Enstilar 50 micrograms/0.5mg/g cutaneous foam.

מדינה: מלטה

שפה: אנגלית

מקור: Malta Medicines Authority

מרכיב פעיל:

CALCIPOTRIOL MONOHYDRATE, BETAMETHASONE DIPROPIONATE

זמין מ:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

קוד ATC:

D05AX52

INN (שם בינלאומי):

CALCIPOTRIOL MONOHYDRATE 50 µg/g BETAMETHASONE DIPROPIONATE 0.5 mg/g

טופס פרצבטיות:

CUTANEOUS FOAM

הרכב:

CALCIPOTRIOL MONOHYDRATE 50 µg/g BETAMETHASONE DIPROPIONATE 0.5 mg/g

סוג מרשם:

POM

איזור תרפויטי:

ANTIPSORIATICS

מצב אישור:

Authorised

תאריך אישור:

2016-04-12

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENSTILAR 50 MICROGRAMS/0.5 MG/G CUTANEOUS FOAM
calcipotriol/betamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Enstilar is and what it is used for
2.
What you need to know before you use Enstilar
3.
How to use Enstilar
4.
Possible side effects
5.
How to store Enstilar
6.
Contents of the pack and other information
1.
WHAT ENSTILAR IS AND WHAT IT 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.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ENSTILAR
DO NOT USE ENSTILAR:
■
if you are allergic to calcipotriol, betamethasone or any of the other
ingredients of this medicine
(listed in section 6)
■
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.

מאפייני מוצר

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Enstilar 50 micrograms/0.5mg/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.
3
_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
calcipotriol c