MOMASONE ALCOHOL FREE mometasone furoate 1 mg/g cream tube

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

mometasone furoate, Quantity: 1 mg/g

Saatavilla:

Aspen Pharma Pty Ltd

Lääkemuoto:

Cream

Koostumus:

Excipient Ingredients: purified water; phosphoric acid; aluminium starch octenylsuccinate; white beeswax; hydrogenated soy phosphatidylcholine; hexylene glycol; white soft paraffin; titanium dioxide

Antoreitti:

Topical

Kpl paketissa:

50 g, 15 g

Prescription tyyppi:

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

Käyttöaiheet:

The short term up to four (4) continuous weeks relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.

Tuoteyhteenveto:

Visual Identification: White to off-white uniform and smooth cream.; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2020-05-29

Pakkausseloste

MOMASONE Alcohol Free cream – Consumer Medicine Information
Page 1 of 3
MOMASONE ALCOHOL FREE CREAM
_mometasone furoate _
CONSUMER PRODUCT INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MOMASONE Alcohol Free
cream.
It does not contain all of 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 Alcohol Free
cream 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
ALCOHOL FREE CREAM
IS USED FOR
The name of your medicine is
MOMASONE Alcohol Free. It
contains the active ingredient
called mometasone furoate.
It is a type of cortisone and
belongs to the group of
medicines called
corticosteroids. It is classified
as a high potency topical
corticosteroid.
MOMASONE Alcohol Free
cream 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 Alcohol Free
cream.
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
ALCOHOL FREE CREAM 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 IT IF YOU HAVE:
•
a viral skin infection
(such as cold sore

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
MOMASONE ALCOHOL FREE (MOMETASONE FUROATE)
CREAM
1
NAME OF THE MEDICINE
Mometasone furoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MOMASONE Alcohol Free cream contains mometasone furoate 1 mg/g (0.1%)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A white to off-white smooth homogenous cream free from foreign matter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The short term up to four (4) continuous weeks relief of inflammatory
and pruritic
manifestations of corticosteroid-responsive dermatoses, such as
psoriasis and atopic
dermatitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A thin film should be applied to the affected skin areas once daily.
MOMASONE Alcohol
Free cream is suitable for moist lesions.
4.3
C
ONTRAINDICATIONS
MOMASONE Alcohol Free cream is contraindicated in patients who are
hypersensitive
to mometasone furoate or to other corticosteroids. Like other topical
corticosteroids,
mometasone furoate is contraindicated in most viral infections of the
skin, tuberculosis,
acne rosacea, perioral dermatitis, fungal skin infections and
ulcerative conditions.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation or sensitisation develops with the use of MOMASONE
Alcohol Free cream
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.
Any of the side effects that have been reported following systemic use
of corticosteroids,
2
including adrenal suppression, may also occur with topical
corticosteroids, especially in
infants and children.
Systemic absorption of topical corticosteroids will be increased if
extensive body surface
areas are treated, if the occlusive technique is used, if used in
areas where the epidermal
barrier is disrupted or if used long-term. Sui