- Audio
ALPHAGAN® P 1.0
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
ALPHAGAN® P 1.0 contains the active ingredient brimonidine tartrate. ALPHAGAN® P
1.0 is used to lower raised pressure in the eye(s) and to treat glaucoma.
For more information, see Section 1. Why am I using ALPHAGAN® P 1.0? in the full CMI.
Check the list of ingredients at the end of the CMI. Do not use ALPHAGAN® P 1.0 if
you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not aware that you have
any other medical conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use ALPHAGAN® P 1.0? in the full CMI.
Some medicines may interfere with ALPHAGAN® P 1.0 and affect how it works, or ALPHAGAN®
P 1.0 may interfere with other medicines and affect how they work.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will tell you how many drops you need to use each day. The usual dosage
of eye drops is one drop in the eye(s) two times a day. More instructions can be found
in Section 4. How do I use ALPHAGAN® P 1.0? in the full CMI.
|
Things you should do
|
Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using
ALPHAGAN® P 1.0
Continue to use ALPHAGAN® P 1.0 every day unless your doctor tells you to stop
Keep all your appointments so your condition can be checked.
|
|---|---|
|
Things you should not do
|
Do not touch the dropper tip against your eye, eye lid or any surface
Do not stop using ALPHAGAN® P 1.0 without checking with your doctor.
|
|
Driving or using machines
|
Wait for your vision to clear after using ALPHAGAN® P 1.0 before you drive or use
machines.
Do not drive or operate machines if you feel tired or drowsy while using ALPHAGAN®
P 1.0.
|
|
Drinking alcohol
|
ALPHAGAN® P 1.0 may cause drowsiness and this can be made worse by drinking alcohol.
|
|
Looking after your medicine
|
Follow all instructions on the carton and label
Store below 30°C.
|
For more information, see Section 5. What should I know while using ALPHAGAN P 1.0? in the full CMI.
The most common side effects are eye redness and allergic reactions in the eye. You
may also experience blurry vision and tearing.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
ALPHAGAN® P 1.0 (al-fah gan pee 1.0)
Active ingredient: brimonidine tartrate (brim-on-id-deen tar-trate)
Consumer Medicine Information (CMI)
This leaflet provides important information about using ALPHAGAN® P 1.0. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ALPHAGAN® P 1.0.
Where to find information in this leaflet:
ALPHAGAN® P 1.0 contains the active ingredient brimonidine tartrate.
ALPHAGAN® P 1.0 is used to lower raised pressure in the eye and to treat glaucoma.
ALPHAGAN P 1.0 eye drops are used to lower raised pressure in the eye and to treat
glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be
high. However, some people with glaucoma may have normal eye pressure.
Glaucoma is usually caused by a build up of the fluid which flows through the eye.
This build up occurs because the fluid drains out of your eye more slowly than it
is being pumped in. Since new fluid continues to enter the eye joining the fluid already
there, the pressure continues to rise. This raised pressure may damage the back of
the eye resulting in gradual loss of sight.
Eye damage can progress so slowly that the person is not aware of this gradual loss
of sight. Sometimes even normal eye pressure is associated with damage to the back
of the eye.
There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma
is to have your eye pressure, optic nerve and visual field checked by an eye specialist
or optometrist.
If glaucoma is not treated it can lead to serious problems, including total blindness.
In fact, untreated glaucoma is one of the most common causes of blindness.
ALPHAGAN P 1.0 eye drops lower the pressure in the eye by decreasing the fluid produced
and helping the flow of fluid out of the eye chamber.
Although ALPHAGAN P 1.0 eye drops help control your glaucoma, it does not cure it.
ALPHAGAN P 1.0 eye drops are used, either alone or together with other eye drops/medicines,
to lower raised pressure within your eye(s).
Your doctor may have prescribed ALPHAGAN P 1.0 eye drops for you instead of ALPHAGAN
eye drops. The main difference between ALPHAGAN P 1.0 and ALPHAGAN is the preservative;
ALPHAGAN P 1.0 contains 'Purite' (hence the 'P') whereas ALPHAGAN contains benzalkonium
chloride.
ALPHAGAN P 1.0 belongs to a family of medicines called alpha-adrenergic agonists.
Your doctor may have prescribed ALPHAGAN P 1.0 eye drops for another reason. Ask your
doctor if you have any questions about why ALPHAGAN P 1.0 eye drops have been prescribed
for you.
Do not use ALPHAGAN® P 1.0 if:
You are allergic to brimonidine tartrate, or any of the ingredients listed at the
end of this leaflet.
You are taking monoamine oxidase antidepressant medication
Do not use in children younger than 2 years of age.
The seal around the cap is broken
The bottle/packaging shows signs of tampering
The product does not look quite right
The expiry date on the bottle or carton has passed. If you use this medicine after
the expiry date has passed, it may not work.
If you are not sure whether you should start using ALPHAGAN P 1.0 eye drops, talk
to your doctor.
Check with your doctor if you:
Have had an allergy to any other medicine or any other medicines or any other foods,
preservatives, or dyes.
Have or have had any medical conditions, especially the following:
liver or kidney disease
severe, uncontrolled heart disease or poor blood flow to the heart
poor blood flow to the brain
depression
Raynaud's syndrome. This is a condition marked by numbness, tingling and colour change
(white, blue, then red) in the fingers when they are exposed to cold
Dizziness on standing up, especially when getting up from a sitting or lying position
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Make sure your doctor is aware that you are pregnant or plan to become pregnant or
are breastfeeding or intend to breastfeed. Your doctor will discuss the possible risks
and benefits of using ALPHAGAN® P 1.0 when pregnant or breast-feeding.
Use in children
Children 2 years of age and above, especially those weighing ≤ 20 kg, should be treated
with caution and closely monitored. Safety and effectiveness in paediatric patients
have not been established.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with
ALPHAGAN® P 1.0
and affect how it works, while ALPHAGAN® P 1.0 may affect how other medicines work.
Do not take ALPHAGAN® P 1.0 if you are taking any of the following medicines:
specific medicines to treat depression called "monoamine oxidase (MAO) inhibitors",
such as phenelzine, tranylcypromine
Medicines where ALPHAGAN® P 1.0 may increase their effect include:
barbiturates, traditionally used to treat epilepsy (seizures, fits)
medicines used to relieve strong pain (such as opiates)
medicines used to calm or put you to sleep
anesthetics
medicines used to treat high blood pressure, including beta blockers
certain medicines used to treat asthma, severe headaches or coughs and colds, known
as sympathomimetics.
alcohol
Other medicines that are broken down by the liver may interact with ALPHAGAN® P 1.0.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
ALPHAGAN® P 1.0.
How much to use
Your doctor will tell you how many drops you need to use each day.
The usual dosage of eye drops is one drop in the eye(s) two times a day (approximately
every 12 hours).
Follow all directions given to you by your doctor carefully. The directions may differ
from the information contained in this leaflet.
When to use ALPHAGAN® P 1.0
Use ALPHAGAN P 1.0 eye drops every day, at about the same time each day, unless your
doctor tells you otherwise. Using your eye drops at the same time each day will have
the best effect on your eye pressure. It will also help you remember when to use
the eye drops.
In some instances, ALPHAGAN® P 1.0 needs to be used with other eye drops. Your doctor
will let you know which drops, how to use them, and how long to use them.
Wait at least 5 to 10 minutes after using ALPHAGAN® P 1.0 before using other eye drops.
How to use ALPHAGAN® P 1.0
You may find it easier to put drops in your eye while you are sitting or lying down.
To open a new bottle of ALPHAGAN P 1.0 eye drops, first tear off the protective seal
from the bottle. The contents are sterile if seal is intact. The seal will break
and you can pull it off and then throw it away.
1. Wash your hands well with soap and water.
2. Shake the bottle gently.
3. Remove the cap.
4. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
6. Tilt your head back and look up.
7. Put the tip of the bottle close to your lower eyelid. Do not let the tip touch your eye.
8. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
9. Close your eye. Do not blink or rub your eye.
10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
11. Replace the cap, sealing it tightly.
12. Wash your hands again with soap and water to remove any residue.
Wait 15 minutes before inserting your contact lenses.
Be careful not to touch the dropper tip against your eye, eyelid or anything else
to avoid contaminating the eye drops.
Contaminated eye drops may give you an eye infection.
ALPHAGAN® P 1.0 eye drops are for use in eyes only.
You may feel a slight burning sensation in the eye shortly after using the eye drops.
If this persists, or is very uncomfortable, contact your doctor or pharmacist.
If you forget to use ALPHAGAN® P 1.0
It is important that you use ALPHAGAN® P 1.0 at the same time each day.
If you forget to use ALPHAGAN® P 1.0 and it is almost time for your next dose, skip
the dose you missed and use your next dose when you are meant to.
Otherwise, use the drops as soon as you remember, and then go back to using them as
you would normally.
Do not take a double dose to make up for the dose you missed.
If ALPHAGAN® P 1.0 is accidentally swallowed
phone the Poisons Information Centre in Australia
(by calling 13 11 26), in New Zealand the National Poisons Centre (by calling 0800 POISON or 0800 764 766), or
(by calling 13 11 26), in New Zealand the National Poisons Centre (by calling 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appear to be no signs of discomfort or poisoning.
Things you should do
Continue to use ALPHAGAN® P 1.0 as instructed by your doctor. ALPHAGAN® P 1.0 helps
to control your condition but does not cure it.
Use all the medication prescribed to treat your eye condition.
Keep all your doctor's appointments so that your condition can be monitored, and your
eye pressure can be checked.
If you develop an eye infection, receive an eye injury, or have eye surgery tell your
doctor. Your doctor may tell you to use a new container of ALPHAGAN P 1.0 eye drops
because of possible contamination of the old one or may advise you to stop your treatment
with ALPHAGAN P 1.0 eye drops.
Call your doctor straight away if you:
suspect an eye infection (e.g. redness, discharge, pain)
become pregnant while using ALPHAGAN® P 1.0.
Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using
ALPHAGAN® P 1.0.
Things you should not do
Do not touch the dropper tip against your eye, eyelid or anything else, to avoid contaminating
the eye drops.
Do not stop using ALPHAGAN® P 1.0 without checking with your doctor. Your eye pressure
can rise again and may cause damage to your eye.
Driving or using machines
Wait for your vision to clear after using ALPHAGAN® P 1.0 before you drive or use
machines.
Do not drive or operate machines if you feel fatigued or drowsy while using ALPHAGAN®
P 1.0.
Drinking alcohol
ALPHAGAN® P 1.0 may cause drowsiness and this can be made worse by drinking alcohol.
Looking after your medicine
Store below 30°C.
To avoid contamination of the solution, keep container tightly closed. Do not touch
the dropper tip to any surface. Contents are sterile if seal is intact.
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
Discard the bottle 4 weeks after first opening it.
Write the date on the bottle when you open the eye drops and throw out the remaining
solution after four weeks.
Eye drops contain a preservative which helps prevent germs growing in the solution
for the first four weeks after opening the bottle. After this time there is a greater
risk that the drops may become contaminated and cause an eye infection. A new bottle
should be opened.
Getting rid of any unwanted medicine
If your doctor advises that you no longer need to use this medicine or it is out of
date, take it to any pharmacy for safe disposal.
Do not open the bottle to use this medicine after the expiry date has passed.
All medicines can have side effects. If you do experience any side effects, most
of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|---|---|
|
Effects on the eye(s)
allergic reactions including red and swollen eye(s), watery eye(s), discomfort or
feeling of something in the eye(s), itchy or irritated eye(s)
redness and/or swelling of the eye(s), eyelids and surrounding areas
burning and stinging of the eye(s)
eye discharge
redness and swelling of the eyelids
sore eye(s)
blurred vision
pink eye
lesions on the clear surface of the eye that look like dots
Effects on the body as a whole:
unusual tiredness or weakness
headache
oral dryness
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|---|---|
|
Effects on the eye(s)
blurred vision, halos around light
a loss of feeling to the surface of the eye
|
Call your doctor straight away, if you notice any of these serious side effects.
|
|
Body as a whole:
severe allergic reaction, including swelling of the tongue, lips and throat, difficulty
breathing.
|
Go straight to the Emergency Department at your nearest hospital if you notice any
of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or to https://nzphvc.otago.ac.nz/reporting/ in New Zealand. By reporting side effects, you can help provide more information
on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
using any of your medicines.
This medicine is only available with a doctor's prescription.
What ALPHAGAN® P 1.0 contains
|
Active ingredient
(main ingredient)
|
Brimonidine tartrate
|
|---|---|
|
Preservative
|
sodium chlorite (as PURITE®)
|
|
Other ingredients
(inactive ingredients)
|
borax
boric acid
calcium chloride dihydrate
carmellose sodium
magnesium chloride hexahydrate
potassium chloride
purified water
hydrochloric acid and/or sodium hydroxide may be added to adjust pH
|
Do not USE this medicine if you are allergic to any of these ingredients.
What ALPHAGAN® P 1.0 looks like
ALPHAGAN® P 1.0 is a clear, greenish-yellow solution. It is supplied in a plastic
dropper bottle containing 5 mL of liquid.
(AUST R 421114).
Who distributes ALPHAGAN® P 1.0?
ALPHAGAN® P 1.0 is distributed in Australia by:
AbbVie Pty Ltd
Mascot NSW 2020
Australia
Toll-free: 1800 252 224
ALPHAGAN® P 1.0 is distributed in New Zealand by:
AbbVie Limited
Wellington 6011
New Zealand
Freephone: 0800 659 912
For more information about glaucoma, contact Glaucoma Australia on 1800 500 880 or
Glaucoma New Zealand on 09 373 9779.
This leaflet was prepared in July 2024
Version 1
© 2024 AbbVie. All rights reserved.
ALPHAGAN and its design are trademarks of Allergan, Inc., an AbbVie company.
