Cloderm Shampoo 0.05%ww

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

CLOBETASOL PROPIONATE

Dostupné z:

HOE PHARMACEUTICALS SDN. BHD.

INN (Medzinárodný Name):

CLOBETASOL PROPIONATE

Počet v balení:

60ml mL; 100ml mL

Výrobca:

HOE PHARMACEUTICALS SDN. BHD.

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CLODERM SHAMPOO
Clobetasol Propionate (0.05% w/w)
WHAT IS IN THIS LEAFLET
1. What cloderm shampoo is used
for
2. How cloderm shampoo works
3. Before you use cloderm
shampoo
4. How to use cloderm shampoo
5. While you are using cloderm
shampoo
6. Side effects
7. Storage and Disposal of
cloderm shampoo
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
This leaflet answers some common
questions about cloderm shampoo.
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 shampoo
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 CLODERM SHAMPOO IS USED
FOR
Cloderm shampoo is used for
topical treatment of scalp psoriasis
(raised, rough, reddened skin
covered with dry, fine silvery
scales) and eczema (itchy skin
condition with redness, swelling,
oozing of fluid, crusting which
may lead to scaling).
HOW CLODERM SHAMPOO WORKS
Cloderm shampoo contains
Clobetasol Propionate as an active
ingredient.
Clobetasol propionate 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.
BEFORE YOU USE CLODERM SHAMPOO
_When you must not take it _
_ _
Do not take cloderm shampoo if
you are hypersensitive to:
•
Any medicine containing
clobetasol propionate or other
corticosteroids.
•
Any of the ingredients listed at
the end of this leaflet.
Do not take cloderm shampoo if
you are under 18 years old.
_Before you start to use it_
_ _
Take special care with cloderm
shampoo:
When giving to children as
systemic absorption can occur in
topical administration causing
growth retardation.
Pregnancy and breast feeding:

Súhrn charakteristických

DESCRIPTION: A clear yellow viscous liquid with characteristic odour
containing Clobetasol
Propionate 0.05% w/w with Methyl Paraben 0.1 % w/w and Propyl Paraben
0.05% w/w as
preservatives.
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
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: Psoriasis and recalcitrant eczemas of the scalp.
Clobetasol propionate 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.
CONTRAINDICATIONS: Use of Cloderm Shampoo is contraindicated in
patients who are
hypersensitive to clobetasol propionate, to other corticosteroids, or
to any ingredient in this
preparation.
WARNINGS AND PRECAUTIONS: Discontinue use if irritation or sensitivity
develops. Avoid
introduction of shampoo into the eyes. Special care must be taken when
giving to paediatric
patients as systemic absorption can occur in topical administration
causing growth retardation.
Caution is advised if the medication is to be applied to extensive
surface area. Long-term
continuous topical therapy should be avoided. Not suitable for
ophthalmic use. Avoid contact
with eyes.
ROUTE OF ADMINISTRATION: Topical.
INTERACTIONS WITH OTHER MEDICAMENTS: Unknown.
PREGNANCY AND LACTATION: Safety of its use during pregnancy and
lactation has not
been established. Thus it should be used only if the potential benefit
outweighs the potential risk
to the foetus or nursing infant.
ADVERSE EFFECTS: Reported local adverse reactions are burning,
itching, irritation, dryness,
folliculitis, hypertrichosis, acneiform erupt