SUMMARY CMI

ILEVRO^® Eye Drops Suspension

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 ILEVRO?

Ilevro contains the active ingredient Nepafenac. Ilevro is used to for prevention and treatment of post-surgical pain and swelling associated with cataract surgery. It also helps in reducing the risk of post-surgery swelling associated with cataract surgery in patients with non-proliferative diabetic retinopathy (an eye disease)

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

2. What should I know before I use ILEVRO?

Do not use if you have ever had an allergic reaction to Ilevro 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 ILEVRO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ilevro and affect how it works.

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 ILEVRO?

• Your doctor will advise you the appropriate dose.
• Follow the instructions provided and use Ilevro eye drops until your doctor tells you to stop.
• More instructions can be found in Section 4. How do I use ILEVRO? in the full CMI.

5. What should I know while using ILEVRO?

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

6. Are there any side effects?

Common side effects include blurred vision, eye pain, dry or itchy eye(s), feeling that something is in your eye(s) (foreign body sensation), eye irritation, reduced vision, eye discharge.

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

ILEVRO^® Eye Drops Suspension

Active ingredient: Nepafenac 3 mg/mL (0.3%).

Consumer Medicine Information (CMI)

This leaflet provides important information about using ILEVRO. 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 ILEVRO.

Where to find information in this leaflet:

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

1. Why am I using ILEVRO?

Ilevro contains the active ingredient Nepafenac. It belongs to class of drug called non-steroidal anti-inflammatory drugs (NSAIDs). They help to reduce pain, swelling.

Ilevro is used for prevention and treatment of post-surgical pain and swelling associated with cataract surgery.

It also helps in reducing the risk of post-surgery macular oedema (buildup of fluid in the macula, an area at the back of the eye) associated with cataract surgery in patients with non-proliferative diabetic retinopathy (an eye disorder, with symptoms such as cloudy or blurred vision, trouble seeing well at night).

2. What should I know before I use ILEVRO?

Warnings

Do not use ILVERO if:

• you are allergic to Nepafenac, or any of the ingredients listed at the end of this leaflet.
• you have an allergy to other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen.

Allergic reaction symptoms include swelling of the face, lips, tongue or other parts of the body, rash or hives on the skin.

• you have ever experienced asthma (A respiratory problem which causes difficulty in breathing, cough, shortness of breath), hives or acute rhinitis (common cold, symptoms include sneezing, runny nose, sore throat, cough) after using acetylsalicylic acid or other NSAIDs medicines.
• the bottle/packaging shows signs of tampering or the expiry date on the bottle/carton has passed.

Always check the ingredients to make sure you can use this medicine.

Do not use Ilevro eye drops if you are wearing soft contact lenses as the benzalkonium chloride (ingredient in Ilevro) may get absorbed by these lenses and may cause eye irritation and discolour the soft contact lenses.

Do not wear contact lens during the post-surgery period after a cataract surgery unless clearly indicated by your doctor.

Do not use Ilevro eye drops in patients under 18 years of age.

Do not use Ilevro eye drops more than 24 hours prior to surgery or beyond 14 days post-surgery as it may increase the risk of developing unwanted side effects.

Check with your doctor if you:

• have any other medical conditions such as known bleeding tendency or have any bleeding problems or had them in past.
• have any eye infection.
• suffer from any other eye disorder such as any corneal diseases, ocular surface disease e.g. dry eye syndrome (a condition in which your tears are inadequate to provide proper lubrication for your eyes), as it may increase the risk for developing side effects which may become sight threatening.
• have had any complicated eye surgeries or repeated eye surgeries within a short period of time
• suffer from diabetes mellitus
• have rheumatoid arthritis (a joint disease that causes pain, swelling, stiffness in joints)

Use Ilevro eye drops for Ophthalmic use only. Do not use for oral use.

Avoid sunlight during treatment with Ilevro eye drops.

Consult your doctor if you have any other medical conditions or take any other medicines.

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.

Ilevro eye drops are not recommended during pregnancy. They may affect your baby's development and/or childbirth process or your child's development after birth.

Do not use Ilevro eye drops in women of childbearing potential who are not using a contraceptive.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Ilevro Eye Drops are not recommended during breast feeding.

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 Ilevro and affect how it works.

Tell your doctor if you take any of the following medicines:

• medicines used for treatment of any other eye problems (prostaglandin analogues drugs e.g. Xalatan, latanoprost)
• any drugs which may prolong the bleeding time.
• topical non-steroidal anti-inflammatory drugs (NSAIDs e.g. Voltaren gel) and topical steroid medicines (e.g. Mometasone)

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ilevro.

4. How do I use ILEVRO?

How much to use

• Follow the instructions provided and use Ilevro eye drops until your doctor tells you to stop.

Dose for the prevention and treatment of pain and swelling:

• Your doctor will advise you the appropriate dose.
• Use 1 drop of Ilevro eye drops in the affected eye(s) once a day, starting from 1 day prior to cataract surgery and continue on the day of surgery.
• Your doctor might administer an additional drop 30 to 120 minutes prior to surgery.
• Do not use Ilevro eye drops greater than 2 weeks and more than once daily.
• If you want to use any other eye drops, wait for at least 5 minutes after using Ilevro eye drops.
• If you want to use any eye ointments, it should be used last.
• Consult your doctor or pharmacist if you do not understand your dose.

Dose for the reduction in the risk of postoperative macular oedema associated with cataract surgery in patients with non-proliferative diabetic retinopathy:

• Your doctor will advise you the appropriate dose.
• Use 1 drop of Ilevro eye drops in the affected eye(s) once daily, starting from 1 day prior to cataract surgery, and continue on the day of surgery and up to 60 days in the post-surgery period as advised by your doctor
• Your doctor might administer an additional drop 30 to 120 minutes prior to surgery.
• Consult your doctor or pharmacist if you do not understand your dose.

When to use ILEVRO

• Ilevro should be used as advised by your doctor.

How to use ILEVRO Eye Drops:

• Sitting or lying down might make putting in your eye drops process simpler.
• Remove contact lenses if you are wearing them before putting in the eye drops.
• Shake the bottle well prior to use.

Follow below steps to use ILEVRO Eye Drops:

• Wash your hands thoroughly with soap and water.
• Before using a bottle for the first time, break the safety seal around the neck area and throw the loose plastic ring away.
• Remove the cap from the bottle.
• After cap is removed, if a tamper evident snap collar is present and loose, remove before using the eye drops.
• Mix the contents of the bottle by inverting 5 to 10 times.
• Hold the bottle upside down in one hand between your thumb and middle finger (see Diagram 1).

• Tilt your head back, gently pull down the lower eyelid of your eye to form a pouch/pocket.
• Place the tip of the bottle close to your eye. Do not touch the tip to your eye as this may cause injury to the eye.
• Do not touch the dropper tip to eyelid or surrounding areas or any surface to avoid contamination of the dropper tip and solution.
• 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).

• Gently close your eye. Do not blink or rub your eye.
• When 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 prevent 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 and may result in a decrease in side effects.
• This will also help to reduce the unpleasant taste sensation that some people experience when using these drops.
• If necessary, repeat the above steps for the other eye.
• It is normal for a small amount of the eye drop to spill onto your cheek since your eyelids can only hold less than one drop at a time. Wipe away any spillage with a tissue.
• Replace the cap on the bottle, closing it tightly.
• Always keep the bottle tightly closed when not in use.
• Wash your hands again with soap and water to remove any residue.
• You may feel a temporary burning sensation in the eye(s) shortly after using Ilevro eye drops.
• Contact your doctor, optometrist or pharmacist immediately if it persists for long time.
• Discard the eye drops after 4 weeks after opening it.

If you forget to use ILEVRO

Ilevro should be used regularly at the same time each day. If you miss your dose at the usual time, one drop should be administered as soon as possible before reverting to the regular dose routine.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. It may cause unwanted side effects.

If you use too much ILEVRO

If you think that you have used too much Ilevro, you may need urgent medical attention.

If you have accidentally put several drops in your eyes, immediately wash your eyes with warm water.

If you or anyone else have accidently swallowed any, or all the contents of a bottle of Ilevro eye drops You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• 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 ILEVRO?

Things you should do

Call your doctor straight away if you:

• develop any signs of allergic reactions.
• become pregnant or if you are breast feeding while using Ilevro eye drops.
• have an allergy to other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen.
• have any other eye problems, corneal diseases, eye infection or take any medicines for eye problems.

Remind any doctor, dentist, pharmacist or optometrist you visit that you are using Ilevro eye drops.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not give Ilevro eye drops to anyone else, even if they seem to have the same condition as you.
• Do not wear contact lens during the post-surgery period after a cataract surgery unless clearly indicated by your doctor.
• Do not use Ilevro eye drops more than 24 hours prior to surgery or beyond 14 days post-surgery as it may increase the risk of developing unwanted side effects.
• Do not use Ilevro eye drops in patients less than 18 years of age.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Ilevro affects you.

Ilevro eye drops may cause temporary blurred vision or other eye problems in some people.

Wait until your vision clears before driving or using machinery.

Looking after your medicine

• Store Ilevro eye drops below 25°C.
• Protect from light.
• Do not leave the top off the bottle for any time. Put the top back on the bottle immediately after use to avoid any contamination.

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.

Keep it where young children cannot reach it.

When to discard your medicine

Do not use the eye drops after 4 weeks after opening it. Discard any remaining solution after four weeks and open a new bottle every four weeks.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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 ILEVRO contains

Do not take this medicine if you are allergic to any of these ingredients.

What ILEVRO looks like

Ilevro is a light yellow to yellow, uniform suspension that comes with 4 mL round or oval white (opaque) low density polyethylene (LDPE) bottles with a LDPE dispensing plug and white polypropylene screw cap. Each bottle contains 3 mL eye drops suspension. The bottle may be presented in a pouch.

Who distributes ILEVRO

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone No. 1800 671 203
www.novartis.com.au

Australian Register Number

AUST R: 230200

AUST R: 309880

^® Registered Trademark.

This leaflet was prepared in March 2025.

Internal document code:

(ilv091123c_V2 based on PI ilv091123i)

Published by MIMS June 2025

1 Name of Medicine

Nepafenac.

2 Qualitative and Quantitative Composition

The active ingredient in Ilevro eye drops is nepafenac 3 mg/mL (0.3%).
May contain potential allergens: benzoates, sulfur dioxide/sulfites and hydroxybenzoates from the manufacturing process.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ilevro is a light yellow to yellow, uniform suspension for multiple-dose topical ophthalmic use.
Nepafenac is a yellow crystalline powder which is poorly soluble in water.

4 Clinical Particulars

4.1 Therapeutic Indications

Ilevro is indicated for the:
prevention and treatment of postoperative pain and inflammation associated with cataract surgery;
reduction in risk of postoperative macular oedema associated with cataract surgery in patients with non proliferative diabetic retinopathy.

4.2 Dose and Method of Administration

For ophthalmic use only.
For individual patient use only.
Shake the bottle well before use. After cap is removed, if a tamper evident snap collar is present and loose, remove before using Ilevro.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Instruct patients to keep the bottle tightly closed when not in use.
For the prevention and treatment of pain and inflammation, the dose is 1 drop of Ilevro in the conjunctival sac of the affected eye(s) once a day beginning 1 day prior to cataract surgery and continued on the day of surgery. In clinical studies, the effectiveness of Ilevro was demonstrated for up to 14 days of the postoperative period. Treatment durations greater than two weeks and a dosing frequency of more than once daily have not been assessed. An additional drop should be administered 30 to 120 minutes prior to surgery.
For the reduction in the risk of postoperative macular oedema associated with cataract surgery in patients with non proliferative diabetic retinopathy, the dose is 1 drop of Ilevro in the conjunctival sac of the affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.
Nasolacrimal occlusion and gently closing the eyelid after instillation are recommended. This may reduce the systemic absorption of eye drops and result in a decrease in systemic adverse reactions.
If a dose is missed, one drop should be administered as soon as possible before reverting to the regular dosage routine. Do not use double the amount to make up for the dose that was missed. Using multiple doses may cause unwanted side effects.

4.3 Contraindications

Hypersensitivity to the active substance nepafenac or to any of the excipients in Ilevro.
Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs).
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
Soft contact lenses should not be used with Ilevro because the benzalkonium chloride preservative may be absorbed by these lenses.

4.4 Special Warnings and Precautions for Use

For ophthalmic use, not for oral ingestion.
Patients should be instructed to avoid sunlight during treatment with Ilevro.

Ocular effects.

Use in hepatic impairment/ renal impairment.

Concomitant therapy.

Delayed healing.

Contact lenses.

Benzalkonium chloride.

Cross-sensitivity.

Paediatric use.

Use in the elderly.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions.
Neither nepafenac nor amfenac inhibit any of the major human cytochrome P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4) metabolic activities in vitro at concentrations up to 3000 nanogram/mL. Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicinal products are unlikely. Interactions mediated by protein binding are also unlikely.
There are very limited data on the concomitant use of prostaglandin analogues and Ilevro. Considering their mechanisms of action, the concomitant use of these medicinal products is not recommended.
Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Concomitant use of Ilevro with medications that prolong bleeding time may increase the risk of haemorrhage.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Adverse events in clinical trials.

Patients with non proliferative diabetic retinopathy.

Paediatric population.

Tabulated list of adverse reactions.

Post marketing.

Reporting suspected adverse effects.

4.9 Overdose

A topical overdose of Ilevro may be flushed from the eye(s) with warm tap water. There is no experience of overdose by the ophthalmic route. The application of more than one drop per eye is unlikely to lead to unwanted side-effects.
A bottle of Ilevro contains 9 mg of nepafenac (3 mg/mL). In a clinical study in which subjects received a single 10 mg oral administration of ¹⁴C-nepafenac, no safety concerns based upon a review of adverse events and an assessment of clinical laboratory, cardiovascular and general physical examination parameters were evident. In an acute toxicity study in mice no signs of toxicity were observed after oral administration of nepafenac up to 2000 mg/kg dose (~4400, and ~13,000 times the potential full bottle dose in a child and adult respectively) and in an acute toxicity study in rats, animals administered orally with nepafenac at a dose of 100 mg/kg, kg (~220, and ~660 times the potential full bottle dose in a child and adult respectively), survived the observation period of 7 days, swollen abdomens, red exudates on face, little or no stool and less active behavior was seen. Therefore, an oral overdose of Ilevro is unlikely to result in significant toxicity. However there is no data of the effects of oral overdose in young children or the elderly.
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.

Clinical study treatment regimen.

Major exclusion criteria.

Efficacy results.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ilevro also contains boric acid, propylene glycol, carbomer 974P, sodium chloride, guar galactomannan, carmellose sodium, disodium edetate, hydrochloric acid and/or sodium hydroxide (to adjust pH), water-purified and benzalkonium chloride (0.05 mg/mL) as preservative.

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 Ilevro below 25°C. Protect from light.
Discard 4 weeks after opening.

6.5 Nature and Contents of Container

4 mL round or oval white (opaque) low density polyethylene (LDPE) bottles with a LDPE dispensing plug and white polypropylene screw cap containing 3 mL eye drops suspension. The bottle may be presented in a pouch.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemical name(s).

Empirical formula.

Molecular weight.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine.

Summary Table of Changes