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BRIMONIDINE 2 MG/ML EYE DROPS SOLUTION

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Apply your eye drops in the following way:
1.

2.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Brimonidine 2 mg/ml eye drops,
solution
Brimonidine tartrate
Read all of this leaflet carefully before you start taking this medicine.
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. 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.
!

!

In this leaflet:
1. What Brimonidine is and what it is used for
2. Before you use Brimonidine
3. How to use Brimonidine
4. Possible side effects
5. How to store Brimonidine
6. Further information
1.WHAT BRIMONIDINE IS AND WHAT IT IS USED FOR
Brimonidine is used to reduce pressure within the eye.
It can be used either alone, when beta-blocker eye drops should not be used, or with another
eye drop, when a single medicine is not enough to lower the increased pressure in the eye,
in the treatment of open angle glaucoma or ocular hypertension.
The active ingredient in Brimonidine is brimonidine tartrate, which works by reducing
pressure within the eyeball.
2. BEFORE YOU USE BRIMONIDINE
Do not use Brimonidine
If you are allergic (hypersensitive) to brimonidine tartrate or any of the other
ingredients of Brimonidine.
If you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You
must inform your doctor if you are taking any antidepressant drug.
! If you are breast-feeding.
! In infants/babies (from birth until 2 years).
!

!

Take special care with Brimonidine
Before you take this medicine, tell your doctor:
! 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.
! If you have or have had in the past kidney or liver problems.
! If being given to a child between the age of 2 and 7 years and/or weighing less than or
equal to 20 kg, because Brimonidine is not recommended for use in this age group due
to high incidence and severity of sleepiness.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:
! pain killers, sedatives, opiates, barbiturates or are regularly consuming alcohol.
! anaesthetics.
! to treat a heart condition or to lower blood pressure.
! that can affect the metabolism like chlorpromazine, methylphenidate and reserpine.
! which work on the same receptor as Brimonidine, for example isoprenaline and
prazosin.
! monoamine oxidase (MAO) inhibitors and other antidepressants.
! medicines for any condition, even if unrelated to your eye condition.
! or if the dose of any of your current medicines is changed.
These could affect your treatment with Brimonidine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if
you are pregnant or planning to become pregnant.
Brimonidine should not be used while breast-feeding.
Driving and using machines
Brimonidine may cause blurred or abnormal vision. This effect may seem worse at
night or in reduced lighting.
! Brimonidine 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.
Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
!

Important information about some of the ingredients of Brimonidine
A preservative in Brimonidine (benzalkonium chloride) may cause eye irritation and is
also known to discolour soft contact lenses. Therefore, avoid contact with soft lenses. If
you wear soft contact lenses take them out before using these eye drops and then wait 15
minutes after using Brimonidine before inserting your lenses.
3. HOW TO USE BRIMONIDINE
Always use Brimonidine 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 in the affected eye(s), approximately 12 hours apart.
Children under 12 years
Brimonidine must not be used for infants below 2 years of age.
Brimonidine is not recommended for use in children (from 2 years until 12 years).
Instructions for use
Brimonidine comes as eye drops. Always wash your hands before applying eye drops.
Your prescription label tells you how many drops to use at each dose. If you use
Brimonidine with another eye drop, wait 5-15 minutes before applying the second eye
drop.
Using the drops for the first time:
These eye drops come in a bottle with a screw cap. The inside of the screw cap contains a
spike. The screw cap is fitted to the bottle in such a way that there is no contact between the
spike and the top of the bottle. In order to open the bottle it is necessary to tighten the screw
cap further, so that the edge of the screw cap and the bottle edge are totally aligned. At this
point the screw cap spike will pierce the top of the bottle which will open the bottle. Once
the bottle has been opened in this way, unscrew the screw cap fully to remove it from the
bottle and apply the eye drops as instructed below:

Tilt your head
back and look
at the ceiling.

Gently pull the
lower eyelid down
until there is a
small pocket.

Squeeze the
upturned dropper
bottle to release a
drop intoyour eye.

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.
If you use more Brimonidine than you should
Adults
There is no experience of overdose in adults using Brimonidine. This is unlikely when
given as eye drops.
Children
Several cases of overdose have been reported in children receiving Brimonidine as part of
medical treatment of glaucoma. Signs include sleepiness, floppiness, low body
temperature and breathing difficulties. Should this happen, contact your doctor
immediately.
Adults and Children
If Brimonidine has been accidentally swallowed or if you have used more Brimonidine
than you should,
please contact your doctor immediately.
If you forget to use Brimonidine
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
To be effective Brimonidine must be used every day. Do not stop using Brimonidine until
your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Brimonidine can cause side effects, although not everybody gets them.
The chance of having a side effect is described by the following categories:
Very common
Occurs in more than 1 out of 10 patients
Common
Occurs in fewer than 1 out of 10 patients
Uncommon
Occurs in fewer than 1 out of 100 patients
Rare
Occurs in fewer than 1 out of 1,000 patients
Very rare
Occurs in fewer than 1 out of 10,000 patients
The following eye side effects may be seen with Brimonidine.
Very common:
An allergic reaction in the eye, follicles or white spots on the seethrough layer which covers the surface of the eye, blurred vision,
eye redness, burning, stinging, a feeling of something in the eye
or itching.
Common:
Changes to the surface of the eye, inflammation of the eyelid,
inflammation of the see-through layer which covers the surface of the
eye, abnormal vision, sticky eyes, swelling of the eyelid or seethrough layer which covers the surface of the eye, sensitivity to light,
irritation, eyelid redness, aching or pain, dryness, erosion on the
surface of the eye and staining, tears or, whitening of the see-through
layer which covers the surface of the eye.
Very rare:

Eye inflammation or a reduction in pupil size.

Not known:

Swelling and irritation of the uvea, itching of eyelid

Some of these effects may be due to an allergy to any of the ingredients.
You may also experience the following effects in other parts of the body:
Very common:
Headache, dry mouth and tiredness/drowsiness.
Common:
Dizziness, cold-like symptoms, symptoms involving the stomach and
digestion, abnormal taste or general weakness.
Uncommon:
Depression, palpitations or changes in heart rate, dry nose and general
allergic reactions.
Rare:
Shortness of breath.
Very rare:
Sleeplessness, fainting and high or low blood pressure.
Not known:
Skin reaction including redness of skin, swelling of face, itching, rash.
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.
5. HOW TO STORE BRIMONIDINE
!
!
!
!
!
!

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions before first
opening of the bottle.
Do not store above 30°C, after first opening of the bottle.
Do not use the bottle if the tamper-proof seal on the bottle is broken before first use.
Do not use Brimonidine after the expiry date which is stated on the bottle label and the
carton after EXP:. The expiry date refers to the last day of that month.
Throw the bottle away 4 weeks 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 contains
The active substance is brimonidine tartrate. One 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, citric acid monohydrate, water for injection and
sodium hydroxide or hydrochloric acid for pH-adjustment.
!

What Brimonidine looks like and contents of the pack
Brimonidine is a clear, colourless to pale-yellow eye drop solution in a plastic bottle. Each
bottle contains either 5 ml or 10 ml of the medicine.
Brimonidine is available in packs of 1, 3 or 6 bottles. For the 3 and 6 pack sizes, there will
be 3 or 6 cartons, each containing a single bottle of Brimonidine eye drops, packaged in a
larger outer carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5, Marryat Close, Hounslow West,
Middlesex, Tw4 5DQ, UK.
This leaflet was last approved on
04/2012

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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