Beta Fusidic Cream

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
21-11-2022
Ciri produk Ciri produk (SPC)
21-11-2022

Bahan aktif:

Fusidic Acid (Micronised); BETAMETHASONE-17 VALERATE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

Fusidic Acid (Micronised); BETAMETHASONE-17 VALERATE

Unit dalam pakej:

15 gm; 50 x 15 gm

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

                                Consumer Medication Information Leaflet (RiMUP)
BETA FUSIDIC CREAM
Fusidic Acid (2% w/w) dan Betamethasone 17-Valerate (0.12% w/w)
1
What is in this leaflet
1.
What Beta Fusidic Cream is
used for
2.
How Beta Fusidic Cream works
3.
Before you use Beta Fusidic
Cream
4.
How to use Beta Fusidic Cream
5.
While you are using Beta Fusidic
Cream
6.
Side effects
7.
Storage and Disposal of Beta
Fusidic Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What Beta Fusidic Cream is used
for
It is used to treat bacterial
inflammatory including itchy, redness
and dry skin where the skin is
infected by germs.
How Beta Fusidic Cream works
It contains fusidic acid which is an
antibiotic that kills the susceptible
germs that cause infections.
It also contains betamethasone
velerate which is a steroid that
reduces swelling, redness or itchiness
of the skin.
Before you use Beta Fusidic Cream
When you must not use it

Allergic to Beta Fusidic Cream
or other ingredients of Beta
Fusidic Cream.

To treat a condition called acne
rosacea (redness and
inflammation over nose and
cheeks) or perioral dermatitis (red
spotty rash around mouth or chin)
or fungus (athlete’s foot).
Before you start to use it

Caution when using near the eyes
as it may cause irritation.

Inform the doctor if pregnant or
lactating

Do not use on open wounds or
sensitive areas such as nostrils,
ears, lips or genitals unless on
doctor’s prescription.
Taking other medicines
Please inform the doctor or
pharmacist if taking other medicines.
The medicine usually will have
minimal effect on ability to drive or
use machines. However, please check
with doctor if any side effects may
effect on ability to drive or use
machines.
How to use Beta Fusidic Cream
How much to use
Uncovered Lesion: Apply to affected
area 2-3 times daily.
Covered Lesion: Less frequent
application may be adequate.
When to use it
Please follow the advice of the doctor
or pharmacist.
How long to use it
Do not use for a long time on face.
You
                                
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Ciri produk

                                BETA FUSIDIC CREAM
MALxxxxxxxxAZ
DESCRIPTION:
CREAM
Colour
:
White
Fragrance :
Natural
CONTENT:
Fusidic Acid
...........................................................................................
2.0%
w/w
Betamethasone 17-Valerate equivalent to Betamethasone
.................. 0.1%
w/w
Chlorocresol
...........................................................................................
0.1%
w/w
PHARMACODYNAMIC:
Beta Fusidic Cream combines the well-known anti-inflammatory and
antipruritic effects of betamethasone with the potent topical
antibacterial action of Fusidic Acid.
Betamethasone Valerate is a topical steroid rapidly effective in those
inflammatory dermatoses which normally respond to this form
of therapy.
When applied topically, Fusidic Acid is effective against Staphyloccus
aureus, Streptococci, Corynebacteria, Neisseria and certain
Clostridia and Bacteroides. The antibacterial activity of Fusidic Acid
is not diminished in the presence of betamethasone.
PHARMACOKINETICS:
There are no data which define the pharmacokinetics of Fusidic Acid,
following topical administration in man.
However, in vitro studies show that Fusidic Acid can penetrate intact
human skin. The degree of penetration depends on factors such
as the duration of exposure to Fusidic Acid and the condition of the
skin. Fusidic Acid is excreted mainly in the bile with little excreted
in the urine.
Betamethasone is absorbed following topical administration. The degree
of absorption is dependent on various factors including skin
condition and site of application. Betamethasone is metabolised
largely in the liver but also to a limited extent in the kidneys, and
the
inactive metabolites are excreted with the urine.
INDICATIONS:
Beta Fusidic Cream is indicated in inflammatory dermatoses where
bacterial infection is present or likely to occur. Inflammatory
dermatoses include atopic eczema, discoid eczema, stasis eczema,
seborrhoeic, dermatitis, contact dermatitis, lichen simplex
chronicus, psoriasis, discoid lupus erythematosus.
RECOMMENDED
                                
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