CLODERM SCALP APPLICATION 0.05%

Nchi: Malesia

Lugha: Kiingereza

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

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
16-08-2021
Tabia za bidhaa Tabia za bidhaa (SPC)
17-08-2021

Viambatanisho vya kazi:

CLOBETASOL PROPIONATE

Inapatikana kutoka:

HOE PHARMACEUTICALS SDN. BHD.

INN (Jina la Kimataifa):

CLOBETASOL PROPIONATE

Vitengo katika mfuko:

30ml mL

Viwandani na:

HOE PHARMACEUTICALS SDN. BHD.

Taarifa za kipeperushi

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CLODERM SCALP APPLICATION 0.05%
Clobetasol Propionate (0.05% w/v)
1
WHAT IS IN THIS LEAFLET
1.
What CLODERM SCALP
APPLICATION is used for
2.
How CLODERM SCALP
APPLICATION works
3.
Before you use CLODERM
SCALP APPLICATION
4.
How to use CLODERM
SCALP APPLICATION
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CLODERM SCALP
APPLICATION
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about CLODERM
SCALP APPLICATION. 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 SCALP
APPLICATION 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 SCALP
APPLICATION IS USED FOR
CLODERM SCALP
APPLICATION is used to treat
psoriasis (raised, rough, reddened
areas covered with dry, fine silvery
scales) and recalcitrant eczemas
(redness, swelling, oozing of fluid,
crusting which may lead to
scaling) of the scalp. Clobetasol is
a highly-active topical
corticosteroid which is indicated
for use in short courses for
conditions which do not respond
satisfactorily to less active
steroids.
HOW CLODERM SCALP
APPLICATION WORKS
CLODERM SCALP
APPLICATION 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
SCALP APPLICATION_ _
_-When you must not use it_
Do not use CLODERM SCALP
APPLICATION if:
•
You are hypersensitive to
Clobetasol Propionate or any of
this medicine related ingredients.
•
You have infection of the scalp.
Not recommended for infants
under 1 year of age.
If you are not sure, talk to your
doc
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                CLODERM SCALP APPLICATION 0.05%
Est. 1979
RECOMMENDED DOSAGE : Wash and dry affected area. Apply Cloderm Scalp
Application
sparingly to the affected areas and rub in once or twice daily as
directed by your doctor or
pharmacist. If symptoms persist please consult your doctor or
pharmacist. This preparation is for
the treatment of your current condition only. Do not allow use by any
other person and dispose of
unused material when your treatment is complete.
SYMPTOMS AND TREATMENT OF OVERDOSE : Corticosteroid applied to the
skin can be
absorbed in sufficient amount to produce systemic effect such as
hypothalamic-pituitary-adrenal
axis suppression, manifestation of Cushing’s syndrome,
hyperglycaemia and glucosuria. Tests
which may be helpful in evaluating hypothalamic-pituitary-adrenal axis
suppression include
urinary free cortisol test and ACTH stimulation test. If the
hypothalamic-pituitary-adrenal axis
suppression is found, then the drug should be withdrawn, frequency of
application reduced or a
weaker steroid used. Supplemental systemic corticosteroids may be
required if signs and
symptoms of steroid withdrawal occur.
PACKING : 30ml plastic bottles.
STORAGE : Keep container well closed. Protect from light. Store below
30°C.
Keep out of the reach of children.
Recommended shelf-life : 3 years.
MANUFACTURED BY :
HOE PHARMACEUTICALS SDN. BHD.
Lot 10, Jalan Sultan Mohamed 6, Bandar Sultan Suleiman,
42000 Port Klang, Selangor, MALAYSIA.
Revision date : March 2021
Front
Back
NAME AND STRENGTH OF ACTIVE SUBSTANCE :
Clobetasol Propionate 0.0568% w/v (equivalent to Clobetasol 0.05% w/
v
).
PRODUCT DESCRIPTION : A colourless and slightly viscous solution.
Other
ingredients
:
Methylparaben,
Isopropyl
Alcohol,
Hydrochloric
Acid,
Hydroxypropyl
Methylcellulose and Purified Water.
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 corticosteroi
                                
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Taarifa za kipeperushi Taarifa za kipeperushi Kimalesia 16-08-2021