SUMMARY CMI

IOPIDINE^®

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.

For more information, see Section 1. Why am I using Iopidine? in the full CMI.

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.

For more information, see Section 2. What should I know before I use Iopidine? in the full CMI.

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.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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.

More instructions can be found in Section 4. How do I use Iopidine? in the full CMI.

5. What should I know while using Iopidine?

For more information, see Section 5. What should I know while using Iopidine? in the full CMI.

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.

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.

FULL CMI

IOPIDINE^®

Active ingredient: apraclonidine hydrochloride

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?
2. What should I know before I use Iopidine?
3. What if I am taking other medicines?
4. How do I use Iopidine?
5. What should I know while using Iopidine?
6. Are there any side effects?
7. Product details

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.
3. Remove the cap.
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

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

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

Published by MIMS April 2023

1 Name of Medicine

Apraclonidine hydrochloride.

2 Qualitative and Quantitative Composition

Iopidine Eye Drops 0.5% contains 5.75 mg/mL apraclonidine hydrochloride equivalent to 5.0 mg/mL of apraclonidine in a sterile isotonic base.

Excipients with known effect.

3 Pharmaceutical Form

Eye drops, solution.
Clear colourless to pale yellow solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Iopidine 0.5% is indicated to control intraocular pressure in glaucoma patients on maximally tolerated glaucoma therapy for a period of 3 months.
In clinical studies the drop in intraocular pressure appeared to decrease after day 60 which may be associated with a progression of the disease or loss of effect of the drug. This phenomenon appears to be an individual occurrence with variable time of onset.
As with any patient on maximally tolerated therapy (see Section 4.2 Dose and Method of Administration), patients using Iopidine 0.5% to delay surgery should have frequent follow-up examinations and treatment with Iopidine 0.5% should be discontinued if IOP rises significantly.
In patients who have maintained a response to Iopidine 0.5% for 3 months and a decision is made to continue treatment, safety aspects, including any evidence of corneal changes (see Section 4.4 Special Warnings and Precautions for Use), and IOP control should be closely monitored.

4.2 Dose and Method of Administration

One drop of Iopidine 0.5% should be instilled into the affected eye(s) three times per day. Since Iopidine 0.5% will be used with other ocular glaucoma therapies, an approximate five minute interval between instillation of each medication should be observed to prevent washout of the previous dose (see Section 4.1 Therapeutic Indications).
Clinical studies to establish safety and efficacy in children have not been conducted, and therefore, Iopidine 0.5% is not recommended for use in children.
There are no special precautions for administration to the elderly.
Patients with impaired renal and/or hepatic function should be carefully monitored (see Section 4.4 Special Warnings and Precautions for Use).
In order to minimise systemic absorption, apply pressure to the tear duct for two minutes immediately after administration.

4.3 Contraindications

Iopidine 0.5% is contraindicated in patients with hypersensitivity to any component of the formulation or to systemic clonidine and in patients receiving monoamine oxidase inhibitors, systemic sympathomimetics or tricyclic antidepressants.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Iopidine 0.5% should not be used in patients receiving MAO inhibitors (see Section 4.3 Contraindications).
No specific drug interactions with topical glaucoma products (betaxolol, carbachol, dipivefrin, ecothiopate, adrenaline, levobunolol, pilocarpine, timolol) or systemic medication (acetazolamide, methazolamide) were identified in the clinical studies with Iopidine 0.5%.
However, since apraclonidine may reduce pulse and blood pressure, caution in concomitant use of drugs such as β-blockers (ophthalmic and systemic), anti-hypertensives and cardiac glycosides is advised. Patients using cardiovascular drugs concurrent with apraclonidine should have their pulse and blood pressure monitored frequently. Caution should be exercised with simultaneous use of clonidine and other similar pharmacologic agents.
The possibility exists for an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, anaesthetics). Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Iopidine 0.5% can lead to a reduction in the IOP-lowering effect. No data on the level of circulating catecholamines after apraclonidine withdrawal are available. Caution is advised, however, in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines (see Section 4.3 Contraindications).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
However, some adverse effects of Iopidine eye drops could affect the ability to drive and use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

Iopidine 0.5% is generally well tolerated at the recommended dosage for up to 3 months (see Section 4.1 Therapeutic Indications) for control of IOP in glaucoma patients. The most frequently observed effects were ocular.
Use of Iopidine 0.5% can lead to an allergic-like reaction characterised wholly or in part by the symptoms of hyperaemia, pruritus, discomfort, tearing, foreign-body sensation, oedema of the lids and conjunctiva. If allergic-like symptoms occur therapy with Iopidine 0.5% should be discontinued.
In clinical studies (n = 458 patients) the overall discontinuation rate related to Iopidine 0.5% was 15%. The most commonly reported events leading to discontinuation were hyperaemia, pruritus, tearing, discomfort, lid oedema, dry mouth, and foreign body sensation. Other adverse reactions related to apraclonidine were generally mild to moderate, non-serious and did not result in sequelae.
The following adverse reactions (incidence) were reported in clinical studies with Iopidine 0.5% as being related to therapy.

Ocular.

< 3% of patients.

< 1% of patients.

Systemic.

< 3% of patients.

< 1% of patients.

< 1% of patients.

< 1% of patients.

< 1% of patients.

< 1% of patients.

< 1% of patients.

Postmarketing events.

Eye disorders.

Infections and infestations.

Psychiatric disorders.

Nervous system disorders.

Vascular disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Paediatric population.

Reporting of suspected adverse reactions.

4.9 Overdose

No information on overdosage with Iopidine 0.5% is available in humans. Based on information with clonidine, signs of a topical or oral overdose with apraclonidine may include hypotension, lethargy, somnolence, bradycardia, hypoventilation, and seizure, particularly in children. A topical overdose of Iopidine 0.5% may be flushed from the eyes with warm tap water. Following accidental overdosage per ora, treatment should include drug removal by emesis or activated charcoal as well as symptomatic treatment.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Excretion.

5.3 Preclinical Safety Data

Apraclonidine is an alpha-adrenergic agonist with higher potency and affinity for α₂ compared to α₁-adrenoreceptors. It has been shown to produce a lowering of intraocular pressure (IOP) in rabbits and monkeys with elevated IOP and in cats with normal IOP. The physicochemical properties of apraclonidine limit its rate of passage across the blood-brain barrier to access the central nervous system. It produced a decrease in blood pressure in rats when given intracerebroventricularly but not intravenously. Topical ocular administration to dogs did not change cardiovascular parameters, but intravenous administration to rats and dogs produced a transient elevation of blood pressure and a slight decrease in heart rate.
Administration of apraclonidine intravenously to cats and via the topical ocular route to monkeys resulted in a reduced anterior segment blood flow, whereas flow to the posterior segment, i.e. retina, choroid or optic nerve head, was not affected. Chronic treatment of primates with apraclonidine 1.5% ocularly three times a day for one year did not result in morphologic effects which would be indicative of vasoconstriction of the anterior or posterior segments of the eye. Although ocular blood flow studies have not been conducted in humans, the animal studies provide a basis for the safe use of this drug in the treatment of ocular hypertension and open angle glaucoma.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzalkonium chloride (0.1 mg/mL as preservative), sodium acetate, sodium chloride, hydrochloric acid/sodium hydroxide (for pH adjustment) and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Iopidine Eye Drops 0.5% is available in LPDE opaque drop dispenser - LDPE plug and white PP cap; pack sizes: 1 x 2.5 mL, 1 x 5 mL and 1 x 10 mL.
How to Use leaflet is supplied with this product.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Apraclonidine hydrochloride is a white to off-white crystalline powder sparingly soluble in water (29.1 mg/mL). The pKa₁ value is 1.16; pKa₂ value is 9.22.

Chemical structure.

Empirical formula.

Chemical name.

Molecular weight.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription only Medicine (Schedule 4).

Summary Table of Changes