DAIVOBET 50/500 calcipotriol 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g gel bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcipotriol, Quantity: 50 microgram/g; betamethasone dipropionate (Equivalent: betamethasone, Qty 500 microgram/g)

Available from:

LEO Pharma Pty Ltd

INN (International Name):

Betamethasone dipropionate,Calcipotriol

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: nitrogen; hydrogenated castor oil; polyoxypropylene-11 stearyl ether; butylated hydroxytoluene; liquid paraffin; dl-alpha-tocopherol

Administration route:

Topical

Units in package:

15g, 30g, 60g, 2 x 60g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Topical treatment of scalp psoriasis. Topical treatment of mild to moderate plaque psoriasis on the body in adults.

Product summary:

Visual Identification: Almost clear, colourless to slightly off-white gel; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-07-22

Patient Information leaflet

DAIVOBET
®
50/500
GEL
1
DAIVOBET

50/500 GEL
_Dye-vo-bet _
Calcipotriol
_(Kal-sippo-try-all)/ _
Betamethasone
_(Beet-ah-meth-ah sown ) _
CONSUMER MEDICINE INFORMATION (CMI)
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
Daivobet
®
50/500 gel is the brand
name. Daivobet
®
gel is a
combination product. The generic
names of the two active ingredients
are calcipotriol and betamethasone
dipropionate.
KEEP THIS LEAFLET. You may want
to read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about using the medicine
Daivobet
®
gel. 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 Daivobet
®
gel
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING DAIVOBET
® GEL, TALK TO YOUR
DOCTOR OR PHARMACIST.
WHAT DAIVOBET
® GEL IS
USED FOR
Daivobet
®
gel is used as topical
treatment of body and scalp
psoriasis. Psoriasis is a skin
disorder in which skin cells are
overactive. This causes redness,
scaling and thickness of your skin.
Daivobet
®
gel contains two active
ingredients:
•
calcipotriol [as monohydrate]
(related to Vitamin D)
•
betamethasone dipropionate (a
corticosteroid).
The calcipotriol in Daivobet
®
gel
treats the overactive skin cells.
The betamethasone dipropionate
relieves redness, swelling, itching
and irritation of the skin.
_ _
Daivobet
®
gel contains an
ingredient hydrogenated castor oil.
Hydrogenated castor oil contains
peanut products.
Daivobet
®
gel is available only with
a doctor’s prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
This medicine is not addictive.
BEFORE YOU USE
DAIVOBET
® GEL
_WHEN YOU MUST NOT USE _
_DAIVOBET_
_®_
_ GEL_
_ _
DO NOT USE DAIVOBET
® GEL IF YOU:
•
are allergic to calcipotriol,
betamethasone dipropionate or
any of the other ingredients
listed at the end of this leafl

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DAIVOBET
®
50/500 (CALCIPOTRIOL
[AS MONOHYDRATE] AND BETAMETHASONE [AS DIPROPIONATE]) GEL
1
NAME OF THE MEDICINE
Calcipotriol monohydrate
Betamethasone dipropionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of Daivobet® gel contains 50 micrograms of calcipotriol (as
monohydrate) and 500 micrograms of
betamethasone (as dipropionate).
Excipients with known effect: hydrogenated castor oil*, butylated
hydroxytoluene
*Hydrogenated castor oil contains peanut products
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Gel.
An almost clear, colourless to slightly off-white gel
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Topical treatment of scalp psoriasis.
Topical treatment of mild to moderate plaque psoriasis on the body in
adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Daivobet
®
gel is FOR TOPICAL USE ONLY. Daivobet
®
gel is NOT FOR OPHTHALMIC USE. Do not use if the pack
shows signs of damage or tampering.
The phototoxic effects of Daivobet
®
gel have not been studied in psoriasis patients in Australia. All
psoriasis-
affected areas treated with Daivobet
®
gel should be, where possible, protected from direct sunlight and UV-
light with items of clothing.
_ADULTS _
_ _
Body psoriasis: Daivobet
®
gel should be applied once daily for up to 8 weeks.
If there is no response after 4 weeks, treatment should be ceased.
Treatment of body psoriasis should be
ceased after 8 weeks.
.
eDoc-000727241 - Version 4.0
2
Scalp psoriasis: Daivobet
®
gel should be applied once daily for up to 4 weeks. After this period,
Daivobet
®
gel
may be used according to need under medical supervision. There is
experience with intermittent courses of
Daivobet
®
gel up to 52 weeks for scalp psoriasis.
All the affected scalp areas may be treated with Daivobet
®
gel. Usually an amount between 1 g and 4 g per
day is sufficient for treatment of the scalp (4 g corresponds to one
teaspoon).
When using calcipotriol containing products, the maximum daily