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BRINZOLAMIDE 10 MG/ML EYE DROPS SUSPENSION

Active substance(s): 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.
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
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.

2. What you need to know before
you use Brinzolamide
Do not use Brinzolamide
- if you have severe kidney problems.
- if you are allergic to brinzolamide. or
any of the other ingredients of this
medicine (listed in section 6).
- if you are allergic to medicines called
sulphonamides. Examples include
medicines used to treat diabetes and
infections and also diuretics (water
tablets). Brinzolamide may cause the
same allergy.
- if you have too much acidity in your
blood (a condition called
hyperchloraemic acidosis).
If you have further questions, ask your
doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist before
using Brinzolamide:
- if you have kidney or liver problems.
- if you have dry eyes or cornea
problems.
- if you are taking other sulphonamide
medicines.
Children and adolescents
Brinzolamide is not to be used by infants,
children or adolescents under 18 of years
of age unless advised by your doctor.
Other medicines and Brinzolamide
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
If you are taking another carbonic
anhydrase inhibitor (acetazolamide or
dorzolamide, see section 1 ‘What
Brinzolamide is and what it is used for’),
talk to your doctor.
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 using
this medicine.
Women who may become pregnant are
advised to use effective contraception
during Brinzolamide treatment. The use
of Brinzolamide is not recommended
during pregnancy or breast-feeding. Do
not use Brinzolamide unless clearly
indicated by your doctor.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Do not drive or use machines until your
vision is clear. You may find that your

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.
How to use


Picture 1

Picture 2

Picture 3

• Get the Brinzolamide bottle and
a mirror.
• Wash your hands
• Shake the bottle and twist off the cap.
After the cap is removed, if tamper
evident snap collar is loose, remove
before using the product.
• Hold the bottle, pointing down,
between your thumb and middle finger.
• Tilt your head back. Pull down your
eyelid with a clean finger, until there is
a ‘pocket’ between the eyelid and your
eye. The drop will go in here (picture 1).
• Bring the bottle tip close to the eye.
Use the mirror if it helps.
• Do not touch your eye or eyelid,
surrounding areas or other
surfaces with the dropper. It could
infect the drops
• Gently press on the base of the bottle
to release one drop of Brinzolamide
at a time.
• Do not squeeze the bottle: it is
designed so that a gentle press on the
bottom is all that it needs (picture 2).
• After using Brinzolamide, press a finger
to the corner of your eye, by the nose
(picture 3) for at least 1 minute. This
helps to stop Brinzolamide getting into
the rest of the body.
• If you take drops in both eyes, repeat
the steps for your other eye.
• Put the bottle cap back on firmly
immediately after use.
• Use up one bottle before opening the
next bottle.
If a drop misses your eye, try again.
If you are using other eye drops, leave at
least 5 minutes between putting in
Brinzolamide and the other drops. Eye
ointments should be administered last.
If you use more Brinzolamide than
you should
If you get too much in your eyes, rinse it
all out with warm water. Do not put in any
more drops until it’s time for your next
regular dose.
If you forget to use Brinzolamide
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 Brinzolamide
If you stop using Brinzolamide without
speaking to your doctor, the pressure in
your eye will not be controlled which
could lead to loss of sight.
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 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 injection 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
Bellamy House
Winton Road, Petersfield
Hampshire
GU32 3HA
UK
This leaflet was last revised in
February 2015.

Reporting of side effects
If you get any side effects, talk to your
doctor or 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-P1.3

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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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