BENOSONE CREAM

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE VALERATE

Available from:

HOE PHARMACEUTICALS SDN. BHD.

INN (International Name):

BETAMETHASONE VALERATE

Units in package:

15 gm

Manufactured by:

HOE PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
BENOSONE CREAM
Betamethasone Valerate (0.12% w/w)
_ _
WHAT IS IN THIS LEAFLET
1.
What BENOSONE CREAM
is used for
2.
How BENOSONE CREAM
works
3.
Before you use BENOSONE
CREAM
4.
How to use BENOSONE
CREAM
5.
While you are using
BENOSONE CREAM
6.
Side effects
7.
Storage and disposal of
BENOSONE CREAM
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about BENOSONE
CREAM. It does not contain all
the available information. It does
not take the place of talking to
your pharmacist or doctor.
All medicines have risks and
benefits. Your pharmacist or
doctor has weighed the risks of
you taking BENOSONE CREAM
against the benefits they expect it
will have for you.
Keep this leaflet with the
medicine.
You may need to read it again.
WHAT BENOSONE CREAM IS
USED FOR
BENOSONE CREAM is used for
the relief of the inflammatory
manifestations of corticosteroid-
responsive skin conditions
example eczema, dermatitis,
inflammation of ear canal,
psoriasis and itching at the back
passage or genital area.
HOW BENOSONE CREAM
WORKS
BENOSONE CREAM contains a
medicine called Betamethasone
Valerate. It belongs to a group of
medicines called steroids. It has
anti-inflammatory, anti-itching and
blood vessel narrowing actions.
Ask your pharmacist or doctor if
you have any questions about this
medicine.
BEFORE YOU USE BENOSONE
CREAM
_ _
_-When you must not use it _
Do not take BENOSONE CREAM
if:
•
You are hypersensitive to
Betamethasone or to any of this
medicine related ingredients.
•
Infants under one year old.
•
Infection at treatment site.
•
You have skin thinning.
•
You have red bumps around the
mouth.
•
You have acne or facial redness.
•
You have viral skin infections
(e.g. Herpes Simplex, chicken
pox), tuberculosis (bacterial
infection) of the skin, acne and
ulcerative condition.
_-Before you start to use it _
_Pregnancy and breast feeding: _
Topical steroids should not be used
extensively i

Summary of Product characteristics

DESCRIPTION:
Cream: A white cream containing Betamethasone Valerate 0.12% w/w
(equivalent to
Betamethasone 0.1%) Methyl Paraben 0.08% w/w and Propyl Paraben 0.02%
w/w as
preservatives.
Ointment: A white ointment containing Betamethasone Valerate 0.12% w/w
(equivalent to
Betamethasone 0.1%).
ACTION: Betamethasone Valerate is a corticosteroid for topical
application and is available
as a cream or ointment. The affected area of skin is treated once or
twice daily. The
anti-inflammatory effect is enhanced by covering with an occlusive
dressing, but if large
areas are treated in this way, sufficient of the drug may be absorbed
to give rise to systemic
effects.
PHARMACOLOGY: The extent of percutaneous absorption of topical
corticosteroids is
determined by many factors including the vehicle, the integrity of the
epidermal barrier, and
the use of occlusive dressings. Topical corticosteroid can be absorbed
from normal intact
skin. Inflammation and/or other disease processes in the skin increase
percutaneous
absorption. Occlusive dressings may be a valuable therapeutic adjunct
for treatment of
resistant dermatoses. Once absorbed through the skin, topical
corticosteroids are handled
through pharmacokinetic pathways similar to systemically administered
corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are
metabolised primarily in the liver and are then excreted by the
kidney. Some of the topical
corticosteroids and their metabolites are also excreted into the bile.
INDICATIONS:
For
the
relief
of
the
inflammatory
manifestations
of
corticosteroid-
responsive
dermatoses
eg.
eczema
(atopic,
infantile,
nummular),
contact
dermatitis,
seborrheic
dermatitis,
neurodermatitis,
solar
dermatitis,
exfoliative
dermatitis,
stasis
dermatitis, dermatitis due to radiation, intertrigo, otitis externa,
psoriasis and anogenital and
senile pruritus.
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in
those patients with a
history of hypersensitivity to any of the components of the
prep