Azathioprine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azathioprine

Available from:

Tillomed Laboratories 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: 5024655001637 5024655003761

Patient Information leaflet

Azathioprine 25/50 mg FCT
Package leaflet
170 mm (w) x 600 mm (L)
Till-Rpg-V.9.1/1502677-4
CC19-297 (PRAC)
UK
All
[NA]
382
1
8 points (Reg text)
Proof 1
Proof 2
Proof 3
Proof 4
Proof 5
Proof 6
Proof 7
Till-Rpg-V.8/1502677-3
29/08/2019
30/08/2019
04/09/2019
10/09/2019
11/09/2019
09/12/2019
16/01/2020
Black C
WHAT AZATHIOPRINE IS AND WHAT IT IS
USED FOR
1
Azathioprine belongs to a group of medicines called
immunosuppressants. These work by reducing the strength
of the body's immune system. Azathioprine may be taken
long-term as it can take weeks or months before an effect
is seen.
Azathioprine is used to treat the following:
 To prevent the body from rejecting kidney, liver or heart
transplants
 Inflammatory bowel disease (Crohn's disease or ulcerative
colitis)
 Severe inflammatory disease of the joints (rheumatoid
arthritis)
 Long-term inflammation of skin and/or intestines (systemic
lupus erythematosus)
 Inflammation of the skin and muscles (dermatomyositis,
polymyositis)
 Inflammation of the liver (hepatitis)
 Inflammation of the walls of the arteries (polyarteritis
nodosa)
 Increased breakdown of red blood cells due to the
presence of auto-antibodies active at body temperature
(warm) causing anaemia (looking pale and feeling tired)
 Autoimmune disorder where the number of platelets
circulating is reduced by the immune system destroying
them, causing a rash and an increased tendency to bleed,
persisting longer than 6 months without a specific cause
and is not responsive to conventional treatment (chronic
refractory idiopathic thrombocytopenic purpura)
 Blistering of the skin (pemphigus vulgaris)
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AZATHIOPRINE
2
DO NOT TAKE AZATHIOPRINE IF:
 You are allergic to Azathioprine, 6-mercaptopurine
(a derivative of Azathioprine) or any of the other
ingredients of this medicine (see section 6
"Contents of the pack and other information")
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING AZATHIOPRINE:
 If you are going to have a vaccination

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine 50 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg azathioprine.
Excipient with known effect: contains 90 mg of lactose (as lactose
monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish-white, biconvex film-coated tablet, of diameter
7.9- 8.3mm and
height of 3.6-4.2mm with a score-line on one side.
The tablet can be divided into equal doses
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,
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 active rheumatoid arthritis;
-
Systemic lupus erythematosus;
-
Dermatomyositis and polymyos