OMNARIS ciclesonide 50 microgram per actuation nasal spray bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciclesonide, Quantity: 50 microgram/actuation

Available from:

Chiesi Australia Pty Ltd

INN (International Name):

Ciclesonide

Pharmaceutical form:

Spray, nasal

Composition:

Excipient Ingredients: potassium sorbate; hypromellose; purified water; microcrystalline cellulose; disodium edetate; carmellose sodium; hydrochloric acid; nitrogen

Administration route:

Nasal

Units in package:

60 Actuation, 120 Actuation

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Omnaris Nasal Spray is indicated for: the treatment of seasonal allergic rhinitis in adults and children 6 years of age and older; and for the treatment of perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Product summary:

Visual Identification: White to off-white suspension in brown glass bottle with a pump; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-12-16

Patient Information leaflet

OMNARIS AU CMI V2.0
1
OMNARIS
® NASAL SPRAY
_ciclesonide _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OMNARIS.
It does not contain all 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
this medicine. Those 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 risks of you using this medicine
against the benefits they expect it
will have for you.
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 OMNARIS IS
USED FOR
The medicine is sprayed into the nose
to help treat symptoms of seasonal
allergic rhinitis in adults and children
6 years of age and older, and
perennial allergic rhinitis in adults
and adolescents 12 years of age and
older.
Allergic rhinitis (hay fever) is an
inflammation or swelling of the nose
lining, which may cause blockage,
runny nose, itching and/or sneezing.
You may have symptoms only during
spring or summer (seasonal). This
type of allergy is generally due to
various pollens. Some people may
experience symptoms all year round
(perennial). This is usually caused by
house dust mites, pets or moulds.
The medicine contains ciclesonide.
This belongs to a family of medicines
called corticosteroids, which are used
to help reduce inflammation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
OMNARIS
_WHEN YOU MUST NOT USE IT _
DO N

Summary of Product characteristics

OMNARIS PI v2.0
1
AUSTRALIAN PRODUCT INFORMATION
OMNARIS
® (CICLESONIDE) NASAL SPRAY
1
NAME OF THE MEDICINE
ciclesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OMNARIS Nasal Spray is a metered-dose, manual-pump spray. Once primed
(see Section 4.2Dose
and method of administration), each actuation of the pump delivers 50
µg ciclesonide in a volume
of 70 µL from the nasal actuator.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Nasal spray presented as a white to off-white suspension in brown
glass bottle with a pump.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OMNARIS Nasal Spray is indicated for:

the treatment of seasonal allergic rhinitis in adults and children 6
years of age and older.

the treatment of perennial allergic rhinitis in adults and adolescents
12 years of age and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
OMNARIS should only be administered by the intranasal route.
DOSAGE CONSIDERATION
The recommended dose of OMNARIS is 200 µg per day administered as 2
actuations
(50 µg/actuation) in each nostril once daily.
The maximum total daily dosage should not exceed 2 actuations in each
nostril (200 µg/day).
ADMINISTRATION
Prior to initial use, OMNARIS must be shaken gently and then the pump
must be primed by
actuating 8 times. If not used for 4 or more consecutive days, it
should be shaken gently and
reprimed with 1 actuation or until a fine mist appears.
During dosing, users are advised to tilt the head forward slightly
and, while keeping the bottle
upright, users are advised to press the pump quickly and firmly and
inhale through the nose as they
spray.
4.3
CONTRAINDICATIONS
Patients with a hypersensitivity to ciclesonide or any of its
ingredients.
OMNARIS PI v2.0
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IMMUNE SYSTEM
Rarely, immediate hypersensitivity reactions or contact dermatitis may
occur after the
administration of intranasal corticosteroids. Patients with a known
hypersensitivity reaction to other
corticosteroid preparations