BETA CREAM 0.1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BETAMETHASONE

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

BETAMETHASONE

Unit dalam pakej:

20 gm; 15 gm

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BETA CREAM 0.1%
Betamethasone 17-Valerate BP (0.1% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Beta Cream is used for
2.
How Beta Cream works
3.
Before you use Beta Cream
4.
How to use Beta Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
8.
Product Description
9.
Manufactured by and Product
Registration Holder
10.
Date of revision
WHAT BETA CREAM 0.1%
IS USED FOR
Beta Cream 0.1% contains the active
ingredient betamethasone 17-valerate,
which is a type of medicine called a
topical corticosteroid.
Betamethasone
Valerate
is
a
potent
corticosteroid
that
can
be
applied
topically
to
treat
eczema
including
infantile (crusty, flaky patches on the
baby's
skin),
atopic
(dry,
itchy
and
inflamed
skin),
contact,
Seborrhoeic
(scaly
patches,
inflamed
skin
and
stubborn
dandruff)
and
neuro-
dermatitis (chronic itching or scaling).
Other
indication
include
to
treat
dermatitis herpetiformis (bumpy, itchy
skin
rash
in
people
with
celiac
disease),
psoriasis
(chronic
itchy,
scaly patches) and intertrigo (common
inflammatory skin condition).
HOW BETA CREAM 0.1%
WORKS
Betamethasone
Valerate
is
a
corticosteroids
and
is
used
for
its
antiinflammatory, antipruritic (relieve
itching)
and
vasoconstrictive
(constriction of blood vessel) actions
on the skin.
BEFORE YOU USE BETA CREAM 0.1%
_When you must not use it _

If you are allergic (hypersensitive)
to
Betamethasone
17-Valerate
or
any of the other ingredients of Beta
Cream 0.1%.

If you have tuberculous infection of
skin,
fungus
infection,
herpes
simplex,
vaccinia,
varicella
and
extensive open wound.
_ _
_Before you start to use it _
You must tell your doctor if:

You have allergies to any medicine
which you have taken previously to
treat your current condition. .

You are pregnant, trying to become
pregnant or breast-feeding.
_Taking other medicines _
Always
inform
your
doctor
and
pharmacist if you are taking any other
medicines,
including
herbal
tonics,
supplements and medicines that you
buy without prescrip

Ciri produk

BETA CREAM 0.1%
NAME AND STRENGTH OF ACTIVE INGREDIENTS(S) :
Betamethasone 17-Valerate
equivalent to Betamethasone BP
………………………..……………….…...… 0.1 % w/w
Preservatives:
Methyl Paraben
…………………………………………….……………..………
0.15% w/w
Propyl Paraben
.……………………………………………..…………..…….….
0.08% w/w
PRODUCT DESCRIPTION :
White to off-white colour, smooth, homogenous cream.
PHARMACODYNAMICS :
It is mostly metabolized in skin.
PHARMACOKINETICS :
Betamethasone: It is absorbed systemically. Occlusion or use over
extensive areas
increases absorption of topical dosage forms. It is mostly metabolized
in skin.
INDICATIONS :
For the treatment of eczema, infantile eczema, atopic dermatitis,
dermatitis herpetiformis,
contact dermatitis, seborrhoeic dermatitis, neuro-dermatitis, forms of
psoriasis and
intertrigo.
RECOMMENDED DOSE :
Apply a thin layer to the affected skin area one to three times daily.
When dilution is
required, the diluted cream should not be used two weeks after issue.
MODE OF ADMINISTRATION :
Topical.
CONTRAINDICATIONS :
In tuberculous infection of skin, fungus infection, herpes simplex,
vaccinia, varicella and
extensive open wound.
WARNING AND PRECAUTIONS :
Prolong use or use of large amount should be avoided.
INTERACTIONS WITH OTHER MEDICAMENTS :
Not Know Drug Interaction.
PREGNANCY AND LACTATION :
Pregnancy Risk Factor C
SIDE EFFECTS :
Impaired
wound
healing,
petechiae
and
ecchymosis,
facial
erythema,
increased
sweating, may suppress reactions to the skin tests.
_ _
STORAGE CONDITIONS :
Keep container tightly closed. Store below 30°C. Protect from
freezing, heat and direct
light.
PACKAGING AVAILABLE :
15 gm tube
20 gm tub
REGISTRATION NUMBER :
MAL19860147AZ
MANUFACTURER & PRODUCT REGISTRATION HOLDER :
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
Plot 61, Bayan Lepas Industrial Park Phase 4,
Lintang Bayan Lepas 1, 11900 Bayan Lepas,
Pulau Pinang, Malaysia.
DATE OF REVISION OF PACKAGE INSERT
22 March 2