Tacroz Ointment 0.1% ww

Country: Malaysia

Language: English

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

Active ingredient:

TACROLIMUS

Available from:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (International Name):

TACROLIMUS

Units in package:

30 gm

Manufactured by:

GLENMARK PHARMACEUTICALS LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
TACROZ™ OINTMENT
Tacrolimus Ointment 0.1% w/w
WHAT IS IN THIS LEAFLET
1.
What Tacroz is used for
2.
How Tacroz works
3.
Before you use Tacroz
4.
How to use Tacroz
5.
While you are using it
Side effects
6.
Storage and Disposal of
Tacroz
7.
Product Description
8.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT TACROZ IS USED FOR
Tacroz is used to treat moderate to
severe atopic dermatitis (eczema) in
adults
who
are
not
adequately
responsive to or are intolerant of
conventional
therapies
such
as
topical corticosteroids.
Only Tacrolimus 0.03% is used to
treat children (2 years of age and
older)
who
failed
to
respond
adequately to conventional therapies
such as topical corticosteroids.
Tacroz is also used to treat moderate
to severe atopic dermatitis (eczema)
for
the
prevention
of
flares
and
prolongation of flare-free intervals in
patients
experiencing
a
high
frequency of disease exacerbations
(i.e. occurring 4 or more times per
year)
who
have
had
an
initial
response
to
maximum
6
weeks
treatment
of
twice
daily
Tacroz
ointment.
HOW TACROZ WORKS
The active substance of Tacroz ,
tacrolimus
monohydrate,
is
an
immunomodulating agent.
In
atopic
dermatitis,
an
over-
reaction
of
the
skin’s
immune
system causes skin inflammation
(itchiness, redness, dryness).
Tacroz
alters
the
abnormal
immune response and relieves the
skin inflammation and the itch.
BEFORE YOU USE TACROZ
-
_When you must not use it _
If you are allergic to tacrolimus or
any of the other ingredients of this
medicine or to macrolide antibiotics
(e.g. azithromycin, clarithromycin,
erythromycin).
-
_Before you start to use it _
Talk to your doctor
•If you have liver failure.
•If you have any skin malignancies
(tumours)
or
if
you
have
a
weakened
immune
system
(immuno-compromised)
whatever
the cause.
•If you have an inherited skin barrier
disease
such
as
Netherton’s
syndrome,
lamellar
ichthyosis
(extensive scaling of the skin due to
a thickening of the outer layer of the
skin),
o

Summary of Product characteristics

SPACE FOR
PHARMACODE
SAME SIZE ARTWORK
LEAFLET SIZE: 140 mm x 352 mm
PE00000 MY
_For the use only of a Registered Medical Practitioner or _
_a Hospital or a Laboratory_
Tacrolimus Ointment 0.1% w/w
COMPOSITION
1g of Tacroz Ointment 0.1% w/w contains 1mg of tacrolimus
(as tacrolimus monohydrate)
PHARMACEUTICAL FORM
Ointment. White to slightly yellowish ointment.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Tacrolimus 0.03% ointment is indicated in adults, adolescents
and children from the age of 2 years.
Tacrolimus
0.1
%
ointment
is
indicated
in
adults
and
adolescents (16 years of age and above)
_Flare treatment_
_Adults and adolescents (16 years of age and above)_
Treatment of moderate to severe atopic dermatitis in adults
who are not adequately responsive to or are intolerant of
conventional therapies such as topical corticosteroids.
_Children (2 years of age and above)_
Treatment of moderate to severe atopic dermatitis in children
who failed to respond adequately to conventional therapies
such as topical corticosteroids.
_Maintenance treatment_
Treatment of moderate to severe atopic dermatitis for the
prevention
of
flares
and
the
prolongation
of
flare-free
intervals in patients experiencing a high frequency of disease
exacerbations (i.e. occurring 4 or more times per year) who
have had an initial response to a maximum of 6 weeks
treatment of twice daily tacrolimus ointment (lesions cleared,
almost cleared or mildly affected).
POSOLOGY AND METHOD OF ADMINISTRATION
Tacrolimus treatment should be initiated by physicians with
experience in the diagnosis and treatment of atopic dermatitis.
Tacrolimus is available in two strengths, Tacrolimus 0.03%
and Tacrolimus 0.1% ointment.
Posology
_Flare treatment_
Tacrolimus can be used for short-term and intermittent long-
term treatment.
Treatment should not be continuous on a long-term basis.
Tacrolimus treatment should begin at the first appearance of
signs and symptoms. Each affected region of the skin should
be treated with Tacrolimus until lesion are cleared, almost
cle