Imuran 25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azathioprine

Available from:

PCO Manufacturing Ltd.

ATC code:

L04AX01

INN (International Name):

Azathioprine

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

azathioprine

Authorization status:

Authorised

Authorization date:

2001-09-07

Patient Information leaflet

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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

Summary of Product characteristics

Health Products Regulatory Authority
12 February 2024
CRN00F2S5
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imuran 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of the active substance azathioprine.
Excipient(s) with known effect: contains lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets
_Product imported from the Netherlands:_
Orange, circular tablets with 'L3C' on one side and plain on the
other.
_Product imported from Portugal:_
Orange, circular tablets with 'IM 2' on one side and plain on the
other.
4 CLINICAL PARTICULARS
As per PA1691/003/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/003/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Excipients present in the product imported from Portugal_:
Lactose,
maize starch,
pregelatinised starch,
stearic acid,
magnesium stearate,
hypromellose,
macrogol,
titanium dioxide (E171),
iron oxide yellow (E172) and
iron oxide red (E172).
_Excipients present in the product imported from the Netherlands:_
Lactose,
hydrolysed maize starch,
maize starch,
stearic acid,
magnesium stearate,
hypromellose,
macrogol,
titanium dioxide (E171)
iron oxide (E172)
Health Products Regulatory Authority
12 February 2024
CRN00F2S5
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is 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.
Blisters: Keep the container in the outer carton.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 50 or 100 tablets and plastic bottles
containing 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
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