CLODERM OINTMENT 0.05% WW

Country: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

CLOBETASOL PROPIONATE

Disponibbli minn:

HOE PHARMACEUTICALS SDN. BHD.

INN (Isem Internazzjonali):

CLOBETASOL PROPIONATE

Unitajiet fil-pakkett:

100gm mcg/mL; (FEO) 450gm mcg/mL; 15gm mcg/mL

Manifatturat minn:

HOE PHARMACEUTICALS SDN. BHD.

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CLODERM OINTMENT 0.05% W/W
Clobetasol Propionate (0.05% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Cloderm Ointment is
used for
2.
How Cloderm Ointment
works
3.
Before you use Cloderm
Ointment
4.
How to use Cloderm
Ointment
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Cloderm Ointment
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about Cloderm
Ointment. 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 Ointment
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 OINTMENT IS USED
FOR
Cloderm Ointment is used for
short-term treatment of
inflammatory and itching
manifestations of moderate to
severe corticosteroid-responsive
skin disease.
HOW CLODERM OINTMENT WORKS
Cloderm Ointment 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 actions.
Ask your pharmacist or doctor if
you have any questions about this
medicine.
BEFORE YOU USE CLODERM
OINTMENT_ _
_-When you must not use it_
Do not take Cloderm Ointment if:
•
You are hypersensitive to any of
this medicine related ingredients.
•
You have viral skin infections
(e.g. Herpes simplex, chicken
pox), acne, skin redness
•
You have peri-oral skin
inflammation and itching.
•
You have skin infection caused
by fungi or bacteria.
•
You have genital itching.
Not recommended for infants
under 1 year of age.
If you are not sure, talk to your
doctor or pharmacist before using
Cloderm Ointment.
_-Before you start to use it_
Pregnancy and breast feeding:
•
Safe use during pregnancy and
lactation has not been
established.
•
Ask your doct

Karatteristiċi tal-prodott

Est. 1979
CLODERM OINTMENT 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 ointment.
Other ingredients are Liquid Paraffin and White Soft Paraffin.
PHARMACODYNAMICS
:
Clobetasol
Propionate
has
anti-inflammatory,
anti-pruritic
and
vasoconstrictive actions.
PHARMACOKINETICS : 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 corticosteroid has
pharmacological effects or is 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 Ointment 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 miliria. Large doses of
corticosteroids may produce symptoms
typical of hyperactivity of the adrenal cortex, with moon face,
sometimes with hirsutism, buffalo
hump, flushing, sometimes leading to a fully developed Cushing's
syndrome. Systemic adverse
reaction, such as vision blurred, have also been reported with the use
of topical corticosteroids.
DRUG INTERACTION : Unknown.
WARNINGS AND PRECAUTIONS : Discontinue use if irritation or
sensitivity develops. Safet