CLODERM CREAM 0.05%

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

CLOBETASOL PROPIONATE

Verfügbar ab:

HOE PHARMACEUTICALS SDN. BHD.

INN (Internationale Bezeichnung):

CLOBETASOL PROPIONATE

Einheiten im Paket:

5gm mcg/mL; 15 gm mcg/mL; 100 gm mcg/mL; 450 gm mcg/mL

Hergestellt von:

HOE PHARMACEUTICALS SDN. BHD.

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CLODERM CREAM
Clobetasol Propionate (0.05% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What CLODERM CREAM
is used for
2.
How CLODERM CREAM
works
3.
Before you use CLODERM
CREAM
4.
How to use CLODERM
CREAM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CLODERM CREAM
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about CLODERM
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 CLODERM 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 CLODERM CREAM IS
USED FOR
CLODERM CREAM is used for
short-term treatment of
inflammatory and itching
manifestations of moderate to
severe skin disorder that
responsive to corticosteroid.
HOW CLODERM CREAM
WORKS
CLODERM CREAM contains a
medicine called clobetasol
propionate. It belongs to a group of
medicines called steroids. It has
anti-inflammatory, anti-itching and
blood vessel narrowing.
Ask your pharmacist or doctor if
you have any questions about this
medicine.
BEFORE YOU USE CLODERM
CREAM_ _
_-When you must not use it_
Do not use CLODERM CREAM
if:
•
You are hypersensitive to
Clobetasol Propionate or any of
this medicine related ingredients.
•
You have acne or skin redness.
•
You have skin inflammation and
itching around the mouth.
•
You have skin infection caused
by virus (e.g. Herpes simplex,
chicken pox), fungi or bacteria.
•
You have genital or anal itching.
Not recommended for infants
under 1 year of age.
If you are not sure, talk to your
doctor or pharmacist before using
CLODERM CREAM.
_-Before you start to use it_
Tell your pharmacist or doctor:
•
If you have infection on your
skin and specify on the infected
area.
•
If you are using any skin
products.

Fachinformation

Est. 1979
CLODERM CREAM 0.05% W/W
NAME AND STRENGTH OF ACTIVE SUBSTANCE
: Clobetasol Propionate 0.0568% w/w
(equivalent to Clobetasol 0.05% w/w).
PRODUCT DESCRIPTION : A white cream.
Other ingredients: Phosphoric Acid, Chlorocresol, Sodium Dihydrogen
Phosphate, Macrogol
Cetostearyl Ether, Propylene Glycol, White Soft Paraffin, Cetostearyl
Alcohol, Liquid Paraffin
and Purified Water.
PHARMACODYNAMICS
:
Clobetasol
Propionate
is
a
topically
active
fluorinated
corticosteroid which has anti-inflammatory, anti-pruritic and
vasoconstrictive actions.
PHARMACOKINETICS
:
Clobetasol
propionate
has
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 plasma proteins. Only unbound corticosteroids
have
pharmacological effects or are metabolized. They are metabolized
mainly in the liver, also in the
kidneys, and are excreted in the urine.
INDICATIONS : For short-term treatment of inflammatory and pruritic
manifestations of moderate
to severe corticosteroid - responsive dermatoses.
CONTRAINDICATIONS : Hypersensitivity to the preparation, rosacea, acne
vulgaris, peri-oral
dermatitis, primary cutaneous viral infections (eg. herpes simplex,
chicken pox). The use of
Cloderm Cream is not indicated in the treatment of primarily infected
skin lesions caused by
infection with fungi (eg. candidiasis, tinea), or bacteria (eg.
impetigo), peri-anal and genital
pruritus. Not recommended for infants under 1 year of age.
ADVERSE EFFECTS : Reported local adverse reactions are burning,
itching, irritation, dryness,
folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation,
maceration of the skin, secondary
infection, skin atrophy, striae and miliaria. Large doses of
corticosteroids may produce symptoms
typical of hyperactivity of the adrenal cortex, with moon face,
sometimes with hirsutism, buffalo
hump, flushing, sometimes