Azathioprine 50mg film-coated Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Azathioprine

Disponible depuis:

Relon Chem Limited

Code ATC:

L04AX; L04AX01

DCI (Dénomination commune internationale):

Azathioprine

Dosage:

50 milligram(s)

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

Product subject to prescription which may not be renewed (A)

Domaine thérapeutique:

Other immunosuppressants; azathioprine

Statut de autorisation:

Not marketed

Date de l'autorisation:

2007-11-23

Notice patient

AZATHIOPRINE 50MG FILM-COATED TABLETS
(Azathioprine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or
nurse.

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 or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Azathioprine 50mg Tablets are and what they are used for
2.
What you need to know before you take Azathioprine 50mg Tablets
3.
How to take Azathioprine 50mg Tablets
4.
Possible side effects
5.
How to store Azathioprine 50mg Tablets
6.
Contents of the pack and other information
1.
WHAT AZATHIOPRINE 50MG TABLETS ARE AND WHAT THEY ARE USED FOR
Azathioprine
50mg
Tablets
belong
to
a
group
of
medicines
called
immunosuppressants. These medicines reduce the activity of your
body’s immune
system. Azathioprine 50mg Tablets are 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 AZATHIOPRINE 50MG TABLETS
DO NOT TAKE AZATHIOPRINE IF:

You
are
allergic
to
azathioprine,
mercaptopurine
or
any
of
the
other
ingredients of Azathioprine (listed in section 6).

You are pregnant or likely to become pregnant (see Pregnancy, breast-
feeding and fertility).
Do not take Azathioprine if any of the above apply to you. If you are
not sure, talk to
your doctor, nurse or pharmacist before taking Azathioprine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist befor

Résumé des caractéristiques du produit

Health Products Regulatory Authority
22 June 2020
CRN008L7T
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azathioprine 50mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg Azathioprine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Azathioprine 50mg Tablets are pale, yellow, circular, film-coated
biconvex tablets engraved with “AZA”, score-lined and “50” on
one face. The other face is plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azathioprine 50mg 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 50mg 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;
and to reduce the corticosteroid requirements of renal transplant
recipients.
Azathioprine 50mg Tablets, 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
Route of administration: Oral
Transplantation - adults and children
Depending on the immunosuppressive regimen employed, a do