ENSTILAR calcipotriol (as monohydrate) 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g foam aerosol can

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcipotriol, Quantity: 20.5 microgram/g; betamethasone dipropionate, Quantity: 264 microgram/g (Equivalent: betamethasone, Qty 205 microgram/g)

Available from:

LEO Pharma Pty Ltd

INN (International Name):

Betamethasone dipropionate,Calcipotriol

Pharmaceutical form:

Foam

Composition:

Excipient Ingredients: polyoxypropylene-11 stearyl ether; liquid paraffin; dl-alpha-tocopherol; white soft paraffin; butane; methyl ether

Administration route:

Topical

Units in package:

60g, 60g x 2

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ENSTILAR is indicated for the topical treatment of psoriasis vulgaris in adults.

Product summary:

Visual Identification: The drug product is a white to off-white opalescent liquid in a pressurised aluminium spray can with a continuous valve and actuator. At administration the product is a white to off-white foam.; Container Type: Aerosol Can; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-10-11

Patient Information leaflet

Enstilar®
1
ENSTILAR®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ENSTILAR®?
Enstilar® is a combination product that contains the active
ingredients calcipotriol and betamethasone dipropionate. Enstilar®
is a topical treatment for a skin condition called psoriasis.
For more information, see Section 1. Why am I using Enstilar®? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ENSTILAR®?
Do not use if you have ever had an allergic reaction to Enstilar® or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Enstilar®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Enstilar® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ENSTILAR®?
•
Enstilar® is designed for direct application (spray on) to your skin
where it is affected by psoriasis
•
Enstilar® should be applied to dry skin on the affected areas of the
body or scalp
•
Your doctor will decide how much Enstilar® you need to use and for
how long
More instructions can be found in Section 4. How do I use Enstilar®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ENSTILAR®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Enstilar®
•
Protect the treated skin areas from sunlight and ultraviolet (UV) rays
•
Inform your doctor and pharmacist that you are using Enstilar® if you
are starting any new medicine
•
Tell your doctor immediately if you become pregnant while using
Enstilar®
THINGS YOU
SHOULD NOT DO
•
Do not give your medicine to anyone else, even if they have the same
condition as you
�

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
– ENSTILAR
® (CALCIPOTRIOL MONOHYDRATE
AND BETAMETHASONE DIPROPIONATE) FOAM SPRAY
1
NAME OF THE MEDICINE
Calcipotriol monohydrate
Betamethasone dipropionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enstilar
®
contains 50 micrograms of calcipotriol (as monohydrate) and 500
micrograms of
betamethasone (as dipropionate) per gram.
Excipients with known effect: butylated hydroxytoluene.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Foam Spray
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
T
HERAPEUTIC INDICATIONS
Topical treatment of psoriasis vulgaris in adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Enstilar
®
is for TOPICAL USE ONLY. Do not use if the pack shows signs of damage
or
tampering.
ADULTS:
_Flare treatment _
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. Treatment
of relapses has been found to be efficacious and well tolerated.
_Long-term maintenance treatment _
Patients who have responded at 4 weeks treatment using Enstilar
®
once daily are suitable for
long-term maintenance treatment. Refer to section 5.1 Clinical trials.
Enstilar
®
should be applied twice weekly on two non-consecutive days to areas
previously
affected by psoriasis vulgaris. Between applications there should be
2-3 days without
Enstilar
®
treatment.
eDoc-000832419 - Version
6. 0
2
If signs of a relapse occur, flare treatment, as described above,
should be re-initiated.
_Maximum dose _
The maximum daily dose of Enstilar
®
should not exceed 15 g, i.e. one 60 g can should last
for at least 4 days of treatment. 15 g corresponds to the amount
administered from the can if
the actuator is fully depressed for approxi