0.3%
Ear Drops
Ciprofloxacin hydrochloride
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 Ear Drops?
Ciloxan Ear Drops contain the active ingredient Ciprofloxacin hydrochloride. Ciloxan
Ear Drops are used to treat chronic suppurative otitis media (CSOM) in adults and
children 1 month old or above. It is a chronic infection of the middle ear.
2. What should I know before I use Ciloxan Ear Drops?
Do not use if you have ever had an allergic reaction to Ciloxan Ear 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.
3. What if I am taking other medicines?
Some medicines may interfere with Ciloxan Ear Drops and affect how it works.
4. How do I use Ciloxan?
Follow the instructions provided by your doctor and use Ciloxan Ear Drops carefully.
Put five Ciloxan Ear Drops into the affected ear(s) twice daily for 9 days.
5. What should I know while using Ciloxan Ear Drops?
|
Things you should do
|
Remind any doctor, dentist, pharmacist or specialist you visit that you are using
Ciloxan Ear Drops.
Tell your doctor immediately if you develop any signs of allergic reaction.
Avoid excessive exposure to sunlight during treatment with Ciloxan Ear Drops.
|
|
Things you should not do
|
Do not stop using this medicine suddenly.
Do not touch the dropper tip with your fingers or to your ear or any other surface.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how Ciloxan
Ear Drops affect you.
|
|
Looking after your medicine
|
Store below 25°C.
Do not refrigerate or freeze.
Do not leave the cap off the bottle for any length of time. Put the cap back on the
bottle immediately after use.
|
6. Are there any side effects?
Common side effects include ear pain, vertigo, fever, ear itching, headache, buzzing,
hissing, whistling, ringing or other persistent noise in the ear(s).
0.3% Ear Drops
Active ingredient:
Ciprofloxacin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Ciloxan Ear 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 Ear Drops.
Where to find information in this leaflet:
1. Why am I using Ciloxan Ear Drops?
Ciloxan Ear Drops contain the active ingredient
Ciprofloxacin hydrochloride
. Ciloxan Ear Drops belong to class of drugs called fluoroquinolone which are used
to treat different types of infections caused by bacteria.
Ciloxan
Ear Drops are used to treat chronic suppurative otitis media (CSOM) in adults and
children 1 month old or above. It is a chronic infection of the middle ear. Symptoms
include severe ear pain, discharge, hearing loss, fever. Ciloxan Ear Drops help to
kill the bacteria that causes infection. It does not work against infections caused
by viruses or fungus.
2. What should I know before I use Ciloxan Ear Drops?
Warnings
Do not use Ciloxan Ear 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 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
take any medicines for any other condition
develop any skin reactions as Ciloxan Ear Drops contain benzalkonium chloride which
may be an irritant.
Do not use this medicine after the expiry date printed on the pack or bottle, or if
the seal around the pack is broken or shows signs of tampering.
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 the use of Ciloxan Ear Drops
during pregnancy. Your doctor will advise you regarding the possible risks and benefits
of using Ciloxan Ear 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
Ear 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 Ear 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 Ear Drops.
4. How do I use Ciloxan Ear Drops?
How much to use
For adults and children 1 month old or above:
Put five Ciloxan Ear Drops into the affected ear(s) twice daily for 9 days.
Follow the instructions provided when Ciloxan Ear Drops were prescribed, including
the number of days it should be taken.
If you do not understand your dose consult your doctor or pharmacist.
When to use Ciloxan Ear Drops
Ciloxan Ear Drops should be used at about the same time every day unless your doctor
tells you otherwise.
How to use Ciloxan Ear Drops
Follow the instructions provided by your doctor and use Ciloxan Ear Drops carefully.
Below are steps to use Ciloxan Ear Drops:
Wash your hands thoroughly.
To open a new bottle of Ciloxan Ear Drops, remove the cap and replace it with the
dropper cap supplied in the carton. Your pharmacist may have already done this for
you.
Do not touch the dropper tip with your fingers or to your ear or any other surface.
This will help prevent the ear drops getting contaminated.
Shake the bottle well prior to use.
If the solution is cold, warm it by holding the bottle in your hand for one or two
minutes before putting it in your ear.
This will help to prevent dizziness which may be associated with putting a cold solution
into the ear.
Put Ciloxan Ear Drops in sitting or lying down position with the affected ear turned
upwards (see Diagram 1).
Diagram 1
Gently squeeze the bulb on the dropper cap to draw up the liquid into the dropper.
Put the tip of the dropper close to the ear and gently squeeze three drops into the
ear. (see Diagram 2)
Diagram 2
Hold the head in the same position for about one min. This will help the drops to
reach deeper into the ear. (see Diagram 3).
Diagram 3
Repeat the above steps for the other ear if necessary.
There might be a slightly unpleasant feeling since the drops flow all the way into
the ear. If it persists, or is very uncomfortable, contact your doctor or pharmacist
immediately.
Place the cap on the bottle and close it tightly.
Wash your hands again with soap and water to remove any residue.
If you forget to use Ciloxan Ear Drops
Ciloxan Ear Drops should be used as prescribed by your doctor. If you miss your dose
at the usual time, use the drop(s) as soon as you remember, and then go back to use
them as you would normally do.
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 Ear Drops
If you think that you have used too much Ciloxan Ear Drops, you may need urgent medical
attention.
If you have accidentally put too many Ciloxan Ear drops in your ear(s) immediately
rinse your ear(s) with warm tap water.
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 Ciloxan Ear Drops?
Things you should do
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).
Call your doctor straight away if you:
develop any signs of an allergic reaction.
become pregnant or if you are breast feeding while using Ciloxan Ear Drops.
are taking any other medicines for any other medical conditions.
Remind any doctor, dentist, pharmacist or specialist you visit that you are using
Ciloxan Ear Drops.
Things you should not do
Do not stop using this medicine suddenly.
Do not give Ciloxan Ear Drops to anyone else, even if they seem to have the same condition
as you.
Do not touch the dropper tip with your fingers or to your ear or any other surface.
Do not use Ciloxan Ear Drops just before having a bath, shower or going swimming.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Ciloxan
Ear Drops affect you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store below 25°C
Do not refrigerate or freeze.
Protect from 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 Ciloxan Ear Drops container 4 weeks after opening.
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 Ear Drops contain
|
Active ingredient
(main ingredient)
|
Ciprofloxacin hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
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.
|
Do not take this medicine if you are allergic to any of these ingredients.
What Ciloxan Ear Drops looks like
Ciloxan Ear Drops are a sterile otic solution that comes in a 1 mL, 2.5 mL and 5 mL
plastic bottle. The safety seal must be removed before use.
Who distributes Ciloxan Ear Drops
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1800 671 203
Australian Registration Number:
AUST R: 121897
This leaflet was prepared in April 2025.
Internal document code:
(cix_ear261023c_v2) based on PI (cix_ear261023i)