Clobex Shampoo 0.05%

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

CLOBETASOL PROPIONATE

Tilgjengelig fra:

ZUELLIG PHARMA SDN BHD

INN (International Name):

CLOBETASOL PROPIONATE

Enheter i pakken:

125 ml; 30 ml; 60 ml

Produsert av:

LABORATORIES GALDERMA

Informasjon til brukeren

1
_Consumer Medication Information Leaflet (RiMUP) _
CLOBEX
® SHAMPOO
Clobetasol propionate (0.05% w/w)
What is in this leaflet
1.
What Clobex
®
Shampoo
is used
for
2.
How Clobex
®
Shampoo works
3.
Before you use
Clobex
®
Shampoo
4.
How to use Clobex
®
Shampoo
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Clobex
®
Shampoo
8.
Product Description
9.
Manufacturer and Product
registration holder
10.
Date of revision
WHAT CLOBEX
® SHAMPOO IS USED FOR
Clobex
®
Shampoo is used in adult for
a short term to treat moderate to
severe scalp psoriasis.
HOW CLOBEX® SHAMPOO WORKS
Clobex
®
Shampoo contains
clobetasol propionate which reduces
the redness, itching and swelling.
This medication is a very strong
topical corticosteroid.
BEFORE YOU USE CLOBEX® SHAMPOO
_- When you must not use _
Do not use Clobex
®
Shampoo if you
are allergic to any of its ingredients,
or any other corticosteroids. Ask your
doctor or pharmacist if you need a list
of other corticosteroids. Shampoo is
not recommended for use by people
under 18 years of age.
_- Before you start to use it _
Tell your doctor:
•
If you are pregnant, think you are
pregnant. Talk with your doctor
before using Clobex
®
Shampoo or
if you are already using Clobex
®
Shampoo. It is not known if
Clobex
®
Shampoo can harm your
unborn baby.
•
If you are breastfeeding. It is not
known if Clobex
®
Shampoo passes
into your milk, and if it can harm
your baby. Clobex
®
Shampoo
should be used cautiously during
pregnancy and breastfeeding only
if the potential benefit justifies the
potential risk to the baby.
•
If you think you have an infection
on your scalp. You may need
another medicine to treat the scalp
infection before you use
Clobex
®
Shampoo.
Manifestations of Cushing’s
syndrome, high blood sugar level,
and presence of sugar in the urine can
also be produced in some people by
systemic absorption of topical
corticosteroids while on treatment.
Conditions which increase systemic
absorption include the application of
the more potent cortic

Preparatomtale

NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
S H A M P O O
C L O B E X
®
(
c l
o b e t a s o l
p r o p i
o n a t e )
S h a m p o o ,
0 .
0 5 %
Product code: MOCK UP
Product description: CLOBEX SHA
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 8 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
GRAPHIC DESIGNER: Bérangère BLANCO
INDUSTRIALIZATION DEPARTMENT
LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE
PMS 432U
CLOBEX
®
(CLOBETASOL PROPIONATE) SHAMPOO, 0.05%
Rx Only
For External Use Only. Not for Ophthalmic Use.
DESCRIPTION:
CLOBEX
®
(clobetasol
propionate)
Shampoo,
0.05%,
contains
clobetasol
propionate, a synthetic fluorinated corticosteroid, for topical
dermatologic use.
The corticosteroids constitute a class of primarily synthetic steroids
used topically as anti-
inflammatory and antipruritic agents.
The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11ß,
17-dihydroxy-16ß-
methylpregna-1, 4-diene-3, 20-dione 17-propionate.
It has the following structural formula:
Clobetasol propionate has a molecular weight of 466.97 (CAS Registry
Number 25122-46-7).
The molecular formula is C
25
H
32
CIFO5. Clobetasol propionate is a white to practically white
crystalline, odorless powder insoluble in water.
Each
mL
of
CLOBEX
®
(clobetasol
propionate)
Shampoo,
0.05%,
contains
clobetasol
propionate, 0.05%, in a shampoo base consisting of alcohol, citric
acid, coco-betaine,
polyquaternium-10, purified water, sodium citrate, and sodium laureth
sulfate. It is a
translucent, colourless to pale yellow viscous liquid, with alcoholic
odour.
CLINICAL
PHARMACOLOGY:
Like
other
topical
corticosteroids,
CLOBEX
®
(clobetasol
propionate) Shampoo, 0.05%, has anti-inflammatory, antipruritic, and
vasoconstrictive
properties. The mechanism of the anti-inflammatory activity of the
topical steroids, in general,
is unclear. However, corticosteroids are thought to act by the
induction of phospholipase
A2 inhibitory proteins, collectively called lipocortins. It is
postulated that thes