CIPROXIN HC EAR DROPS 0.2% ciprofloxacin (as hydrochloride) and 1% hydrocortisone ear drops

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

ciprofloxacin, Quantity: 2 mg/mL; hydrocortisone, Quantity: 10 mg/mL

Saatavilla:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

Ciprofloxacin,Hydrocortisone

Lääkemuoto:

Ear Drops, suspension

Koostumus:

Excipient Ingredients: polysorbate 20; sodium acetate; glacial acetic acid; benzyl alcohol; hydrogenated soy phosphatidylcholine; sodium chloride; polyvinyl alcohol; purified water

Antoreitti:

Otic

Kpl paketissa:

10mL

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

For the treatment of acute bacterial otitis externa, caused by organisms susceptible to ciprofloxacin (see PHARMACOLOGY), in adults and children aged 2 years and older.

Tuoteyhteenveto:

Visual Identification: Slightly viscous white to off-white opaque suspension with acetous odour.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2008-03-12

Pakkausseloste

CIPROXIN
®
HC
1
CIPROXIN
® HC
_EAR DROPS _
_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 infection.

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
Cipro

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION – CIPROXIN® HC
(CIPROFLOXACIN AND HYDROCORTISONE) EAR DROPS
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride and Hydrocortisone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIPROXIN HC Ear Drops contains 2.33 mg/mL ciprofloxacin hydrochloride
(corresponding to 2.0 mg/mL
ciprofloxacin), 10 mg/mL hydrocortisone and 9.0 mg/mL benzyl alcohol
as preservative.
CIPROXIN HC Ear Drops contain benzyl alcohol as a preservative. Other
excipients are: polysorbate
20, sodium acetate, acetic acid-glacial, sodium chloride, hydrogenated
soy phosphatidylcholine,
polyvinyl alcohol, water-purified. CIPROXIN HC Ear Drops contain soya
bean products.
3
PHARMACEUTICAL FORM
CIPROXIN HC Ear Drops is supplied as a non-sterile, slightly viscous
white to off-white opaque
suspension in a 10 mL bottle with acetous odour with a separately
wrapped non-sterile dropper
assembly.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CIPROXIN HC Ear Drops are indicated for the treatment of acute
bacterial otitis externa, caused by
organisms susceptible to ciprofloxacin (see PHARMACOLOGY), in adults
and children aged 2 years and
older.
4.2
D
OSE AND METHOD OF ADMINISTRATION
FOR CHILDREN (AGE 2 AND OLDER) AND ADULTS
Three drops of the suspension (equivalent to about 0.09 mL CIPROXIN HC
Ear Drops containing 0.18
mg ciprofloxacin and 0.9 mg hydrocortisone) should be instilled into
the affected ear twice daily for
seven days. The bottle should be shaken well, immediately before use.
The patient should be either sitting or lying down with the affected
ear turned upwards and then the
drops should be instilled. This position should be maintained for
30-60 seconds to facilitate
penetration of the drops into the external ear canal. Repeat if
necessary, for the opposite ear.
USE IN ELDERLY
No specific limitation.
USE IN CHILDREN
For children less than 2 years of age, there is insufficient data
available.
2
USE IN HEPATIC IMPAIRMENT
No specific limitation.
USE IN RENAL IMPAIRMENT
No specific limitation.
4.3
C
ONTRAINDICATIONS