Skip to Content

BRINZOLAMIDE SANDOZ 10 MG/ML EYE DROPS SUSPENSION

Active substance(s): BRINZOLAMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
KAPVORM

PMS ZWART
à 100 % - 20 %

64932-1
SZ13001LT02A

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.
2.
3.
4.
5.
6.

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

1

What Brinzolamide is and
what it is used for

Brinzolamide contains benzalkonium
chloride

Brinzolamide eye drops 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.

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.

If the pressure in the eye is too high, it can
damage your sight.

2

3

What you need to know before
you use Brinzolamide

Do not use Brinzolamide







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.

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.

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. Take it for as
long as your doctor told you to.
How to use

if you have too much acidity in your blood
(a condition called hyperchloraemic acidosis)

If you have further questions, ask your doctor for
advice.

1



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.

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.

Continued on the next page >>

DATE:

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.

DATE:



Ask your doctor or pharmacist for advice before
taking any medicine.

Do not squeeze the bottle : it is designed so
that a gentle press on the bottom is all that it
needs ( picture 2 ).

DATE:



Gently press on the base of the bottle to
release one drop of Brinzolamide at a time.

DATE:

Women who may become pregnant are advised
to use effective contraception during Brinzolamide
treatment. The use of Brinzolamide is not
recommended during pregnancy or breastfeeding. Do not use Brinzolamide unless clearly
indicated by your doctor.



ARTCENTER ALCON
BELGIUM APPROVAL
Approved
Correct & Return

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.

SIGNATURE:



Pregnancy and breast-feeding

Do not touch your eye or eyelid,
surrounding areas or other surfaces with
the dropper. It could infect the drops.

SIGNATURE:



Bring the bottle tip close to the eye. Use the
mirror if it helps.

SIGNATURE:



PACKAGING

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.

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 ).

SIGNATURE:

Other medicines and Brinzolamide

Hold the bottle, pointing down, between your
thumb and middle finger.

GLOBAL GRAPHICS BELGIUM



Shake the bottle and twist off the cap. After
the cap is removed, if the tamper evident snap
collar is loose, remove before using product.

ARTWORK SANDOZ
APPROVAL
Approved
Correct & Return



Wash your hands.

Approved
Correct & Return

Children and adolescents

Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.

3

QA SANDOZ APPROVAL:





Brinzolamide is not to be used by infants, children
or adolescents under 18 years of age unless
advised by your doctor.

2

Get the Brinzolamide bottle and a mirror

Approved
Correct & Return

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

DRA SANDOZ APPROVAL:

Warnings and precautions

InDesign CS6

BELGIUM 64932-1
Brinzolamide 10 mg/ml
5 ml - 10 ml -SZ13001LT02A-

recto-verso

GB

AANTAL KLEUREN : 1

DS

Local
Ready for sending:
Graphics

Approval

140 x 504 / 140 x 22 mm

BESOP-00326

25-01-2016

Affiliates

as is.

new proof.

The undersigned:
confirms that this proof contains an accurate translation of the English Corporate
Standard text, and is in compliance with the registered information and the legal
rules. Please also carefully check: local barcodes if any, formula,
shelflife if mentioned, storage conditions and trademarks.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.

Local
Final release:
Graphics

as is.

new proof.

KAPVORM

PMS ZWART
à 100 % - 20 %

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.

4

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. 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.

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects have been seen with
Brinzolamide.
Common side effects (may affect up to 1 to 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 to
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.

6

Contents of the pack and
other information

What Brinzolamide contains
The active substance is brinzolamide 0.33 mg per
drop, corresponding with 10 mg / ml.
The other ingredients are : benzalkonium chloride,
disodium edetate, mannitol ( E421 ), carbomer
( 974P ), tyloxapol, sodium chloride, sodium
hydroxide and / or hydrochloric acid ( for pH
adjustment ) and purified water.

What Brinzolamide looks like and
contents of the pack
Brinzolamide is a white to off-white suspension,
pH 7.1 – 7.9 and osmolality 270 – 320 mOsm / kg
supplied in a pack containing a 5 ml or a 10 ml
plastic ( 5 and 10 ml LDPE bottles with LDPE
dropper with a PP tamper-proof screw cap
( DROPTAINER ).
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
United Kingdom
Manufacturer

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.

Alcon-Couvreur, Rijksweg 14, B-2870 Puurs,
Belgium
or

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.

Alcon Cusi S.A., Camil Fabra 58,
08320 El Masnou, Barcelona, Spain

Not known (frequency cannot be estimated from
the available data)

Lek Pharmaceuticals d.d., Verovskova 57,
1526 Ljubljana, Slovenia

Effects in the eye: eyelid abnormality, visual
disturbance, corneal disorder, eye allergy,
decreased growth or number of eyelashes.

or

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.
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 ( www.mhra.gov.uk / yellowcard ).
By reporting side effects you can help provide
more information on the safety of this medicine.

Aeropharm GmbH, Francois Mitterand Allee 1,
07407 Rudolstadt, Germany
or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
This leaflet was last revised in 01/2016.

DATE:
DATE:

DATE:

SIGNATURE:

ARTCENTER ALCON
BELGIUM APPROVAL
Approved
Correct & Return
ARTWORK SANDOZ
APPROVAL
Approved
Correct & Return

SIGNATURE:

DATE:

64932-1
SZ13001LT02A

SIGNATURE:

are registered trademarks

08-2015

SIGNATURE:

Brinzolamide and
of Novartis.

Approved
Correct & Return

PACKAGING

This medicine does not require any special
storage conditions.

QA SANDOZ APPROVAL:

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.

Approved
Correct & Return

GLOBAL GRAPHICS BELGIUM

How to store Brinzolamide

Keep out of the sight and reach of children.

DRA SANDOZ APPROVAL:

5

or

InDesign CS6

BELGIUM 64932-1
Brinzolamide 10 mg/ml
5 ml - 10 ml -SZ13001LT02A-

recto-verso

GB

AANTAL KLEUREN : 1

DS

Local
Ready for sending:
Graphics

Approval

140 x 504 / 140 x 22 mm

BESOP-00326

25-01-2016

Affiliates

as is.

new proof.

The undersigned:
confirms that this proof contains an accurate translation of the English Corporate
Standard text, and is in compliance with the registered information and the legal
rules. Please also carefully check: local barcodes if any, formula,
shelflife if mentioned, storage conditions and trademarks.
This proof is approved
Signature and date:
as is.
as is, waiting for M.O.H. approval.
(do not order component yet)
Customer requests
new proof.

Local
Final release:
Graphics

as is.

new proof.

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