Imuran 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azathioprine

Available from:

DE Pharmaceuticals

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMURAN
® 25MG AND 50MG
FILM-COATED 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, nurse 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, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Imuran Tablets are and what they are used for
2. What you need to know before you take Imuran
3. How to take Imuran
4. Possible side effects
5. How to store Imuran
6. Contents of the pack and other information
1. WHAT IMURAN TABLETS ARE AND WHAT THEY ARE USED FOR
Imuran tablets contain the active substance azathioprine. They belong
to a group of
medicines called immunosuppressives. This means that they reduce the
strength of your
immune system.
Imuran 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,
yello

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imuran 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azathioprine
Each tablet contains 50 mg of the active substance azathioprine.
Excipient(s) with known effect
Each 50 mg tablet contains 74 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, scored, film-coated tablets, branded ‘IM
5’
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;
•
dermatomyositis and polymyositis;
•
auto-immune chronic active hepa