Enstilar® (Calcipotriol 50 mcgg + Bethamethasone Dipropionate 0.5 mgg) Cutaneous Foam

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Betamethasone Dipropionate; Calcipotriol monohydrate

Available from:

DKSH MALAYSIA SDN. BHD.

INN (International Name):

Betamethasone Dipropionate; Calcipotriol monohydrate

Units in package:

60 gm

Manufactured by:

LEO Laboratories Ltd

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ENSTILAR CUTANEOUS FOAM
®
Calcipotriol/Betamethasone (50mcg / 0.5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Enstilar is used for
2.
How Enstilar works
3.
Before you use Enstilar
4.
How to use Enstilar
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Enstilar
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ENSTILAR IS USED FOR
Enstilar is used on the skin to treat
psoriasis vulgaris in adults. Psoriasis is
caused by your skin cells being
produced too quickly. This causes
redness, scaling and thickness of your
skin.
HOW ENSTILAR WORKS
Enstilar contains calcipotriol and
betamethasone. Calcipotriol helps to
bring the rate of skin cell growth
back to normal and betamethasone
helps to reduce the inflammation.
BEFORE YOU USE ENSTILAR
-
_When you must not use it_
_ _
Do not use Enstilar:
■
if you are allergic to calcipotriol,
betamethasone or any of the other
ingredients of this medicine
(listed in section Product Description)
■
if you have problems with calcium
levels in your blood (ask your doctor)
■
if you have certain types of psoriasis
called: erythrodermic psoriasis or
pustular psoriasis (ask your doctor if
you are unsure).
As Enstilar contains a strong steroid, do
NOT use Enstilar on skin areas affected
by:
■
skin infections caused by viruses
(e.g. cold sores or chicken pox)
■
skin infections caused by a fungus
(e.g. athlete
’
s foot and ringworm)
■
skin infections caused by bacteria
■
skin infections caused by parasites
(e.g. scabies)
■
tuberculosis (TB)
■
perioral dermatitis (red rash around
the mouth)
■
thin skin, easily damaged veins,
stretch marks
■
ichthyosis (dry skin with fish-like
scales)
■
acne (pimples)
■
rosacea (severe flushing or redness
of the skin on the face)
■
ulcers and wounds.
_Pregnancy and breast-feeding _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor for advice bef

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enstilar® 50 micrograms/g + 0.5 mg/g cutaneous foam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cutaneous foam contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5
mg of betamethasone (as dipropionate).
Excipient with known effect:
Butylhydroxytoluene (E321) 50 micrograms/g cutaneous foam.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous foam.
After spraying, a white to off-white foam is formed.
The foam has the appearance of a 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
_Flare treatment _
Enstilar® foam 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
supervision.
_Long-term maintenance treatment _
Patients who have responded at 4 weeks’ treatment using Enstilar
once daily are suitable for
long-term maintenance treatment. 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. If signs of a relapse
occur, flare treatment, as
described above, should be re-initiated.
_Maximum dose _
The daily maximum 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 approximately one minute. A two-second
application delivers
approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of
skin roughly
corresponding to the surface area of an adult hand.
If using other topical products containing calcipotriol in addition to
Enstilar®, the total dose of
all calcipotri