ALPHAGAN EYE DROPS, BRIMONIDINE TARTRATE 0.2% EYE DROPS - patient leaflet, side effects, dosage

1. What Alphagan is and what it is used for

2. What you need to know before you use Alphagan

3. How to use Alphagan

4. Possible side effects

5. How to store Alphagan

6. Contents of the pack and other information

1. what alphagan is and what it is used for

Alphagan is used to reduce pressure within the eye.

The active ingredient in Alphagan is brimonidine tartrate, which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by reducing pressure within the eyeball.

It can be used either alone, when beta-blocker eye drops are contraindicated, 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.

2. what you need to know before you use alphagan

Do not use Alphagan

• If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase (MAO) inhibitors or certain other 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).

Warnings and precautions

Talk to your doctor before using Alphagan

• 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.

Children and Adolescents

Alphagan is not recommended for use in children between the ages of 2 and 12 years.

Alphagan should not usually be used in adolescents aged 12 to 17 as clinical studies have not been performed in this age group.

Other medicines and Alphagan

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 Alphagan, 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 Alphagan.

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. Do not use Alphagan if you are pregnant unless your doctor considers it necessary.

Alphagan should not be used while breast-feeding.

Driving and using machines

Alphagan may cause blurred or abnormal vision. This effect may seem worse at night or in reduced lighting.

Alphagan 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.

Alphagan contains Benzalkonium chloride

Alphagan contains 0.25mg benzalkonium chloride in each 5ml of solution which is equivalent to 0.05mg/ml.

Benzalkonium chloride is a preservative which may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

3. how to use alphagan

Always use Alphagan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart. Do not change the dose or stop taking Alphagan without speaking to your doctor.

Children under 12 years

Alphagan must not be used for infants below 2 years of age. Alphagan is not recommended for use in children (from 2 years until 12 years).

Instructions for use

Alphagan 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 Alphagan with another eye drop, wait 5–15 minutes before applying the second eye drop.

Apply your eye drops in the following way:

3.

4.

• 1. Tilt your head back and look at the ceiling.

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

• 3. Squeeze the upturned dropper bottle to release a drop into your eye.

• 4. 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.

If a drop misses your eye, try again.

To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Replace and tighten the cap straight after use.

If you use more Alphagan than you should

Adults

In adults who were instilling more drops than prescribed, the side effects reported were those already known to occur with Alphagan.

Adults who accidentally swallowed Alphagan 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 Alphagan. Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.

Adults and Children

If Alphagan has been accidentally swallowed or if you have used more Alphagan than you should, please contact your doctor immediately.

If you forget to use Alphagan

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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following eye side effects may be seen with Alphagan.

Affecting the eye

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

• Irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye, itching, follicles or white spots on the see-through layer which covers the surface of the eye)
• Blurred vision
• An allergic reaction in the eye

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

• Local irritation (inflammation and swelling of the eyelid, swelling of the see-through layer which covers the surface of the eye, sticky eyes, pain and tearing)
• Sensitivity to light
• Erosion on the surface of the eye and staining
• Eye dryness
• Whitening of the see-through layer which covers the surface of the eye
• Abnormal vision
• Inflammation of the see-through layer which covers the surface of the eye

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

• Inflammation within the eye
• Reduction in pupil size

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

• Itching of eyelids

Affecting the body

Very common (may affect up to 1 in 10 people):

• Headache
• Dry mouth
• Tiredness/drow­siness

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

• Dizziness
• Cold-like symptoms
• Symptoms involving the stomach and digestion
• Abnormal taste
• General weakness

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

• Depression
• Palpitations or changes in heart rate
• Dry nose
• General allergic reactions.

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

• Shortness of breath

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

• Sleeplessness
• Fainting
• High blood pressure
• Low blood pressure

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

• 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: Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store alphagan

• Keep out of the sight and reach of children.
• Store the bottle at or below room temperature (25°C).
• 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). The expiry date refers to the last day of that month.
• Throw the bottle away 28 days after opening, even if there is solution remaining.
• If your doctor decides to stop your treatment, take any leftover medicine back to the pharmacy.
• If your medicine appears to be discoloured or shows any other signs of deterioration, take it to your pharmacist who will advise you.
• 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. CONTENT OF THE PACK AND OTHER INFORMATION

What Alphagan contains

• The active ingredient is brimonidine tartrate 0.2% w/v (2.0mg/ml) equivalent to brimonidine base 0.13% w/v (1.3mg/ml).

One ml solution contains 2mg of brimonidine tartrate equivalent to 1.3mg brimonidine base.

• It also contains benzalkonium chloride as a preservative, polyvinyl alcohol 1.4% (14mg/ml), sodium chloride, sodium citrate dihydrate, citric acid monohydrate, purified water, hydrochloric acid or sodium hydroxide to adjust pH.

What Alphagan looks like and contents of the pack

Alphagan is a clear, greenish-yellow to light greenish-yellow eye drop solution in a plastic bottle.

Each bottle contains 5ml of the medicine.

Manufacturer

Manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0035 POM

Leaflet revision and issue date (Ref): 10.08.21

Alphagan® is a registered trademark of Allergan Inc.

Further information about glaucoma is available from: International Glaucoma Association (IGA) Tel: 01233 64 81 70

Fax: 01233 64 81 79

Email:

Blind or partially sighted?

Is this leaflet hard to see or read?

Call +44 (0) 1302 365000 (Regulatory)

Please be ready to give the following information:

Product name: Alphagan Eye Drops Reference No: 08929/0035

Package Leaflet: Information for the user

BRIMONIDINE TARTRATE 0.2% EYE DROPS (brimonidine tartrate)

Your medicine is avaliable using the name Brimonidine Tartrate 0.2% Eye Drops, but will be referred to as Brimonidine Tartrate Eye Drops throughout the leaflet.

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.

What is in this leaflet:

• 1. What Brimonidine Tartrate Eye Drops are and what they are used for

2. What you need to know before you use Brimonidine Tartrate Eye Drops

3. How to use Brimonidine Tartrate Eye Drops

4. Possible side effects

5. How to store Brimonidine Tartrate Eye Drops

6. Contents of the pack and other information

• 1. WHAT BRIMONIDINE TARTRATE EYE DROPS ARE AND WHAT THEY ARE USED FOR

Brimonidine Tartrate Eye Drops are used to reduce pressure within the eye.

The active ingredient in Brimonidine Tartrate Eye Drops is brimonidine tartrate, which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by reducing pressure within the eyeball.

It can be used either alone, when beta-blocker eye drops are contraindicated, 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.

2. what you need to know before you use brimonidine tartrate eye drops

Do not use Brimonidine Tartrate Eye Drops

• If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase (MAO) inhibitors or certain other 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).

Warnings and precautions

Talk to your doctor before using Brimonidine Tartrate Eye Drops

• 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.

Children and Adolescents

Brimonidine Tartrate Eye Drops are not recommended for use in children between the ages of

• 2 and 12 years.

Brimonidine Tartrate Eye Drops should not usually be used in adolescents aged 12 to 17 as clinical studies have not been performed in this age group.

Other medicines and Brimonidine Tartrate 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.

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 Tartrate Eye Drops, 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 Tartrate Eye Drops.

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. Do not use Brimonidine Tartrate Eye Drops if you are pregnant unless your doctor considers it necessary. Brimonidine Tartrate Eye Drops should not be used while breast-feeding.

Driving and using machines

Brimonidine Tartrate Eye Drops may cause blurred or abnormal vision. This effect may seem worse at night or in reduced lighting.

Brimonidine Tartrate Eye Drops 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.

Brimonidine Tartrate Eye Drops contain Benzalkonium chloride

Brimonidine Tartrate Eye Drops contain 0.25mg benzalkonium chloride in each 5ml of solution which is equivalent to 0.05mg/ml.

Benzalkonium chloride is a preservative which may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

3. how to use brimonidine tartrate eye drops

Always use Brimonidine Tartrate Eye Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart. Do not change the dose or stop taking Brimonidine Tartrate Eye Drops without speaking to your doctor.

Children under 12 years

Brimonidine Tartrate Eye Drops must not be used for infants below 2 years of age. Brimonidine Tartrate Eye Drops is not recommended for use in children (from 2 years until 12 years).

Instructions for use

Brimonidine Tartrate Eye Drops 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 Tartrate Eye Drops with another eye drop, wait 5–15 minutes before applying the second eye drop.

Apply your eye drops in the following way:

2.

• 4.

  
  
  
  

• 1. Tilt your head back and look at the ceiling.

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

• 3. Squeeze the upturned dropper bottle to release a drop into your eye.

• 4. 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.

If a drop misses your eye, try again.

To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Replace and tighten the cap straight after use.

If you use more Brimonidine Tartrate Eye Drops than you should

Adults

In adults who were instilling more drops than prescribed, the side effects reported were those already known to occur with Brimonidine Tartrate Eye Drops.

Adults who accidentally swallowed Brimonidine Tartrate Eye Drops 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 Eye Drops. Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.

Adults and Children

If Brimonidine Tartrate Eye Drops have been accidentally swallowed or if you have used more Brimonidine Tartrate Eye Drops than you should, please contact your doctor immediately.

5. HOW TO STORE BRIMONIDINE TARTRATE EYE DROPS

• Keep out of the sight and reach of children.
• Store the bottle at or below room temperature (25°C).
• 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

If you stop using Brimonidine Tartrate Eye Drops

To be effective Brimonidine Tartrate Eye Drops must be used every day. Do not stop using Brimonidine Tartrate Eye Drops until your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.

on the carton the bottle is packed in). The expiry date refers to the last day of that month.

• Throw the bottle away 28 days after opening, even if there is solution remaining.
• If your doctor decides to stop your treatment, take any leftover medicine back to the

pharmacy.

• If your medicine appears to be discoloured or shows any other signs of deterioration, take it

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

to your pharmacist who will advise you.

• 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

The following eye side effects may be seen with Brimonidine Tartrate Eye Drops.

protect the environment.

Affecting the eye

6. CONTENT OF THE PACK AND OTHER INFORMATION What Brimonidine Tartrate Eye Drops contain

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

• Irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye, itching, follicles or white spots on the see-through layer which covers the surface of the eye)
• Blurred vision
• An allergic reaction in the eye

• The active ingredient is brimonidine tartrate 0.2% w/v (2.0mg/ml) equivalent to brimonidine base 0.13% w/v (1.3mg/ml).

One ml solution contains 2mg of brimonidine tartrate equivalent to 1.3mg brimonidine base.

• It also contains benzalkonium chloride as a preservative, polyvinyl alcohol 1.4% (14mg/ml), sodium chloride, sodium citrate dihydrate, citric acid monohydrate,

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

• Local irritation (inflammation and swelling of the eyelid, swelling of the see-through layer which covers the surface of the eye, sticky eyes, pain and tearing)
• Sensitivity to light
• Erosion on the surface of the eye and staining
• Eye dryness
• Whitening of the see-through layer which covers the surface of the eye
• Abnormal vision
• Inflammation of the see-through layer which covers the surface of the eye

purified water, hydrochloric acid or sodium hydroxide to adjust pH.

What Brimonidine Tartrate Eye Drops look like and contents of the pack

Each bottle contains 5ml of the medicine.

Manufacturer

Manufactured by: Allergan Pharmaceuticals Ireland,

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

• Inflammation within the eye
• Reduction in pupil size

Westport, Co. Mayo, Ireland.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

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

• Itching of eyelids

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Affecting the body

PL No: 08929/0035 POM

Very common (may affect up to 1 in 10 people):

• Headache
• Dry mouth
• Tiredness/drow­siness

Leaflet revision and issue date (Ref): 10.08.21

Further information about glaucoma is available from: International Glaucoma Association (IGA) Tel: 01233 64 81 70

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

• Dizziness
• Cold-like symptoms
• Symptoms involving the stomach and digestion
• Abnormal taste
• General weakness

Fax: 01233 64 81 79

Email:

Blind or partially sighted?

Is this leaflet hard to see or read?

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

• Depression
• Palpitations or changes in heart rate
• Dry nose
• General allergic reactions.

Call +44 (0) 1302 365000 (Regulatory)

Please be ready to give the following

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

• Shortness of breath

information:

Product name: Brimidone Tartrate

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

• Sleeplessness
• Fainting
• High blood pressure
• Low blood pressure

0.2% Eye Drops

Reference No: 08929/0035

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

• Skin reactions including redness, face swelling, itching, rash and widening of blood vessels