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IMURAN 50MG TABLETS

Active substance: AZATHIOPRINE

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ASPEN Artwork Panel
AW Version:
6
New Item Code:
7308166-6745

Azathioprine

Read all of this leaflet carefully
before you start taking
this medicine.
• 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. Do not pass it
on to others. It may harm them,
even if their symptoms are the
same as yours.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, nurse or
pharmacist.
In this leaflet:
1. What Imuran is and what it
is used for
2. Before you take Imuran
3. How to take Imuran
4. Possible side effects
5. How to store Imuran
6. Further information
1. What Imuran is and
what it is used for
Imuran tablets contain a medicine
called azathioprine. This belongs
to a group of medicines called
immunosuppressants. These
medicines reduce the activity
of your body’s immune system.
Imuran is 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.
PHARMA CODE N° 822

2. Before you take Imuran
Do not take Imuran if:
• you are allergic (hypersensitive)
to azathioprine, mercaptopurine
or any of the other ingredients
of Imuran (listed in section 6).
Do not take Imuran if any of the
above apply to you. If you are not
sure, talk to your doctor, nurse or
pharmacist before taking Imuran.

Taking other medicines
Please tell your doctor, nurse or
pharmacist if you are taking or
have recently taken any other
medicines. This includes medicines
obtained without a prescription,
including herbal medicines. This is
because Imuran can affect the way
some medicines work.
Also some other medicines can
affect the way Imuran works.
In particular, tell your doctor,
nurse or pharmacist if you are
taking any of the following
medicines:
• allopurinol - used for gout
• tubocurarine or succinylcholine used during operations
• warfarin - used for blood clots
• penicillamine - used for
rheumatoid arthritis
• co-trimoxazole - used for
infections
• captopril - used for high blood
pressure or heart problems
• cimetidine - used for stomach
ulcers and indigestion
• indomethacin - used for pain and
inflammation
• furosemide - used for high blood
pressure and heart problems
• olsalazine or mesalazine - used
for a bowel problem called
ulcerative colitis
• sulfasalzine or balsalazide used for rheumatoid arthritis or
ulcerative colitis.
If you are not sure if any of the
above apply to you, talk to your
doctor, nurse or pharmacist before
taking Imuran.

Having vaccines while you are
taking Imuran
If you are going to have
a vaccination speak to your
doctor or nurse before you have
it. This is because vaccines may
not work properly while you are
taking Imuran.

Replacement:
7111766-4830
Market:
UK
Product Name:
Imuran Tablets
Number of Colours:
1

Tests you may have while
taking Imuran
Your doctor may ask you to have
a blood test while you are taking
Imuran. This is to check your
blood cell count. Your doctor
may change your dose of Imuran
after the test.

Black

Manufacturing Site:
Excella
Drawing Ref. Number:
148 x 630 folded Plano

Trying for a baby, pregnancy
and breast-feeding
• Do not take Imuran if you are
a man trying to have a baby. This
is because it may affect the baby.
• Do not take Imuran if you are
a women who is pregnant
or think you might become
pregnant. This is because it may
affect the baby.
• Do not take Imuran if you are
breast-feeding. This is because
small amounts may pass into
the mother’s milk. Ask your
doctor, midwife or pharmacist
for advice before taking any
medicine, if you are pregnant or
breast-feeding.

Drawing Version:
V02
Originated by:
Aidan Collins
Originated at:
APTL
Originated on:
04 Oct 2013
Amended on:
14 Apr 2015

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Artwork Studio‘s Check:

Imuran and the sun
While taking Imuran you may
be more likely to develop some
types of cancers such as skin
cancer. Some people also become
sensitive to sunlight which can
cause skin discolouration or a rash.
Take care to avoid too much sun,
cover up and use sunscreen.

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Chickenpox /Shingles infection
Infection with chickenpox or
shingles can become severe in
patients taking immunosuppressive
medicine. Therefore you should
avoid contact with anyone
suffering from chickenpox
or shingles.

Market Approval:

Date Signature

3. How to take Imuran
Always take Imuran exactly as your
doctor has told you. You should
check with your doctor, nurse or
pharmacist if you are not sure. The
dose of Imuran you take depends
on your illness and how bad it is.
The dose also depends on your
age, your weight and how
well your liver and kidneys are
working. Your doctor will explain
this to you.
To stop your body rejecting an
organ transplant
On the first day
• the usual dose is up to 5 mg per
kg of body weight.
For the rest of your treatment
• you will take between
1 and 4 mg per kg of body
weight each day.
For other conditions
At the start of your treatment
• you will take 1 to 3 mg per kg of
body weight each day
• your doctor may reduce your
dose later.
If you take more Imuran than
you should
If you take more Imuran than you
should, talk to your doctor or go
to a hospital straight away. Take
the medicine pack with you.
If you forget to take Imuran
• If you forget to take Imuran, tell
your doctor.
• Do not take a double dose to
make up for a forgotten dose.
If you have any further questions
about Imuran and how to take
it, ask your doctor, nurse or
pharmacist.
4. Possible side effects
Like all medicines, Imuran can
cause side effects, although
not everybody gets them. The
following side effects may happen
with this medicine:
Stop taking Imuran and see
a doctor straight away, if you
notice any of the following
serious side effects, you may
need urgent medical treatment:
• allergic reaction, the signs
may include:
- general tiredness, dizziness,
feeling sick (nausea), being sick
(vomiting) or diarrhoea
- high temperature (fever),
shivering or chills
- redness of the skin or
a skin rash
- pain in the muscles or joints
- changes in the amount
and colour of the urine
(kidney problems)
- dizziness, confusion, feeling
light headed or weak, caused
by low blood pressure

PHARMA CODE N° 822

Take special care with Imuran
Check with your doctor, nurse
or pharmacist before taking
Imuran if:
• you have liver or kidney disease
• you have ‘Lesch-Nyhan
Syndrome’.
This is a rare condition that
runs in families caused by a lack
of something called HPRT
or ‘hypoxanthine- guaninephosphoribosyltransferase’
• you have a condition where
your body produces too little
of something called TPMT or
‘thiopurine methyltransferase’
• you have ever suffered from
chickenpox or shingles.
If you are not sure if any of the
above apply to you, talk to your
doctor, nurse or pharmacist before
taking Imuran.

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160 mm Measuring Bar

Imuran Tablets

7308166-6745

®

ASPEN Artwork Panel • May 2013 • Version 5

Package Leaflet: Information for the User

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Other side effects include:
Very common
(affects more than 1 in 10 people)
• infections caused by a virus,
fungus or bacteria
• reduction in your bone marrow
function, which may make you
feel unwell or show up in your
blood tests
• low white blood cell level in your
blood tests, which may cause an
infection.
Common
(affects less than 1 in 10 people)
• low blood platelet level, which
may cause you to bruise or
bleed easily.
Uncommon
(affects less than 1 in 100 people)
• low red blood cell level, which
may cause you to be tired, get
headaches, be short of breath
when exercising, feel dizzy
and look pale
• inflammation of the pancreas,
which may cause you severe
upper stomach pain, with feeling
sick (nausea) and being sick
(vomiting)
• liver problems, which may
cause pale stools, dark urine,
itchiness and yellowing of your
skin and eyes.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Service-Tel: 0800 008 7392
(+ 44 1748 828 391)
Imuran 25 mg
PL 39699/0004
Imuran 50 mg
PL 39699/0005
Manufacturer: EXCELLA GmBH,
Feucht, Germany
Leaflet date: August 2014
Imuran is a registered trademark
of Aspen. All rights reserved

AW Version:
6

Page:
2 of 2

New Item Code:
7308166-6745
Replacement:
7111766-4830
Market:
UK
Product Name:
Imuran Tablets
Number of Colours:
1
Black

Manufacturing Site:
Excella
Drawing Ref. Number:
148 x 630 folded Plano
Drawing Version:
V02
Originated by:
Aidan Collins
Originated at:
APTL
Originated on:
04 Oct 2013
Amended on:
14 Apr 2015

ASPEN Signature Panel
Artwork Studio‘s Check:

Date Signature

Proof Reader‘s Check:

Date Signature

Technical Site Check:

Date Signature

Market Approval:

Rare
(affects less than 1 in
1,000 people)
• problems with your blood and
bone marrow which may cause
weakness, tiredness, paleness,
headaches, sore tongue,
breathlessness, bruising or
infections
• problems with your bowel
leading to diarrhoea, abdominal
pain, constipation, feeling
sick (nausea) and being sick
(vomiting)
• hair loss which may get better
even though you continue to
take Imuran
• severe liver damage which can
be life threatening
• various types of cancers
including blood, lymph and
skin cancers
• sensitivity to sunlight which
can cause skin discolouration
or a rash.

Date Signature

Very rare
(affects less than 1 in
10,000 people)
• inflammation of your lungs
causing breathlessness, cough
and a fever.
If any of the side effects gets
serious, or if you notice any other
side effects not listed in this leaflet,
please tell your doctor, nurse or
pharmacist.
5. How to store Imuran
• Do not store above 25°C.
• Protect from light.
• Keep out of the reach and sight
of children.
• Do not use Imuran after the
expiry date which is stated on
the label. The expiry date refers
to the last day of that month.
• Medicines should not be
disposed of via wastewater or
household waste.
Ask your pharmacist how
to dispose of medicines no
longer required.
These measures will help to
protect the environment.
6. Further Information
What Imuran contains
• The active substance is
azathioprine.
• The other ingredients are
lactose, pregelatinised
starch, maize starch, stearic
acid, magnesium stearate,
methylhydroxypropyl cellulose,
and propylene glycol 400.
• There is no colouring in the
yellow tablets.
• The colouring in the orange
tablets contains titanium dioxide
(E171), iron oxide yellow
(E172) and iron oxide red (E172).

7308166-6745

160 mm Measuring Bar

What Imuran looks like and
contents of the pack
• Imuran tablets are covered by
a thin coating and come in two
strengths and colours.
• The orange tablets contain
25 mg of the active ingredient
azathioprine and are marked
with ‘GX EL5’.
• The yellow tablets contain 50 mg
of azathioprine and are marked
with ‘GX CH1’.
Imuran tablets come in packs of
28, 30, 56, 60 and 100 tablets.
The 50 mg tablets are also
available in packs of 1000 tablets.
Not all pack sizes may
be marketed.

ASPEN Artwork Panel • May 2013 • Version 5

• you bruise more easily or notice
any unusual bleeding
• you have a high temperature
(fever) or other signs of
an infection
• you feel extremely tired
• you notice lumps anywhere
on your body
• you notice any changes to
your skin, for example blisters
or peeling
• your health suddenly gets worse
• you come into contact with
anyone who is suffering from
chickenpox or shingles. If you
notice any of the above, stop
taking Imuran and see a doctor
straight away.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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