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AZATHIOPRINE 50 MG FILM COATED TABLETS

Active substance(s): AZATHIOPRINE

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Package leaflet: Information for the patient

Azathioprine Tablets
25 mg
Azathioprine Tablets
50 mg
(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. What Azathioprine is and what it is
used for
Azathioprine belongs to a group of medicines
called immunosuppressants. Azathioprine helps to
reduce or suppress your body’s own immune system.
Your immune system helps to protect you against
infections. However, sometimes it can produce illness
and unwanted effects. For example, if you have just
had an organ transplant, your immune system will try
to reject the new organ. Azathioprine helps to prevent
this immune response, and so allows the organ to
carry on working. It is therefore used together with
other medicines such as corticosteroids to:
• improve the survival of organ transplants
Azathioprine is also used to treat conditions caused
by your immune system over reacting or reacting
abnormally. For example:

• rheumatoid arthritis (inflammation and pain in
your joints)
• hepatitis (inflamed liver)
• systemic lupus erythematosus (a disease which
affects your skin and major organs)
• blood disorders such as thrombocytopenia
(reduced numbers of blood cells called platelets).
This can affect blood clotting and increase the risk
of bleeding or bruising.
• haemolytic anaemia (when you do not have
enough red blood cells)
• pemphigus (blisters and sores on your skin)
• dermatomyositis (inflammation of your muscles
and skin)
• polyarteritis nodosa (inflammation of your blood
vessels)
For these conditions, Azathioprine may be used
alone, or in combination with other medicines.
2. What you need to know before you take
Azathioprine
Do not take Azathioprine if you
• are allergic to azathioprine, to mercaptopurine (a
medicine used to treat leukaemia, a cancer of the
white blood cells) or any of the other ingredients
of this medicine (listed in section 6).
• are pregnant or intend to become pregnant
• are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you:
• know you have a metabolic abnormality called
Lesch-Nyhan syndrome. Azathioprine is not
recommended if you have this condition.
• know you have a shortage of a liver enzyme
called thiopurine methyltransferase (TPMT). TPMT
breaks down azathioprine and other medicines.
• have liver or kidney disease. You may have to take a
lower dose and your doctor will closely monitor you.
• have ever suffered from chickenpox or shingles.
Azathioprine and the sun
While taking Azathioprine 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.

Date: 14 Oct 2013
Description Azathioprine 25/50mg
Component Type Leaflet

Vendor Job No. 217985

Affiliate Item Code 307869

Proof No. 2

TrackWise PR No. N/A
MA No.

04569/0234 & 0073

Packing Site/Printer Delpharm
Supplier Code tBc
Pharma Code tBc
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A
Dimensions 180 x 210mm

No. of colours
Colours

1

Time: 15:44
Page Count

1/4

Black

Non-Print
Colours
Main Font

Myriad Pro

Body Text Size 10 pt

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.
Your doctor will need to monitor you closely
throughout your treatment. You should
therefore visit your doctor regularly whilst taking
Azathioprine so your condition can be checked.
You will need to have your blood count checked
at least once a week for the first two months of
treatment and then monthly.
Other medicines and Azathioprine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without a
prescription, or the following:
• other immunosuppressants e.g. ciclosporin,
methotrexate, tacrolimus
• medicines to treat cancer e.g. doxorubicin
• allopurinol, oxipurinol or thiopurinol (for gout or
kidney stones)
• cimetidine (for gut or stomach ulcers)
• furosemide ('water tablets')
• penicillamine (for rheumatoid arthritis)
• warfarin (to 'thin' the blood)
• captopril (for blood pressure or heart failure)
• indometacin (an anti-inflammatory)
• co-trimoxazole (an antibiotic)
• mesalazine, olsalazine, sulfasalazine or balsalazide
(mainly used to treat ulcerative colitis).
If you are going to have an operation, tell your
doctor or the hospital staff as Azathioprine can
interact with medicines called muscle relaxants
(e.g. succinylcholine or tubocurarine), which you
might be given during your operation.
If you are going to have a vaccination, tell your doctor
as some vaccines should not be given or may be less
effective, when given together with Azathioprine.
Pregnancy and breast-feeding
Do not take Azathioprine if you are pregnant,
become pregnant, or suspect you may already be
pregnant as the product could harm your baby
(see section 2 'Do not take Azathioprine' above).
Contact your doctor as soon as possible for advice.
Do not take Azathioprine if you are planning to
have a baby, this applies to both men and women.

You and your partner must use a reliable method of
contraception whilst taking Azathioprine.
Do not breast-feed your baby. Azathioprine may
pass into breast milk.
Driving and using machines
Do not drive or operate machinery if you feel dizzy
while taking this medicine.
3. How to take Azathioprine
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults, adolescents and children
Your dose will be adjusted depending on your
weight. The recommended doses are:
To prevent organ rejection
The recommended starting dose is up to 5 mg per kg
of body weight per day. Your doctor will then assess
your response to Azathioprine and choose the best
dose for you. This may take weeks or months. After
this assessment your dose will usually be between 1
and 4 mg per kg of body weight per day.
Other conditions
The recommended starting dose is between 1
and 3 mg per kg of body weight per day. Your
doctor will adjust the dose until it is right for you.
Your doctor will prescribe the lowest dose that
is effective to treat your condition. If there is no
improvement within three months, your doctor
may stop giving you this medicine.
Older people or people with kidney or liver
disease
If you are elderly or you have kidney or liver
disease, you may be started on a lower dose of
Azathioprine. Your doctor will monitor your blood
and liver function tests carefully. Your dose may
be reduced further if there are any signs that your
blood or liver is affected.
Taking Azathioprine
• Swallow the tablets whole with a glass of water.
Do not break, chew or crush them.
• The 50 mg tablets have a score line but this is not
intended for breaking the tablet.
• If you feel sick after taking your Azathioprine, it
should help to take your tablets after meals.

Date: 14 Oct 2013
Description Azathioprine 25/50mg
Component Type Leaflet

Vendor Job No. 217985

Affiliate Item Code 307869

Proof No. 2

TrackWise PR No. N/A
MA No.

04569/0234 & 0073

Packing Site/Printer Delpharm
Supplier Code TBC
Pharma Code TBC
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A
Dimensions 180 x 210mm

No. of colours
Colours

1

Time: 15:44
Page Count

2/4

Black

Non-Print
Colours
Main Font

Myriad Pro

Body Text Size 10 pt

If you take more Azathioprine than you should
Contact your doctor or nearest hospital emergency
department immediately. Take the container and
any remaining tablets with you. Symptoms of
overdose include nausea (feeling sick), vomiting
and diarrhoea, lack of white blood cells which may
cause frequent infections such as fever, severe
chills, sore throat or mouth ulcers, disturbances of
your liver function, bruising and bleeding.
If you forget to take Azathioprine
If you forget to take your tablets, take the missed
dose as soon as you remember. If it is nearly time
for your next dose and if you take only one dose
a day, do not double your next dose, carry on as
usual and check with your doctor. If you miss a
dose, check with your doctor.
If you stop taking Azathioprine
Do not stop taking this medicine without talking
to your doctor. You may need to take it indefinitely
to help stop transplant rejection.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen stop taking
Azathioprine and tell your doctor immediately or go
to your nearest hospital emergency department:
Very common (may affect more than 1 in 10
people):
• you have any signs of a viral, fungal or bacterial
infection or fever. Infections are very common if you
are taking Azathioprine after an organ transplant, and
with another immunosuppressant or corticosteroid.
• low levels of white blood cells that means you are
more likely to catch infections.
Common (may affect up to 1 in 10 people):
• reduction in blood platelets which increase the
risk of bleeding or bruising

Uncommon (may affect up to 1 in 100 people):
• allergic reactions which may cause: feeling
generally unwell, dizziness, nausea (feeling sick),
vomiting (being sick), diarrhoea, fever, chills, rash
or red spots, muscle or joint pain, problems with
your kidneys (which may cause changes in the
amount and colour of your urine), problems with
your liver (which may cause yellowing of your skin
and whites of your eyes), or a fall in blood pressure
(hypotension) which may cause light-headedness
or sweating. Your doctor may tell you to stop taking
Azathioprine if you develop these symptoms.
• inflamed pancreas which causes severe pain in
the abdomen and back.
• cholestasis (when the flow of bile is blocked) or
abnormal liver enzyme levels in the blood. The
symptoms of these conditions include dark urine,
pale stools, itchy skin and yellowing of your skin
and whites of your eyes.
Rare (may affect up to 1 in 1,000 people):
• stomach pain and swelling; yellowing of the skin or
whites of the eyes. These may be due to problems
with your liver. Azathioprine can cause a rare but
severe form of liver disease which can be fatal.
• disturbances of the bowel such as inflammation
which causes abdominal pain, fever, discomfort,
vomiting or diarrhoea. This is more likely
to happen if you also take high doses of
corticosteroids. Also, severe diarrhoea may
happen, especially if you are being treated for
inflammatory bowel disease.
• severe reduction of all types of blood cells which
can cause weakness, bruising or make infections
more likely.
• severe blistering of the skin, mouth, throat, nose,
genitals and conjunctivitis (red and swollen eyes).
Very rare (may affect up to 1 in 1,000 people):
• inflammation of the lungs which can cause
weakness, breathlessness, cough and fever.
Stop taking Azathioprine and tell your doctor
immediately if you come into contact with anyone
who is suffering from chickenpox or shingles.
Tell your doctor straight away if you develop any
lumps or cysts on your body.

Date: 14 Oct 2013
Description Azathioprine 25/50mg
Component Type Leaflet

Vendor Job No. 217985

Affiliate Item Code 307869

Proof No. 2

TrackWise PR No. N/A
MA No.

04569/0234 & 0073

Packing Site/Printer Delpharm
Supplier Code TBC
Pharma Code TBC
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A
Dimensions 180 x 210mm

No. of colours
Colours

1

Time: 15:44
Page Count

3/4

Black

Non-Print
Colours
Main Font

Myriad Pro

Body Text Size 10 pt

Rare (may affect up to 1 in 1,000 people):
Patients taking an immunosuppressant such as
Azathioprine may be more likely to develop certain
cancers including skin cancer, blood cancers,
cancer of the womb or lymph glands. Your doctor
will make sure that you take the lowest effective
dose of immunosuppressant to minimise any risk.
To help reduce the risk of skin cancer, take care to
avoid too much sun, wear protective clothing and
use a high factor sunscreen.
Other side effects include:
Uncommon (may affect up to 1 in 100 people):
• Rare side effects (may affect up to 1 in 1,000
people): hair loss, especially if you are also taking
another immunosuppressant. Your hair will
usually grow back even when you carry on taking
Azathioprine.
• increased sensitivity of the skin to sunlight.
Not known (frequency cannot be estimated from
the available data):
• nausea (feeling sick) especially when first taking
Azathioprine. This can be relieved if you take your
tablets after meals.
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 at:
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.
Do not use this medicine after the expiry date
which is stated on the carton after 'EXP'. The expiry
date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Azathioprine tablets contain
The active substance is azathioprine. Each tablet
contains either 25 mg or 50 mg azathioprine.
The other ingredients are maize starch,
microcrystalline cellulose, mannitol, povidone
K25, croscarmellose sodium and stearylfumarate
sodium. The film-coating contains hypromellose
and macrogol.
What Azathioprine tablets looks like and contents
of the pack
Your medicine comes as a pale yellow, round, filmcoated tablet.
The 25 mg tablet is marked 'AE' over '25' on one
side with a 'G' on the other.
The 50 mg tablet is marked 'AE' over '50' on one
side and a scoreline on the reverse.
Azathioprine is available in blister packs or plastic
containers of 28, 30, 50, 56, 60, 84, 90, 100, 112, 168,
500 and 1,000 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Mylan
Station Close
Potters Bar
Herts EN6 1TL
Manufacturers
Generics [UK] Limited
Station Close
Potters Bar
Herts EN6 1TL
Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland.
Delpharm Lille S.A.S
ZI de Roubaix Est, Rue de Toufflers
59390 Lys lez Lannoy
France

This leaflet was last revised in
09/2013

Date: 14 Oct 2013
Description Azathioprine 25/50mg
Component Type Leaflet

Vendor Job No. 217985

Affiliate Item Code 307869

Proof No. 2

TrackWise PR No. N/A
MA No.

04569/0234 & 0073

Packing Site/Printer Delpharm
Supplier Code TBC
Pharma Code TBC
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A
Dimensions 180 x 210mm

No. of colours
Colours

1

00000000 307869

Time: 15:44
Page Count

4/4

Black

Non-Print
Colours
Main Font

Myriad Pro

Body Text Size 10 pt

Expand view ⇕

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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