Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Locacorten-Vioform ear drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Locacorten-Vioform against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Locacorten-Vioform is used for

Locacorten-Vioform ear drops contain flumetasone pivalate and clioquinol.

Flumetasone pivalate belongs to a group of medicines called corticosteroids. It is used to relieve symptoms of ear infection such as itching, redness and swelling.

Clioquinol is an anti-infective medicine. It is used to fight the germs which are causing the ear infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

Locacorten-Vioform is available only with a doctor's prescription.

There is not enough information to recommend the use of this medicine for children under the age of 2 years.

Before you use Locacorten-Vioform

When you must not use it

Do not use Locacorten-Vioform if you have an allergy to:

• any medicine containing flumetasone or clioquinol
• any of the ingredients listed at the end of this leaflet.
• other quinoline medicines which are similar to clioquinol
• iodine of other medicines that contain iodine.

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 Locacorten-Vioform if you have any of the following medical conditions as it may make your condition worse:

• a perforated ear drum
• a viral infection of the skin (e.g. chicken pox, cold sores, warts)
• skin infection caused by tuberculosis or syphilis.

Do not give this medicine to a child under 2 years of age. Safety and effectiveness in children younger than 2 years have not been established.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have any other problems with your ear or you have other skin infections. Your doctor may want to take special precautions in that case.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you experience blurred vision or other visual disturbances.

If you have not told your doctor about any of the above, tell him/her before you start using Locacorten-Vioform.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop (e.g. other ear drops).

Some medicines and Locacorten-Vioform may interfere with each other. You may need different amounts of your medicines or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Locacorten-Vioform

Follow all directions given to you by your doctor or pharmacist 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 for help.

How much to use

You will usually use two or three drops in the affected ear twice a day.

How to use the drops

Unless your doctor gives you other instructions, follow these directions:

• Wash your hands with soap and water, then carefully clean and dry the inside of your ear.
• Warm the ear drops to body temperature by holding the bottle in your hand for a few minutes. Do not heat the drops in hot water because they may get too hot and cause pain and dizziness.
• Either sit and tilt your head or lie down so that the ear you are treating is facing up.
• Gently pull the top of the ear up and back. This helps to straighten the ear canal so the ear drops can reach the eardrum.
• Hold the dropper above the ear canal and gently squeeze the plastic bottle until the right number of drops go into the canal. Do not touch the dropper against the ear, your fingers or any other surface. Do not put the dropper into the ear canal as it may cause injury.
• Stay in the same position for 1 or 2 minutes to let the drops run down inside the ear.
• If you have to put ear drops into both ears, wait 5 or 10 minutes after the first ear before placing drops into the second ear. This keeps the drops in the first ear from running out.
• Alternatively, use a piece of gauze or cotton wick then soak with the ear drops and place it inside the ear.

Try to keep the ear drops from running out of your ear. The ear drops may stain hair, clothing and bed linen yellow.

If you accidentally get some of the drops in your eyes, flush them at once with plenty of cold water. The active ingredients in the ear drops could hurt your eyes.

How long to use them

Locacorten-Vioform ear drops should give you fast relief from any itchiness, redness and swelling of your ear. Treatment usually should not last longer than 10 days.

If there is no improvement or if your symptoms become worse after you have used the drops for one week, tell your doctor.

If you forget to use them

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

Otherwise, use them as soon as you remember, and then go back to using them as you would normally.

Do not use a double dose to make up for the one that you missed. This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to use the drops, ask your pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much Locacorten-Vioform. Do this even if there are no signs of discomfort or poisoning.

It is unlikely that an overdose will happen if this medicine is used correctly. But, if it is used on large areas of broken skin, placed in the eye or swallowed, it could cause unwanted side effects.

If this medicine is swallowed by children, it can cause stomach upset, nausea and vomiting.

While you are using Locacorten-Vioform

Things you must do

If your ear problem seems to be getting worse, tell your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Locacorten-Vioform.

Tell any other doctors, dentists, and pharmacists who treat you that you are using Locacorten-Vioform.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while using Locacorten-Vioform, tell your doctor immediately. Your doctor can decide if treatment should continue.

If you are going to have any tests on your thyroid, tell the person doing the test that you are using Locacorten-Vioform. This medicine can interfere with the results of some thyroid tests.

Things you must not do

Do not use any other medicines for your ears without first telling your doctor. Using other medicines together with Locacorten-Vioform could cause unwanted side effects.

Do not use Locacorten-Vioform to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop using it, your condition may worsen.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Locacorten-Vioform.

This medicine helps most people with ear infections, 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 lists of 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:

• ear irritation such as a burning sensation, redness, itching or rash on the ear
• blurred vision
• thinning of the skin
• skin infection.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• serious allergic reaction (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).

This is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.

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.

After using Locacorten-Vioform

Storage

Keep your ear drops in a cool dry place where the temperature stays below 25°C.

Do not store Locacorten-Vioform or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using the ear drops or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Locacorten-Vioform ear drops come in a plastic dropper bottle containing 7.5 mL of clear, thick yellowish solution.

Ingredients

Locacorten-Vioform ear drops contain flumetasone pivalate 200 micrograms/mL and clioquinol 10 mg/mL as the active ingredients.

They also contain macrogol 300.

Sponsor

Locacorten-Vioform is supplied in Australia by:

Amdipharm Mercury (Australia) Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060

Date of preparation:

4 August 2017

Australian Registration Number:

AUST R 11040

Amdipharm Mercury (Australia) Pty Ltd is licensed to use the trademark Locacorten.

Published by MIMS November 2017

1 Name of Medicine

Flumetasone pivalate/ clioquinol.

2 Qualitative and Quantitative Composition

Locacorten Ear drops contain flumetasone pivalate 200 microgram/mL and clioquinol 10 mg/mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Locacorten-Vioform Ear Drops are a practically odourless clear, yellowish to brownish-yellow solution.
Locacorten-Vioform is dissolved in a macrogol 300 vehicle, which forms an inert, non-irritant, rather viscous medium. This medium has a softening effect on the cerumen and ensures prolonged contact of the active ingredients with the surface of the ear canal.

4 Clinical Particulars

4.1 Therapeutic Indications

Eczema of the external auditory meatus in which secondary infection with microorganisms sensitive to clioquinol has occurred.
Otitis externa.
Otomycosis.

4.2 Dose and Method of Administration

Before application, the auditory meatus should be cleaned and dried carefully.
Instil 2 or 3 drops twice daily into the auditory meatus by gently squeezing the plastic bottle. The patient should be either sitting or lying down with the treated ear turned upwards during application.
This position should be maintained for at least 1 or 2 minutes following the application.
Alternatively, a gauze or cotton wick saturated with the solution may be inserted into the ear canal.
Keep the wick moistened by adding further solution. It should be replaced at least once every 24 hours.
The solution may be warmed to body temperature prior to each application (e.g. by holding the bottle in the hands). Heating above body temperature should be avoided.
Contamination of the dropper with material from the ear, fingers, or other sources should be avoided.
Treatment should normally not exceed 10 days.

4.3 Contraindications

Perforation of the ear-drum (suspected or verified).
Application to the eye.
Viral infections of the skin (e.g. varicella, herpes simplex, herpes zoster, common warts, plane warts, condylomata, mollusca contagiosa).
Syphilitic skin affections.
Tuberculosis of the skin.
Known hypersensitivity to flumetasone pivalate.
Known hypersensitivity to clioquinol, hydroxyquinolines and other quinoline derivatives.
Known hypersensitivity to iodine.
Known hypersensitivity to other components contained in Locacorten-Vioform Ear Drops.
Use in children under 2 years of age.

4.4 Special Warnings and Precautions for Use

Prior to the beginning of therapy, the ear-drum should be examined by the physician. If there is a risk that perforation of the ear-drum may occur, Locacorten-Vioform Ear Drops should not be used.
If no improvement occurs within about 1 week, therapy should be discontinued. It is then advisable to identify the pathogens and to institute appropriate treatment.
Locacorten-Vioform Ear Drops should not be allowed to come into contact with the conjunctiva.
Severe neurotoxic effects have been observed during oral administration of clioquinol but not following topical application. Nevertheless, caution is recommended especially in children and when using a moistened wick.
Cross-sensitivity between clioquinol and other quinoline derivatives is possible. It is therefore important to include clioquinol in routine patch testing because the clinical reaction may be relatively mild and sensitivity can easily go unnoticed, especially in the presence of a corticosteroid that suppresses or reduces the reaction. In the event of a suspected allergic skin reaction, Locacorten-Vioform Ear Drops should be withdrawn.
Contact with Locacorten-Vioform Ear Drops may cause discoloration of the hair, clothing and bed linen.
Topical use of clioquinol-containing preparations may lead to a marked increase in protein-bound iodine (PBI) (see Section 4.4 Special Warnings and Precautions for Use, Effects on laboratory tests).

Visual disturbance.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse effects have been derived from post marketing experience with Locacorten-Vioform Ear Drops, i.e. reported from a population of uncertain size. Hence, it is not possible to reliably estimate the frequency and they are categorised as indeterminate frequency. The adverse effects are listed according to MedDRA system organ class (SOC). Within each SOC, adverse effects are presented in order of decreasing seriousness.
Frequency estimates: very rare < 1/10,000; rare ≥ 1/10,000 to < 1/1,000; uncommon ≥ 1/1,000 to < 1/100; common ≥ 1/100 to < 1/10; very common ≥ 1/10.

Immune system disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Eye disorders.

Reporting suspected adverse effects.

4.9 Overdose

Treatment with clioquinol-containing preparations applied to extensive or eroded areas of skin may lead within 1 week to increased PBI values. Elevated PBI values also occur when relatively small areas of skin are treated for more than 1 week.
No similar reports with Locacorten-Vioform Ear Drops have been received to date. However, the possibility of such an occurrence owing to accidental ingestion by children cannot be excluded. This would result in gastrointestinal disorders accompanied by vomiting and nausea.
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.

5.2 Pharmacokinetic Properties

No pharmacokinetic data on Locacorten-Vioform Ear Drops are available.

Absorption.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Macrogol 300.

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.

6.5 Nature and Contents of Container

Ear drops solution 7.5 mL in polyethylene bottle.

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.

CAS number.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes