CALCIPOTRIOL/BETAMETHASONE SANDOZ 50/500 calcipotriol 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g ointment tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcipotriol, Quantity: 52.2 microgram/g; betamethasone dipropionate, Quantity: 643 microgram/g (Equivalent: betamethasone, Qty microgram/g)

Available from:

Sandoz Pty Ltd

INN (International Name):

Betamethasone dipropionate,Calcipotriol

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: dl-alpha-tocopherol; oleyl alcohol; liquid paraffin; white soft paraffin

Administration route:

Topical

Units in package:

30 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.

Product summary:

Visual Identification: Off white ointment; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-08-26

Patient Information leaflet

CALCIPOTRIOL / BETAMETHASONE SANDOZ
®
50/500
1
CALCIPOTRIOL /
BETAMETHASONE
SANDOZ
® 50/500
_Calcipotriol and betamethasone dipropionate ointment _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about using the medicine
Calcipotriol / Betamethasone Sandoz
ointment. 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 Calcipotriol /
Betamethasone Sandoz ointment
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT CALCIPOTRIOL /
BETAMETHASONE
SANDOZ 50/500
OINTMENT IS USED FOR
Calcipotriol / Betamethasone Sandoz
ointment is an anti-psoriasis
medicine. Calcipotriol /
Betamethasone Sandoz ointment
contains two active ingredients:
•
Calcipotriol (related to Vitamin
D);
•
Betamethasone dipropionate (a
corticosteroid).
Calcipotriol / Betamethasone Sandoz
ointment is used only on skin
affected by plaque-type psoriasis.
Psoriasis is a skin disorder in which
skin cells are overactive. The
calcipotriol in Calcipotriol /
Betamethasone Sandoz ointment
treats the overactive skin cells. The
betamethasone dipropionate relieves
redness, swelling, itching and
irritation of the skin.
Calcipotriol / Betamethasone Sandoz
ointment is used in the type of
psoriasis, where "plaques" form in
the skin. Plaques are raised, rough,
reddened areas covered with fine, dry
silvery scales. Plaques are usually
about one to two centimetres across.
Calcipotriol / Betamethasone Sandoz
ointment 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
CALCIPOTRIOL /
BETAMETHASONE
SANDOZ 50/500
OINTMENT
_WHEN YOU MUST NOT USE _
_CALCIPOTRIOL / _
_BETAMETHASONE SANDO

Summary of Product characteristics

201216-calcipotriol/betamethasone sandoz 50/500-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
CALCIPOTRIOL/BETAMETHASONE SANDOZ
® 50/500
(CALCIPOTRIOL/BETAMETHASONE) OINTMENT
1.
NAME OF THE MEDICINE
Calcipotriol and betamethasone (as dipropionate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcipotriol/Betamethasone Sandoz
®
50/500 is a combination ointment containing calcipotriol
50 microgram/g and betamethasone (as dipropionate) 500 microgram/g.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Calcipotriol/Betamethasone Sandoz 50/500 is an off-white ointment
base.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Calcipotriol and betamethasone ointment is indicated for the once
daily topical treatment of
plaque-type psoriasis vulgaris amenable to topical therapy.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Calcipotriol/Betamethasone Sandoz 50/500 ointment is indicated FOR
TOPICAL USE ONLY.
Calcipotriol/Betamethasone Sandoz 50/500 ointment is NOT FOR
OPHTHALMIC USE.
The phototoxic effects of calcipotriol and betamethasone ointment have
not been studied in
psoriasis patients. All psoriasis-affected areas treated with
calcipotriol and betamethasone
ointment should be, where possible, protected from direct sunlight and
UV-light with items of
clothing.
ADULTS:
Calcipotriol and betamethasone ointment should be applied topically to
the affected area once
daily. The maximum daily dose should not exceed 15 grams.
_THE MAXIMUM RECOMMENDED WEEKLY DOSE OF CALCIPOTRIOL AND BETAMETHASONE
OINTMENT IS 100 _
_GRAMS/WEEK. _
The treated area should not be more than 30% of the body surface.
The use of calcipotriol and betamethasone ointment should be
intermittent for up to
one year under close medical supervision. Treatment should be limited
to four week periods
with calcipotriol used alone for one month between periods of use of
calcipotriol and
betamethasone ointment as needed.
CHILDREN:
Calcipotriol and betamethasone ointment is not recommended for use in
children and
adolescents b