BETNOVATE-N CREAM

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BETAMETHASONE ACETATE; NEOMYCIN SULPHATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

BETAMETHASONE ACETATE; NEOMYCIN SULPHATE

Unit dalam pakej:

15 gm

Dikeluarkan oleh:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
BETNOVATE-N CREAM
Betamethasone 17-valerate/neomycin sulphate (0.1/0.5% w/w)
______________________________________________________________________________________________
1
What is in this leaflet
1. What BETNOVATE-N is
used for
2. How BETNOVATE-N
works
3. Before you use
BETNOVATE-N
4. How to use BETNOVATE-N
5. While you are using it
6. Side Effects
7. Storage and Disposal of
BETNOVATE-N
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
What BETNOVATE-N is used
for
BETNOVATE-N relieves the
symptoms of certain skin
problems which may be
infected, including:
eczema, psoriasis, lichen
simplex, lichen planus, contact
sensitivity reactions, insect bites
and other conditions.
How BETNOVATE-N works
The name of your medicine is
BETNOVATE-N.
BETNOVATE-N contains
betamethasone valerate which
belongs to a group of medicines
called steroids and neomycin
sulphate which is an antibiotic.
Steroids help to reduce redness,
swelling and irritation of the
skin. Antibiotics help to treat
bacterial infections.
Before you use BETNOVATE-
N
- When you must not use it
Do not use BETNOVATE-N
 on children under 2 years
 on large areas for a prolonged
period of time
 to treat any of the following
skin problems - it could make
them worse:
- viral infections such as cold
sores, herpes or chicken pox
- fungal infections such as
ringworm, athlete’s foot, or
thrush
- acne
- face redness
- rashes around the mouth
- itchy skin which is not
inflamed
- inflamed, red, flaky skin of
the outer ear and ear canal if
your ear drum is perforated
- itching around the anus or
genitals (penis and vagina).
If you think any of these apply
to you, do not use
BETNOVATE-N until you have
checked with your doctor or
pharmacist.
- Before you start to use it
 Tell your doctor if you are
allergic (hypersensitive) to
BETNOVATE-N or any of
the ingredients of
BETNOVATE-N.
 Do not dilute BETNOVATE-
N.
 If you experience blurred
vision or other visual
disturbances,

Ciri produk

CONFIDENTIAL
[GSK logo]
BETNOVATE-N
BETAMETHASONE 17-VALERATE-NEOMYCIN SULPHATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_BETNOVATE-N _
Cream is a smooth white to off-white cream containing 0.1% w/w
betamethasone 17-valerate with 0.5% w/w neomycin sulphate.
_BETNOVATE-N_
Cream
also contains 0.1% w/w chlorocresol as preservative.
PHARMACEUTICAL FORM
Cream
CLINICAL INFORMATION
INDICATIONS
Betamethasone valerate is a potent topical corticosteroid indicated
for the relief of the
inflammatory and pruritic manifestations of steroid responsive
dermatoses. Neomycin
sulphate is an aminoglycoside broad spectrum antibiotic.
Topical preparations combining betamethasone valerate and neomycin
sulphate are
indicated for the treatment of the following conditions where
secondary bacterial
infection is present, suspected, or likely to occur:
−
Eczema including atopic infantile and discoid eczemas.
−
Prurigo nodularis.
−
Psoriasis (excluding widespread plaque psoriasis).
−
Neurodermatoses including lichen simplex, lichen planus.
−
Seborrhoeic dermatitis.
−
Contact sensitivity reactions.
−
Insect bites reactions.
−
Betnovate-N preparations can also be used in the management of
secondary
infected insect bites and anal and genital intertrigo.
_ _
DOSAGE AND ADMINISTRATION
_Cream _
_BETNOVATE-N_
cream is especially appropriate for moist or weeping surfaces.
ADULTS AND ADOLESCENTS
CONFIDENTIAL
Apply thinly and gently rub in using enough to cover the entire
affected area once or
twice daily for up to seven days, then change to another
corticosteroid preparation not
containing neomycin sulphate if further treatment is required. Allow
adequate time for
absorption after each application before applying an emollient.
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and
knees, the effect of
_BETNOVATE-N_
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, therea