TACROLIMUS APOTEX tacrolimus 1 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tacrolimus monohydrate, Quantity: 1.02 mg (Equivalent: tacrolimus, Qty 1 mg)

Available from:

Pharmacor Pty Ltd

INN (International Name):

tacrolimus monohydrate

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: hypromellose; dichloromethane; lactose; ethanol absolute; magnesium stearate; croscarmellose sodium; titanium dioxide; purified water; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

100's [2x(5x10's)], 100's [10x(1x10's)]

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tacrolimus is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Product summary:

Visual Identification: White to off white powder filled in size '5' white cap/white body HGC printed with '1 mg' on cap and 'Tacro' on body with red ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-29

Patient Information leaflet

__________________________________________________________________________________________________
TACROLIMUS APOTEX CMI
Version 06
1
TACROLIMUS APOTEX CAPSULES
_Tacrolimus monohydrate _
CONSUMER MEDICINE INFORMATION
_FOR _
_A _
_COPY _
_OF _
_A _
_LARGE _
_PRINT _
_LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET_ _
_ _
This leaflet answers some common
questions
about
TACROLIMUS
APOTEX
Capsules.
It
does
not
contain
all
the
available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
TACROLIMUS APOTEX against
the
benefits
this
medicine
is
expected to have for you.
If
you
have
any
concerns
about
using
TACROLIMUS
APOTEX
ask
your
doctor
or
pharmacist.
Keep
this
leaflet
with
your
medicine. You may need to read it
again._ _
WHAT TACROLIMUS
APOTEX IS USED FOR
You
have
been
given
a
new
transplanted
liver
or
kidney,
lung
or
heart
from
another
person because your own was
no longer healthy. Your body
recognises that this new organ
is
different
from
your
other
organs and will try to reject it
by attacking it in the same way
that it would attack germs that
enter
your
body.
This
could
make
you
become
ill
again.
TACROLIMUS
APOTEX
stops
this attack; it is very important
to take
TACROLIMUS APOTEX
given
to
you
by
your
doctor
regularly so that your new liver,
kidney, lung or heart will not be
attacked or rejected.
If you have been taking other
medicines for this purpose, but
are
still
feeling
unwell,
your
doctor
may
change
your
treatment and begin giving you
TACROLIMUS APOTEX.
TACROLIMUS
APOTEX
contains
the
active
ingredient
tacrolimus,
which
is
an
immunosuppressive agent.
Your
doctor
may
have
prescribed
TACROLIMUS
APOTEX
for another reason.
Ask your doctor if you have any
questions
about
why
this
medicine
has
been
prescribed
for you.
BEFORE YOU USE
TACROLIMUS
APOTEX
_WHEN YOU MUST NOT USE IT _
Do
not
use
TACROLIMUS
APOTEX
if you have an allergy
to:

Any
medicine
containing
tacrolimus
or
other
macrolides
(thes

Summary of Product characteristics

___________________________________________________________________________________
TACROLIMUS APOTEX PI
Version 05
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
TACROLIMUS APOTEX (TACROLIMUS MONOHYDRATE)
CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus (as monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg, 1 mg or 5 mg tacrolimus.
EXCIPIENTS WITH KNOWN EFFECT
Lactose, gelatin (contains sulfites).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TACROLIMUS APOTEX CAPSULES 0.5 MG: White to off white powder filled in
size ‘5’ yellow
cap/yellow coloured body HGC printed with “0.5 mg” on cap and
“Tacro” on body with red ink.
TACROLIMUS APOTEX CAPSULES 1 MG: White to off white powder filled in
size ‘5’ white cap/white
coloured body HGC printed with “1 mg” on cap and “Tacro” on
body with red ink.
TACROLIMUS APOTEX CAPSULES 5 MG: White to off white powder filled in
size ‘4’ greyish red cap/
greyish red coloured body HGC printed with “5 mg” on cap and
“Tacro” on body with white ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for use as an adjunct to liver, kidney, lung or heart
allograft transplantation in adults and
children.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage recommendations given below for oral and intravenous
administration (intravenous
dosage form can be available from other brand/s) should act as a
guideline. Tacrolimus doses should
be adjusted according to individual patient requirements.
If allograft rejection or adverse events occur, alteration in the
immunosuppressive regimen should be
considered.
METHOD OF ADMINISTRATION
It is recommended that the oral daily dose of Tacrolimus APOTEX be
administered as two divided
doses, in the morning and in the evening.
Tacrolimus APOTEX capsules should generally be administered on an
empty stomach or at least 1
hour before or 2 to 3 hours after a meal, to achieve maximum
absorption (Refer to section 5.2
PHARMACOKINETIC PROPERTIES -