Azathioprine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azathioprine

Available from:

Ennogen Pharma Ltd

ATC code:

L04AX01

INN (International Name):

Azathioprine

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020100; GTIN: 05060313370363

Patient Information leaflet

AZATHIOPRINE TABLETS 50MG
[Azathioprine]
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or nurse.
!
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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT AZATHIOPRINE TABLETS ARE AND WHAT
THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AZATHIOPRINE TABLETS
3.
HOW TO TAKE AZATHIOPRINE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE AZATHIOPRINE TABLETS
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
1.
WHAT AZATHIOPRINE TABLETS ARE
AND WHAT THEY ARE USED FOR
Azathioprine Tablets contain the active ingredient
Azathioprine which belongs to a group of
medicines called immunosuppressants.
Azathioprine Tablets may be used to help your
body accept an organ transplant, such as a new
kidney, heart or liver, or to treat some diseases
where your immune system is reacting against
your own body (autoimmune diseases).
Autoimmune diseases may include:
!
severe rheumatoid arthritis (a disease where
the immune system attacks cells lining the
joints causing swelling, pain, stiffness of the
joints),
!
systemic lupus erythematosus (a disease
where the immune system attacks many of
the body's organs and tissues, including skin,
joints, kidneys, brain, and other organs
causing severe fatigue, fever, stiffness and
joint pain),
!
dermatomyositis and polymyositis (a group of
diseases causing inflammation of the
muscles, muscle weakness and skin rash),
!
auto-immune chronic active hepatitis (a
disease in which the immune system attacks
liver cells causing liver inflammation, fatigue,
muscle aches, yellowing of the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azapress Tablets 50 mg
Azathioprine Tablets 50 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active substance Azathioprine BP
Excipient(s) with known effect:
Lactose BP
3
PHARMACEUTICAL FORM
Pale yellow, biconvex tablets, scored on one side and engraved with
‘A10’ on
the other side.
The score line is not for breaking the tablet.
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, in 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 rheumatoid arthritis
•
systemic lupus erythematosus (SLE)
•
dermatomyositis and polymyositis
•
auto-immune chronic active hepatitis
•
pemphigus vulgaris
•
polyarteritis nodosa
•
auto-im