UNICLAR AQUEOUS NASAL SPRAY 0.05 % mometasone furoate (as monohydrate) 50 microgram/actuation, suspension spray, pump actuated metered dose aerosol

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mometasone furoate, Quantity: 50 microgram/actuation

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

mometasone furoate

Pharmaceutical form:

Spray, suspension

Composition:

Excipient Ingredients: benzalkonium chloride; citric acid monohydrate; sodium citrate dihydrate; dispersible cellulose; glycerol; citric acid; polysorbate 80; purified water

Administration route:

Nasal

Units in package:

1 x 140 metered sprays, 2 x 140 metered sprays, 1 x 65 metered sprays

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

UNICLAR Aqueous Nasal Spray 0.05% is indicated for the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis in adults, adolescents and children between the ages of 3 and 11 years. UNICLAR Aqueous Nasal Spray 0.05% is also indicated for the treatment of nasal polyps in adult patients 18 years of age and older. UNICLAR Aqueous Nasal Spray 0.05% is indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of severe bacterial infection.

Product summary:

Visual Identification: A white to off-white opaque suspension; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-07-12

Patient Information leaflet

UNICLAR
® AQUEOUS
NASAL SPRAY 0.05%
_Mometasone Furoate Monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about UNICLAR. 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 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 want to read it again.
WHAT UNICLAR IS
USED FOR
UNICLAR contains the active
ingredient mometasone furoate. This
belongs to a family of medicines
called corticosteroids, which are used
to help reduce inflammation.
ALLERGIC RHINITIS (HAYFEVER):
UNICLAR is sprayed into the nose to
help relieve symptoms that may
occur with hayfever or other year-
round allergies, including stuffiness
(congestion) in the nose, discharge,
itching and sneezing. Your doctor
may also prescribe this medicine to
help prevent these symptoms two to
four weeks before the beginning of
the pollen season.
NASAL POLYPS:
Swollen tissue in the nose can cause
grape-like swellings called 'polyps'.
Polyps can cause nasal stuffiness,
discomfort and loss of smell.
UNICLAR can be used for the
treatment of nasal polyps in patients
over 18 years of age.
ACUTE RHINOSINUSITIS:
Rhinosinusitis is the swelling of the
sinuses resulting in stuffiness of the
nose, large quantities of mucus from
the nose, cough, face pain and/or
fever. These symptoms usually last
for less than 4 weeks. UNICLAR is
used to treat the symptoms of
rhinosinusitis in adults and children
12 years of age and older, who do not
have the signs or symptoms of a
severe bacterial infection.
Your doctor may have prescribed it
for another reason. Ask your doctor
if you have any questions about why
this medicine has been prescribed for
you.
There is no evidence that this
medicine is addictive.
This medicine is available only w

Summary of Product characteristics

REF: LRN#: 032088-NSX-NS-PIPB.4 D20131217 Version 2
PAGE
1
PRODUCT INFORMATION
UNICLAR
® AQUEOUS NASAL SPRAY 0.05%
NAME OF THE MEDICINE
UNICLAR Aqueous Nasal Spray 0.05% is a metered-dose, manual pump spray
unit containing a
suspension
of
mometasone
furoate.
Each
actuation
delivers
approximately
100 mg
of
mometasone furoate monohydrate
suspension,
containing mometasone furoate monohydrate
equivalent to mometasone furoate 50

g.
Chemical structure:
Mometasone furoate monohydrate is
9,21-Dichloro-11
_ß_
,17-dihydroxy-16
_α_
-methylpregna-1,4-
diene-3,20-dione 17-(2-furoate)
monohydrate.
The
empirical
formula
is
C
27
H
30
Cl
2
O
6

H
2
O.
MW=539.45. CAS Registry number: 83919-23-7 (mometasone furoate
anhydrous)
DESCRIPTION
Mometasone furoate is a white to off white powder and it is
practically insoluble in water; slightly
soluble in menthanol, ethanol and isopropanol; soluble in acetone.
UNICLAR Aqueous Nasal
Spray 0.05% contains mometasone furoate 0.5 mg/g (as the monohydrate).
_ _
_List of excipients _
Dispersible cellulose, glycerol, citric acid monohydrate or anhydrous
citric acid, sodium citrate,
polysorbate 80 and purified water with benzalkonium chloride 0.2 mg/g
as preservative. UNICLAR
Aqueous Nasal Spray 0.05% does not contain fluorocarbon propellants.
PHARMACOLOGY
_PHARMACOLOGY AND PHARMACOLOGICAL ACTIONS _
Mometasone furoate is a topical glucocorticosteroid with local
anti-inflammatory properties at
doses that are not systemically active.
In studies utilising nasal antigen challenge, mometasone furoate has
shown anti-inflammatory
activity in both the early- and late-phase allergic responses. This
has been demonstrated by
decreases (vs placebo) in histamine and eosinophil activity and
reductions (vs baseline) in
eosinophils, neutrophils and epithelial cell adhesion proteins.
_ _
_PHARMACOKINETICS _
Systemic bioavailability of mometasone furoate was investigated in 24
healthy volunteers following
intranasal administration of 400

g of the suspension. Mometasone was detectable in plasma (at
spor