Azathioprine 50mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Azathioprine

متاح من:

Strides Pharma UK Ltd

ATC رمز:

L04AX01

INN (الاسم الدولي):

Azathioprine

جرعة:

50mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 08020100; GTIN: 5031676000181 5031676004202

نشرة المعلومات

Strides Pharma UK Ltd.
Front & Back Printing. To be supplied in the folded size of 150 x
200mm
Record Number: 304566
60 GSM Paper.
Pack Insert
150 X 400 MM
1042986
--
1
12.0
AZATHIOPRINE TABLETS - 50 MG
BLACK
Printing clarity to be clear & sharp.
1042190
PACKAGE LEAFLET:
INFORMATION FOR THE USER
AZATHIOPRINE TABLETS 50 MG
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 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 contains the active substance
azathioprine which belongs to a group of medicines
called immunosuppressants. This means that they
reduce the strength of your immune system.
Azathioprine is used for protection against organ
transplant rejection.
It can also be used to treat various conditions in
which the usual treatment (with steroids) is not
working properly, is causing problems or where
steroids cannot be used. These conditions include
hepatitis, rheumatoid arthritis, systemic lupus
erythematosus (SLE), dermatomyositis and
polymyositis (conditions which affect the muscles
and skin), various blood and bleeding disorders and
skin disorders.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AZATHIOPRINE TABLETS
DO NOT TAKE AZATHIOPRINE TABLETS IF YOU:
•
Are allergic to azathioprine, 6-mercaptop

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine Tablets 50 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains azathioprine 50mg
Excipient(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Pale yellow, biconvex tablets scored on one side and engraved with a
logo mortar
and pestle on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azathioprine tablets are 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 tablets, 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 tablets are 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 tablets, 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
•
polyarterit