MOMASONE mometasone furoate 1mg/g ointment tube

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

mometasone furoate, Quantity: 1 mg/g

Διαθέσιμο από:

Aspen Pharma Pty Ltd

INN (Διεθνής Όνομα):

mometasone furoate

Φαρμακοτεχνική μορφή:

Ointment

Σύνθεση:

Excipient Ingredients: white soft paraffin; hexylene glycol; white beeswax; purified water; propylene glycol monostearate; phosphoric acid

Οδός χορήγησης:

Topical

Μονάδες σε πακέτο:

50g, 15g

Τρόπος διάθεσης:

(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine

Θεραπευτικές ενδείξεις:

Indicated for short-term (up to four continuous weeks) relief of inflammatory & pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis & atopic dermatitis.

Περίληψη προϊόντος:

Visual Identification: Translucent, white, soft, uniform and smooth ointment; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2017-03-06

Φύλλο οδηγιών χρήσης

MOMASONE
_mometasone furoate 1 mg/g ointment _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOMASONE.
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 MOMASONE against the
benefits it is expected to 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 MOMASONE IS
USED FOR
The name of your medicine is
MOMASONE. It contains the
active ingredient called
mometasone furoate. It is a
type of cortisone and belongs
to the group of medicines
called corticosteroids.
MOMASONE is classified as a
high potency topical
corticosteroid.
MOMASONE 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.
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.
A doctor’s prescription is required for
the 50 g tube of MOMASONE
ointment.
The 15 g tube can be purchased
without a doctor’s prescription.
BEFORE YOU USE IT
_ _
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE MOMASONE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
mometasone furoate
•
any other corticosteroid
•
any of the ingredients listed at the
end of this leaflet.
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 MOMASONE 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
•

Αρχείο Π.Χ.Π.

MOMASONE mometasone furoate 1 mg/g (0.1%) ointment – Product
Information
Page 1 of 6
AUSTRALIAN PRODUCT
I
NFO
R
MAT
I
O
N
MOMASONE
1 MG/G (0.1%) OINTMENT
1.
NAME OF THE MEDICINE
Mometasone fu
roate
.
2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Each gram
of
MOMASONE ointment contains mometasone furoate 1 mg in an
oin
tm
ent
base
of soft
white paraffin, hexylene
glycol, white beeswax, purified water,
prop
ylene glycol
monostearate
and
phosphoric ac
id
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOMASONE
ointment
is
indicated
for
sh
or
t
-
ter
m
(up
to
fo
ur
(4)
continuous
weeks)
r
elie
f
of
inflammatory
and pruritic manifestations
o
f
corticosteroid-responsive
dermatoses, such as psoriasis
and atopic
d
er
matitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
A
thin
film
of
MOMASONE ointment should
be applied to
the
affected skin
areas once
daily.
MOMASONE ointment should be
u
sed
for dry, scaling and fissured
le
sio
n
s.
Note:
1.
There are other registered mometasone furoate dosage forms, such as
creams and lotions.
Mometasone furoate creams are suitable for moist lesions. Mometasone
furoate lotions are
suitable for hairy areas, such as scalp sites.
2.
Avoid using mometasone on open skin (see SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE).
4.3
CONTRAINDICATIONS
MOMASONE ointment is contraindicated in patients who are
hypersensitive to mometasone furoate or
to other
corticosteroids.
Like other
to
p
ic
al
corticosteroids, MOMASONE
is contraindicated in most
viral infections
of
the
skin,
tuberculosis, acne rosacea, perioral dermatitis, fungal skin
infections and
u
lc
er
ative
cond
itions.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
MOMASONE
ointment is
not
for ophthalmic
u
se.
If
irritation or sensitisation develops with the use
of
MOMASONE ointment, treatment should
be
discontinued and appropriate therapy
in
stitu
ted.
In the presence
of
an
infection,
use
of
an appropriate
antifungal or antibacterial
agen
t
should be
instituted. If
a favourable response does
not
occur promptly,
th
e
cor