THIOPRINE

Azathioprine Tablets 50mg

What is in this leaflet

This leaflet answers some common questions about THIOPRINE. It does not
contain all the information available on this medicine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks and
benefits. Your doctor has weighed the risks of using THIOPRINE against the
benefits expected it will have for you. If you have any concerns about using
this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What THIOPRINE is used for and how it works

Your THIOPRINE tablets contain the active ingredient, azathioprine. It
belongs to a group of medicines commonly known as immunosuppressants.

THIOPRINE is used to help prevent the body rejecting organ transplants
following surgery. It may also reduce the dose of corticosteroid treatment
needed, and therefore, decrease the side effects associated with high dosage and
prolonged usage of corticosteroids (e.g. prednisolone).

THIOPRINE can be used alone or in combination with corticosteroids and with
other medicines. It can help control diseases that involve the body's immune
system such as:

  • severe rheumatoid arthritis
  • polyarteritis nodosa, a disease with inflammation of the arteries
  • pemphigus vulgaris, an autoimmune disorder of the skin
  • systemic lupus erythematous (SLE)
  • some forms of hepatitis
  • certain types of blood diseases
  • ulcerative colitis, an autoimmune disorder that affects the large colon

Your doctor may however, have prescribed THIOPRINE for another reason. Ask
your doctor if you have any questions about why THIOPRINE has been prescribed
for you.

THIOPRINE is a very powerful medicine. Do not let anyone else take
your medicine, even if his or her symptoms are similar to yours.

There is no evidence that THIOPRINE tablets are addictive.

THIOPRINE is available on prescription from your doctor.

Before you take THIOPRINE

When you must not take it

Do NOT take THIOPRINE if:

  • You are allergic to thioprine or any of the other ingredients listed at
    the end of this leaflet


    Symptoms of an allergic reaction may include shortness of breath, wheezing or
    difficulty breathing, swelling of the face, lips, tongue or other parts of the
    body; rash, itching or hives on the skin.


  • You are pregnant, intend to become pregnant or you intend to father a
    child


    Azathioprine is not recommended during pregnancy. It may cause birth defects
    if either the male or female are using it at the time of conception. Your
    partner should take adequate contraceptive precautions while you are taking
    THIOPRINE


  • You are breastfeeding

    Thioprine passes into the breast milk and may harmful to your baby.

Do not use THIOPRINE after the expiry date (EXP) printed on the pack.

Do not use THIOPRINE if the packaging is torn or shows signs of tampering.

Before you take it

Tell your doctor if:

  • You are allergic to any medicines or foods
  • You are pregnant, planning on becoming pregnant, or planning to father
    a child

    THIOPRINE is not recommended during pregnancy.

  • You are breastfeeding or plan to breastfeed

    THIOPRINE passes into breast milk and may cause serious side effects to your
    baby
  • You have recently been immunised or plan to do so
  • You have kidney or liver disease
  • You have Lesch-Nyhan Syndrome (a metabolic disorder)
  • You have a condition where your body does not produce enough of a
    natural chemical called thiopurine methyltransferase (TPMT)
  • You have rheumatoid arthritis that has been previously treated by
    immunosuppressive therapy
  • You have any other medical conditions

Taking other medicines

If you are taking any other medicines, including any you get without a
prescription from a pharmacy, supermarket or health food shop, tell your doctor
or pharmacist.

Some medicines may interfere with how well THIOPRINE works. These medicines
may include:

  • Aminosalicylate derivatives e.g. olsalazine, mesalazine, sulphasalazine
  • Allopurinol, oxypurinol, thiopurinol
  • Frusemide, co-trimoxazole, captopril, cimetidine
  • Some of the neuromuscular blocking agents including succinylcholine
  • Medicines used to prevent blood clots such as warfarin
  • Some other medications used to treat rheumatoid arthritis eg.
    penicillamine,
  • Some vaccines eg. the hepatitis B vaccination

These medicines may be affected by THIOPRINE or may affect how well THIOPRINE
works. You may need different amounts of your medicines or you may need to take
a different medicine. It is therefore important that you discuss this with your
doctor or pharmacist.

Your doctor or pharmacist has more information on these medicines, and on
other medicines that you need to be careful with, or to avoid while taking
THIOPRINE.

How to take THIOPRINE properly

How much to take

Your doctor will tell you how much THIOPRINE you need to take each day. It
is important that you take THIOPRINE only as directed by your doctor.

Your dose of THIOPRINE depends on your health condition, your response to the
medicine and whether you are receiving other therapies at the same time. Your
doctor may change the number of tablets you take, particularly at the beginning
of treatment. Do not take more than the recommended dose.

Elderly patients can be more susceptible to the risk of side effects and so
lower dosages are generally recommended.

In patients with kidney or liver problems, lower dosages are recommended.

If you do not understand the instructions printed on the label, ask your
doctor or pharmacist for help.

How to take it

Swallow THIOPRINE tablets with a glass of water. Do not break, chew or crush
the tablets.

It is best to take your THIOPRINE immediately after a meal. This will help to
minimise nausea, vomiting or stomach discomfort effects.

It is best to take your THIOPRINE tablets at the same time every day to help
you remember to take them.

How long to take it

THIOPRINE helps to control your condition but does not cure it. It could take
several weeks or months for THIOPRINE to take full effect.

For patients with a transplant, THIOPRINE must be taken everyday thereafter,
to reduce the risks of the body rejecting a transplanted organ.

For other purposes, continue taking THIOPRINE for as long as your doctor
prescribes.

If you forget a dose

If you forget a dose, just take the next dose when it is due. Do not take
more than one dose at a time to make up for missed doses.

Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.

While you are taking THIOPRINE

Things you must do

Tell all doctors, dentists and pharmacists who are treating you, that you
are taking THIOPRINE.

Before you start any new medicine, tell your doctor or pharmacist that you
are taking THIOPRINE

Visit your doctor regularly, especially when you start using THIOPRINE.

Your doctor will be able to make sure that THIOPRINE is working properly and
check for any unwanted side effects. You may be asked to have blood tests.

Tell your doctor if you plan to have any immunisations.

Tell your doctor if you come into contact with someone that is suffering
from chickenpox or shingles

If you are taking THIOPRINE long term your doctor may wish to check that
your liver and kidney functions are not being affected.


The doctor will determine if this is necessary in a case-by-case manner.

Tell your doctor if you become pregnant while taking THIOPRINE.

Protect yourself from the sun while you are taking THIOPRINE.

If you go out in the sun, wear protective clothing and use sunscreen.

If you plan to have surgery, tell the surgeon or anaesthetist that you are
taking THIOPRINE.

If you are going to have any blood tests, tell your doctor that you are
taking THIOPRINE.

Things you must not do

Do not stop taking THIOPRINE or change the dose, without first checking
with your doctor.

Do NOT give this medicine to anyone else, even if his or her symptoms seem
similar to yours. This is very important as THIOPRINE is a very powerful
medicine.

Things to be careful of

Be careful driving or operating machinery until you know how THIOPRINE
tablets affect you.

THIOPRINE does not usually affect your ability to drive a car or operate
machinery. However, as with many other medicines, THIOPRINE tablets may cause
headache or dizziness in some people.

Side effects

Check with your doctor as soon as possible if you do not feel well while
you are taking THIOPRINE. Do this even if you do not think the problems are
connected with this medicine or are not listed in this leaflet.

Like all medicines, THIOPRINE can have some unwanted effects. Sometimes they
are serious, but most of the time they are not. You may need medical treatment
if you get some of the side effects.

Tell your doctor if you notice any of the following effects:

  • viral, fungal or bacterial infection
  • hair loss
  • fever and vomiting
  • diarrhoea that may be associated with blood and mucous
  • sores on the mouth and lips
  • tiredness and generally feeling unwell

These are the more common side effects of THIOPRINE

Tell your doctor or pharmacist immediately if you notice any of the
following:

  • any infection or fever, unexpected bruising or bleeding, blood in the
    urine or stools
  • severe stomach pain that may be associated with nausea, vomiting and fever
  • dizziness, sleepiness, drowsiness and generally feeling unwell
  • muscle pain, weakness or stiffness
  • irregular heart beat
  • yellow discolouration of the skin and eyes
  • coughing or difficulty breathing

The side effects listed above can be serious. You may need urgent medical
attention.

IMMEDIATELY CONTACT YOUR DOCTOR or go to the accident and emergency
department at your nearest hospital if you observe any of the following
symptoms:

  • wheezing
  • swelling of the face, lips, mouth or throat
  • difficulty in breathing
  • hives
  • fainting.

These side are effects can be very serious. If you experience any of them,
you may be having an allergic reaction to THIOPRINE and you may need urgent
medical attention.

All of these side effects are very rare.

If you should suffer from any of these side effects or any other undesired
effect please tell your doctor or pharmacist.

This list of possible side effects is not complete. Other effects may occur
in some people.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any THIOPRINE by mistake. Do this even if there are no signs of discomfort
or poisoning. You may need urgent medical attention. Take the container of
THIOPRINE with you if you can.

Immediate toxic effects of an overdose include nausea, vomiting and
diarrhoea. Long-term signs of overdosage may include unexplained infection,
ulceration of the throat, bruising and bleeding and are a result of bone marrow
depression (a reduction in the number of blood cells).

Keep telephone numbers for these places handy.

Storage conditions

Keep your THIOPRINE tablets in the pack until it is time to take them.

Store below 25°C and out of reach of children. Avoid exposure to heat, light
and moisture.

Do not store THIOPRINE, or any other medicine, in the bathroom or near a
sink.

Disposal

If your doctor tells you to stop taking THIOPRINE or if the tablets have
passed the expiry date, ask your pharmacist what to do with the remaining
medicine.

Product Description

What THIOPRINE tablets look like

Each THIOPRINE tablet contains the active ingredient azathioprine.

THIOPRINE tablets 50mg are pale yellow round tablets with a bisect on one
side.

The tablets also contain maize starch, microcrystalline cellulose, lactose,
purified water, magnesium stearate, purified talc and sodium starch glycollate.


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