SUMMARY CMI

Ciloxan^® Eye Drops 0.3%

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 Ciloxan Eye Drops?

Ciloxan Eye Drops contain the active ingredient Ciprofloxacin hydrochloride. Ciloxan Eye Drops are used to treat certain types of eye infections such as bacterial keratitis (infected ulcer of cornea) and severe bacterial conjunctivitis (swelling of conjunctiva)

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

2. What should I know before I use Ciloxan Eye Drops?

Do not use if you have ever had an allergic reaction to Ciloxan Eye Drops 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 Ciloxan Eye Drops? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ciloxan Eye Drops 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 Ciloxan Eye Drops?

• Your doctor will advise you regarding your dose.
• Use the Ciloxan Eye Drops as prescribed by your doctor.
• Consult your doctor or pharmacist if you do not understand your dose.

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

5. What should I know while using Ciloxan Eye Drops?

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

6. Are there any side effects?

Common side effects include discomfort in eye(s), redness of the eye(s), itching, burning sensation in eye(s), feeling that something is in your eye(s), increased sensitivity to light (Photophobia)

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

Ciloxan^® Eye Drops 0.3%

Active ingredient: Ciprofloxacin hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ciloxan Eye Drops. 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 Ciloxan Eye Drops.

Where to find information in this leaflet:

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

1. Why am I using Ciloxan Eye Drops?

Ciloxan Eye Drops contain the active ingredient Ciprofloxacin hydrochloride. Ciloxan Eye Drops belongs to class of drugs called fluoroquinolone which are used to treat different types of infections caused by bacteria.

Ciloxan Eye Drops are used to treat certain eye infections such as bacterial keratitis (infected ulcer of cornea, symptoms include eye pain, blurred vision, discharge from eye) and severe bacterial conjunctivitis (swelling of conjunctiva with symptoms such as eye irritation, discharge) in adults and children 12 months old and above. Ciloxan Eye Drops help to kill the bacteria that cause infection.

2. What should I know before I use Ciloxan Eye Drops?

Warnings

Do not use Ciloxan Eye Drops:

• If you are allergic to Ciprofloxacin hydrochloride, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• If you are allergic to other quinolone antibiotics e.g. nalidixic acid, Levaquin.
  Symptoms of an allergic reaction may include:
  shortness of breath, difficulty breathing,
  swelling of the face, lips, tongue or other parts of the body rash, hives.
• If you suffer from any muscle problem or have any swelling to your tendons (strands of connective tissue between muscles and bones).

Check with your doctor if you:

• have any other medical conditions or 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.

As a precautionary measure, it is preferable to avoid Ciloxan Eye Drops during pregnancy. Your doctor will advise you regarding the possible risks and benefits of using Ciloxan Eye Drops during pregnancy.

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

Your doctor will advise you regarding the possible risks and benefits of using Ciloxan Eye Drops 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 Ciloxan Eye Drops and affect how it works.

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

• medicines that help to thin your blood e.g. warfarin
• medicines to prevent tissue rejection e.g. cyclosporin
• medicines such as theophylline which are used for asthma or other breathing problems
• caffeine for the treatment of migraines

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

4. How do I use Ciloxan Eye Drops?

How much to use

• Follow the instructions provided when Ciloxan Eye Drops were prescribed, including the number of days it should be taken.

Dose for bacterial conjunctivitis (corneal ulcers)

Day 1

• Put two drops into the affected eye(s) every 15 minutes for the first six hours and then two drops into the affected eye(s) every 30 minutes for the remainder of the 1st day.

Day 2

• Put two drops in the affected eye(s) hourly.

Day 3 to 14

• Put two drops in the affected eye(s) every four hours.

Dose for bacterial conjunctivitis

Day 1 & Day 2

• Put one drop into the conjunctival sac(s) every two hours while you are awake.

Day 3 to 7

• Put one drop every four hours while you are awake
• If you do not understand your dose consult your doctor or pharmacist.

When to use Ciloxan Eye Drops

• Ciloxan Eye Drops should be used as prescribed by your doctor.

How to use Ciloxan 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 the steps below to use Ciloxan 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 the 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.
• You may feel a slight burning sensation in the eye shortly after using Ciloxan Eye Drops. If it persists, or is uncomfortable, contact your doctor or pharmacist.
• If you want to use any other eye drops, wait at least 5 minutes after putting Ciloxan Eye Drops in.
• It is normal for a small amount of eye drops 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.
• Discard the Ciloxan Eye Drops after 4 weeks after opening it.

If you forget to use Ciloxan Eye Drops

Ciloxan Eye Drops should be used as prescribed by your doctor. If you miss your dose at the usual time, put in the drops that you missed as soon as you remember and then go back to using them as recommended by your doctor.

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.

If you use too much Ciloxan Eye Drops

If you think that you have used too much Ciloxan Eye Drops, you may need urgent medical attention.

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.

If you accidentally put several Ciloxan Eye Drops in your eyes, immediately wash your eyes with warm tap water.

5. What should I know while using Ciloxan Eye Drops?

Things you should do

Use Ciloxan Eye Drops in adults and children 12 months old and above.

Avoid excessive exposure to sunlight as it may cause moderate to severe phototoxicity (increased sensitivity of the skin to sun having symptoms such as redness, itching, swelling).

Ciloxan Eye drops are for Eye use only.

Call your doctor straight away if you:

• develop any signs of allergic reaction.
• become pregnant or if you are breast feeding while using Ciloxan Eye Drops.

Avoid excessive exposure to sunlight as it may cause moderate to severe phototoxicity (increased sensitivity of the skin to sun having symptoms such as redness, itching, swelling).

Remind any doctor, dentist, pharmacist or specialist you visit that you are using Ciloxan Eye Drops.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not wear contact lenses during treatment with Ciloxan Eye Drops. Ciloxan Eye Drops contain benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses.
• Do not give Ciloxan Eye Drops to anyone else, even if they seem to have the same condition as you.
• Do not use Ciloxan Eye Drops in newborn babies with conjunctivitis (eye infection caused by certain bacteria).

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Ciloxan Eye Drops affect you.

Ciloxan Eye Drops may cause temporary blurred vision or other eye problems.

If the blurred vision occurs after putting in Ciloxan Eye Drops, wait until the vision clears before driving or using machinery.

Looking after your medicine

• Store below 25°C.
• Do not refrigerate or freeze.
• Protect from the light.

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

Discard the Ciloxan Eye Drops container after 4 weeks after opening it.

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 Ciloxan Eye Drops contain

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

What Ciloxan Eye Drops look like

Ciloxan Eye Drops is a sterile ophthalmic solution 5 mL supplied in a pack containing a plastic bottle.

Australian registration number: AUST R No. 42899

Who distributes Ciloxan Eye Drops

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1800 671 203
Web Site: www.novartis.com.au

This leaflet was prepared in April 2025.

Internal document code:

(cix_eye261023c_V2) based on PI (cix_eye261023i)

Published by MIMS July 2025

1 Name of Medicine

Ciprofloxacin hydrochloride.

2 Qualitative and Quantitative Composition

Ciloxan eye drops contain ciprofloxacin hydrochloride (equivalent of 3 mg/mL ciprofloxacin base).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ciloxan eye drops is a sterile, multiple-dose product, for topical ophthalmic use.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of bacterial keratitis (infected corneal ulcers) and severe bacterial conjunctivitis caused by organisms susceptible to ciprofloxacin in adults and children 12 months of age or older.

4.2 Dose and Method of Administration

The recommended dosage regimen for the treatment of corneal ulcers is: two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instil two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: one drop instilled into the conjunctival sac(s) every two hours while awake for two days and one drop every four hours while awake for the next five days.

4.3 Contraindications

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones, including nalidixic acid, may also contraindicate the use of ciprofloxacin.

4.4 Special Warnings and Precautions for Use

For topical use only, not for injection.
For ocular use only.

Identified precautions.

General.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving ciclosporin concomitantly.
Given the low systemic concentration of ciprofloxacin following topical ocular administration, drug interactions are unlikely to occur.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

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

4.8 Adverse Effects (Undesirable Effects)

The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients (see Section 4.4 Special Warnings and Precautions for Use).
Tabulated adverse reaction data (considered to be related or possible related to treatment), providing comparisons to placebo and other active comparators (to an incidence of 1% or greater in the Ciloxan eye drops 0.3% treatment group), which have been generated from all adult clinical studies with Ciloxan eye drops 0.3%, are provided in Table 1.
Uncommon ophthalmic events (occurring in less than 1% and greater than 0.1% of patients) included lid margin crusting, crystals/scales, dryness/dry eye, discharge, corneal staining, keratopathy/keratitis, tearing, photophobia, pain, vision decrease, chemosis, corneal infiltrates, inflammation, blurred vision, corneal toxicity, allergy, intolerance, lid oedema, heavy sensation, swelling, conjunctival reaction, numbing sensation, conjunctivitis, punctate epithelial erosion and progression of infiltrate.
Uncommon systemic events (occurring in less than 1% and greater than 0.1% of patients) included nausea and sinus drainage.

Postmarketing events.

Infections and infestations.

Immune system disorders.

Nervous system disorders.

Eye disorders.

Ear and labyrinth disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Investigations.

Musculoskeletal and connective tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

A topical overdose of Ciloxan eye drops may be flushed from the eye(s) with warm tap water. Accidental oral ingestion of Ciloxan is not likely to be associated with toxicity.
Treatment of any exposure is symptomatic and supportive.
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.

Gram positive.

Gram negative.

Other organisms.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

5.3 Preclinical Safety Data

Animal pharmacology.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ciloxan eye drops also contain sodium acetate, glacial acetic acid, mannitol, disodium edetate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and benzalkonium chloride (0.06 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 below 25°C. Do not refrigerate or freeze. Protect from light.
Discard container 4 weeks after opening.

6.5 Nature and Contents of Container

As a sterile ophthalmic solution 5 mL in plastic bottle.

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

Ciprofloxacin, a faint to light yellow crystalline powder which is soluble in water, is a fluoroquinolone antibacterial active against a broad spectrum of Gram positive and Gram negative ocular pathogens.
The pH of Ciloxan eye drops is approximately 4.5 and the osmolality is approximately 300 mOsm.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes