Ciproxin HC Ear Drops

Ciproxin HC Ear Drops is a brand of medicine containing the active ingredients ciprofloxacin - hydrocortisone.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

CIPROXIN® HC Ear Drops

Ciprofloxacin & Hydrocortisone


Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before you start to use CIPROXIN HC Ear Drops. This leaflet has been written to answer some common questions about CIPROXIN HC Ear Drops. It does not contain all of the available information and does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. In deciding to prescribe CIPROXIN HC Ear Drops for you or your child, your doctor has weighed the potential risks and benefits of using this medicine.

The information in this leaflet applies to CIPROXIN HC Ear Drops only. This information does not apply to similar products, even if they contain the same ingredients.

If you have any concerns about using CIPROXIN HC Ear Drops, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need it again.

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What CIPROXIN HC Ear Drops is used for

CIPROXIN HC Ear Drops contains two active ingredients:

  • Ciprofloxacin; a “fluoroquinolone” antibiotic, which kills the bacteria causing the infection.
  • Hydrocortisone; a corticosteroid, that reduces the pain, redness and/or inflammation.

CIPROXIN HC Ear Drops is used to treat bacterial otitis externa, which is an infection of the outer ear caused by bacteria and may cause itching or pain.

Before prescribing CIPROXIN HC Ear Drops for you or your child, your doctor will have examined the ear and decided that CIPROXIN HC Ear Drops is the right medicine.

Your doctor may have prescribed CIPROXIN HC Ear drops for another reason. Ask your doctor if you have any questions about why CIPROXIN HC Ear Drops has been prescribed for you or your child.

CIPROXIN HC Ear Drops is not addictive.

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Before you use CIPROXIN HC Ear Drops

When you must not use it

Do not use CIPROXIN HC Ear Drops if:

You or your child:

  • are allergic to ciprofloxacin, any other “quinolone” antibiotics (eg nalidixic acid), hydrocortisone or to any of the other ingredients in CIPROXIN HC Ear Drops (these are listed under Product Description)
  • have, or think you/your child might have, a perforated ear drum
  • are being treated for a condition called necrotising malignant otitis externa, 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 Ear Drops just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of CIPROXIN HC Ear Drops.

Do not use CIPROXIN HC Ear Drops if the packaging is torn or shows signs of tampering

Do not use CIPROXIN HC Ear Drops if the date (EXP) printed on the label and carton has passed. If you use CIPROXIN HC Ear Drops after the expiry date has passed, it may not work.

Do not give CIPROXIN HC Ear Drops to a child under 2 years. The safety and effectiveness of CIPROXIN HC Ear Drops in children under 2 years have not been established.

CIPROXIN HC Ear Drops 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

Let your doctor know if any of the following applies before you or your child start using CIPROXIN HC Ear Drops:

You or your child have:

  • diabetes
  • allergies to any other medicines or any substances such as foods, preservatives, dyes or latex. The dropper cap contains natural rubber (latex) which may cause severe allergic reactions.
  • any other medical conditions.

If you:

  • Are pregnant or are intending to become pregnant. Your doctor will discuss the risks and benefits of using CIPROXIN HC Ear Drops when pregnant.
  • Are breast feeding or intending to breast feed. Your doctor will discuss the risks and benefits of using CIPROXIN HC Ear Drops when breast feeding.

If you have not told your doctor about any of the above, tell them before you use CIPROXIN HC Ear Drops.

Using other medicines

Tell your doctor or pharmacist if you or your child are taking any other medicines, including medicines that you buy at a pharmacy or health food shop without a doctor’s prescription. This is particularly important if you or your child are currently using any other type of ear drops.

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when using CIPROXIN HC Ear Drops with other medicines.

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How to use CIPROXIN HC Ear Drops

How much to use

The usual dose of CIPROXIN HC Ear Drops is three drops in the affected ear(s) twice each day for 7 days. The dosing instructions will be printed on the label your pharmacist put on the bottle or carton.

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 label, ask your doctor or pharmacist.

How to use it

It is important to use CIPROXIN HC Ear Drops 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 Ear Drops at about the same time every day unless your doctor tells you otherwise.

To open a new bottle of CIPROXIN HC 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 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 Ear Drops:

  1. Wash your hands thoroughly
  2. Shake the bottle
  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 (see Diagram 1).

  1. Open the bottle and remove the dropper which has the liquid in it.
  2. Put the tip of the dropper close to the ear and gently squeeze three drops into the ear (see Diagram 2).

  1. Hold the head in the same position for about one minute. This will help the drops to reach deeper into the ear (see Diagram 3).

  1. 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.

How long to use it

As CIPROXIN HC Ear Drops starts to kill the bacteria that are causing the infection, the ear(s) will start to feel better. It is very important that you continue to use CIPROXIN HC Ear Drops for the full treatment period as directed by your doctor to ensure that the infection does not return.

Do not use CIPROXIN HC Ear Drops longer than your doctor tells you. If you use CIPROXIN HC Ear Drops longer than your doctor or pharmacist tells you, the chance of side effects may increase.

If you are unsure about when or how to stop using CIPROXIN HC Ear Drops you should talk to your doctor or pharmacist.

If you forget to use it

If you forget to use CIPROXIN HC Ear Drops 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 hints.

If you or your child swallow it

Immediately telephone the nearest Poisons Information Centre (in Australia call 13 1126; in New Zealand call 0800 POISON or 0800 764 766, your doctor or go to Casualty in the nearest hospital, if you think that you or someone else has swallowed CIPROXIN HC Ear Drops. Do this even if there are no signs of discomfort or poisoning.

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While using CIPROXIN HC Ear Drops

Things you must do

Tell all doctors and pharmacists who are treating you or your child that CIPROXIN HC Ear Drops is being used.

If you feel that CIPROXIN HC Ear Drops is not helping the ear problem, tell your doctor or pharmacist.

Tell your doctor if, for any reason, you have not used CIPROXIN HC Ear Drops exactly as prescribed. Otherwise your doctor may think that it was not effective and change the treatment unnecessarily.

You should tell your doctor if you become pregnant while you are using CIPROXIN HC Ear Drops

Things you must not do

Do not:

  • stop using CIPROXIN HC Ear Drops without first asking your doctor
  • give this medicine to anyone else, even if they appear to have the same condition as you or your child.
  • let children handle CIPROXIN HC Ear Drops.
  • use CIPROXIN HC Ear Drops to treat another complaint unless your doctor or pharmacist tells you to.

Things to be careful of

You should be very careful driving or operating any machinery if CIPROXIN HC Ear Drops affects your hearing in any way.

Ask your doctor or pharmacist if you are concerned about the length of time that you or your child have been using CIPROXIN HC Ear Drops.

Side Effects

All medicines can have side effects. Sometimes they are serious, however most of the time they are not. You may need to seek medical treatment if you or your child get some of the side effects.

Tell your doctor as soon as possible if you or your child do not feel well while using CIPROXIN HC Ear Drops.

CIPROXIN HC Ear Drops is generally well tolerated. Reactions that affect the ears have been reported including:

  • Itchy ears
  • Earache
  • A sensation of fullness of ear
  • Ear discomfort
  • Redness of the ears

Occasionally some people notice unwanted effects in the rest of their body as a result of using CIPROXIN HC Ear Drops. These effects may include:

  • Decreased sense of touch, pain or light
  • Decreased sense of hearing
  • Fever
  • Headaches
  • Dizziness
  • Nausea
  • 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 Ear Drops. 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 Ear Drops at the first sign of a skin rash or any other sign of allergy (eg hives).

Other side effects not listed above may also occur in some patients. Let your doctor know if you observe any unwanted effects while using CIPROXIN HC Ear Drops, even if they do not appear in the list above.

Do not feel alarmed by this list of possible side effects. You may not experience any of them.

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After using CIPROXIN HC Ear Drops

Storage

Store CIPROXIN HC Ear Drops in a cool, dry place where the temperature stays below 25°C. Do not leave CIPROXIN HC Ear Drops in the car, in the bathroom or in other warm, damp places. Heat and temperature can destroy some medicines

Do not refrigerate CIPROXIN HC Ear Drops.

CIPROXIN HC Ear Drops should be protected from light. Store the bottle in the carton.

Keep CIPROXIN HC Ear Drops, and all other medicines, in a safe place away from children. A locked cupboard at least one and a half meters above the ground is a good place to store medicines.

Disposal

Discard each bottle of CIPROXIN HC Ear Drops 14 days after it has been opened. Write the date the bottle was opened on the label to remind you when to discard the bottle.

If your doctor tells you to stop using CIPROXIN HC Ear Drops or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

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Product Description

What it looks like

CIPROXIN HC Ear Drops is a slightly viscous white to off-white suspension that comes in a 10 ml bottle with a dropper cap supplied in the carton.

Ingredients

Active drugs:
ciprofloxacin and hydrocortisone.

Other ingredients:

  • benzyl alcohol,
  • polysorbate 20,
  • sodium acetate,
  • acetic acid (glacial),
  • sodium chloride,
  • hydrogenated soy phosphatidylcholine,
  • polyvinyl alcohol,
  • purified water.

Supplier

In Australia this product is supplied by:
Alcon Laboratories (Australia) Pty Ltd
25 Frenchs Forest Rd East
FRENCHS FOREST NSW 2086

AUST R 136662

In New Zealand this product is distributed by:
Alcon New Zealand Limited
Auckland New Zealand

This leaflet was revised in March 2014.

U.S. Patent No: 4,670,444; 4,844,902; 5,843,930.

Aust Pat App. 59840/96; and Pats Pending.

Licensed to Alcon, Inc. by Bayer HealthCare AG

CIPROXIN® is a registered trademark of Bayer AG, licensed to Alcon, Inc. by Bayer AG.

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CMI provided by MIMS Australia, December 2014  

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