NOVASONE mometasone furoate 1 mg/g cream tube
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
29-04-2021
Summary of Product characteristics
(SPC)
29-04-2021
Public Assessment Report
(PAR)
23-11-2017
Active ingredient:
mometasone furoate, Quantity: 1 mg/g
Available from:
ORGANON PHARMA PTY LTD
INN (International Name):
mometasone furoate
Pharmaceutical form:
Cream
Composition:
Excipient Ingredients: aluminium starch octenylsuccinate; white soft paraffin; titanium dioxide; phosphoric acid; purified water; white beeswax; hexylene glycol; hydrogenated soy phosphatidylcholine
Administration route:
Topical
Units in package:
50g, 45g, 2g, 5g - sample, 15g
Prescription type:
(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine
Therapeutic indications:
NOVASONE Cream, Ointment and Lotion are indicated for short-term (up to four (4) continuous weeks) relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis. NOVASONE Lotion is also suitable for short-term use for scalp psoriasis and seborrhoeic dermatitis.
Product summary:
Visual Identification: A white to off-white smooth homogenous cream free from foreign matter.; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-09-11
Patient Information leaflet
NOVASONE
_Mometasone furoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOVASONE.
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 or pharmacist
has weighed the risks of you using
NOVASONE against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT NOVASONE IS
USED FOR
The name of your medicine is
NOVASONE. It contains the active
ingredient called mometasone
furoate.
It is a type of cortisone and belongs
to the group of medicines called
corticosteroids. NOVASONE is
classified as a high potency topical
corticosteroid.
There are three forms of
NOVASONE: cream, ointment and
lotion.
NOVASONE is used on the skin to
relieve the redness, swelling, itching
and discomfort of many skin
problems such as:
•
psoriasis
•
eczema
•
other types of dermatitis
NOVASONE Lotion is also used on
the scalp and hairy parts of the body.
Your doctor, however, may have
prescribed NOVASONE for another
purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
NOVASONE HAS BEEN PRESCRIBED
FOR YOU.
All NOVASONE pack sizes 15 g/ 15
mL or less are available from your
pharmacist behind the counter
without a doctors prescription.
All other pack sizes remain
prescription only presentations.
BEFORE YOU USE
NOVASONE
_WHEN YOU MUST NOT USE IT_
DO NOT USE NOVASONE IF YOU
HAVE HAD AN ALLERGIC REACTION TO:
•
MOMETASONE FUROATE
•
ANY OTHER CORTICOSTEROID
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
DO NOT USE NOVASONE IF YOU
HAVE:
•
A VIRAL SKIN INFECTION (SUCH AS
COLD SORES, SHINGLES OR CHICKEN
POX)
•
A FUNGAL SKIN INFECTION (SUCH AS
THRUSH, TINEA OR RINGWORM)
•
TUBERCULOSIS OF THE SKIN
•
ACNE ROSACEA
•
INFLAMMATION AROUND THE
MOUTH
•
SKIN CONDITIONS WITH ULCERS
UNLESS YOUR DOCTOR
Read the complete document
Summary of Product characteristics
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
NOVASONE
®
(MOMETASONE FUROATE)
OINTMENT, LOTION AND CREAM
1
NAME OF THE MEDICINE
Mometasone furoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone furoate 0.1% (1 mg/g)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
NOVASONE (mometasone furoate) 0.1% (1 mg/g) is available as ointment,
cream, and lotion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOVASONE Cream, Ointment and Lotion are indicated for short-term (up
to four (4)
continuous
weeks)
relief
of
inflammatory
and
pruritic
manifestations
of
corticosteroid-
responsive dermatoses, such as psoriasis and atopic dermatitis.
NOVASONE Lotion is also suitable for short-term use for scalp
psoriasis and seborrhoeic
dermatitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
A thin film of NOVASONE Cream or Ointment should be applied to the
affected skin areas
once daily. NOVASONE Cream is suitable for moist lesions; the ointment
should be used for
dry, scaling and fissured lesions.
A few drops of NOVASONE Lotion should be applied to affected skin
areas including scalp
sites once daily; massage gently and thoroughly until the medication
disappears.
4.3
CONTRAINDICATIONS
NOVASONE
Cream,
Ointment
and
Lotion
are
contraindicated
in
patients
who
are
hypersensitive
to
mometasone
furoate
or
to
other
corticosteroids.
Like
other
topical
corticosteroids,
NOVASONE
is
contraindicated
in
most
viral
infections
of
the
skin,
tuberculosis,
acne
rosacea,
perioral
dermatitis,
fungal
skin
infections
and
ulcerative
conditions.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation or sensitisation develops with the use of NOVASONE
Cream, Ointment or Lotion
treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, use of an appropriate antifungal or
antibacterial agent should
be instituted. If a favourable response does not occur promptly, the
corticosteroid should be
discontinued until the infection is controlled adequately.
Page 2 of 7
Any of the si
Read the complete document
