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BRINZOLAMIDE ACTAVIS 10 MG/ML EYE DROPS SUSPENSION

Active substance(s): BRINZOLAMIDE

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Package leaflet: Information for the user

Brinzolamide 10mg/ml Eye Drops, Suspension
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, pharmacist or
nurse.
• 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
• The full name of this medicine is
Brinzolamide 10mg/ml Eye Drops,
Suspension but within the leaflet it
will be referred to as Brinzolamide
Eye Drops.

What is in this leaflet
1 What Brinzolamide Eye Drops
are and what they are used
for
2 What you need to know
before you use Brinzolamide
Eye Drops
3 How to use Brinzolamide Eye
Drops
4 Possible side effects
5 How to store Brinzolamide
Eye Drops
6 Contents of the pack and
other information
1 What Brinzolamide Eye Drops

are and what they are used
for

Brinzolamide Eye Drops contain
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
Eye Drops
Do not use Brinzolamide Eye
Drops:

• 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 sulfonamides. Examples
include medicines used to treat
diabetes and infections and also
diuretics (water tablets). Brinzolamide
Eye Drops may cause the same
allergy
• if you have too much acidity in
your blood (a condition called
hyperchloraemic acidosis).

Other medicines and
Brinzolamide Eye Drops

Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.
If you are taking another carbonic
anhydrase inhibitor (acetazolamide
or dorzolamide, see section 1, What
Brinzolamide Eye Drops are and what
they are used for), talk to your doctor.

Pregnancy, breast-feeding and
fertility

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
Eye Drops treatment. The use of
Brinzolamide Eye Drops is not
recommended during pregnancy
or breast‑feeding. Do not use
Brinzolamide Eye Drops 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 you use Brinzolamide Eye Drops.
Brinzolamide Eye Drops may impair
the ability to perform tasks requiring
mental alertness and/or physical
coordination. If affected, take care
when driving or using machines.

Brinzolamide Eye Drops contain
benzalkonium chloride

Brinzolamide Eye Drops contain a
preservative (benzalkonium chloride)
which may cause eye irritation and is
known to discolour soft contact lenses.
Contact with soft contact lenses is to
be avoided.
If you wear contact lenses you should
remove them prior to application of
Brinzolamide Eye Drops and wait at
least 15 minutes after instillation of the
dose before putting your lenses back
in.

3 How to use Brinzolamide Eye

Drops

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 Eye Drops 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 Eye Drops in both
eyes if your doctor told you to. Use it
for as long as your doctor told you to.

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

Warnings and precautions

Talk to your doctor, pharmacist or
nurse before using Brinzolamide Eye
Drops
• if you have kidney or liver
problems
• if you have dry eyes or cornea
problems
• if you are taking other sulfonamide
medicines.

Children and adolescents

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

1 2 3

• Get the Brinzolamide Eye Drops
bottle and a mirror.

• Wash your hands.
• Shake the bottle and twist off the

cap. After the cap is removed, if the
tamper evident snap collar is loose,
remove before using the product.
• Hold the bottle, pointing down,
between your thumb and forefinger.
• 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 (picture 2).
• Gently squeeze the bottle to release
one drop at a time.
Continued over page

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AAAI2277

Brinzolamide 10mg/ml 1x5ml Eye Drops PIL - UK
item no: AAAI2277

dimensions: 140 x 460

print proof no: 3

pharmacode:

origination date: 21.08.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 28.08.15

Technical Approval

revised by: S.Anson

date sent: 21.08.15

supplier: IL/Lusomedicamentao
Sociedade Tecnica Farmaceutica SA

technically app. date:

Non Printing Colours
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• After using Brinzolamide Eye Drops,

press a finger to the corner of your
eye, by the nose (picture 3). This
helps to stop Brinzolamide Eye Drops
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 Eye Drops and
the other drops. Eye ointments should
be administered last.
If you use more Brinzolamide Eye
Drops 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 Eye
Drops
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 Eye
Drops
If you stop using Brinzolamide Eye
Drops without speaking to your doctor,
the pressure in your eye will not be
controlled which could lead to loss of
sight.

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 Eye Drops.
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 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, generalised 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,
generalised 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.
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

Eye Drops

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 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 on the
bottle label and box.
For a pack containing a single bottle,
write only one date.
Opened:
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 Eye Drops
contain

The active substance is brinzolamide
10mg/ml.
The other ingredients are:
benzalkonium chloride, carbomer
974P, disodium edetate, mannitol
(E421), purified water, sodium chloride.
Tiny amounts of hydrochloric acid or
sodium hydroxide are added to keep
pH levels normal.

What Brinzolamide Eye Drops
look like and the contents of the
pack

Brinzolamide Eye Drops is a white
to off-white liquid (a suspension)
supplied in a pack containing a 5ml
plastic bottle with a screw cap, tamper
evident snap collar and insert dropper.
Marketing Authorization Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Lusomedicamenta Sociedade Técnica
Farmacêutica, S.A.
Rua Norberto de Oliveira, no 1/5
Póvoa de Santo Adrião
2620-111
Portugal
This leaflet was last revised in
August 2015.

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
AAAI2277

Actavis, Barnstaple, EX32 8NS, UK

Brinzolamide 10mg/ml 1x5ml Eye Drops PIL - UK
item no: AAAI2277

dimensions: 140 x 460

print proof no: 3

pharmacode:

origination date: 21.08.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 28.08.15

Technical Approval

revised by: S.Anson

date sent: 21.08.15

supplier: IL/Lusomedicamentao
Sociedade Tecnica Farmaceutica SA

technically app. date:

Non Printing Colours
1.
2.
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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