TACROLIMUS SANDOZ tacrolimus 1mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tacrolimus monohydrate, Quantity: 1.022 mg (Equivalent: tacrolimus, Qty 1 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

tacrolimus monohydrate,Tacrolimus

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; Shellac; isopropyl alcohol; ethanol absolute; butan-1-ol; propylene glycol; strong ammonia solution; iron oxide black; potassium hydroxide; purified water; titanium dioxide; iron oxide yellow; sorbitan monolaurate; iron oxide red; potable water; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Product summary:

Visual Identification: Capsule with white coloured opaque body and light brown coloured cap; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-02-15

Patient Information leaflet

TACROLIMUS SANDOZ
®
1
TACROLIMUS SANDOZ
®
_tacrolimus monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tacrolimus Sandoz.
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 this medicine
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TACROLIMUS
SANDOZ 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 Sandoz stops
this attack; it is very important to
take Tacrolimus Sandoz given to you
by your doctor regularly so you’re
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 Sandoz.
Tacrolimus Sandoz contains the
active ingredient tacrolimus.
Tacrolimus belongs to a group of
medicines called macrolide lactones,
which is an immunosuppressive
agent. It is very important to take
Tacrolimus Sandoz, given to you by
your doctor, regularly so that your
new liver, kidney, lung or heart will
not be attacked or rejected.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
TACROLIMUS SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO

Summary of Product characteristics

201008-Tacrolimus Sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
TACROLIMUS SANDOZ ®
(TACROLIMUS MONOHYDRATE) CAPSULES
1.
NAME OF THE MEDICINE
Tacrolimus monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tacrolimus Sandoz
®
0.5 mg capsules contains 0.5 mg Tacrolimus (as monohydrate).
Each Tacrolimus Sandoz
®
0.75 mg capsules contains 0.75 mg Tacrolimus (as monohydrate).
Each Tacrolimus Sandoz
®
1.0 mg capsules contains 1.0 mg Tacrolimus (as monohydrate).
Each Tacrolimus Sandoz
®
2.0 mg capsules contains 2.0 mg Tacrolimus (as monohydrate).
Each Tacrolimus Sandoz
®
5.0 mg capsules contains 5.0 mg Tacrolimus (as monohydrate).
_Excipients with known effect: _
Each tablet contains sugars (as lactose monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tacrolimus Sandoz 0.5 mg: White to off-white powder filled in size
“4” capsule with white
coloured opaque body and ivory coloured cap.
Tacrolimus Sandoz 0.75 mg: White to off-white powder filled in size
“4” capsule with light
green opaque body and cap, imprinted in black with 0.75 mg on cap.
Tacrolimus Sandoz 1 mg: White to off-white powder filled in size
“4” capsule with white
coloured opaque body and light brown coloured cap.
Tacrolimus Sandoz 2 mg: White to off-white powder filled in size
“4” capsule with dark green
opaque body and cap, imprinted in black with 2 mg on cap.
Tacrolimus Sandoz 5 mg: White to off-white powder filled in size
“3” capsule with white
coloured opaque body and Swedish orange coloured cap.
_Not all strengths may be marketed in Australia. _
_Not all strengths may be marketed in New Zealand. _
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Adjunct to liver, kidney, lung or heart allograft transplantation in
adults and children.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage recommendations given below for oral administration should
act as a guideline.
Tacrolimus doses should be adjusted according to individual patient
requirements.
20