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AZATHIOPRINE 50MG FILM-COATED TABLETS

Active substance(s): AZATHIOPRINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Azathioprine 25 mg film-coated tablets
Azathioprine 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 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Azathioprine is and what it is used for
2. What you need to know before you take
Azathioprine
3. How to take Azathioprine
4. Possible side effects
5. How to store Azathioprine
6. Contents of the pack and other information

1

used to treat gout)
• penicillamine (mainly used in the treatment of
rheumatoid arthritis)
• ACE inhibitor (mainly used to treat high blood
pressure – hypertension)
• anticoagulants such as warfarin or
acenocoumarol (used to prevent blood clots)
• cimetidine (used to treat stomach ulcers and
indigestion)
• indomethacin (used as a pain killer and
anti-inflammatory)
• cytostatic drugs (includes some antibiotics and
also drugs used to treat various types of cancer)
• aminosalicylates e.g. olsalazine, mesalazine or
sulfasalazine (mainly used in the treatment of
ulcerative colitis and Crohn’s disease)
• co-trimoxazole (an antibiotic, used to treat
infections caused by bacteria).

What Azathioprine is and what it
is used for

Azathioprine belong to a group of medicines
called immunosuppressives. This means that
they reduce the strength of your immune system.

Immunosuppressive medicines are sometimes
necessary to help your body accept an organ
transplant, or to treat some diseases where your
immune system is reacting against your own
body (autoimmune diseases, such as rheumatoid
arthritis).

2

What you need to know before you
take Azathioprine

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Azathioprine.

Do not take Azathioprine:
• if you are allergic to azathioprine or any of the
other ingredients of this medicine (listed in
section 6)
• if you are allergic to mercaptopurine.

Azathioprine with food and drink

Do not take Azathioprine less than 1 hour before,
or less than 3 hours after eating any food, or
drinking milk. You should swallow your tablet with
some water (see section 3 “How to take
Azathioprine”).

Warnings and precautions
Talk to your doctor or pharmacist before taking
Azathioprine
• if you suffer from the condition known as
Lesch-Nyhan Syndrome. This is a rare
condition that runs in families caused by a lack
of something called HPRT or ‘hypoxanthineguanine-phosphoribosyltransferase’.
• if you suffer from liver or kidney problems
• if you are planning to become pregnant, or if your
partner is planning to become pregnant (see
section 2 “Pregnancy, breast-feeding and fertility”)
• if you have a condition where your body
produces too little of something called
thiopurine methyltransferase (TPMT)
• if you have ever suffered from chickenpox or
shingles
• if you are going to have a vaccination (see
section 2 “Other medicines and Azathioprine”).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to become pregnant,
ask your doctor for advice before taking this
medicine (see section 2 “Warnings and
precautions”).
If you are pregnant or you are likely to become
pregnant, you must consult your doctor before
taking Azathioprine. Your doctor will carefully
consider whether you should take this medicine,
based on the risks and benefits of treatment.

You should not breast-feed during treatment with
Azathioprine. This is because small amounts may
pass into the breast milk.

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking this medicine.

Azathioprine may increase fertility in both male
and female patients; therefore, while being
treated with Azathioprine, you should take extra
precautions, including using a contraceptive other
than an intrauterine device (e.g. coil, Copper T).

Your doctor will want to take regular blood
samples while you are taking Azathioprine, to
check for any changes (see section 3 “How to
take Azathioprine”).

Driving and using machines

If you are receiving immunosuppressive therapy,
taking Azathioprine could put you at greater risk of:
• tumours, including skin cancer. Therefore, when
taking Azathioprine, avoid excessive exposure
to sunlight, wear protective clothing and use
protective sunscreen with a high protection factor.
• severe chickenpox or shingles infection.
Therefore, when taking Azathioprine, avoid
contact with people who have chickenpox or
shingles.
• other infections such as PML (Progressive
Multifocal Leukoencephalopathy) which is an
opportunistic infection. If you experience any
signs of infection please contact your doctor
(see section 4 “ Possible side effects)
• Lymphoproliferative disorder
- treatment with Immunoprin 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).

Azathioprine is not known to affect your ability to
drive or use machinery. If you experience any
side effect from this medicine, you may not be
able to drive or operate machinery.
Azathioprine contains lactose

Azathioprine contains lactose monohydrate. If
you have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before taking this medicinal product.

3

Always take this medicine exactly as your doctor
has told you. Do not change the dose or stop
taking Azathioprine without first consulting your
doctor. Check with your doctor or pharmacist if
you are not sure.

The quantity of Azathioprine taken may vary from
patient to patient and will be prescribed by your
doctor. The dose depends on the condition for
which you are being treated.

Taking Immunoprin could put you at greater risk of:
• developing a serious condition called
Marcophage Activation Syndrome (excessive
activation of white blood cells associated with
inflammation), which usually occurs in people
who have certain types of arthritis.

Your doctor will want to take regular blood
samples while you are taking Azathioprine, to
check for any changes (see section 2 “Warnings
and precautions”).
The recommended dose is:

Infections
When you are treated with azathioprine the risk
of viral, fungal and bacterial infections is increased
and the infections may be more serious. See also
section 4.
Tell your doctor before starting treatment whether
or not you have had chickenpox, shingles or
hepatitis B (a liver disease caused by a virus).

Adults who have had an organ transplant: On
the first day of treatment, the usual dose is up to
5 mg per kilogram of body weight, then a usual
daily dose of 1 to 4 mg per kilogram of body weight.
During treatment your doctor will adjust the dose
depending on your reaction to the medicine.
Adults with other conditions: The usual daily
dose is 1 to 3 mg per kilogram of body weight.
During treatment your doctor will adjust the dose
depending on your reaction to the medicine.

NUDT15-gene mutation
If you have an inherited mutation in the
NUDT15-gene (a gene which is involved in the
break-down of azathioprine in the body), you have
a higher risk of infections and hair loss and your
doctor may in this case give you a lower dose.

Elderly patients may need a reduced dose.

Patients with kidney or liver problems may need
a reduced dose.

Other medicines and Azathioprine

Tell your doctor if you are taking, have recently
taken or might take any other medicines. This
includes medicines obtained without a
prescription, including herbal medicines. This
is because this medicine can affect the way
some medicines work. Also some other
medicines can affect the way this medicine
works. In particular tell your doctor if you are
taking, or are planning to take:

Use in children
The dosing for children who have had an organ
transplant is the same as adults.
Children who are considered overweight may
require a higher dose.
Method of administration

Take Azathioprine as instructed by your doctor.
It is important that you take this medicine on time.
The pharmacy label tells you how much and how
often you should take your medicine.

• vaccines (used to prevent diseases) (see
section 2 “Warnings and precautions”)
• ribavirin (used to treat viral infections)
• methotrexate (mainly used to treat cancers)
• allopurinol, oxipurinol or thiopurinol (mainly

Swallow whole with a little water.
The tablet should not be divided or broken.

The following information is intended for
healthcare professionals only:

However, immunosuppressive agents should be
handled in strict accordance with the instructions
when nursing staff have halved the tablets (see
sections 4.2 and 4.4 of the SmPC).

Instructions for use and handling and
disposal

There are no risks associated with handling
tablets with intact coating. In that case no special
safety precautions are necessary.
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How to take Azathioprine

Surplus medical products as well as
contaminated appliances should be temporarily
stored in clearly labelled containers.

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Take the tablets at least 1 hour before eating food
or drinking milk, or at least 3 hours after eating
food or drinking milk (see section 2 “Azathioprine
with food and drink”).

carton after “EXP”. The expiry date refers to the
last day of that month.

If you forget to take Azathioprine
Do not take a double dose to make up for the
dose that you missed. Inform your doctor if you
do miss a dose.
If it is almost time for your next dose, skip the
dose you missed and take your next dose when
you are meant to. Otherwise, take it as soon as
you remember, then go back to taking it as you
would normally.

Do not dispose of any medicines via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These
measures will help protect the environment.

If you take more Azathioprine than you should
If you take too many tablets, contact your doctor
or pharmacist immediately.

If you stop taking Azathioprine
Before you stop taking Azathioprine, consult with
your doctor or pharmacist. Do not stop taking
Azathioprine until your doctor tells you it is safe to
do so.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4

Possible side effects

If the Azathioprine 50 mg film-coated tablet has to
be halved, contact of the skin with the powder or
the broken part of the tablet should be avoided.
Residues should be disposed of with the same
caution.

6

Contents of the pack and other
information

What Azathioprine Film-coated Tablets contain
Active Substance: 25mg of azathioprine
(Azathioprine 25 mg Film−Coated Tablets) and
50mg of azathioprine (Azathioprine 50 mg
Film−Coated Tablets)
Other ingredients: lactose monohydrate, maize
starch, povidone, colloidal silicon dioxide,
magnesium stearate, hypromellose,
microcrystalline cellulose, polyoxyl-8-stearate, talc.
Colouring agent: titanium dioxide (E171).
What Azathioprine 25 mg looks like and
contents of the pack

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects may happen with this
medicine:

Azathioprine film-coated tablets are white to
yellowish-white film-coated tablets, biconvex with
no score-line.
Pack sizes: 20, 28, 30, 50 or 100 film-coated
tablets.

Stop taking this medicine and see a doctor
straight away, if you notice any of the
following serious side effects, you may need
urgent medical treatment:

What Azathioprine 50 mg looks like and
contents of the pack

• 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 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 this
medicine and see a doctor straight away.

Azathioprine 50 mg film-coated tablets are white
to yellowish-white film-coated tablets, biconvex
with score-line on one side.
Pack sizes: 20, 30, 50, 56 or 100 film-coated
tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder
Sandoz Ltd,
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

If you get any of the following side effects,
talk to your specialist doctor or go to hospital
immediately:
• Any signs of fever or infection (sore throat,
sore mouth or urinary problems)

This leaflet was last revised in 09/2017

Other side effects include:

Very Common (may affect more than 1 in 10
people)

• infections caused by a virus, fungus or bacteria
in transplant patients
• reduction in your bone marrow function, which
may make you feel unwell or show up in your
blood tests.
Common (may affect up to 1 in 10 people)

• nausea (feeling sick)
• low blood platelet level, which may cause you
to bruise or bleed easily.

Uncommon (may affect up to 1 in 100 people)

• anaemia
• hypersensitivity reactions (allergic reactions)
• pancreatitis (inflammation of the pancreas),
which may cause you severe upper stomach
pain, with feeling sick (nausea) and being sick
(vomiting)
• infections caused by a virus, fungus or bacteria
• liver problems, which may cause pale stools,
dark urine, itchiness and yellowing of your skin
and eyes, and abnormalities in the results of
liver function tests.
Rare (may affect up to 1 in 1,000 people)

• severe liver damage which can be life
threatening
• hair loss
• problems with your blood and bone marrow
(signs include weakness, tiredness, paleness,
bruising or infections)
• various types of cancers including blood,
lymph and skin cancers (see section 2
Warnings and precautions).

Very Rare (may affect up to 1 in 10,000 people)

• Inflammation of your lungs causing
breathlessness, cough and fever
• Problems with your bowels leading to
diarrhoea, abdominal pain, constipation,
feeling or being sick (bowel perforation)
• Skin rashes or redness, which may develop
into life-threatening skin reactions including
widespread rash with blisters and peeling skin,
particularly occurring around the mouth, nose,
eyes and genitals (Stevens-Johnson
syndrome), extensive peeling of the skin (toxic
epidermal necrolysis)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme (www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.

5

How to store Azathioprine

Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any
special storage conditions.

Do not use this medicine after the expiry date
which is stated on the blister strip and on the

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Shelf life
3 years

Any unused product or waste material should be
disposed of in accordance with local requirements.

Special precautions for storage
This medicinal product does not require any
special storage conditions.

Incompatibilities
Not applicable.

draft: 44052565, 44052564,
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Administration
For oral use.
The tablet should be taken with at least a glass of
liquid (200 ml).

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Artwork Proof Box
Ref: V048: : SPC and PL in line with the CMDh
Proof no.
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Date prepared:
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Colours:
Black
Dimensions: 148 x 594 mm

Font size:
8pt
Fonts:
Helvetica

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