Azathioprine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azathioprine

Available from:

Teva UK Ltd

ATC code:

L04AX01

INN (International Name):

Azathioprine

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020100; GTIN: 5017007398912 5017007314639

Patient Information leaflet

Sandoz
Business use only
Page 1 of 8
1.3.1 spc-label-pl - common-pl-001 - 46
(NL/H/0326-0327-0328/001 changeID 165986)
20180827
AZATHIOPRINE 25 MG FILM-COATED TABLET
800-0036.00
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[NATIONALLY APPROVED NAME] 25 MG TABLETS
Azathioprine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally approved name] are and what they are used for
2.
What you need to know before you take [Nationally approved name]
3.
How to take [Nationally approved name]
4.
Possible side effects
5.
How to store [Nationally approved name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY APPROVED NAME] ARE AND WHAT THEY ARE USED FOR
[Nationally approved name] belong to a group of medicines called
immunosuppressives. This means
that they reduce the strength of your immune system.
Immunosuppressive medicines are sometimes necessary to help your body
accept an organ transplant,
or to treat some diseases where your immune system is reacting against
your own body (autoimmune
diseases, such as rheumatoid arthritis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY APPROVED NAME]
DO NOT TAKE [NATIONALLY APPROVED NAME]:

if you are allergic to azathioprine or any of the other ingredients of
this medicine (listed in section
6)

if you are allergic to mercaptopurine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking [Nationally approved
name]:

if you suffer from the condition known as Lesch-Nyhan Syndrome. This
is a rare condition that
r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg azathioprine.
Excipient with known effect: Each tablet contains 45 mg of lactose (as
lactose
monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish-white, round, biconvex film-coated tablet of
diameter 6.0-6.4mm
and height of 3.1-3.7mm,with no score-line.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azathioprine 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,
combination
with
corticosteroids
and/or
other
immunosuppressive
agents and procedures, is indicated to enhance the survival of organ
transplants, such
as renal transplants, cardiac transplants, and hepatic transplants. It
also reduces the
corticosteroid requirements of renal transplant recipients.
Azathioprine is indicated for the treatment of moderate to severe
inflammatory bowel
disease
(IBD)
(Crohn's
disease
or
ulcerative
colitis)
in
patients
in
whom
corticosteroid therapy is required, in patients who cannot tolerate
corticosteroid
therapy, or in patients whose disease is refractory to other standard
first line therapy.
Azathioprine either alone or more usually in combination with
corticosteroids and/or
other medicinal products and 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 active rheumatoid arthritis;
-
Systemic lupus erythematosus;
-
Dermatomyositis and polymyositis;
-
Auto-immune chronic active he