Enstilar

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Betamethasone dipropionate 643 µg/g equivalent to 500 µg/g Betamethasone;  ; Calcipotriol monohydrate 52.2 µg/g equivalent to 50 µg/g Calcipotriol

Available from:

LEO Pharma Limited

Pharmaceutical form:

Foam

Composition:

Active: Betamethasone dipropionate 643 µg/g equivalent to 500 µg/g Betamethasone   Calcipotriol monohydrate 52.2 µg/g equivalent to 50 µg/g Calcipotriol Excipient: Butane Liquid paraffin Methyl ether Polyoxypropylene monostearyl ether Tocoferols White soft paraffin

Prescription type:

Prescription

Therapeutic indications:

Topical treatment of psoriasis vulgaris in adults.

Product summary:

Package - Contents - Shelf Life: Aerosol, Pressurised coated aluminium can with non-metered valve, actuator and cap - 1 unit per carton - 60 g - 24 months from date of manufacture stored at or below 25°C protect from light 6 months opened stored at or below 25°C protect from light - Aerosol, Pressurised coated aluminium can with non-metered valve, actuator and cap - 2 units per carton - 120 g - 24 months from date of manufacture stored at or below 25°C protect from light 6 months opened stored at or below 25°C protect from light

Authorization date:

2016-07-15

Patient Information leaflet

ENSTILAR
®
1
ENSTILAR

_ _
_Calcipotriol 50 microgram/g Betamethasone 500 microgram/g present as
dipropionate _
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.
Enstilar
®
is the brand name.
Enstilar
®
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
Enstilar
®
. 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 Enstilar
®
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING ENSTILAR
®
, TALK TO YOUR
DOCTOR OR PHARMACIST.
WHAT ENSTILAR
® IS USED
FOR
Enstilar
®
is a topical treatment for
psoriasis. Psoriasis is a skin
disorder in which skin cells are
overactive. This causes redness,
scaling and thickness of your skin.
Enstilar
®
contains two active
ingredients:

calcipotriol (related to Vitamin
D);

betamethasone dipropionate (a
corticosteroid).
The calcipotriol in Enstilar
®
treats
the overactive skin cells. The
betamethasone dipropionate
relieves redness, swelling, itching
and irritation of the skin.
_ _
Enstilar
®
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
ENSTILAR
®
_WHEN YOU MUST NOT USE _
_ENSTILAR_
_®_
_ _
_ _
DO NOT USE ENSTILAR
®
IF YOU:

are allergic to calcipotriol,
betamethasone dipropionate or
any of the other ingredients
listed at the end of this leaflet
(see PRODUCT DESCRIPTION) or
any other similar medicine, such
as topical corticosteroids

have high blood calcium levels
(ask your doctor)

have

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
NAME OF THE MEDICINAL PRODUCT
Enstilar
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of Enstilar
®
contains 50 micrograms of calcipotriol (as monohydrate) and 500
micrograms
of betamethasone (as dipropionate).
Excipient with known effect:
Butylated hydroxytoluene (E321) (See section 4.4)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Foam.
After spraying, a white to off-white foam is formed. The foam has the
appearance of non-expanding
foam that gradually collapses after spraying.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of psoriasis vulgaris in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Enstilar
®
should be applied to the affected area once daily. The recommended
treatment period is 4
weeks. If it is necessary to continue or restart treatment after this
period, treatment should be
continued after medical review and under regular medical supervision.
There is clinical experience on the use of the fixed dose combination
of calcipotriol and
betamethasone dipropionate in topical formulations up to 52 weeks.
The daily maximum dose of Enstilar
®
should not exceed 15 g, i.e. one 60 g can should last for at least
4 days. 15 g corresponds to the amount administered from the can if
the actuator is fully depressed for
approximately one minute. A two-second application delivers
approximately 0.5 g. As a guide, 0.5 g
of Enstilar
®
should cover an area of skin roughly corresponding to the surface area
of an adult hand.
eDoc-000600719 - Version 12. 0
2
If using other topical products containing calcipotriol in addition to
Enstilar
®
, the total dose of all
calcipotriol containing products should not exceed 15 g per day.
The total body surface area treated should not exceed 30%.
Special populations
_Renal and hepatic impairment _
The safety and efficacy of Enstilar
®
in patients with severe renal insufficiency or severe hepatic
disorders have not been evaluated.
_Paediatric population _
The safety and efficacy of E