U-CLOSONE CREAM

País: Malàisia

Idioma: anglès

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

Compra'l ara

Descargar Fitxa tècnica (SPC)
15-04-2021

ingredients actius:

CLOBETASONE BUTYRATE

Disponible des:

HOE PHARMACEUTICALS SDN. BHD.

Designació comuna internacional (DCI):

CLOBETASONE BUTYRATE

Unidades en paquete:

15 gm; 100 gm

Fabricat per:

HOE PHARMACEUTICALS SDN. BHD.

Informació per a l'usuari

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
U-CLOSONE CREAM
Clobetasone Butyrate (0.05%w/w)
1
WHAT IS IN THIS LEAFLET
1.
What U-Closone Cream is
used for
2.
How U-Closone Cream
works
3.
Before you use U-Closone
Cream
4.
How to use U-Closone
Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of U-
Closone Cream
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about U-Closone 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
U-Closone
Cream
against the benefits they expect it
will have for you.
If
you
have
any
concerns
about
taking
this
medicine,
ask
your
pharmacist or doctor.
Keep this leaflet with the
medicine.
You may need to read it again.
WHAT U-CLOSONE CREAM IS USED
FOR
U-Closone Cream is used to treat
of
skin
disease
in
which
inflammation
is
the
prominent
feature.
These
skin
problems
include all types of eczema and
dermatitis and insect bite reactions.
HOW U-CLOSONE CREAM WORKS
U-Closone
Cream
contains
Clobetasone Butyrate. It belongs to
a
group
of
steroid
called
corticosteroids.
It has anti-inflammatory, relieves
itching
and
blood
vessels
narrowing.
BEFORE YOU USE U-CLOSONE
CREAM_ _
_-When you must not use it_
Do not take U-Closone Cream if:
•
You
are
hypersensitive
to
Clobetasone Butyrate or any of
this
medicine
related
ingredients.
•
You have viral skin infections
(e.g.
herpes
simplex,
chicken
pox), fungal, yeasts or bacterial
infection
(e.g.
candidiasis,
tinea, impetigo), skin condition
that gives flushed appearance
at the face, acne, rash around
mouth
and
severe
itching
around the anus and genital.
_-Before you start to use it_
Tell your pharmacist or doctor:
•
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 pa
                                
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Fitxa tècnica

                                U-CLOSONE CREAM & OINTMENT
Est. 1979
NAME AND STRENGTH OF ACTIVE SUBSTANCE: Clobetasone Butyrate 0.05% w/w.
PRODUCT DESCRIPTION:
Cream: A white cream.
Ointment: White ointment.
Other ingredients for cream are Sodium Citrate. Chlorocresol, Glyceryl
Monostearate, Glycerin,
Cetostearyl Alcohol, Glyceryl Monostearate (and) PEG-100 Stearate,
Dimethicone and Purified
Water.
Other ingredients for ointment are Liquid Paraffin and White Soft
Paraffin.
PHARMACODYNAMICS: Clobetasone Butyrate is a topically active
fluorinated corticosteroid
which has anti-inflammatory, anti-pruritic and vasoconstrictive
actions.
PHARMACOKINETICS:
Topical
corticosteroids
have
anti-inflammatory,
anti-pruritic
and
vasoconstrictive actions. When administered topically, particularly
under occlusive dressings or
when the skin is broken, sufficient corticosteroid may be absorbed to
give systemic effects.
Corticosteroids are extensively bound to plasmaproteins. Only unbound
corticosteroids have
pharmacological effects or are metabolised. They are metabolised
mainly in the liver, also in the
kidney, and are excreted in the urine.
INDICATIONS: All types of eczema and dermatitis, including atopic
eczema, photodermatitis,
otitis externa, primary irritant and allergic dermatitis, prurigo
nodularis, seborrhoeic dermatitis
and insect bite reactions. Maintenance between courses of more potent
topical steroids in more
resistant dermatoses.
CONTRAINDICATIONS: Hypersensitivity to Clobetasone Butyrate, to other
corticosteroids or to
any ingredient in this preparation, rosacea, acne vulgaris, peri-oral
dermatitis, primary cutaneous
viral infections (eg. herpessimplex, chicken pox). The use of
U-Closone is not indicated in the
treatment of primarily infected skin lesions
caused by infection with fungi or
yeasts (eg.
candidiasis, tinea), or bacteria (eg. impetigo), peri-anal and genital
pruritus.
DRUG INTERACTIONS: Unknown.
ADVERSE
EFFECTS: Reported
local
adverse
reactions
are
burning,
itching,
irritation,
dryness, folliculitis, hypertrichosis, acneiform eruptions
                                
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