Skip to Content

IMURAN 50MG TABLETS

Active substance(s): AZATHIOPRINE / AZATHIOPRINE / AZATHIOPRINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package Leaflet: Information for the User

0000000-0000

Imuran® Tablets

160 mm Measuring Bar

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

ASPEN Artwork Panel • May 2013 • Version 5

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° xxxx

2. Before you take Imuran

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.

PHARMA CODE N° xxxx

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- guanine-phosphoribosyltransferase’
• 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.
Talk to your doctor, pharmacist or nurse before taking Imuran
If you are receiving immunosuppressive therapy, taking Imuran could put
you at greater risk of:
• tumours, including skin cancer. Therefore, when taking Imuran,
avoid excessive exposure to sunlight, wear protective clothing and
use protective sunscreen with a high protection factor.
• lymphoproliferative disorders
○○ treatment with Imuran increases your risk of getting a type
of cancer called lymphoproliferative disorder. With treatment
regimen containing multiple immunosuppressants (including
thiopurines), this may lead to death.
○○ A combination of multiple immunosuppressants, given
concomitantly increases the risk of disorders of the lymph system
due to a viral infection (Epstein-Barr virus (EBV)-associated
lymphoproliferative disorders).
Taking Imuran could put you at greater risk of:
• developing a serious condition called Macrophage Activation
Syndrome (excessive activation of white blood cells associated with
inflammation), which usually occurs in people who have certain
types of arthritis
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.
• 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.

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 & Co. KG, Nürnberger Strasse 12,
90537 Feucht, Germany
Leaflet date: February 2017
Imuran is a registered trademark of Aspen. All rights reserved
0000000-0000

160 mm Measuring Bar

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
• 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.

ASPEN Artwork Panel • May 2013 • Version 5

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.

Expand Transcript

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.

Hide