IMURAN 50MG TABLETS

Active substance: AZATHIOPRINE

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Package Leaflet: Information for the User

7308166-6745

Imuran® Tablets
Azathioprine

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.
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.
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.
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.
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.
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.

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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.

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.
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.
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
• 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.
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.
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
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• Do not take Imuran if you are breastfeeding. 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.

• 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.
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).
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.

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

PHARMA CODE N° 822

7308166-6745
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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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