EFFICORT CREAM

País: Malásia

Língua: inglês

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

Ingredientes ativos:

HYDROCORTISONE ACEPONATE

Disponível em:

PHARMAFORTE (MALAYSIA) SDN. BHD.

DCI (Denominação Comum Internacional):

HYDROCORTISONE ACEPONATE

Unidades em pacote:

15gm mcg/mL; 30gm mcg/mL

Fabricado por:

LABS GALDERMA

Folheto informativo - Bula

_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 take Efficort
®
Cream
While you are using
5.
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 USED FOR
Efficort
®
Cream
is
best
used
for
contact dermatitis, atopic dermatitis
such
as
eczema,
psoriasis
and
lichenification.
HOW 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 USE IT
Efficort
®
Cream is recom

Características técnicas

EFFICORT
HYDROCORTISONE ACEPONATE
CREAM 0,127%
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 corticos-
teroid (class II) according to the European classification.
It acts on certain inflammatory and allergic processes occur-
ring 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 f