Azathioprine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azathioprine

Available from:

Resolution Chemicals 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: 5060301920211 5060301920228

Patient Information leaflet

DESCRIPTION: Azathioprine UK 310655
SIZE: 510 x 210 mm
PRINTED: Black
DATE: Thursday 24 June 2021
V5
THIS PIL HAS BEEN PREPARED BY VICTOR DESIGN ON BEHALF OF RESOLUTION
CHEMICALS, UNITED KINGDOM.
PLEASE REFER TO THIS LEAFLET
RES AZATHIOPRINE FIFTH PROOF 07.12.20 - (First Proof created 22.07.20)
Size 210 x 510 (text area allowed to profile supplied 190 x 490 mm)
Main Text Font size 10pt, Font used UNIVERS LT STD Roman and Bold and
Bold Italic as placed
Section Headings Text Font size 12pt, Font used UNIVERS LT STD Bold as
placed
Minimum overall document line spacing 4.mm
_1. WHAT AZATHIOPRINE 50MG TABLETS ARE_
_AND WHAT THEY ARE USED FOR_
Azathioprine 50mg Tablets contain the active substance
azathioprine which belongs to a group of medicines called
immunosuppressants. This means that they reduce the strength
of your immune system.
Immunosuppressant 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).
Azathioprine 50mg Tablets are used to:
•
Help your body accept a kidney, liver, heart, lung or pancreas
transplant. (Azathioprine Tablets are usually used together
with other medicines in order to enhance their effect).
•
Treat severe rheumatoid arthritis
•
Treat severe inflammation of the gut (Crohn’s disease or
ulcerative colitis)
•
Treat some diseases where your immune system is reacting
against your own body (autoimmune diseases) including
severe inflammatory diseases of the skin, liver, arteries and
some blood disorders.
_2. WHAT YOU NEED TO KNOW BEFORE YOU_
_TAKE AZATHIOPRINE 50MG TABLETS_
DO NOT TAKE AZATHIOPRINE 50MG TABLETS:
•
If you are allergic to azathioprine, 6-mercaptopurine or any of
the other ingredients of this medicine (listed in section 6)
•
If you have a severe infection
•
If you have severe liver disease or severe bone marrow disease
•
If you have an inflamed pancreas
•
If you need or are going to have a vaccination containing a
living virus or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg azathioprine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, round, biconvex tablet, engraved “AZA” and “50”
separated by a line
on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azathioprine is indicated in immunosuppressive regimens as an adjunct
to
immunosuppressive agents that form the mainstay of treatment (basic
immunosuppression).
Azathioprine is indicated in combination with other immunosuppressive
agents for
the prophylaxis of transplant rejection in patients receiving
allogenic kidney, liver,
heart, lung, or pancreas transplants.
Azathioprine is indicated either alone or in combination with
corticosteroids and/or
other drugs and procedures in severe cases of the following diseases,
in patients who
are intolerant to steroids or who are dependent on steroids and in
whom the
therapeutic response is inadequate despite treatment with high doses
of steroids:
-
Severe active rheumatoid arthritis that cannot be kept under control
by less
toxic agents (disease modifying anti-rheumatic drugs, DMARDs)
-
Severe or moderately severe inflammatory intestinal disease (Crohn’s
disease
or ulcerative colitis)
-
Systemic lupus erythematosus
-
Dermatomyositis
-
Auto-immune chronic active hepatitis
-
Polyarteritis nodosa
-
Refractory warm auto-immune haemolytic anaemia
-
Chronic refractory idiopathic thrombocytopenic purpura
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Transplantation
Depending on the immunosuppressive regime selected, a dosage of up to
5mg/kg/body weight/day may be given on the first day of therapy. The
maintenance
dose can range from 1-4 mg/kg/body weight/day and must be adjusted
according to
the clinical requirements and haematological tolerance.
Other conditions
In general, the starting dosage is 1-3mg/kg/body weight/day and shoul