NOUMED AZATHIOPRINE azathioprine 50 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

azathioprine, Quantity: 50 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; maize starch; purified talc; povidone; 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 white to yellowish white film-coated tablets, with one-sided breaking notch.; 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:

Registered

Authorization date:

2018-02-26

Patient Information leaflet

NOUMED AZATHIOPRINE
1
NOUMED AZATHIOPRINE
_azathioprine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
AZATHIOPRINE.
It does not contain all of 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 taking this medicine
against the benefits it is expected to
have for you or your child.
IF YOUR CHILD IS BEING TREATED WITH
NOUMED AZATHIOPRINE,
FOLLOW THE SAME INSTRUCTIONS IN THIS
LEAFLET AS YOU WOULD AS THE PATIENT.
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 NOUMED
AZATHIOPRINE IS
USED FOR
NOUMED AZATHIOPRINE tablets
contain the active ingredient
azathioprine.
Azathioprine belongs to a group of
medicines called immuno-
suppressants. It works by reducing
the body's own natural immunity.
This medicine is used to prevent the
body from rejecting transplanted
organs.
NOUMED AZATHIOPRINE can
also be used to treat diseases
involving the body’s immune
defence system such as:
•
severe rheumatoid arthritis
•
systemic lupus erythematosus
(SLE)
•
chronic active hepatitis
•
certain skin, muscle and blood
diseases.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU OR
YOUR CHILD.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU TAKE IT
_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.
•
any other similar medicines such
as mercaptopurine.
Some of the symptoms of an allergic
reaction may include shortness of
breath; wheezing or difficulty in
breathing; swelling of the face, lips
tongue or other parts of the body;
rash, itching or hives on

Summary of Product characteristics

Product Information - Australia
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION -
NOUMED AZATHIOPRINE
1. NAME OF THE MEDICINE
Azathioprine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NOUMED AZATHIOPRINE film-coated tablets contain 25 mg or 50 mg of
azathioprine.
Excipients with known effect: sugars (as lactose). For the full list
of excipients, see SECTION 6.1 LIST OF
EXCIPIENTS.
3. PHARMACEUTICAL FORM
NOUMED AZATHIOPRINE tablets are round, biconvex, white to
yellowish-white, film-coated tablets with
no marks or embossments. The 50 mg tablet has a one-sided breaking
notch.
4. CLINICAL PARTICULARS
4.1 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 high dosage and prolonged usage of
corticosteroids.
Azathioprine,
in
combination
with
corticosteroids
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.
4.2 DOSE AND METHOD OF ADMINISTRATION
Specialist medical literature should be consulted for guidance as to
clinical experience in particular
conditions.
DOSAGE IN TRANSPLANTATION
_Adults and children_: Depending on the immunosuppressive regimen
adopted, a loading dose of up to
5 mg/kg/day is usually given.
Maintenance dosage may range