Betasone Actavis Cream 0.1%ww

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BETAMETHASONE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BETAMETHASONE

Unit dalam pakej:

15 gm

Dikeluarkan oleh:

PT Actavis Indonesia

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BETASONE ACTAVIS CREAM 0.1%W/W
Betamethasone [as 17-Valerate] (0.1% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Betasone is used for
2.
How Betasone works
3.
Before you use Betasone
4.
How to use Betasone
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Betasone
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT BETASONE IS USED FOR
Betasone is used to help reduce
the
redness
and
itchiness
of
certain skin problems, such as
eczema,
psoriasis
and
dermatitis.
HOW BETASONE WORKS
Betasone
contains
a
medicine
called
Betamethasone
(as
17-
Valerate). It belongs to a group
of medicines called steroids. It
helps
to
reduce
swelling
and
irritation.
BEFORE YOU USE BETASONE
_- When you must not use it _
Do not use Betasone:
•
If
you
are
allergic
(hypersensitive)
to
betamethasone
•
on a child under 1 year
•
to treat any of the following
skin problems, it could make
them worse:
- acne
- severe flushing of skin on
and
around
your
nose
(rosacea)
- spotty red rash around your
mouth (perioral dermatitis)
-
itching
around
your
back
passage
or
private
parts
-
unless
your
doctor
has
told
you to do so
- viral infections, such as cold
sores, herpes or chicken pox
-
fungal
infections,
such
as
ringworm,
athletes
foot
or
thrush
- skin blisters or sores that are
caused by bacterial infections,
such as impetigo.
Do not use if any of the above
applies to you. If you are not
sure,
talk
to
your
doctor
or
pharmacist
before
using
Betasone.
_- Before you start to use it _
Check
with
your
doctor
or
pharmacist
before
using
your
medicine if:
•
you are applying the cream
under
an
airtight
dressing,
including
a
child’s
nappy.
These
dressings
make
it
easier
for
the
active
ingredient to pass through the
skin.
It
is
possible
to
accidentally end up using too
much.
•
you
have
psoriasis,
your
doctor will want to see you
more often.
_- Taking other medicines _
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
a

Ciri produk

3
01.11.2021
V.H.
18.11.2021
V.H.
105x171 mm
Actavis Jakarta
10 pt
01.11.2021
09.11.2021
12.11.2021
1. Profile
2.
3.
1. Black
2.
3.
4.
5.
6.
AAAN8787 - Betamethasone 0.1% 15g, PIL - Malaysia
BETASONE ACTAVIS CREAM 0.1%W/W
PRODUCT DESCRIPTION:
White, non-greasy cream.
COMPOSITION:
Betamethasone (as 17-valerate) BP 0.1% w/w
PRESERVATIVES:
Methyl Hydroxybenzoate BP 0.2% w/w
Propyl Hydroxybenzoate BP 0.02% w/w
PHARMACOLOGY:
Betamethasone 17-valerate is a potent topical corticosteroid
with mainly glucocorticoid activity with anti-inflammatory, anti-
allergic and anti-pruritic actions. It produces a rapid response in
those inflammatory dermatoses that are normally responsive to
topical corticosteroid therapy, and is also often effective in the
less
responsive conditions.
PHARMACOKINETIC:
Following topical application to normal skin, Betasone is minimally
absorbed. Only small amounts of drug reach the dermis and are
then absorbed into the systemic circulation. When applied topically,
particularly to large areas, when the skin is broken, or under
occlusive dressings, corticosteroids may be absorbed in sufficient
amounts to cause systemic effects.
INDICATIONS:
For inflammatory skin disorders.
RECOMMENDED DOSAGE:
Apply sparingly 2-3 times daily, reducing frequency as condition
responds.
SIDE EFFECTS:
Prolonged and intensive treatment with Betasone cream may
cause local atrophic changes in the skin such as striae, thinning and
dilatation of the vessels.
PRECAUTIONS:
Avoid prolonged use in infants and children, and on the face.
3
01.11.2021
V.H.
18.11.2021
V.H.
105x171 mm
Actavis Jakarta
10 pt
01.11.2021
09.11.2021
12.11.2021
1. Profile
2.
3.
1. Black
2.
3.
4.
5.
6.
AAAN8787 - Betamethasone 0.1% 15g, PIL - Malaysia
AAAN8787
Absorption of Betasone is greater from areas of thin skin, raw
surfaces, and intertriginous areas, and is increased by occlusion.
USE IN PREGNANCY:
Although there are no reported adverse effects on pregnancy, there
is inadequate evidence of safety in human pregnancy. Therefore,
they should not be used ext