Skip to Content

AZATHIOPRINE TABLETS 50MG

Active substance(s): AZATHIOPRINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Azathioprine Tablets 50mg
[Azathioprine]

Read all of this leaflet carefully before
Since many of the effects of Azathioprine
you start taking this medicine
cause changes in the blood, your doctor
because it contains important
will probably want to take regular blood
information for you.
samples whilst you are taking this
!
Keep this leaflet. You may need to
medicine to look out for any such
read it again.
changes.
!
If you have any further questions,
ask your doctor or pharmacist or
Whilst undergoing treatment with
nurse.
Azathioprine, avoid excessive exposure
!
This medicine has been prescribed
to the sun. In addition, examine your
for you only. Do not pass it on to
skin regularly for any skin reactions or
others. It may harm them, even if
lumps. If you experience any changes in
their signs of illness are the same as
your skin or develop any lumps
yours.
(especially if you have had an organ
!
If you get any side effects, talk to
transplant) tell your doctor immediately.
your doctor, or pharmacist or nurse.
This includes any possible side
You should contact your doctor
effects not listed in this leaflet. See
immediately if you notice any evidence
section 4.
of infection, unexpected bruising or
bleeding as this may indicate a serious
What is in this leaflet:
blood disorder (bone marrow
1. What Azathioprine Tablets are and
depression).
what they are used for
2. What you need to know before you
Azathioprine has been known to cause
take Azathioprine Tablets
alterations to chromosomes (the sites for
3. How to take Azathioprine Tablets
genes) in body cells, which is reversible
4. Possible side effects
on withdrawal of the drug. Further advice
5. How to store Azathioprine Tablets
should be obtained from your doctor.
6. Contents of the pack and other
information
Use of Azathioprine in renal transplant
patients may lead to an increase in
1. WHAT AZATHIOPRINE TABLETS
fertility in both males and females.
ARE AND WHAT THEY ARE USED
FOR
Whilst taking Azathioprine patients are at
an increased risk of developing nonAzathioprine Tablets contain the active
Hodgkin's lymphomas and other
ingredient Azathioprine which belongs to
malignancies particularly skin cancers,
a group of medicines called
sarcomas, uterine or cervical cancer.
immunosuppressants. It is most
commonly used for protection against
Patients receiving multiple
organ transplant rejection. It is also used
immunosuppressants may be at risk of
for treatment of various conditions in
over-immunosuppression.
which the usual treatment (with steroids)
is not working properly or is causing
You should talk to your doctor if you
problems, or where steroids cannot be
have ever suffered with chicken pox or
used. These include hepatitis (liver
shingles.
disease), rheumatoid arthritis, a
condition called systemic lupus
Other medicines and Azathioprine
erythematosus (SLE), various blood and
Tablets
bleeding disorders and skin disorders.
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
2. WHAT YOU NEED TO KNOW
any other medicines.
BEFORE YOU TAKE
In particular tell your doctor if you are
AZATHIOPRINE TABLETS
taking any of the following:
!
Medicines for gout such as
Do not take this medicine if:
allopurinol, oxipurinol and thiopurinol
!
You are pregnant, or may become
!
Neuromuscular blocking agents such
pregnant or if you are breast-feeding
as succinylcholine and tubocurarine
!
You have been given Azathioprine
!
Warfarin which is a medicine used to
before and had an allergic reaction
prevent blood clots
!
You have had an allergic reaction
!
Penicillamine used to treat
before to 6-mercaptopurine (6-MP)
rheumatoid arthritis
as you are more likely to be
!
Co-trimoxazole used to treat
hypersensitive to Azathioprine.
infections
!
Captopril used to treat high blood
Warnings and precautions
pressure
Talk to your doctor or pharmacist or
!
Cimetidine used to treat excess
nurse before taking Azathioprine Tablets
stomach acid
if:
!
Indomethacin used for pain and
!
You have the inherited deficiency of
inflammation
the enzyme thiopurine
!
Medicines that inhibit the TPMT
methyltransferase (TPMT) or Leschenzyme such as olsalazine,
Nyhan Syndrome (hypoxanthinemesalazine and sulfasalazine
guanine-phosphoribosyltransferase
!
Furosemide used to treat heart
deficiency)
failure
!
You have kidney or liver disease.
!
Vaccination with live vaccines is not
advised.
If you are receiving immunosuppressive
therapy, taking Azathioprine Tablets could
Having vaccines whilst taking
put you at greater risk of:
Azathioprine Tablets
!
Tumours, including skin cancer.
Speak to your doctor or nurse before
Therefore, when taking Azathioprine
you have it. This is because vaccines
Tablets, avoid excessive exposure to
may not work properly while you are
sunlight, wear protective clothing and
taking Azathioprine Tablets.
use protective sunscreen with a high
protection factor
Pregnancy, breast-feeding and
!
Lymphoproliferative disorders
fertility
?
treatment with Azathioprine
Do not take Azathioprine Tablets if you
Tablets increases your risk of
are a man trying to have a baby. This is
getting a type of cancer
because it may affect the baby.
called lymphoproliferative disorder.
Do not take Azathioprine Tablets if you
With treatment regimen containing
are a woman who is pregnant or think
multiple immunosuppressants
you might become pregnant. This is
(including thiopurines), this may
because it may affect the baby.
lead to death
Do not take Azathioprine Tablets if you
?
A combination of multiple
are breast-feeding. This is because
immunosuppressants, given
small amounts may pass into the
concomitantly increases the risk of
mother's milk. Ask your doctor, midwife
disorders of the lymph system due
or pharmacist for advice before taking
to a viral infection (Epstein-Barr
any medicine, if you are pregnant or
virus (EBV) - associated
breast-feeding.
lymphoproliferative disorders).

Driving and using machines
Taking Azathioprine Tablets could put you
Do not drive or use machines if you are
at greater risk of:
affected by this medication.
!
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.

Azathioprine Tablets contain lactose
This medicine contains lactose (a type of
sugar), if you have been told by your
doctor that you have an intolerance to
some sugars talk to your doctor before
taking this medicine.
3. HOW TO TAKE AZATHIOPRINE
TABLETS
Always take Azathioprine Tablets exactly
as your doctor has instructed you. You
should check with your doctor or
pharmacist if you are unsure.
The dose of Azathioprine 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.
Swallow tablets with water, with meals.
Do not chew the tablets.
The usual dose is:-

!
You come into contact with anyone
who is suffering from chickenpox or
shingles.
If you notice any of the above, stop
taking these tablets and see a doctor
straightaway.

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.

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
!
Liver problems, which may cause
pale stools, itchiness and yellowing
of your skin and eyes.

To stop your body rejecting an organ
transplant:
Rare (affects less than 1 in 1,000
On the first day
people)
!
The usual dose is up to 5mg per kg
!
Problems with your bowel leading to
of body weight.
diarrhoea, abdominal pain,
For the rest of your treatment
constipation, feeling sick and being
!
You will take between 1 and 4 mg
sick
per kg of body weight each day.
!
Hair loss which may get better even
though you continue to take
The exact dosage for treatment for other
azathioprine
conditions where steroids cannot be
!
Severe liver damage which can be
used or when steroids are not working
life threatening
properly may vary. This includes
!
Various types of cancers including
hepatitis (liver disease), rheumatoid
blood, lymph and skin cancers
arthritis, systemic lupus erythematosus
!
Sensitivity to sunlight which can
(SLE), skin disorders, various blood and
cause skin discolouration or a rash.
bleeding disorders.
This will normally be between 1mg to
Very rare (affects less than 1 in 10,000
3mg/kg body weight per day.
people)
!
Inflammation of your lungs causing
Exactly how many tablets and how often
breathlessness, cough and a fever.
you must take them will be written on the
label. Please read the label carefully.
Reporting of side effects
If you get any side effects, talk to your
If you are unsure of the dosage check
doctor, pharmacist or nurse. This
with your doctor.
includes any possible side effects not
listed in this leaflet. You can also report
If you take more Azathioprine Tablets
side effects directly via the Yellow Card
than you should
Scheme at:
This medicine is to be taken at regular
www.mhra.gov.uk/yellowcard
intervals, as determined by the
By reporting side effects you can help
physician. If you take too many tablets
provide more information on the safety
by mistake contact your nearest hospital
of this medicine.
casualty department or tell your doctor
immediately. Take your tablet pack with
5. HOW TO STORE AZATHIOPRINE
you.
TABLETS
If you stop taking Azathioprine
Tablets
You should finish all the tablets your
doctor has prescribed. Even if you feel
better, you should still take all the tablets
you have been given. It may be
dangerous to stop taking the medicine
without your doctor's advice.
If you forget to take Azathioprine
Tablets
If you forget to take a dose, take the
missed dose as soon as you remember,
unless it is nearly time to take the next
one. Never take two doses together.
Take the remaining tablets at the correct
times.

Check the expiry date printed on the
label or side of the box. Do not use after
the expiry date stated on the label.
Store in a dry place, below 25°C. Store
in the original package to protect from
light.
In case of any visible signs of
deterioration, you should discard the
package.
Medicines should not be disposed of via
waste water or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures help to protect the
environment.
Keep out of the sight and reach of
children

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
cause side effects, although not
everyone gets them.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Azathioprine Tablets contain:
Each tablet contains 50mg azathioprine.

If you experience any of the following
then STOP taking the medicine and
The other ingredients are: lactose,
contact a doctor immediately
starch maize, microcrystalline cellulose,
!
Allergic reactions may occur rarely,
magnesium stearate, purified talc and
with symptoms such as rash, itching,
sodium starch glycollate.
swelling of the face, wheeziness,
shortness of breath, tightness in the
What Azathioprine Tablets look like
chest, fever, low blood pressure and
and contents of the pack
feeling dizzy particularly when
Azathioprine Tablets are pale yellow
standing up
biconvex tablets scored on one side and
!
Pancreatitis (inflammation of the
engraved with 'A10' on the other side.
pancreas) with symptoms of stomach
The scoreline is not intended for
pain, nausea and vomiting
breaking the tablet.
!
High temperature (fever), shivering
or chills
These tablets are supplied in packs of
!
Redness of the skin or a skin rash
28, 50, 56, 100 or 250 tablets or in
!
Pain in the muscles or joints
securitainers of 50 or 100 tablets.
!
Changes in the amount and colour of
Not all pack sizes may be marketed.
the urine (kidney problems)
!
Dizziness, confusion, feeling light
Manufacturer and Marketing
headed or weak caused by low blood
Authorisation Holder:
pressure
Ennogen Pharma Limited
!
You bruise more easily or notice any
Unit G4, Riverside Industrial Estate,
unusual bleeding
Riverside Way, Dartford, DA1 5BS, UK.
!
You feel extremely tired
!
You notice lumps anywhere on your
This leaflet was last revised in May
body
2016.
!
You notice any changes in your skin
for example blisters or peeling
!
Your health suddenly gets worse

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.

Hide