Imuran 50 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Azathioprine

זמין מ:

PCO Manufacturing Ltd.

קוד ATC:

L04AX01

INN (שם בינלאומי):

Azathioprine

כמות:

50 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

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

איזור תרפויטי:

azathioprine

מצב אישור:

Authorised

תאריך אישור:

2001-09-07

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMURAN
®
25 MG FILM-COATED TABLETS
IMURAN
®
50 MG FILM-COATED 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, 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 diseases causing
inflammation of the
muscles, muscle weakness and skin rash),
–
auto-immune chronic active hepatitis (a disease in which

מאפייני מוצר

Health Products Regulatory Authority
12 February 2024
CRN00F2S5
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imuran 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active substance azathioprine.
Excipient(s) with known effect: lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Portugal and Romania_
Yellow, circular tablets with 'GX CH1' scored 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
_Excipients present in the product imported from Portugal and Romania_
Lactose
Pregelatinised starch
Maize 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. Store in the original package in order to
protect from light.
Keep the blister in outer carton.
Health Products Regulatory Authority
12 February 2024
CRN00F2S5
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 50 or 100 tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Safe handling
Health professionals who handle uncoated azathioprine tablets should
follow guidelines for the handling of cytotoxic medicinal
products according to prevailing local recommendations and/or
regulations.
Providing that the film-coating is intact, there is no risk in
handling film-coated Imuran tablets.
Film-coated Imuran tablets should not be divided and, provided the
coating is intact, no additional p