AZATHIOPRINE SANDOZ azathioprine 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

azathioprine, Quantity: 25 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; lactose monohydrate; magnesium stearate; maize starch; povidone; colloidal anhydrous silica; titanium dioxide; hypromellose; microcrystalline cellulose; PEG-8 stearate

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with higher dosage and prolonged usage of corticosteroids. Azathioprine, in combination with cortocosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. Azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura.

Product summary:

Visual Identification: Round, biconvex yellowish-white film coated tablets.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2000-05-19

Patient Information leaflet

AZATHIOPRINE SANDOZ
®
1
AZATHIOPRINE SANDOZ
®
_azathioprine film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Azathioprine
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 they expect it
will 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 AZATHIOPRINE
SANDOZ IS USED FOR
Azathioprine Sandoz contains
azathioprine as the active ingredient.
Azathioprine belongs to a group of
medicines called
immunosuppressants.
This medicine is used to help prevent
the rejection of a transplanted organ
such as a kidney, liver or heart. It
works by suppressing the body's
immune defence system.
Azathioprine Sandoz can also be
used to treat other diseases called
autoimmune diseases where your
immune system is reacting against
your own body.
These may include:
•
severe rheumatoid arthritis
•
systemic lupus erythematosus
(SLE)
•
chronic active hepatitis
•
certain skin, muscle and blood
diseases.
Azathioprine Sandoz is usually taken
in combination with other medicines
such as corticosteroids or other
immunosuppressive drugs.
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 not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
AZATHIOPRINE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
azathioprine, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description
•
any other similar medicines such
as 6-mercaptopurine (Puri-
Nethol
®
).
Some of the symptoms of an allergic
reaction may i

Summary of Product characteristics

211027-azathioprine-sandoz-pi
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
AZATHIOPRINE SANDOZ
® (AZATHIOPRINE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Azathioprine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Azathioprine Sandoz
®
25 mg film coated tablet contains 25 mg azathioprine.
Each Azathioprine Sandoz
®
50 mg film coated tablet contains 50 mg azathioprine.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Azathioprine Sandoz 25 mg film-coated tablets are round, biconvex
yellowish-white film-
coated tablets.
Azathioprine Sandoz 50 mg film-coated tablets are round, biconvex
white to yellowish-white
film-coated tablets, with one-sided breaking notch.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azathioprine Sandoz is used as an immunosuppressant antimetabolite
either alone, or more
commonly, in combination with other agents (usually corticosteroids)
and procedures which
influence the immune response. Therapeutic effect may be evident only
after weeks or months
and can include a steroid-sparing effect, thereby reducing the
toxicity associated with high
dosage and prolonged usage of corticosteroids.
Azathioprine Sandoz, in combination with corticosteroids and/or other
immunosuppressive
agents and procedures, is indicated in the management of patients
receiving organ transplants.
Azathioprine Sandoz, either alone or more usually in combination with
corticosteroids and/or
other procedures, has been used with clinical benefit which may
include reduction of dosage
or discontinuation of corticosteroids, in a proportion of patients
suffering from the following:
severe rheumatoid arthritis, systemic lupus erythematosus,
dermatomyositis/polymyositis,
autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis
nodosa, autoimmune
haemolytic anaemia, chronic refractory idiopathic thrombocytopenic
purpura.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_DOS