Brimonidine Tartrate 2 Mg/Ml Eye Drops Solution

Document: leaflet MAH GENERIC_PL 00289-1034 change

TEVAUK Ref: 231-30-40219-A LEA BRIMONIDINE TARTRATE 2mg /ml EYE DROPS 5ml TUK<ISR Verson: 4 26 April 2016







Length: 465 mm Width: 135 mm Depth: -

Colours Used: 1 Template 1


Package leaflet: Information for the


Text area 119 x 425 mm


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.

| medicines, including medicines obtained without a prescription.

What is in this leaflet:

1.    What Brimonidine is and what it is used for

2. What you need to know before you use Brimonidine

3. How to use Brimonidine

4. Possible side effects

5. How to store Brimonidine

6. Contents of the pack and other information

[1 What Brimonidine is and what it is used for

This medicine is an eye drop that is used to control glaucoma. It contains brimonidine which reduces high pressure in the eye and belongs to a group of medicines called alpha-2 adrenergic receptor agonists. Brimonidine is prescribed to reduce high pressure in the eye when beta-blocker eye drops can't be used or when a second medicine is required to reduce the pressure in the eye to the desired level.

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight. Brimonidine works by reducing the production of liquid and increasing the amount of liquid that is drained. This reduces the pressure inside the eye whilst still continuing to feed the eye.

What you need to know before you use Brimonidine

Do not use Brimonidine:

•    if you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6)

•    if the patient is less than 2 years old

•    if you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressant drugs.

Tell your doctor if you are taking any of the following medicines:

•    monoamine oxidase (MAO) inhibitors and certain other antidepressants

•    painkillers, sedatives, opiates, barbiturates or are regularly consuming alcohol

•    anaesthetics

•    that can affect the metabolism like chlorpromazine, methylphenidate and reserpine

•    to treat a heart condition or to lower blood pressure

•    which work on the same receptor as Brimonidine, for example isoprenaline and prazosin.

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 taking this medicine.

This medicine should not be used during pregnancy unless your doctor still recommends it.

This medicine should not be used if you are breast-feeding.

Driving and using machines

This medicine may cause drowsiness, tiredness or blurred vision in some patients. Do not drive or use machinery until the symptoms have cleared. If you experience any problems, talk to your doctor.

Brimonidine contains benzalkonium chloride

This medicine contains 0.05 mg/ml benzalkonium chloride. Benzalkonium chloride may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

^ How to use Brimonidine

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Ocular use.

The recommended dose is one drop of this medicine, twice a day about 12 hours apart. Do not change the dose or stop taking it without speaking to your doctor.

If you use this medicine together with other eye drops, leave at least five minutes between putting in brimonidine and the other drops.

Instructions for use

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first begin to use it.

Wash your hands before opening the bottle.

Tilt your head back and look at the ceiling.

Warnings and precautions

Talk to your doctor or pharmacist before using Brimonidine

•    if you have now or have had in the past

•    depression or other psychiatric problems

•    heart or blood pressure problems

•    reduced or altered blood supply affecting the brain, legs or arms

•    kidney or liver problems

•    if you wear contact lenses. You can still use Brimonidine but follow the instructions for contact lens wearers in section “Brimonidine contains benzalkonium chloride'.'


Brimonidine is not recommended for use in children aged 2-12 years.

Other medicines and Brimonidine

Please tell your doctor or pharmacist if you are taking or have recently taken any other

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

4.Keep the eye closed and press your finger against the corner of your eye (the side where your eye meets your nose) for one minute.

2.Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.

3. Let go of the lower lid, and close your eye.

TEVA UK Ref: 231-30-40219-A LEA BRIMONIDINE TARTRATE 2mg /ml EYE DROPS 5ml TUK<ISR Verson: 4 26 April 2016






Length: 465 mm Width: 135 mm Depth: -

Colours Used: 1 Template 1


Text area 119 x 425 mm


If a drop misses your eye, try again. To help prevent infection, do not let the tip of the bottle touch your eye or anything else. Put the screw-cap back on to close the bottle, straight after you have used it.

Use in children

Brimonidine is not recommended for use in patients below 12 years of age and must not be used in babies and children under 2 years of age.

if you use more Brimonidine than you should


If you use more of this medicine than you should, it is unlikely to cause you any harm. Put your next drop in at the usual time. If you are worried, talk to your doctor or pharmacist. If this medicine is swallowed then you should contact your doctor.

Adults who accidentally swallowed Brimonidine experienced decrease in blood pressure, which in some patients was followed by the increase in blood pressure.


A few incidences of overdose have been reported in babies (up to 4 weeks old) using brimonidine. Signs include sleepiness, floppiness, low body temperature, paleness and breathing difficulties. If any of these occur, contact your doctor immediately.

if you forget to use Brimonidine

If you forget to use your medicine, use a single drop in each eye that needs treatment as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.

if you stop using Brimonidine

Brimonidine should be used every day to work properly.

Do not stop using your medicine unless your doctor tells you to.

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 everybody gets them.

Very common (may affect more than 1 in 10 people):

•    Eye irritation (eye redness, burning, stinging, itching, a feeling of something in the eye, white spots under the eyelid), blurred vision, an allergic reaction in the eye

•    Headache, drowsiness

•    Dry mouth

•    Tiredness.

Common (may affect up to 1 in 10 people):

•    Irritation around the eye, swelling, redness and inflammation of or under the eyelid, sticky or painful eyes, tears, sensitivity to light, small breaks in the surface of the eye, dryness of the eye, whiteness under the eyelid, sight problems.

•    Dizziness, taste disturbance

•    Cold-like symptoms

•    Digestive problems

•    Weakness.

Uncommon (may affect up to 1 in 100 people):

•    General allergic reactions

•    Depression

•    Palpitations, effects on the heart beat

•    Dry nose.

Rare (may affect up to 1 in 1,000 people):

•    Shortness of breath.

Very rare (may affect up to 1 in 10,000 people):

•    Eye inflammation or a reduction in pupil size

•    Sleeplessness

•    Fainting

•    High or low blood pressure.

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

•    Itching of eyelids

•    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 via the Yellow Card Scheme at: By reporting side effects you can help provide more information on the safety of this medicine.

How to store Brimonidine

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 carton and on the bottle. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not refrigerate or freeze.

Throw the bottle away 28 days after opening, even if there is solution remaining.

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.

r0 Contents of the pack and other information

What Brimonidine contains

•    The active substance is brimonidine tartrate. One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg brimonidine.

•    The other ingredients are benzalkonium chloride solution 50%, polyvinyl alcohol, sodium citrate, citric acid monohydrate, sodium chloride, water for injection and sodium hydroxide or hydrochloric acid to adjust pH.

What Brimonidine looks like and contents of the pack

Eye drop, solution Clear, greenish-yellow solution in a 5 ml plastic bottle with a screw cap.

Pack sizes: 1,3 and 6 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.

Company responsible for manufacture: Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The Netherlands.

This leaflet was revised in: April 2016

PL 00289/1034