MYCLOB 0.05% (CLOBETASOL PROPIONATE SCALP APPLICATION 0.05% WW)

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

CLOBETASOL PROPIONATE

Saatavilla:

SYNERRV SDN BHD

INN (Kansainvälinen yleisnimi):

CLOBETASOL PROPIONATE

Kpl paketissa:

50 ml

Valmistaja:

Oxalis Lab

Pakkausseloste

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MYCLOB 0.05% (CLOBETASOL PROPIONATE SCALP
APPLICATION 0.05% W/W)
Clobetasol Propionate (0.05%w/w)
WHAT IS IN THIS LEAFLET
1.
What MYCLOB is used
for
2.
How MYCLOB works
3.
Before you use MYCLOB
4.
How to use MYCLOB
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MYCLOB
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet answers some common
questions about MYCLOB. 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 MYCLOB against
the benefits they expect it will
have for you.
Keep this leaflet with the
medicine.
You may need to read it again.
WHAT MYCLOB IS USED FOR
MYCLOB 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 MYCLOB WORKS
MYCLOB 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 MYCLOB
_-When you must not use it _
Do not use MYCLOB 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
doctor or pharmacist before using
MYCLOB.
_-Before you start to use it _
Tell your pharmacist or doctor:
•
If you are using any skin
products.
Pregnancy and breast feeding:
•
Safe use during pregnancy and
lactation has

Valmisteyhteenveto

MYCLOB 0.05 % (CLOBETASOL PROPIONATE SCALP APPLICATION 0.05% W/W)
MACLEODS PHARMACEUTICALS LTD.
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A
LABORATORY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
FOR EXTERNAL USE ONLY
MYCLOB 0.05% (CLOBETASOL PROPIONATE SCALP
APPLICATION 0.05%W/W)
COMPOSITION
Each 1 gm contains:
Clobetasol Propionate Ph. Eur 0.5 mg
PHARMACEUTICAL FORM
Colourless Solution
PHARMACOLOGICAL ACTION
Pharmacotherapeutic group: Corticosteroids, very potent (group IV),
ATC code: D07AD
Mechanism of action
Topical corticosteroids act as anti-inflammatory agents via multiple
mechanisms to inhibit late
phase allergic reactions including decreasing the density of mast
cells, decreasing chemotaxis
and activation of eosinophils, decreasing cytokine production by
lymphocytes, monocytes,
mast cells and eosinophils, and inhibiting the metabolism of
arachidonic acid.
Pharmacodynamic effects
Topical corticosteroids have anti-inflammatory, antipruritic, and
vasoconstrictive properties.
MYCLOB 0.05 % (CLOBETASOL PROPIONATE SCALP APPLICATION 0.05% W/W)
MACLEODS PHARMACEUTICALS LTD.
PHARMACOKINETICS:
Absorption
Topical corticosteroids can be systemically absorbed from intact
healthy skin. The extent of
percutaneous absorption of topical corticosteroids is determined by
many factors, including the
vehicle and the integrity of the epidermal barrier. Occlusion,
inflammation and/or other disease
processes in the skin may also increase percutaneous absorption.
Distribution
The
use
of
pharmacodynamic
endpoints
for
assessing
the
systemic
exposure
of
topical
corticosteroids is necessary due to the fact that circulating levels
are well below the level of
detection.
Metabolism
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic
pathways similar to systemically administered corticosteroids. They
are metabolised, primarily
in the liver.
Elimination
Topical corticosteroids are excreted by the kidneys. In addition, some
corticosteroids and their
metabolites are a