ROYCE BETASONE CREAM 0.1 % WW

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE

Available from:

ROYCE PHARMA MANUFACTURING SDN. BHD.

INN (International Name):

BETAMETHASONE

Units in package:

500 gm; 30 gm; 10 gm; 15 gm

Manufactured by:

ROYCE PHARMA MANUFACTURING SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ROYCE BETASONE CREAM 0.1 % W/W
_ _
Betamethasone Valerate (0.1%w/w)
_ _
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Royce Betasone Cream 0.1% w/w
is used for
2.
How Royce Betasone Cream 0.1% w/w
works
3.
Before you use Royce Betasone Cream
0.1% w/w
4.
How
to
use
Royce
Betasone
Cream
0.1% w/w
5.
While you are using Royce Betasone
Cream 0.1% w/w
6.
Side effects
7.
Storage and disposal of Royce Betasone
Cream 0.1% w/w
8.
Product description
9.
Manufacturer and Product registration
holder
10.
Date of revision
WHAT ROYCE BETASONE CREAM 0.1% W/W
IS USED FOR
Betamethasone valerate is an active topical
corticosteroid
which
produces
a
rapid
response
in
those
inflammatory
skin
conditions that are normally responsive to
topical corticosteroid therapy.
HOW ROYCE BETASONE CREAM 0.1% W/W
WORKS
Betamethasone
17
Valerate
is
a
topical
corticosteroid and is an anti-inflammatory
agent.
BEFORE YOU USE ROYCE BETASONE CREAM
0.1% W/W
_-When you must not use it _
Do not take Royce Betasone Cream 0.1%
w/w if you:

are pregnant.
_ _

are breast-feeding.
_ _

are
allergic
(hypersensitive)
to
Betamethasone or other ingredients in
this product.
_ _
_ _
Ask your doctor or pharmacist for advice
before taking any medicine.
_-Before you start to use it: _
Tell your doctor or pharmacist if you are
suffering or have ever suffered from any of
the following conditions or illnesses:

Facial redness.

Acne and small bumps around the
mouth.

Skin
lesions
caused
by
infection
with
viruses
(e.g.
herpes
simplex,
chickenpox), fungi (e.g. candidiasis;
tinea) or bacteria (e.g. impetigo).
_ -Taking other medicines: _
Tell your doctor or pharmacist if you
are taking or have recently taken any
other
medicines,
including
medicines
obtained without a prescription.
Betamethasone is often effective in the
less responsive conditions and increased
risk
of
low
potassium
level
with
amphotericin
(avoid
concomitant
use
unless
corticosteroids
required
to
control reactions).
HOW TO TAKE ROYCE BETASONE CREAM
0

Summary of Product characteristics

1
4
Royce Betasone Cream 0.1%
w/w
(Betamethasone Valerate – Topical
Corticosteroid)
of
methylprednisolone
and
possibly
other
corticosteroids;
itraconazole possibly inhibits metabolism of methylprednisolone.
SYMPTOMS AND TREATMENT OF OVERDOSE:
No
overdosage
symptoms
occur
except
on
excessive
use
of
steroid cream may cause systemic absorption that may result in
adrenal suppresion.
STORAGE CONDITION:
Keep container tightly closed. Store in a dry place (below
30
o
C). Protect from light.
PACK SIZE:
Plastic jar containing 500g of cream.
Aluminium tube containing 10g, 15g and 30g of cream.
PRODUCTS REGISTRATION NUMBER:
MAL19870604AZ
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
doctor or
pharmacist.
PRODUCT REGISTRATION HOLDER / MANUFACTURED BY:
ROYCE PHARMA MFG. SDN.BHD. (650435-X)
PT 1663, Nilai Industrial Estate,
71800 Nilai, Negeri Sembilan Darul Khusus, Malaysia.
Revision date:13122
PRESENTATION :
A white colour, smooth cream.
CONTENTS:
Betamethasone (17-Valerate) 0.1%w/w
PRESERVATIVES:
Methyl Paraben 0.15%w/w
Propyl Paraben 0.08%w/w
PHARMACOLOGICAL INFORMATION:
Betamethasone 17 Valerate is an topical corticosteroid and
is a
v e r y
a c t i v e
anti-inflammatory agent. Bethamethasone 17
V a l e r a t e
p r o d u c e s
a
r a p i d
r e s p o n s e
i n
those
inflammatory
dermatoses such as eczemas. Betamethasone
is a synthetic glucocorticoid and has the general properties as
C o r t i c o s t e r o i d s .
When
administrated
by
topical
application,
particularly under an occlusive
dressing
or
when
the
skin
is
broken. Sufficient steroid may
b e
a b s o r b e d
t o
g i v e
systemic
e f f e c t s .
Betamethasone valerate
is
absorbed
through
the
skin
when
applied
topically.
It is
metabolized
mainly
in
the
liver
but
also in the kidney, and is excreted in the urine.
INDICATION:
Betamethasone valerate is an active topical corticosteroid which
produces
a
rapid
response
in
those
inflammatory dermatoses
that
are
normally
responsive
to
topical
corticosteroid
therapy. Betasone
is
indicated
for
th