EFFICORT CREAM

Country: Malaysia

Language: English

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

Active ingredient:

HYDROCORTISONE ACEPONATE

Available from:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (International Name):

HYDROCORTISONE ACEPONATE

Units in package:

15gm mcg/mL; 30gm mcg/mL

Manufactured by:

LICHTENHELDT GMBH, PHARMAZEUTISCHE FABRIK

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
EFFICORT
®
CREAM
Hydrocortisone aceponate
1
What is in this leaflet
1.
What is Efficort
®
Cream used
for
2.
How Efficort
®
Cream works
3.
Before you use Efficort
®
Cream
4.
How to use Efficort
®
Cream
5.
While you are using Efficort
®
Cream
6.
Side Effects
7.
Storage and disposal of
Efficort
®
Cream
8.
Product description
9.
Manufacturer
10.
Product registration
holder
11.
Date of revision
WHAT IS EFFICORT® CREAM USED FOR
Efficort
®
Cream
is
best
used
for
contact
dermatitis,
atopic
dermatitis
such
as
eczema,
psoriasis
and lichenification.
HOW EFFICORT® CREAM WORKS
Efficort
Cream
contains
menthol
hydrocortisone
acepoanate
which
acts
on
certain
inflammatory
and
allergic
processes
occurring
in
the
course
of
atopic
and/or
contact
dermatitis.
BEFORE YOU USE EFFICORT
® CREAM
WHEN YOU MUST NOT USE
EFFICORT
® CREAM
Efficort
®
Cream must not be used
on open wounds or damage skin.
HOW TO USE EFFICORT
® CREAM
Squeeze the tube gently at its base to
place
a
quantity
of
cream
on
the
fingertips sufficient to cover the area
to be treated. Wash hands thoroughly
and replace cap tightly after use.
HOW MUCH TO USE
ADULTS:
Unless
otherwise
prescribed,
Efficort
®
Cream should
be
applied once to twice daily in a
thin layer over the affected skin
areas. For the application
to
be
reasonable
it
is
advisable to dab a small amount of
product
on
to
several
sites
at
the
affected areas and to gently massage
in
until
has
been
completely
absorbed.
Application should be limited to twice
a day. An increase in the number of
daily applications would be likely to
aggravate
the
side
effects
without
improving the therapeutic efficacy of
the preparation.
INFANTS AND YOUNG CHILDREN
Unless otherwise prescribed, one daily
application
is
generally
adequate.
Continuous daily treatment should be
limited
to
a
short
period
(about
1
week). If used for a longer duration,
periodical steroid-free breaks should be
interposed. Occlusive dressings should
be
avoided
in
infants
and
young
children.
WHEN TO

Summary of Product characteristics

PRODUCT INFORMATION
COMPOSITION
Efficort Cream contains hydrocortisone aceponate 0.127% w/w
as the active ingredient in an oil-in-water cream base containing
selfemulsifying
wax,
white
petrolatum,
stearyl
alcohol,
benzyl
alcohol and purified water.
PHARMACEUTICAL FORM
Efficort Cream is for cutaneous use only.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC
PROPERTIES:
Efficort
is
a
potent
corticosteroid (class II) according to the European classification.
It acts on certain inflammatory and allergic processes occurring in
the course of atopic and/or contact dermatitis and on pruriginous
effects linked to these processes. It has a vasoconstrictor (anti-
exudative)
activity
and
it
inhibits
cellular
replication
and
the
synthesis processes in the dermis and epidermis.
PHARMACOKINETIC PROPERTIES: Systemic absorption measured in
terms of the effect on blood cortisol levels occurs after cutaneous
application of Efficort.
The extent of absorption and of systemic effects depends on the
area treated and the condition of the epidermis, the duration of
the treatment: the more the treatment is prolonged, the greater
the likelihood of these effects is, the site of application, the use
of
occlusive dressings.
PRECLINICAL
SAFETY
DATA:
In
animal
studies,
hydrocortisone
aceponate was well tolerated on cutaneous application for periods
of up to six months in rats and rabbits. The major symptoms
of
toxicity
found
in
all
animal
species
by
systemic
routes
of
administration were related to adrenocorticosteroid effects, and
included
alterations
of
the
pituitary-adrenal
axis,
and
a
slight
anemia.
Principal
organs
of
toxicity
were
the
stomach,
liver,
adrenal, pituitary, lungs and spleen. In the cutaneous route studies
hydrocortisone aceponate the majority of these findings were
either absent or considerably reduced in magnitude.
INDICATIONS AND USAGE
Efficort
is
recommended
for
steroid-responsive
dermatoses
(eczema, atopic dermatitis, psoriasis, lichenification).
Efficort
Cream
is
recommended
for
the
treatment
of
acute
exudative lesions.
CONTR