Imuran Film-coated Tablets 50 mg

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Azathioprine

Saadav alates:

Imbat Limited

ATC kood:

L04AX; L04AX01

INN (Rahvusvaheline Nimetus):

Azathioprine

Annus:

50 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

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

Terapeutiline ala:

Other immunosuppressants; azathioprine

Volitamisolek:

Authorised

Loa andmise kuupäev:

2007-06-15

Infovoldik

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMURAN
® FILM-COATED TABLETS 50MG
(azathioprine)
Your medicine is available using the name Imuran
Film-coated Tablets 50mg, but will be referred to as
Imuran Tablets throughout this leaflet. This medicine is also
available in 25mg strength.
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,
nurse 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, nurse or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imuran Tablets are and what they are used for
2.
What you need to know before you take Imuran Tablets
3.
How to take Imuran Tablets
4.
Possible side effects
5.
How to store Imuran Tablets
6.
Contents of the pack and other information
1.
WHAT IMURAN TABLETS ARE AND WHAT THEY
ARE USED FOR
Imuran Tablets contain the active substance azathioprine.
They belong to a group of medicines called
immunosuppressives. This means that they reduce the
strength of your immune system.
Imuran Tablets may be used to help your body accept an
organ transplant, such as a new kidney, heart or liver, or to
treat some diseases where your immune system is reacting
against your own body (autoimmune diseases).
Autoimmune diseases may include:

severe rheumatoid arthritis (a disease where the
immune system attacks cells lining the joints causing
swelling, pain, stiffness of the joints)

systemic lupus erythematosus (a disease where the
immune system attacks many of the body’s organs and
tissues, including skin, joints, kidneys, brain and other
organs causing severe fatigue, fever, stiffness and joint
pain)

dermatomyositis and polymyositis (a group of

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imuran Film-coated Tablets 50 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of azathioprine.
Excipient: Contains lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
Yellow, round, biconvex tablets with “GX CH1” and a breakline on
one side and plain on the other.
The scoreline should not be used to break the tablet.
4 CLINICAL PARTICULARS
As per PA1691/003/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/003/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose
Maize starch
Pregelatinised starch
Stearic acid
Magnesium stearate
Hypromellose
Macrogol 400
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Keep the blister in the outer carton.
Protect from light.
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6.5 NATURE AND CONTENTS OF CONTAINER
White opaque PVC/aluminium foil blister packs in a cardboard carton.
Pack size: 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Safe handling of Imuran: Health professionals who handle u