Uniqler Cream 0.05% ww

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE DIPROPIONATE

Available from:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (International Name):

BETAMETHASONE DIPROPIONATE

Units in package:

15g

Manufactured by:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
UNIQLER CREAM
Betamethasone 0.05% w/w (as Bethamethasone Dipropionate)
WHAT IS IN THIS LEAFLET:
1.
What Uniqler Cream is used for
2.
How Uniqler Cream works
3.
Before you use Uniqler Cream
4.
How to use Uniqler Cream
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Uniqler Cream
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT IS UNIQLER CREAM USED FOR
Uniqler Cream is used for the relief of
•
Eczema.
•
Psoriasis
(skin
disorder
with
raised,
rough, reddened areas covered with dry,
fine silvery scales).
•
Contact dermatitis (skin disorder with
red, itchy rash).
•
Atopic dermatitis (chronic, itchy skin
condition).
•
Chronic
skin
disease
such
as
Neurodermatitis which include Lichen
Palnus.
•
Intertrigo (inflammation of the body
folds).
•
Dyshidrosis (skin disease that mainly
affects the palm and sole).
•
Seborrrheic
dermatitis
(skin
inflammation that mainly affects the
scalp).
•
Exfoliative
dermatitis
(redness
and
peeling of skin over large area of the
body).
•
Solar dermatitis (chronic inflammatory
reaction of the skin to sunlight).
•
Stasis
dermatitis
(skin
disease
that
mainly affects the lower leg).
•
Pruritus (severe itching of the skin).
HOW UNIQLER CREAM WORKS
Betamethasone
dipropionate,
a
synthetic
glucocorticoid,
is
thought
to
act
by
controlling the rate of synthesis of protein.
It works by reducing redness, inflammation,
swelling, and irritation of the skin.
BEFORE YOU USE UNIQLER CREAM
_When you must not use it _
Do not use Uniqler Cream if you have:
•
Known hypersensitivity to any ingredients
in this medicine
Pregnancy and lactation
•
Do
not
use
this
medicine
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
•
Do not use this medicine if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
_Before you start to use it _
Tell your pharmacist or doctor:
•
Your medical condi

Summary of Product characteristics

Important information. Please read carefully.
UNIQLER
CREAM 0.05% W/W
COMPOSITION
Contains 0.05% w/w Betamethasone (as Betamethasone Dipropionate).
Chlorocresol 0.15% w/w as preservative.
PHARMACODYNAMICS
Diprosone preparations contain the dipropionate ester of betamethasone
which is a
glucocorticoid exhibiting the general properties of corticosteroids.
In pharmacological doses, corticosteroids are used primarily for their
anti-inflammatory
and/or immune suppressive effects.
Topical corticosteroids such as betamethasone dipropionate are
effective in the treatment of
a range of dermatoses because of their anti-inflammatory,
anti-pruritic and vasoconstrictive
actions.
However,
while
the
physiologic,
pharmacologic
and
clinical
effects
of
the
corticosteroids are well known, the exact mechanisms of their action
in each disease are
uncertain.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including vehicle, integrity of the epidermal barrier and the
use of occlusive
dressings.
Topical corticosteroids can be absorbed through intact, normal skin.
Inflammation and/or
other disease processes in the skin may increase percutaneous
absorption.
Occlusive dressings substantially increase the percutaneous absorption
of topical
corticosteroids.
Once absorbed through the skin, topical corticosteroids enter
pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma
proteins in varying degrees, are metabolised primarily in the liver
and excreted by the
kidneys. Some of the topical corticosteroids and their metabolites are
also excreted in the
bile.
INDICATIONS
Uniqler
Cream
is
indicated
for
the
relief
of
the
inflammatory
manifestations
of
corticosteroid-responsive
dermatoses
such
as:
psoriasis,
contact
dermatitis
(dermatitis
venenata), atopic dermatitis (infantile eczema, allergic dermatitis),
neurodermatitis (lichen
simplex chronicus), lichen palnus, eczema (including nummular eczema,
hand eczema,
eczematous
derm