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BRIMONIDINE TARTRATE 2MG/ML EYE DROPS SOLUTION

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BRIMONIDINE TARTRATE
2 mg/ml Eye Drops, Solution
Brimonidine Tartrate

Please read this leaflet carefully
before you start to take your
medicine.

• isoprenaline or prazosin
• monoamine oxidase (MAO) inhibitors
and other antidepressants.

• Keep this leaflet. You may need to read
it again.
• If you have any further questions,
please ask your doctor or pharmacist.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Please tell your doctor or pharmacist if
you are using or have recently taken any
other medicines, including medicines
obtained without prescription.

In this leaflet:
1. What Brimonidine Tartrate is and
what it is used for
2. Before you use Brimonidine Tartrate
3. How to use Brimonidine Tartrate
4. Possible side effects
5. How to store Brimonidine Tartrate
6. Further information
1. What Brimonidine Tartrate is and
what it is used for
The active ingredient in Brimonidine
Tartrate is brimonidine tartrate that is
used to reduce pressure within the eye. It
can be used either alone or with another
eye drop which lowers pressure within
the eye for the treatment of glaucoma or
ocular hypertension.
2. Before you use Brimonidine
Tartrate
Do not use this medicine if you are
• allergic (hypersensitive) to brimonidine
tartrate or any of the other ingredients
of Brimonidine Tartrate
• taking monoamine oxidase (MAO)
inhibitors or certain antidepressants.
You must inform your doctor if you are
taking any antidepressant medicinal
product.
• breast-feeding
• infants/babies (from birth until 2 years)
Take special care with this medicine
Consult your doctor before using this
medicine if you:
• suffer or have suffered from depression,
reduced mental capacity, reduced
blood supply to the brain, heart
problems, a disturbed blood supply of
the limbs or a blood pressure disorder
• have or have had kidney or liver
problems
• are pregnant or breast -feeding
• wear soft (hydrophilic) contact lenses
(see section “Important information
about some ingredient of Brimonidine
Tartrate)
• regularly consume alcohol.
These eye drops are not recommended
for use in children under 12 years of age.
If Brimonidine Tartrate was prescribed
for a child under 12 years, please clarify
with your doctor before using.
Using other medicines
Please tell your doctor if you are using
any of following medicines as they may
affect your treatment:
• medicines acting on the central
nervous system (opiates, painkillers,
sleeping tablets and alcohol)
• chlorpromazine, methylphenidate or
reserpine
• medicines for treating your high
blood pressure or heart
• medicines for treating a problem with
your metabolism

Pregnancy and breast-feeding
• Ask your doctor or pharmacist for
advice before taking any medicines.
• Tell your doctor if you are pregnant or
planning to become pregnant
• This medicine should not be used
during pregnancy unless the benefit
to the mother outweighs the potential
risk to a baby.
• This medicine should not be used
while breast-feeding
Driving and using machines
• This medicine may cause blurred
and/or abnormal vision. This effect
may seem worse at night or in
reduced lighting.
• This medicine may also cause
drowsiness or tiredness in some
patients.
If you experience any of these symptoms,
do not drive or use machinery until the
symptoms are cleared.
Important information about some
ingredients of Brimonidine Tartrate
This product contains benzalkonium
chloride as preservative which may cause
irritation and discolour soft contact
lenses. If you wear soft contact lenses
remove them prior to application and
wait at least 15 minutes before
reinsertion.
3. How to use Brimonidine Tartrate
Always use this product exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
Adults
The usual dose is one drop twice daily,
approximately 12 hours apart. If you use
it with another eye drops, wait 5-15
minutes before applying the second eye
drops.
To be effective it must be used every day.
Children under 12 years
This medicine must not be used in
newborns and infants below two years of
age.
This medicine is not recommended for
use in children (from 2 years until 12
years).
Always wash your hands before applying
eye drops. Your prescription label tells
you how many drops to use at each dose.
Apply your eye drops in the following
way:
1. Remove protective cap.
2. Tilt your head back and look at the
ceiling.
3. Gently pull the lower eyelid down until
there is a small pocket.
4. Squeeze the upturned dropper bottle
to release a drop into your eye.
5. Whilst keeping the affected eye closed,
press your finger against the corner of
the closed eye (the side where the eye
meets the nose) and hold for 1 minute.
Avoid touching the dropper tip against
your eye or anything else.
Replace and tighten the cap straight
after use.
Turn over to continue reading

FRONT

Overdose
If you use more Brimonidine Tartrate
than you should
Adults
In adults who were instilling more drops
than prescribed, the side effects reported
were those already known. Adults who
accidentally swallowed brimonidine
tartrate experienced decrease in blood
pressure, which in some patients was
followed by the increase in blood
pressure.
Children
Serious side effects were reported in
children who accidentally swallowed
brimonidine tartrate. Signs included
sleepiness, floppiness, low body
temperature, paleness and breathing
difficulties. Should this happen, contact
your doctor immediately.
Adults and Children
If this medicine has been accidentally
swallowed or if you have used more
product than you should, please contact
your doctor immediately.
If you forget to use Brimonidine Tartrate
If you forget to take a dose, apply it as
soon as you remember. If, however, it is
almost time for your next dose, you
should omit the missed dose altogether
and then follow your normal routine.
If you stop using Brimonidine Tartrate
As you suffer from glaucoma or ocular
hypertension, if you stop using this
medicine your ocular pressure will rise to
the values prior the treatment and your
vision might be damaged with time.
Inform your doctor if you need to
interrupt the treatment.
If you have any further question on the
use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Brimonidine Tartrate
can cause side effects, although not
everybody gets them.
If you experience a rare (affect less than 1
in 1,000) but serious allergic reaction
(difficulty breathing, closing of the
throat, swelling of the lips, tongue, or
face or hives, ocular allergic reactions) to
brimonidine, stop using the medication
and contact your doctor immediately.

pupil size.
Some of these effects may be due to
an allergy to the active ingredient or
any of the other ingredients
• fainting, high or low blood pressure or
sleeplessness.
Side effects where the occurrence is
unknown:
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 includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly (see details below). By reporting
side effects you can help provide more
information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Brimonidine Tartrate
Keep the bottle in a safe place out of the
reach and sight of children.
No special storage conditions are required.
Do not use the bottle if the tamper-proof
seal on the bottle is broken before first use.
The product should not be used after the
expiry date (this is printed on both the
bottle label and on the carton the bottle
is packed in).
Discard the bottle 28 days after opening,
even if there is solution remaining.
Medicines should not be disposed of via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.
6. Further information
What Brimonidine Tartrate contains
• The active substance is brimonidine
tartrate
• 1 ml solution contains 2.0 mg
brimonidine tartrate, equivalent to 1.3
mg of brimonidine.
The other ingredients are benzalkonium
chloride as a preservative, polyvinyl
alcohol, sodium chloride, sodium citrate
dihydrate, citric acid monohydrate,
purified water and sodium hydroxide or
hydrochloric acid to adjust pH.

Please tell your doctor if you notice any
of the following side effects:

What Brimonidine Tartrate looks like
and contents of the pack

Very common (occur in more than 1 user
in 10):
• an allergic reaction in the eye, follicles
or white spots on the conjunctiva,
blurred vision, eye redness, burning,
stinging, a feeling of something in the
eye or itching
• headache, tiredness, drowsiness and
dry mouth.

A plastic dropper bottle with screw cap
contains 5 ml of clear, light
greenish-yellow solution.
Pack sizes: 1 x 5 ml, 3 x 5 ml, 6 x 5 ml

Common (occur in 1 to 10 users in 100):
• local irritation (inflammation and
swelling of the eyelid, swelling of the
conjunctiva, sticky eyes, pain and
tearing), sensitivity to light, erosion on
the surface of the eye and staining, eye
dryness, whitening of the conjunctiva,
abnormal vision, inflammation of the
conjunctiva
• dizziness, gastrointestinal symptoms,
general weakness
• cold-like symptoms or abnormal taste.

Manufacturer
TUBILUX PHARMA S.p.A.
Via Costarica 20/22, 00071 Pomezia (RM)
ITALY

Uncommon (occur in 1 to 10 users in 1,000):
• depression
• palpitations or changes in heart rate or
dry nose
• general allergic reactions.
Rare (occur in 1 to 10 users in 10,000):
• shortness of breath.
Very rare (occur in less than 1 user in
10,000):
• eye inflammation or a reduction in

Not all packaging sizes may be marketed.
Marketing Authorisation Holder
Medicom Healthcare Limited.,
235 Hunts Pond Road, Titchfield
Common, Fareham, Hants, PO14 4PJ

This medicinal product is authorized in
the Member States of the EEA under the
following names:
Italy
Brimonidina Angelini 2 mg/ml collirio,
soluzione
Germany
Brimo-Vision 2 mg/ml Augentropfen
Spain
Brimonidina cinfa 2 mg/ml colirio en
solución
UK
Brimonidine Tartrate 2 mg/ml eye drops
solution
This leaflet was last revised in November 2016
9-BRIMPOM-11-GB-PV3

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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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