened (2):
Opened (3):
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 Brinzolamide contains
The active substance is Brinzolamide
10mg/ml.
The other ingredients are: benzalkonium
chloride solution 50%, carbomer 974P,
disodium edetate, mannitol (E421),
Poloxamer 407, water for injections and
sodium chloride. Tiny amounts of sodium
hydroxide are added to keep acidity levels
(pH levels) normal.
What Brinzolamide looks like and the
contents of the pack
Brinzolamide is a milky liquid (a suspension)
supplied in a pack containing 1, 3 or 6 plastic
(dropper container) bottles with a screw cap
which includes 5ml white homogenous
suspension.
The following pack sizes are available:
outer cartons containing 1 x 5ml, 3 x 5ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki, Greece
Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki, Greece
or
Famar S.A.
Plant A
63 Agiou Dimitriou Street
174 56 Alimos
Athens Greece
or
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd.,
Razgrad,
7200, Bulgaria
Distributed by:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road, Petersfield
Hampshire
GU32 3QG
UK
This leaflet was last revised in
March 2017.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the 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.

5. How to store Brinzolamide
Keep out of the sight and reach of children.
Do not use Brinzolamide after the expiry date
which is stated on the bottle and box after
“EXP”. The expiry date refers to the last day
of the month.
This medicine does not require any special
storage conditions.
You must throw away a bottle four weeks
after you first opened it, to prevent infections.
Write down the date you opened each bottle
in the space below and in the space on the
bottle label and box.
1010189-P3.1

Package leaflet: Information for
the user

Brinzolamide 10 mg/ml eye
drops, suspension
Brinzolamide

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 Brinzolamide is and what it is
used for
2. What you need to know before you
use Brinzolamide
3. How to use Brinzolamide
4. Possible side effects
5. How to store Brinzolamide
6. Contents of the pack and other
information

1. What Brinzolamide is and what
it is used for

vision is blurred for a time just after using
Brinzolamide.
Brinzolamide may impair the ability to
perform tasks requiring mental alertness
and/or physical coordination. If affected,
take care when driving or using machines.
Brinzolamide contains benzalkonium
chloride
Brinzolamide contains a preservative
(benzalkonium chloride) which may cause
eye irritation and is known to discolour
soft contact lenses. Contact with soft
contact lenses should be avoided. If you
wear contact lenses you should remove
them prior to the application of
Brinzolamide and wait at least 15 minutes
after instillation of the dose before putting
your lenses back in.

3. How to use Brinzolamide
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
Only use Brinzolamide for your eyes.
Do not swallow or inject.
The recommended dose is
1 drop in the affected eye or eyes, twice
a day - morning and night.
Use this much unless your doctor told you
to do something different. Only use
Brinzolamide in both eyes if your doctor
told you to. Use it for as long as your
doctor told you to.

Brinzolamide contains brinzolamide, which How to use
belongs to a group of medicines called
carbonic anhydrase inhibitors. It reduces
pressure within the eye.
Brinzolamide eye drops are used to treat
high pressure in the eye. This pressure

can lead to an illness called glaucoma.
If the pressure in the eye is too high,
Picture 1
Picture 2
Picture 3
it can damage your sight.
• Get the Brinzolamide bottle and
a mirror.
2. What you need to know before
• Wash your hands.
you use Brinzolamide
• Shake the bottle and twist off the cap.
Do not use Brinzolamide
After the cap is removed, if tamper
evident snap collar is loose, remove
- if you have severe kidney problems.
before using the product.
- if you are allergic to brinzolamide, or
• Hold the bottle, pointing down,
any of the other ingredients of this
between your thumb and middle finger.
medicine (listed in section 6).
• Tilt your head back. Pull down your
- if you are allergic to medicines called
eyelid with a clean finger, until there is
sulphonamides. Examples include
a ‘pocket’ between the eyelid and your
medicines used to treat diabetes and
eye. The drop will go in here (picture 1).
infections and also diuretics (water
• Bring the bottle tip close to the eye.
tablets). Brinzolamide may cause the
Use the mirror if it helps.
same allergy.
• Do not touch your eye or eyelid,
- if you have too much acidity in your
surrounding areas or other
blood (a condition called
surfaces with the dropper. It could
hyperchloraemic acidosis).
infect the drops.
If you have further questions, ask your
• Gently press on the base of the bottle
doctor for advice.
to release one drop of Brinzolamide
Warnings and precautions
at a time.
• Do not squeeze the bottle: it is
Talk to your doctor or pharmacist before
designed so that a gentle press on the
using Brinzolamide:
bottom is all that it needs (picture 2).
- if you have kidney or liver problems.

A

fter using Brinzolamide, press a finger
- if you have dry eyes or cornea problems.
to
the corner of your eye, by the nose
- if you are taking other sulphonamide
(picture 3) for at least 1 minute. This
medicines.
helps to stop Brinzolamide getting into
Children and adolescents
the rest of the body.
Brinzolamide is not to be used by infants, • If you take drops in both eyes, repeat
the steps for your other eye.
children or adolescents under 18 years of
• Put the bottle cap back on firmly
age unless advised by your doctor.
immediately after use.
Other medicines and Brinzolamide
• Use up one bottle before opening the
Tell your doctor or pharmacist if you are
next bottle.
taking, have recently taken or might take If a drop misses your eye, try again.
any other medicines.
If you are using other eye drops, leave at
If you are taking another carbonic
least 5 minutes between putting in
anhydrase inhibitor (acetazolamide or
Brinzolamide and the other drops. Eye
dorzolamide, see section 1 ‘What
ointments should be administered last.
Brinzolamide is and what it is used for’),
If you use more Brinzolamide than
talk to your doctor.
you should
Pregnancy and breast-feeding
If you get too much in your eyes, rinse it
If you are pregnant or breast-feeding,
all out with warm water. Do not put in any
think you may be pregnant or are
more drops until it’s time for your next
planning to have a baby, ask your doctor
regular dose.
or pharmacist for advice before using
If you forget to use Brinzolamide
this medicine.
Use a single drop as soon as you
Women who may become pregnant are
remember, and then go back to your
advised to use effective contraception
regular routine. Do not use a double dose
during Brinzolamide treatment. The use
to make up for a forgotten dose.
of Brinzolamide is not recommended
during pregnancy or breast-feeding.
If you stop using Brinzolamide
Do not use Brinzolamide unless clearly
If you stop using Brinzolamide without
indicated by your doctor.
speaking to your doctor, the pressure in
Ask your doctor or pharmacist for advice
your eye will not be controlled which
before taking any medicine.
could lead to loss of sight.
Driving and using machines
If you have any further questions on the
use of this medicine, ask your doctor or
Do not drive or use machines until your
pharmacist.
vision is clear. You may find that your

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not everyone
gets them.
The following side effects have been seen
with brinzolamide.
Common side effects
(may affect up to 1 in 10 people)
- Effects in the eye: blurred vision, eye
irritation, eye pain, eye discharge, itchy
eye, dry eye, abnormal eye sensation,
redness of the eye.
- General side effects: bad taste.
Uncommon side effects
(may affect up to 1 in 100 people)
- Effects in the eye: sensitivity to light,
inflammation or infection of the
conjunctiva, eye swelling, eyelid itching,
redness or swelling, growth on surface
of eye, increased pigmentation of the
eye, tired eyes, eyelid crusting, or
increased tear production.
- General side effects: decreased or
reduced heart function, palpitations,
decreased heart rate, difficulty
breathing, shortness of breath, cough,
decreased red blood cell count in blood,
increased chlorine level in blood,
dizziness, drowsiness, difficulty with
memory, depression, nervousness,
generalized weakness, fatigue, feeling
abnormal, pain, shaking, decreased sex
drive, male sexual difficulty, cold
symptoms, chest congestion, sinus
infection, throat irritation, throat pain,
abnormal or decreased sensation in
mouth, inflammation of the lining of the
oesophagus, abdominal pain, nausea,
vomiting, upset stomach, frequent
bowel movements, diarrhoea, intestinal
gas, digestive disorder, kidney pain,
muscle pain, muscle spasms, back pain,
nose bleeds, runny nose, stuffy nose,
sneezing, rash, abnormal skin sensation,
itching, headache, dry mouth.

For a pack containing a single bottle,
write only one date.
Opened (1):
Opened (2):
Opened (3):
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 Brinzolamide contains
The active substance is Brinzolamide
10mg/ml.
The other ingredients are: benzalkonium
chloride solution 50%, carbomer 974P,
disodium edetate, mannitol (E421),
Poloxamer 407, water for injections and
sodium chloride. Tiny amounts of sodium
hydroxide are added to keep acidity levels
(pH levels) normal.
What Brinzolamide looks like and the
contents of the pack
Brinzolamide is a milky liquid (a suspension)
supplied in a pack containing 1, 3 or 6
plastic (dropper container) bottles with a
screw cap which includes 5ml white
homogenous suspension.
The following pack sizes are available:
outer cartons containing 1 x 5ml, 3 x 5ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki, Greece

Manufacturer
Pharmathen S.A.
Rare side effects
Dervenakion 6
(may affect up to 1 in 1,000 people)
Pallini 15351
- Effects in the eye: corneal swelling,
Attiki, Greece
double or reduced vision, abnormal
vision, decreased eye sensation, swelling or
Famar S.A.
around the eye, increased pressure in
Plant A
eye, damage to the optic nerve.
63 Agiou Dimitriou Street
- General side effects: memory
174 56 Alimos
impairment, drowsiness, chest pain,
Athens Greece
upper respiratory tract congestion,
or
sinus congestion, nasal congestion, dry
nose, ringing in ears, hair loss,
Balkanpharma-Razgrad AD
generalized itching, feeling jittery,
68 Aprilsko vastanie Blvd.,
irritability, irregular heart rate, body
Razgrad,
weakness, difficulty sleeping.
7200, Bulgaria
Not known (frequency cannot be
Distributed by:
estimated from the available data):
Aspire Pharma Ltd
- Effects in the eye: eyelid abnormality, Unit 4, Rotherbrook Court
visual disturbance, corneal disorder, eye Bedford Road, Petersfield
allergy, decreased growth or number
Hampshire
of eyelashes.
GU32 3QG
- General side effects: increased
allergic symptoms, decreased sensation, UK
tremor, loss or decrease in taste,
decreased blood pressure, increased
This leaflet was last revised in
blood pressure, increased heart rate,
March 2017.
joint pain, asthma, pain in extremity,
skin redness, inflammation, or itching,
abnormal liver blood tests, swelling of
the extremities, frequent urination,
decreased appetite.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the 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.

5. How to store Brinzolamide
Keep out of the sight and reach of children.
Do not use Brinzolamide after the expiry
date which is stated on the bottle and box
after “EXP”. The expiry date refers to the
last day of the month.
This medicine does not require any
special storage conditions.
You must throw away a bottle four weeks
after you first opened it, to prevent
infections. Write down the date you
opened each bottle in the space below
and in the space on the bottle label
and box.

1010189-P3.1F

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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