ENSTILAR

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS MONOHYDRATE

Tersedia dari:

DEXCEL LTD, ISRAEL

Kode ATC:

D05AX52

Bentuk farmasi:

CUTANEOUS FOAM

Komposisi:

BETAMETHASONE AS DIPROPIONATE 0.5 MG / 1 G; CALCIPOTRIOL AS MONOHYDRATE 50 MCG / 1 G

Rute administrasi :

TOPICAL

Jenis Resep:

Required

Diproduksi oleh:

LEO PHARMA A/S , DENMARK

Area terapi:

CALCIPOTRIOL, COMBINATIONS

Indikasi Terapi:

Topical treatment of psoriasis vulgaris in adults

Tanggal Otorisasi:

2020-03-10

Selebaran informasi

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine can be sold with a physician’s prescription only
®
NSTILAR
E
CUTANEOUS FOAM
ACTIVE INGREDIENTS:
Betamethasone (as dipropionate) 0.5 mg/g
Calcipotriol (as monohydrate) 50 mcg/g
Inactive ingredients and allergens in the medicine - see section 6
"Additional information" and in
section 2 "Important information about some of the ingredients of the
medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
you think that their medical condition is the same as yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
ENSTILAR is used on the skin to treat psoriasis vulgaris in adults.
THERAPEUTIC GROUP:
Calcipotriol
–
a synthetic vitamin D derivative used for external treatment of
psoriasis.
Betamethasone
–
a synthetic corticosteroid.
Psoriasis is caused by the skin cells being produced too quickly,
which causes redness, scaling and
thickening of the skin.
ENSTILAR contains Calcipotriol and Betamethasone. Calcipotriol helps
control the rate of skin cell
formation and Betamethasone reduces inflammation.
2.
BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
•
You are hypersensitive (allergic) to the active ingredients
(Calcipotriol, Betamethasone) or to
any of the other ingredients this medicine contains (see section 6).
•
You have problems with calcium levels in the blood (ask the doctor).
•
You have certain types of psoriasis: erythrodermic or pustular
psoriasis (ask the doctor if you
are unsure).
•
As ENSTILAR contains a strong steroid, do NOT use ENSTILAR on skin
areas affected by:
o
skin infections caused by viruses (e.g. cold sores or chicken pox)
o
skin infections caused by a fungus (e.g. athlete’s foot or ringworm)
o
skin infections caused by bacteria
o
skin infections caus

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enstilar
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of psoriasis vulgaris in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Enstilar foam should be applied to the affected area once daily. The
recommended treatment period is 4 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 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 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 foam in patients with severe renal
insufficiency or severe hepatic disorders have not
been evaluated.
_Paediatric population_
The safety and efficacy of Enstilar foam in children below 18 years
have not been established. Enstilar is not indicated for
children below 18 years of age.
Method of administration
For cutaneous use.
The can should be shaken for a few seconds before use. Enstilar should
be applied by spraying holding the can at least
3 cm from the skin. The foam can be sprayed holding the can in any
orientation except horizontally.
Enstilar should be sprayed d