BETNOVATE CREAM 0.1%

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
26-05-2023
Ciri produk Ciri produk (SPC)
30-01-2023

Bahan aktif:

BETAMETHASONE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

BETAMETHASONE

Unit dalam pakej:

15gm mcg/mL; 100gm mcg/mL

Dikeluarkan oleh:

GLAXO WELLCOME OPERATIONS

Risalah maklumat

                                _ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BETNOVATE CREAM
Betamethasone valerate 0.1%
1
WHAT IS IN THIS LEAFLET
1.
What Betnovate is used for
2.
How Betnovate works
3.
Before you use Betnovate
4.
How to use Betnovate
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Betnovate
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT BETNOVATE IS USED FOR
Betnovate relieves the
inflammatory and itching skin
problems which are responsive
to steroid including:
eczema, psoriasis, dandruff,
allergic reactions, insect bites,
prickly heat and other
conditions.
For children over the age of one
year Betnovate is used for skin
condition that has not responded
to milder steroid creams or
ointments.
HOW BETNOVATE WORKS
Betnovate belongs to a group of
medicines called steroids.
Steroids help to reduce redness,
swelling and irritation of the
skin.
BEFORE YOU USE BETNOVATE
-
_When you must not use it _
Do not use Betnovate to treat
any of the following skin
problems, it could make them
worse:
•
infected skin (unless the
infection is being treated with
an anti-infective medicine at
the same time)
•
acne
•
face redness
•
rashes around the mouth
•
itchy skin which is not
inflamed
•
itchiness around the anus or
genitals (penis and vagina)
•
on children under 1 year
If you think any of these apply
to you, do not use Betnovate
until you have checked with
your doctor or pharmacist.
-
_Before you start to use it _
If you are pregnant, or think you
could be, or if you are planning
to become pregnant, do not use
Betnovate without talking to
your doctor first.
If you are breast-feeding, you
must check with your doctor
before you use Betnovate.
If you do use Betnovate when
breast-feeding, do not use
Betnovate on your breast area to
ensure that the baby does not
accidentally get Betnovate in
their mouth.
_ _
-
_Taking other medicines _
Some medicines may affect how
Betnovate works or make it
more likely that you will have
side effects. Examples of these

                                
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Ciri produk

                                CONFIDENTIAL
[GSK logo]
BETNOVATE
Betamethasone 17-valerate
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betnovate Cream is a smooth white cream containing 0.1% w/w
betamethasone 17-
valerate in a water miscible cream based. Betnovate Cream also
contains chlorocresol
0.1% w/w as preservative.
CLINICAL INFORMATION
INDICATIONS
_BETNOVATE _
is a potent topical corticosteroid indicated for adults, elderly and
children
over 1 year for the relief of the inflammatory and pruritic
manifestations of steroid
responsive dermatoses. These include the following:
-
Atopic dermatitis (including infantile atopic dermatitis)
-
Nummular dermatitis (discoid eczema)
-
Prurigo nodularis.
-
Psoriasis (excluding widespread plaque psoriasis)
-
Lichen simplex chronicus (neurodermatitis) and lichen planus
-
Seborrhoeic dermatitis.
-
Irritant or allergic contact dermatitis
-
Discoid lupus erythematosus
-
Adjunct to systemic steroid therapy in generalised erythroderma
-
Insect bite reactions
-
Miliaria (prickly heat)
DOSAGE AND ADMINISTRATION
PHARMACEUTICAL FORM
Cream
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire
affected area once or
twice daily for up to 4 weeks until improvement occurs, then reduce
the frequency of
application or change the treatment to a less potent preparation.
Allow adequate time for
absorption after each application before applying an emollient.
CONFIDENTIAL
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and
knees, the effect of
_BETNOVATE_
can be enhanced, if necessary, by occluding the
treatment area with polythene film. Overnight occlusion only is
usually adequate to bring
about a satisfactory response in such lesions; thereafter, improvement
can usually be
maintained by regular application without occlusion.
If the condition worsens or does not improve within 2-4 weeks,
treatment and diagnosis
should be re-evaluated.
ATOPIC DERMATITIS (ECZEMA)
Therapy wi
                                
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Risalah maklumat Risalah maklumat Bahasa Melayu 26-05-2023

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