Ciprofloxacin and Hydrocortisone
CONSUMER MEDICINE INFORMATION
What is in this leaflet
Please read this leaflet carefully before you use Ciproxin HC Ear Drops.
This leaflet answers some common questions about Ciproxin HC Ear Drops. It does not
contain all of the available information. It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine.
You can also download the most up to date leaflet from www.novartis.com.au
The updates may contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the expected benefits
of you using Ciproxin HC against the risks this medicine could have for you.
The information in this leaflet applies to Ciproxin HC only. This information does
not apply to similar products, even if they contain the same ingredients.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Ciproxin HC is used for
Ciproxin HC is used to treat an infection of the outer ear caused by bacteria. This
condition is known as bacterial otitis externa. It may cause itching or pain.
Ciproxin HC contains two active ingredients:
Ciprofloxacin; a "fluoroquinolone" antibiotic which kills the bacteria causing the
Hydrocortisone; a corticosteroid that reduces the pain, redness and/or inflammation.
Ciproxin HC will not work against infections caused by viruses, such as colds or the
flu, or infections caused by fungus.
Before prescribing Ciproxin HC for you or your child, your doctor will have examined
the ears and decided that Ciproxin HC is the right medicine.
Your doctor may have prescribed Ciproxin HC for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
Ciproxin HC is only available on a doctor's prescription.
Use in children
Ciproxin HC is not recommended in children under the age of 2 years.
The safety and effectiveness of Ciproxin HC in children under 2 years has not been
Before you use Ciproxin HC
When you must not use it
Do not use Ciproxin HC if you or your child is allergic to:
Any other "quinolone" antibiotics e.g. nalidixic acid
Benzyl alcohol used as a preservative
Any of the other ingredients in Ciproxin HC Ear Drops that are listed under "Product
Some of the symptoms of an allergic reaction may 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.
Do not use Ciproxin HC if you or your child:
have a perforated ear drum
are being treated for a condition called necrotising malignant otitis externa
This is a condition common to people who suffer from diabetes.
have a viral or fungal infection of the external ear canal.
Ask your doctor or pharmacist to be sure you do not have any of these conditions.
Do not use Ciproxin HC just before having a bath, shower or going swimming.
If you do, you may reduce the effectiveness of Ciproxin HC.
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.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you use this medicine after the expiry date has passed, it may not work.
Ciproxin HC has been developed for use in the ear only. This product is not suitable
for use in the eye.
Before you start to use it
Tell your doctor if you have had an allergy to any other medicines or any other substances,
such as foods, preservatives or dyes.
Tell your doctor if you are allergic to latex.
The dropper cap contains natural rubber (latex) which may cause severe allergic reactions
in some people.
Tell your doctor if you or your child have diabetes or any other medical condition.
Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will discuss the possible risks and benefits of using Ciproxin HC during
Tell your doctor if you are breastfeeding.
Your doctor will discuss the possible risks and benefits of using Ciproxin HC when
you are breastfeeding.
If you have not told your doctor about any of the above, tell him/ her before you
use Ciproxin HC.
Using other medicines
Tell your doctor or pharmacist if you are using or taking any other medicines, including
other ear drops and any other medicines that you get without a prescription from a
pharmacy, supermarket or health food shop.
Some medicines and Ciproxin HC may interact with each other.
Your doctor or pharmacist will be able to tell you what to do when using Ciproxin
HC with other medicines.
How to use Ciproxin HC
Carefully follow all directions given to you by your doctor and pharmacist.
They may differ from the information contained in this leaflet.
If you are being changed from one medicine to another, follow your doctor's instructions
carefully as to when to stop this medicine and when to start the new ear drops.
If you do not understand the instructions on the carton / bottle, ask your doctor
or pharmacist for help.
How much to use
The usual dose in adults and children (2 years and older is 3 (three) drops in the
affected ear(s) twice a day for 7 (seven) days.
The dosing instructions will be printed on the label your pharmacist puts on the bottle
How to use it
It is important to use Ciproxin HC exactly as your doctor or pharmacist has told you.
If you use it less often than you should, it may not work as well and the ear problem
may not improve. Using it more often than you should, may not improve the ear problem
any faster and may cause increased side effects.
Use Ciproxin HC at about the same time every day unless your doctor tells you otherwise.
To open a new bottle of Ciproxin HC, 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 tip of the dropper tip with your fingers, to the ear or any other
surface. This will help prevent the ear drops becoming dirty or contaminated.
Follow these steps to use Ciproxin HC:
1. Wash your hands thoroughly.
3. Squeeze the bulb on the dropper cap to draw up the liquid into the dropper.
4. Tilt your/your child's head to one side so that the affected ear is facing up. This
may be easier in the sitting or lying down position.
5. Open the bottle and remove the dropper which has the liquid in it.
6. Put the tip of the dropper close to the ear and gently squeeze three drops into the
7. Hold the head in the same position for about one minute. This will help the drops
to reach deeper into the ear.
8. Repeat the above steps for the other ear if necessary.
There might be a slightly unpleasant feeling as the drops flow all the way into the
ear. If this persists, or is very uncomfortable, contact your doctor or pharmacist.
When to use it
Use Ciproxin HC at about the same time every day unless your doctor tells you otherwise.
Using your ear drops at the same time each day will have the best effect on your ear
infection. It will also help you remember when to use it.
How long to use it
Continue using your medicine for as long as your doctor tells you.
As Ciproxin HC starts to kill the bacteria that are causing the infection in your
ear(s) you will start to feel better. However, it is very important that you continue
to use Ciproxin HC for the full treatment period advised by your doctor to ensure
that the infection does not return.
If you are unsure about when to stop using Ciproxin HC, you should talk to your doctor
Do not use Ciproxin HC longer than your doctor tells you.
If you use Ciproxin HC longer than your doctor or pharmacist tells you, the chance
of side effects may increase.
If you forget to use it
If you forget to use Ciproxin HC you should put the drops that you missed in the ear(s)
as soon as you remember and then go back to using them as recommended by your doctor.
If it is almost time for the next dose, skip the dose that you missed and continue
using them as recommended.
Never take a double dose to make up for the one that you missed.
If you are not sure what to do, contact your doctor or pharmacist.
If you have trouble remembering to use the medicine, ask your pharmacist for some
If you use too much (overdose)
If you think that you, your child or someone else has swallowed any, or all, of the
contents of Ciproxin HC, or used too many drops, immediately telephone your doctor
or the Poisons Information Centre on 131126 for advice or go to Accident and Emergency
at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
While using Ciproxin HC
Things you must do
If the symptoms of the infection do not improve within a few days, or if it becomes
worse, tell your doctor.
Tell your doctor if, for any reason, you have not used Ciproxin HC exactly as prescribed.
Otherwise your doctor may think that the ear drops were not effective and change the
If you become pregnant while you are using this medicine, tell your doctor immediately.
If you or your child are about to be started on any new medicine, remind your doctor
or pharmacist that you are using Ciproxin HC.
Tell all the doctors, dentists and pharmacists who are treating you or your child
that you are using Ciproxin HC.
Things you must not do
Do not use Ciproxin HC to treat other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if they appear to have the same condition
Do not stop using Ciproxin HC or lower the dose without first asking your doctor.
Do not let children handle Ciproxin HC.
Things to be careful of
Be careful driving or operating machinery until you know how Ciproxin HC affects you
and your hearing.
Be careful of sun exposure.
Ciproxin HC may cause some people to sunburn more readily.
Ask your doctor or pharmacist if you are concerned about the length of time that you
or your child have been using Ciproxin HC.
Tell your doctor or pharmacist as soon as possible if you or your child do not feel
well while you are using Ciproxin HC.
This medicine helps most people with an ear infection, but it may have unwanted side
effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following list of possible side effects. You may not experience
any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
A sensation of fullness of ear
Redness of the ears.
Occasionally some people notice unwanted effects in the rest of their body as a result
of using Ciproxin HC.
These effects may include:
Decreased sense of touch, pain or light
Decreased sense of hearing
Numbness or tingling
Itching and/or rash
Sensitivity to sunlight
Fungal nail infection
Flaking of skin.
On very rare occasions, you or your child may find a little bit of white material
remaining in the ear while using Ciproxin HC. The formation of this white material
may or may not be associated with symptoms such as ear discomfort, hearing disorder
or ear pain.
Tell your doctor immediately and stop using Ciproxin HC at the first sign of an allergy.
Symptoms of an allergy include:
swelling of the face, hands or feet
wheezing, difficulty in breathing
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Do not feel alarmed by this list of possible side effects. You may not experience
any of them.
After using Ciproxin HC
Keep Ciproxin HC in a cool dry place, where the temperature stays below 25°C. Do not
refrigerate or freeze.
Cold ear drops may hurt your ear(s) or cause temporary dizziness.
Protect from light.
Do not store Ciproxin HC or any other medicine in the car, the bathroom or any other
warm, damp place.
Heat and dampness can destroy some medicines.
Do not carry the ear drops in the pockets of your clothes.
Do not leave the top off the bottle for any length of time, to avoid contaminating
the ear drops.
Keep it out of the sight and reach of children.
A locked cupboard at least one and a half metres above the ground is a good place
to store medicines.
Write the date on the bottle when you first open the ear drops and throw out any remaining
solution after 14 days.
Ciproxin HC contains a preservative which helps prevent germs growing in the solution
for the first 14 days after opening the bottle. After this time there is a greater
risk that the drops may become contaminated and cause an ear infection.
If your doctor tells you to stop using Ciproxin HC or it has passed its expiry date,
ask your pharmacist what to do with any that is left over.
What it looks like
Ciproxin HC Ear Drops is a non-sterile slightly viscous white to off-white suspension
that comes in a 10 mL bottle with a separately wrapped non-sterile dropper cap in
Ciproxin HC contains the active ingredients ciprofloxacin hydrochloride equivalent
to ciprofloxacin 2.0 mg in 1 mL and hydrocortisone 10 mg in 1 mL.
Ciproxacin HC also contains:
Benzyl alcohol as a preservative
Acetic acid (glacial)
Hydrogenated soy phosphatidylcholine
This product is supplied in Australia by:
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
Australian Registration Number
AUST R No. 136662
Date of preparation
This leaflet was prepared in November 2017.
© Novartis Pharmaceuticals Australia Pty Limited 2017
Internal document code:
(cip260717c_v2) based on PI (cip260717i)