EUMOVATE CREAM clobetasone butyrate 0.5mg/g cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clobetasone butyrate, Quantity: 0.5 mg/g

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Clobetasone butyrate

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: citric acid monohydrate; chlorocresol; purified water; glycerol; cetostearyl alcohol; glyceryl monostearate; sodium citrate dihydrate; PEG-100 stearate; stearic acid; Carnauba Wax; hard paraffin

Administration route:

Topical

Units in package:

30g, 15g, 5g

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

Short-term (up to 7 days) treatment of milder forms of eczema, dermatitis and other steroid responsive skin conditions.

Product summary:

Visual Identification: Smooth white to off-white cream.; Container Type: Tube; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-12-10

Patient Information leaflet

1
EUMOVATE
CLOBETASONE BUTYRATE 0.05% W/W CREAM
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET _ _
_ _
Please read this leaflet carefully
before you start using EUMOVATE
Cream.
This leaflet answers some common
questions about EUMOVATE. 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
EUMOVATE against the benefits
they expect it will have for you.
Use EUMOVATE as instructed and
follow the advice given in this
leaflet._ _
_ _
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EUMOVATE IS
USED FOR
EUMOVATE is used to treat
eczema and dermatitis. It can help
you to control patches of dry, red,
itchy, flaky or inflamed skin caused
by eczema and dermatitis.
EUMOVATE contains clobetasone
butyrate. Clobetasone butyrate is a
topical corticosteroid. It is used to
control inflammation on the skin.
EUMOVATE works to stop the
skin’s over-reaction to the triggers
that cause skin flare ups. It
suppresses the inflammation that
causes eczema or dermatitis.
EUMOVATE cream base also has
moisturising properties.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
RECOMMENDED FOR YOU.
Your doctor or pharmacist may
have recommended it for another
reason.
BEFORE USING
EUMOVATE
_WHEN YOU MUST NOT USE IT _
DO NOT USE EUMOVATE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
clobetasone butyrate
•
any of the ingredients listed at
the end of this leaflet.
•
any other similar medicines
such as hydrocortisone.
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 EUMOVATE ON:
•
cuts or open wounds
•
infected skin
•
inflamed skin near

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
EUMOVATE (CLOBETASONE BUTYRATE) CREAM
1
NAME OF THE MEDICINE
Clobetasone butyrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EUMOVATE cream contains 0.05% w/w clobetasone butyrate as the active
ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cream
White cream for topical use
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term (up to 7 days) treatment of milder forms of eczema,
dermatitis and other steroid
responsive skin conditions.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER
Apply a thin film and gently rub in, using only enough to cover the
affected area twice daily
for up to 7 days.
If the condition resolves within 7 days, treatment with EUMOVATE cream
should be
stopped.
If the condition does not improve within the first 7 days or becomes
worse, the patient should
see a doctor.
If after 7 days of treatment, improvement is seen but further
treatment is required, the patient
should see a doctor.
After application, the hands should be washed unless they are the site
being treated.
Patients advised by their doctors to use this cream for prolonged
periods should be advised
to tell subsequent doctors about this use.
All patients should be warned against prolonged used on one area of
skin, or use of
excessive quantities.
2
All patients should also be informed that the preparation is
prescribed only for a specific
condition occurring in a specific individual.
CHILDREN
Use in children under 12 years only on the advice of a doctor.
Children are more likely to
develop local and systemic adverse reactions of topical
corticosteroids and, in general,
require shorter courses and less potent agents than adults.
Care should be taken when using EUMOVATE cream to ensure the amount
applied is the
minimum that provided therapeutic benefit.
ELDERLY
Clinical studies have not identified differences in responses between
the elderly and younger
patients. The greater frequency of decreased hepatic or renal fu