Locacorten-Vioform Ear Drops

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flumetasone pivalate, Quantity: 0.2 mg/mL; clioquinol, Quantity: 10 mg/mL

Available from:

Amdipharm Mercury Australia Pty Ltd

Pharmaceutical form:

Ear Drops

Composition:

Excipient Ingredients: macrogol 300

Administration route:

Otic

Units in package:

7.5mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. New indications were approved as specified in the letter of 29 June 1992 from Dr Alex Proudfoot. Indicated for the treatment of eczema of the external auditory meatus in which secondary infection with micro-organisms sensitive to clioquinol has occurred. Otitis externa. Otomycosis.

Product summary:

Visual Identification: Clear, yellowish solution; Container Type: Bottle; Container Material: PE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

Locacorten
®
-Vioform
1
LOCACORTEN
®
-VIOFORM
_flumetasone pivalate / clioquinol _
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 A

Summary of Product characteristics

LOCACORTEN
®
-VIOFORM
1
AUSTRALIAN PRODUCT INFORMATION
LOCACORTEN
®
-VIOFORM
FLUMETASONE PIVALATE/ CLIOQUINOL
EAR DROPS
1
NAME OF THE MEDICINE
Flumetasone pivalate/ Clioquinol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Locacorten Ear drops contain flumetasone pivalate 200 µg/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.
LOCACORTEN
®
-VIOFORM
2
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 i