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.
1. Why am I using Iopidine?
Iopidine contains the active ingredient apraclonidine hydrochloride. Iopidine is used
to lower raised pressure in the eye and to treat glaucoma.
2. What should I know before I use Iopidine?
Do not use if you have ever had an allergic reaction to Iopidine, clonidine, pilocarpine
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Iopidine and affect how it works or may be affected
by Iopidine.
4. How do I use Iopidine?
The usual dose of Iopidine is one drop in the affected eye(s) three times each day.
Follow the instructions provided on ‘How to use’ the Iopidine, and use Iopidine until
your doctor tells you to stop.
5. What should I know while using Iopidine?
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Things you should do
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Remind any doctor or pharmacist you visit that you are using Iopidine.
Keep all your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not stop using this medicine or lower the dose without first asking your doctor.
If you stop using your medicine your condition may worsen.
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Driving or using machines
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You should not drive, operate machinery or perform tasks requiring mental alertness
and/or physical coordination as you may feel dizzy or tired after using Iopidine.
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Addiction
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There is no evidence that Iopidine is addictive.
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Looking after your medicine
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Store below 25°C. Do not freeze.
Keep the bottle in the carton to protect the drops from light.
Do not leave the top off the bottle for any length of time, to avoid contaminating
the eye drops.
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6. Are there any side effects?
Most side effects from Iopidine occur in, or around, the eye. These include: a feeling
that the eye is dry or watery, blurred vision, problems seeing clearly, itchy eyes,
eye/eyelid redness, discharge from the eye or crusty eyelashes, discomfort, grittiness,
irritation, or pain in the eye(s), excessive sensitivity to bright light, dilated
pupils, swelling, difficult opening the eye, scales on or around the eyelid, raising
of the upper eyelid, droopy eyelids. If you think that you may be having an allergic
or allergic-like reaction to Iopidine contact your doctor immediately. Symptoms include
redness and swelling of the eye(s), eyelid(s) and/or the areas surrounding the eye(s),
shortness of breath, wheezing or difficulty breathing, swelling of the face, lips,
tongue or other parts of the body, rash, itching or hives on the skin.
Active ingredient: apraclonidine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Iopidine. 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 Iopidine.
Where to find information in this leaflet:
1. Why am I using Iopidine?
Iopidine contains the active ingredient apraclonidine hydrochloride. Iopidine (apraclonidine hydrochloride) belongs to a class of medicines known as alpha-adrenergic
agonists. Iopidine is an eye drop used in conjunction with other medications, to lower
raised pressure within your eyes. Iopidine does this by reducing the amount of fluid
produced within your eyes.
Iopidine is used to lower raised pressure in the eye and to treat glaucoma.
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. 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.
If glaucoma is not treated, it can lead to serious problems, including total blindness.
Untreated glaucoma is one of the most common causes of blindness.
Ask your doctor if you have questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I use Iopidine?
Warnings
Do not use Iopidine if:
you are allergic to apraclonidine hydrochloride, clonidine, pilocarpine or any of
the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction include shortness of breath, wheezing
or difficulty breathing, swelling of the face, lips, tongue or other parts of the
body, rash, itching or hives on the skin.
Always check the ingredients to make sure you can use this medicine.
you are currently taking any monoamine oxidase inhibitors (MAOI) which are used to
treat depression.
you are currently taking a tricyclic antidepressant for depression.
you are currently taking any sympathomimetic medications which are used to treat asthma,
severe headaches, or coughs and colds.
If you are not sure whether you should start using Iopidine, talk to your doctor.
Check with your doctor if you:
have any other medical conditions, especially:
Heart problems. These include coronary heart disease (symptoms can include chest pain
or tightness, breathlessness or choking), heart failure, a recent heart attack
Circulation conditions. These include Raynaud's disease, thromboangiitis obliterans
(Buerger disease) where there is inflammation and clotting of the small and medium
arteries and veins of the hands and feet, poor circulation of blood in the brain.
High blood pressure
Kidney problems
Liver problems
Depression
A type of glaucoma called angle-closure or narrow-angle glaucoma.
take any medicines for any other condition
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
Check with your doctor if you are pregnant or intend to become pregnant.
Iopidine is not recommended for use in pregnancy. Your doctor will discuss the possible
risks and benefits of using Iopidine during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should stop breastfeeding while you are using this medicine as Iopidine is not
recommended whilst breastfeeding.
Use in children
Iopidine is not recommended in children and infants due to the risk of serious side
effects.
Use in older adults
There are no special warnings or precautions regarding the use of Iopidine in older
adults.
3. What if I am taking other medicines?
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 Iopidine and affect how it works or may be affected
by Iopidine.
Telling your doctor of pharmacist is particularly important if you are currently using
any type of beta-blocker medication, any medicine for the treatment of high blood
pressure, any medicine for the treatment of a heart condition, any sedative-type medicine
including alcohol and strong pain-killers, tricyclic antidepressants.
You may need different amounts of your medicines, or you may need to take or use different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Iopidine.
Your doctor of pharmacist have more information on medicines to be careful with or
avoid while using this medicine.
4. How do I use Iopidine?
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box or bottle, ask your doctor or
pharmacist for help.
How much to use
The usual dose of Iopidine is one drop in the affected eye(s).
Follow the instructions provided and use Iopidine until your doctor tells you to stop.
When to use Iopidine
Iopidine should be used three times each day.
Do not put Iopidine into your eye(s) while you are wearing soft contact lenses. You can insert soft contact lenses 15 minutes after you have used Iopidine.
Do not use Iopidine more often than your doctor or pharmacist has told you.
After using Iopidine, wait at least 5 minutes before putting any other eye drops in
your eyes. This ensures that you do not wash any of the eye drops from your eyes.
It is important to use Iopidine exactly as your doctor or pharmacist has told you.
If you use the drops less often than prescribed, they may not work as well and the
eye problem may not improve. Using the drops more often than prescribed may not improve
the eye problem any faster and may cause increased side effects.
How to use Iopidine
1. Wash your hands well with soap and water.
2. Immediately before using a bottle for the first time, break the safety seal around
the neck area and throw the loose plastic ring away.
4. Hold the bottle upside down in one hand between your thumb and middle finger (see
Diagram 1).
5. Tilt you head back and look up.
6. Using your other hand, gently pull down your lower eyelid to form a pouch/pocket.
7. Place the dropper tip close to, but not touching, your eye. Release one drop into
the pouch/pocket formed between your eye and eyelid by gently tapping or pressing
the base of the bottle with your forefinger (see Diagrams 2 and 3).
8. Close your eye. Do not blink or rub your eye.
9. 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.
10. 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.
11. Replace the cap on the bottle, closing it tightly.
12. Wash your hands again with soap and water to remove any residue.
You may feel a slight burning sensation in the eye shortly after using Iopidine.
If this persists, or is very uncomfortable, contact your doctor or pharmacist.
Most people who use Iopidine will notice a whitening of the eye shortly after using
the product.
Do not touch the tip of the dropper to your eye or to any other surface.
This will help to prevent your eye drops becoming dirty or contaminated.
How long to use it
Continue using your medicine for as long as your doctor tells you.
This medicine helps control your condition but does not cure it.
If you are unsure about when, or how, to stop using Iopidine you should talk to your
doctor.
If you forget to use Iopidine
If 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 use a double dose to make up for the dose you missed.
If you are not sure what to do, contact your doctor or pharmacist.
If you use too much Iopidine
If you think that you have used too much Iopidine, immediately rinse your eye(s) with
warm water.
If you think that you or anyone else may have swallowed any or all of the contents
of a bottle of Iopidine, immediately:
phone the Poisons Information Centre
by calling
13 11 26 in Australia, or 0800 POISON or 0800 764 766 in New Zealand
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Iopidine?
Things you should do
Keep all your doctor's appointments so that your progress can be checked.
Your doctor will usually ask you to return regularly to make sure that Iopidine are
working. It is very important that you return to see your doctor when instructed.
Remind any doctor or pharmacist you visit that you are using Iopidine.
Call your doctor straight away if you:
become pregnant while you are using Iopidine.
Things you should not do
Do not use Iopidine to treat any other complaints unless your doctor tells you.
Do not give this medicine to anyone else, even if they appear to have the same condition
as you.
Do not stop using this medicine or lower the dose without first asking your doctor.
If you stop using your medicine your condition may worsen.
Do not let children handle Iopidine. If a child accidentally swallows any of the Iopidine follow the instructions under
the "If you use too much (overdose)" section above.
Do not use if the expiry date printed on the pack has passed, the packaging is torn,
the safety seal around the closure and neck area is broken or the bottle/packaging
shows signs of tampering.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Iopidine
affects you.
Iopidine may cause dizziness or tiredness in some people.
Addiction
There is no evidence that Iopidine is addictive.
Looking after your medicine
Store below 25°C
Do not freeze
Keep the bottle in the carton to protect the drops from light
Do not leave the top off the bottle for any length of time, to avoid contaminating
the eye drops.
Follow the instructions in 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
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
Write the date on the bottle when you open the eye drops and throw out any 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 then be used.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date or damaged, take it
to any pharmacy for safe disposal.
Do not use this medicine after the expiry date. If you use this medicine after the
expiry date has passed, it may not work.
6. Are there any side effects?
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
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Less serious side effects
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What to do
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In or around the eye (ocular):
A feeling that the eye is dry or watery
Blurred vision and/or problems seeing clearly
Itchy eyes
Eye/eyelid redness
Discharge from the eye and/or crusty eyelashes
Discomfort, grittiness, irritation or pain in the eye(s)
Excessive sensitivity to bright light
Dilated pupils
Swelling to the front part of the eye
Difficult opening the eye
Eyelid swelling
Scales on or around the eyelid
Raising of the upper eyelid
Droopy eyelids
Conjunctiva (layer of skin between eyelid and eye) swelling.
Body as a whole:
Headache and/or feeling sick
Senses:
Changes in the sensations of taste and/or smell
Heart related:
Irregular heartbeat
Central nervous system:
Dizziness, tiredness, lack of co-ordination, fainting
Inability to sleep
Mood changes, such as depression, irritability or nervousness
Numbness or tingling in fingers or toes
Digestive system:
Dry mouth
Nausea and/or Constipation
Breathing:
Dry nose
Sore throat and/or runny nose
Muscle/bone related:
Aching or painful muscles, not caused by exercise
Skin:
Skin rash.
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Speak to your doctor if you have any of these less serious side effects and they worry
you
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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 . 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
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Iopidine contains
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Active ingredient
(main ingredient)
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apraclonidine hydrochloride 5 mg in 1 mL (0.5%)
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Other ingredients
(inactive ingredients)
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benzalkonium chloride (as a preservative)
sodium acetate
sodium chloride
purified water
sodium hydroxide and or hydrochloric acid to adjust pH
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Potential allergens
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benzoates, sulfites and hydroxybenzoates.
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Do not use this medicine if you are allergic to any of these ingredients.
What Iopidine looks like
Iopidine is a sterile isotonic solution supplied in dispenser bottles of 5 mL or 10
mL. (Aust R 51190).
Who distributes Iopidine
Iopidine is distributed in Australia by:
Clinect Pty Ltd
120-132 Atlantic Drive
Keysborough VIC 3173
Australia
Free Call Australia: 1800 899 005
Iopidine is distributed in New Zealand by:
Clinect NZ Pty Limited
C/- Ebos Group Limited
108 Wrights Road
Christchurch 8024
New Zealand
Free Call New Zealand: 0800 138 803
You can also obtain a copy of the most up to date leaflet from your pharmacist. The
updates may contain important information about the medicine and its use of which
you should be aware.
For more information about glaucoma in Australia contact Glaucoma Australia (telephone
1800 500 880).
For more information about glaucoma in New Zealand contact Glaucoma New Zealand on
09 373 8779.
This leaflet was prepared in September 2022.
® Registered Trademark