ELOCON ALCOHOL FREE mometasone furoate 1mg/g cream
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
19-04-2021
Summary of Product characteristics
(SPC)
25-02-2021
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: hexylene glycol; white beeswax; purified water; aluminium starch octenylsuccinate; phosphoric acid; titanium dioxide; white soft paraffin; hydrogenated soy phosphatidylcholine
Administration route:
Topical
Units in package:
50g, 5g, 15g
Prescription type:
(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine
Therapeutic indications:
ELOCON ALCOHOL FREE 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. ELOCON 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
ELOCON
®
_Mometasone Furoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ELOCON.
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
ELOCON 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 ELOCON IS USED
FOR
The name of your medicine is
ELOCON. It contains the active
ingredient called mometasone
furoate.
It is a type of cortisone and belongs
to the group of medicines called
corticosteroids. ELOCON is
classified as a high potency topical
corticosteroid.
There are three forms of ELOCON:
Alcohol Free cream, ointment and
lotion.
ELOCON 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.
ELOCON Lotion is also used on the
scalp and hairy parts of the body.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
All ELOCON 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
ELOCON
_WHEN YOU MUST NOT USE IT_
DO NOT USE ELOCON 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 ELOCON IF YOU HAVE:
•
a viral skin infection (such as
cold sores,
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Summary of Product characteristics
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
ELOCON
®
(MOMETASONE FUROATE)
OINTMENT, LOTION AND ALCOHOL FREE 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
ELOCON (mometasone furoate) 0.1% (1 mg/g) is available as ointment,
alcohol free cream,
and lotion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELOCON Alcohol Free Cream, ELOCON 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.
ELOCON 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 ELOCON Alcohol Free Cream or ELOCON Ointment should be
applied to the
affected skin areas once daily. ELOCON Alcohol Free Cream is suitable
for moist lesions; the
ointment should be used for dry, scaling and fissured lesions.
A few drops of ELOCON Lotion should be applied to affected skin areas
including scalp sites
once daily; massage gently and thoroughly until the medication
disappears.
4.3
CONTRAINDICATIONS
ELOCON Alcohol Free Cream, Ointment and Lotion are contraindicated in
patients who are
hypersensitive
to
mometasone
furoate
or
to
other
corticosteroids.
Like
other
topical
corticosteroids, ELOCON 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 ELOCON Alcohol
Free Cream, ELOCON
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 sho
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