PHARMACOR TACROLIMUS tacrolimus 5 mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-11-2020
Summary of Product characteristics
(SPC)
10-11-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
tacrolimus monohydrate, Quantity: 5.1 mg (Equivalent: tacrolimus, Qty 5 mg)
Available from:
Pharmacor Pty Ltd
INN (International Name):
tacrolimus monohydrate
Pharmaceutical form:
Capsule
Composition:
Excipient Ingredients: lactose; dichloromethane; croscarmellose sodium; hypromellose; ethanol absolute; magnesium stearate; titanium dioxide; purified water; iron oxide red; Gelatin; sodium lauryl sulfate
Administration route:
Oral
Units in package:
50's [5x(1x10's)], 50's [1x(5x10'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 '4' greyish red cap/body HGC printed with '5 mg' on cap and 'Tacro' on body with white 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
__________________________________________________________________________________________________
PHARMACOR TACROLIMUS CMI
Version 04
1
PHARMACOR TACROLIMUS CAPSULES
_Tacrolimus monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET_ _
_ _
This leaflet answers some common
questions
about
PHARMACOR
TACROLIMUS 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
PHARMACOR
TACROLIMUS
against the benefits this medicine
is expected to have for you.
If
you
have
any
concerns
about
using
PHARMACOR
TACROLIMUS ask your doctor or
pharmacist. Keep this leaflet with
your medicine. You may need to
read it again._ _
WHAT PHARMACOR
TACROLIMUS 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.
PHARMACOR
TACROLIMUS
stops
this
attack;
it
is
very
important to take
PHARMACOR
TACROLIMUS
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
PHARMACOR TACROLIMUS.
PHARMACOR
TACROLIMUS
contains
the
active
ingredient
tacrolimus,
which
is
an
immunosuppressive agent.
Your
doctor
may
have
prescribed
PHARMACOR
TACROLIMUS
for
another
reason.
Ask your doctor if you have any
questions
about
why
this
medicine
has
been
prescribed
for you.
BEFORE YOU USE
PHARMACOR
TACROLIMUS
_WHEN YOU MUST NOT USE IT _
Do
not
use
PHARMACOR
TACROLIMUS
if you have an
allergy to:
Any
medicine
containing
tacrolimus
or
other
macrolides
(these
are
antibiotics
of
the
erythromycin f
Read the complete document
Summary of Product characteristics
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PHARMACOR TACROLIMUS PI
Version 04
Page 1 of 24
AUSTRALIAN
PRODUCT
INFORMATION
-
PHARMACOR
TACROLIMUS
(TACROLIMUS
MONOHYDRATE)
CAPSULES
1.
NAME OF THE MEDICINE
Tacrolimus (as monohydrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR TACROLIMUS 0.5 MG:
Each capsule contains 0.5 mg tacrolimus.
PHARMACOR TACROLIMUS 1 MG:
Each capsule contains 1 mg tacrolimus.
PHARMACOR TACROLIMUS 5 MG:
Each capsule contains 5 mg tacrolimus.
Contains Lactose. Gelatin (contains sulfites).
For the full list of excipients, see SECTION 6.1 - LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Capsules.
PHARMACOR TACROLIMUS CAPSULES 0.5 MG: White to off white powder filled
in size ‘5’
yellow cap/yellow coloured body HCG printed with “0.5mg” on cap
and “Tacro” on body with
red ink.
PHARMACOR TACROLIMUS CAPSULES 1 MG: White to off white powder filled
in size ‘5’
white cap/white coloured body HCG printed with “1 mg” on cap and
“Tacro” on body with red
ink.
PHARMACOR TACROLIMUS CAPSULES 5 MG:
White to off white powder filled in size ‘4’
greyish red cap/ greyish red coloured body HCG printed with “5 mg”
on cap and “Tacro” on
body with white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACOR TACROLIMUS is indicated for use as an adjunct to liver,
kidney, lung or heart
allograft transplantation in adults and children.
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PHARMACOR TACROLIMUS PI
Version 04
Page 2 of 24
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 d
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