Azathioprine 25mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Azathioprine

Fáanlegur frá:

DE Pharmaceuticals

ATC númer:

L04AX01

INN (Alþjóðlegt nafn):

Azathioprine

Skammtar:

25mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 08020100

Upplýsingar fylgiseðill

Sandoz
Business use only
Page 1 of 8
1.3.1 spc-label-pl - common-pl-001 - 46
(NL/H/0326-0327-0328/001 changeID 165986)
20180827
AZATHIOPRINE 25 MG FILM-COATED TABLET
800-0036.00
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[NATIONALLY APPROVED NAME] 25 MG 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 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 [Nationally approved name] are and what they are used for
2.
What you need to know before you take [Nationally approved name]
3.
How to take [Nationally approved name]
4.
Possible side effects
5.
How to store [Nationally approved name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY APPROVED NAME] ARE AND WHAT THEY ARE USED FOR
[Nationally approved name] belong to a group of medicines called
immunosuppressives. This means
that they reduce the strength of your immune system.
Immunosuppressive 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, such as rheumatoid arthritis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY APPROVED NAME]
DO NOT TAKE [NATIONALLY APPROVED NAME]:

if you are allergic to azathioprine or any of the other ingredients of
this medicine (listed in section
6)

if you are allergic to mercaptopurine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking [Nationally approved
name]:

if you suffer from the condition known as Lesch-Nyhan Syndrome. This
is a rare condition that
r

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 25 mg azathioprine.
Excipient(s) with known effect: Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish-white film-coated tablet, biconvex, no score-line.
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;
and to reduce the
corticosteroid requirements of renal transplant recipients.
Azathioprine either alone or
more usually in combination with corticosteroids and/or other drugs
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
-
polyarteritis nodosa
-
auto-immune haemolytic anaemia
-
chronic refractory idiopathic thrombocytopenic purpura
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Specialist medical literature should be consulted for guidance as to
clinical experience
in particular conditions.
_General _
When the oral route is impractical, azathioprine injection may be
administered by the
i.v. route only, however, this route should be discontinued as soon as