Royce Hydrocortisone Acetate Cream 1% ww

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

HYDROCORTISONE ACETATE

Disponible depuis:

ROYCE PHARMA MANUFACTURING SDN. BHD.

DCI (Dénomination commune internationale):

HYDROCORTISONE ACETATE

Unités en paquet:

100 gm; 15 gm; 450 gm; 15 gm

Fabriqué par:

ROYCE PHARMA MANUFACTURING SDN. BHD.

Notice patient

ROYCE HYDROCORTISONE ACETATE
CREAM
Hydrocortisone Acetate (1% w/w)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Royce
Hydrocortisone
Acetate Cream 1% w/w is used for
2.
How
Royce
Hydrocortisone
Acetate Cream 1% w/w works
3.
Before
you
use
Royce
Hydrocortisone Acetate Cream 1%
w/w
4.
How to use Royce Hydrocortisone
Acetate Cream 1% w/w
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Royce
Hydrocortisone Acetate Cream 1%
w/w
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ROYCE HYDROCORTISONE ACETATE
CREAM 1% W/W IS USED FOR
For the treatment of skin inflammation
such as:

Eczema

Prurigo;

Neurodermatoses

Discoid
lupus
erythematosus,
generalized erythroderma.
HOW ROYCE HYDROCORTISONE ACETATE
CREAM 1% W/W WORKS
The active ingredient, hydrocortisone,
is
a
corticosteroid
that
has
an
anti-
inflammatory,
anti-itch
and
blood
vessel narrowing actions.
BEFORE
YOU
USE
ROYCE
HYDROCORTISONE ACETATE CREAM 1%
W/W
_-When you must not use it _
Do
not
use
Royce
Hydrocortisone
Acetate Cream 1% w/w if you have:

Known allergies to hydrocortisone
or any of the other ingredients used
in this medicine.

Skin lesion caused by infection with
viruses
(e.g.
herpes
simplex,
chickenpox).

Skin
conditions
caused
by
fungal
(e.g. candidiasis, tinea) or bacterial
infection (e.g. impetigo).
If you are not sure whether you should
start using this medicine, talk to your
doctor or pharmacist.
_-Before you start to use it _

Do not use around eyes to avoid
contact.

Do not bandage or wrap the treated
skin area unless directed to do so by
physician.
Avoid
applying
the
cream
under
an
airtight
dressing,
including
a
child’s
nappy.
These
dressings
make
it
easier
for
the
active ingredient to pass through the
skin. It is possible to accidentally
end up using too much cream.

Tell your pharmacist or doctor if
you have infection on your skin and
specify on the infected area.
_PREGNANCY AND BREASTFEEDING _
Ask
your
doc

Résumé des caractéristiques du produit

1
4
Hydrocortisone
Acetate Cream 1% w/w
(Hydrocortisone Acetate- Topical Corticosteroid)
PRESENTATION:
A white colour, smooth cream.
CONTENT:
Hydrocortisone Acetate 1% w/w
PRESERVATIVES:
Methylparaben 0.08% w/w
Propylparaben 0.15% w/w
PHARMACOLOGICAL INFORMATION:
Following
topical
application,
hydrocortisone
produce
anti-
inflammatory,
antipruritic
and
vasoconstrictor
actions.
The
activity of the drugs is thought to result at least in part from
binding
with
a
steroid
receptor.
Hydrocortisone
decrease
inflammatory by stabilizing leukocyte lysosomal membranes,
preventing
release
of
destructive
acid
hydrolyses
from
leukocytes;
inhibiting
macrophage
accumulation
in
inflamed
areas; reducing leukocyte adhesion to capillary endothelium;
reducing
capillary
w a l l
permeability
and
edema
formation;
decreasing complement components; antagonizing histamine
activity and release of kinin from substrates; reducing fibroblast
proliferation,
collagen
deposition
and
subsequent
scar
tissue formation.
Percutaneous
penetration
of
hydrocortisone
varies
among
individual patients and can be increased by the use of occlusive
dressings, by increasing the concentration of the hydrocortisone
and by using different vehicles. Following topical application of
a
hydrocortisone
to
most
areas
of
normal
skin
only
minimal
amounts
of
the
drug
reach
the
dermis
and
subsequently
the systemic circulation, however absorption is
markedly increased when the skin has lost its keratin layer.
STORAGE CONDITION:
Keep container tightly closed. Store in a dry place (below
30
o
C). Protect from light.
PACK SIZE:
i)
15g & 100g in an aluminium tube.
ii)
450g of cream in a plastic jar (for tender only).
REGISTRATION NUMBER:
MAL19870461AZ
F u r t h e r
i n f o r m a t i o n
c a n
b e
o b t a i n e d
f r o m
y o u r
d o c t o r
or
pharmacist.
PRODUCT HOLDER/ MANUFACTURED BY:
ROYCE PHARMA MFG SDN. BHD.
650435-X
PT 1663, Nilai Industrial Estate,
71800 Nilai, Negeri Sembilan, Malaysia.
Revision Date: 290917
®
®
2
3
The drugs are absorbed to a greater degree from t