Imuran 25mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Azathioprine

Saadav alates:

Stephar (U.K.) Ltd

ATC kood:

L04AX01

INN (Rahvusvaheline Nimetus):

Azathioprine

Annus:

25mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 08020100

Infovoldik

PATIENT INFORMATION LEAFLET
IMURAN
® 25MG TABLETS
(azathioprine)
The name of your medicine is Imuran 25mg Tablets, but will be
referred to as Imuran throughout the remainder of the leaflet.
Imuran is also available in a 50mg strength.
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. 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 is and what it is 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 IS AND WHAT IT IS USED FOR
Imuran tablets contain a medicine called azathioprine. This
belongs to a group of medicines called immunosuppressants.
These medicines reduce the activity of your body’s immune
system. Imuran is used to:
•
stop your body rejecting an organ transplant
•
treat diseases where your immune system reacts against
your own body (called autoimmune diseases, such as
rheumatoid arthritis).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMURAN
DO NOT TAKE IMURAN IF:
•
you are allergic (hypersensitive) to azathioprine,
mercaptopurine or any of the other ingredients of Imuran
(listed in section 6).
Do not take Imuran if any of the above apply to you. If you are
not sure, talk to your doctor, nurse or pharmacist before taking
Imuran.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before taking Imuran if:
•
you have liver or kidney disease
•
you have ‘Lesch-

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imuran 25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azathioprine
Each tablet contains 25 mg of the active substance azathioprine.
Excipient(s) with known effect
Each 25 mg tablet contains 37 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Orange, round, biconvex, film-coated tablets, unscored, branded ‘IM
2’
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 hepatitis;
•
pemphigus vulgaris;
•
polyarte