PACKAGE LEAFLET: INFORMATION FOR THE USER

Brimonidiue 2 mg/ml eye drops,

solution

Brimonidine tartrate

u

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again

•    Ifyouhaveany further questions, ask your doctor or phaimacist.

•    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 asyours.

•    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 andwhatitis used for

2.    Before you use Brimonidine

3.    Howto use Brimonidine

4.    Possible side effects

5.    Howto store Brimonidine

6.    Further information

Brimonidine is used to reduce pressure within the eye.

It canbe used either alone, when beta-blocker eyedrops should notbe 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.

Do not use Brimonidine

•    If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of Brimonidine.

•    Ifyou are taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You must inform your doctor if you are taking any antidepressant drug.

•    Ifyou are breast-feeding.

•    Ininfants/babies (from birth until 2 years).

Take special care with Brimonidine Before you take this medicine, tell your doctor:

•    Ifyou 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.

•    Ifyouhaveorhavehadinthepastkidney 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 doctorifyou are taking any ofthe following medicines:

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

•    anaesthetics.

•    to treat aheart condition orto lower blood pressure.

•    that can affect the metabolism like chlorpromazine, methylphenidate andreserpine.

•    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.

•    orifthedoseofany ofyour cuirenl medicines is changed.

These could affectyour 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 orplanning to become pregnant.

Brimonidine should notbe 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 ortiredness 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 ofthe ingredients ofBrimonidine

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.

Always use Brimonidine exactly as your doctor has told you. You should check with your doctor or pharmacistifyouarenot 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 forinfants below 2 years of age.

Brimonidine is not recommended foruse 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

Using the dropsfor    the first time:

These eye drops come in a bottle with a screw cap. The inside ofthe screw cap contains a spike. The screw cap is fitted to the bottle in such a way thatthere is no contact between the spike and the top ofthe bottle. In order to open the bottle it is necessaty to tighten the screw cap further, so that the edge ofthe screw cap and the bottle edge are totally aligned. At this point the screw cap spike will pierce the top ofthe 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:

Applyyour eye drops in thefoOowingway:

Avoidtouchingthedroppertip against your eye or anything else.

Replace and tighten the cap straight afteruse.

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 eyedrops.

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

Ifyou 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 yourdoctortellsyouto.

Ifyouhave any further questions onthe use ofthis product, askyour doctor orpharmacist.

Like all medicines, Brimonidine can cause side effects, although not everybody gets them. The chance ofhaving a side effectis described by the following categories:

Verycommon    Occursinmorethanl outoflOpatients

Common    Occursinfewerthanl outoflOpatients

Uncommon    OccursinfewerthanlouloflOOpatients

Rare    Occursinfewerthanl oulof l,000patients

Veryrare    Occursinfewerthanl oulof 10,000patients

The following eye side effects maybe seen with Brimonidine.

Veryayrnmont An allergic reaction in the eye, follicles or white spots on the see-through 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 ofthe see-through layer which covers the surface ofthe eye, abnormal vision, sticky eyes, swelling of the eyelid or see-through layer which covers the surface ofthe eye, sensitivity to light, imitation, eyelid redness, aching or pain, dtyness, erosion on the surface ofthe eye and staining, tears or, whitening ofthe see-through layer which covers the surface ofthe eye.

Veryrare:    Eye inflammation or a reduction in pupil size.

Not known:    Swelling andirritation ofthe uvea, itching of eyelid

Some ofthese effects may be due to an allergy to any ofthe ingredients. Youmayalsoexperiencethefollowingeffectsinotherpartsofthebody:

Verycommon:    Headache, dry mouth andtiredness/drowsiness.

Common:    Dizziness, cold-like symptoms, symptoms involving the stomach and

digestion, abnormal taste or general weakness.

Uncommon:    Depression, palpitations or changes in heartrate, dry nose and general

allergic reactions.

Rare:    Shortness ofbreath.

Veryrare:    Sleeplessness, fainting andhigh 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 orphaimacist.

•    Keep out ofthe reach and sight of children.

•    This medicinal product does not require any special storage conditions before first opening ofthebottle.

•    Do not store above 30°C, after first opening ofthe bottle.

•    Do not use the bottle if the tamper-proof seal on the bottle is broken before firstuse.

•    Do not use Brimonidine after the expiry date which is stated onthe bottle label and the carton after EXP:. The expiry date refers to the last day of thatmonth.

•    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.

What Brimonidine contains

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

•    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 forpH-adjustment.

What Brimonidine looks like and contents ofthe pack

Brimonidine is a clear, colourless to pale-yellow eye drop solution in aplastic bottle. Each bottle contains either 5 ml or 10 ml ofthe 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 ofBrimonidine eye drops, packagedin a larger outer carton.

Not all pack sizes may be maiketed.

Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5, Mariyat Close, Hounslow West,

Middlesex, Tw4 5DQ, UK.

This leaflet was last approved on 04/2012