PURINETHOL 50MG TABLETS

Active substance: MERCAPTOPURINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

PURINETHOL 50mg TABLETS
(mercaptopurine)
Your medicine is known as Purinethol 50mg Tablets but will be
referred to as Purinethol throughout the following leaflet.
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 about your illness or
medicine, 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 get 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 Purinethol is and what it is used for
2 Before you take Purinethol
3 How to take Purinethol
4 Possible side effects
5 How to store Purinethol
6 Further information
1 WHAT PURINETHOL IS AND WHAT IT IS USED FOR
Purinethol tablets contain a medicine called mercaptopurine.
This belongs to a group of medicines called cytotoxics (also
called chemotherapy). Purinethol is used to treat leukaemia
(cancer of the blood). It works by reducing the number of new
blood cells your body makes.
Purinethol is used for:
 Acute myelogenous leukaemia (also called acute myeloid
leukaemia or AML) - a fast-growing disease that increases
the number of white blood cells produced by the bone
marrow. This can cause infections and bleeding.




Acute lymphoblastic leukaemia (also called acute
lymphocytic leukaemia or ALL) - a fast-growing disease
which increases the number of immature white blood cells.
These immature white blood cells are unable to grow and
work properly. They therefore cannot fight infections and
may cause bleeding.
Chronic granulocytic leukaemia (also called chronic
myeloid leukaemia) - a disease that increases the number
of white blood cells. This can cause infections and bleeding.

Ask your doctor if you would like more explanation about these
diseases.
2 BEFORE YOU TAKE PURINETHOL
Do not take Purinethol if:
 You are allergic (hypersensitive) to mercaptopurine or any of
the other ingredients of Purinethol tablets (See section 6:
Further information)
Do not take if the above applies to you. If you are not sure, talk
to your doctor or pharmacist before taking Purinethol.

Take special care with Purinethol
Before you take Purinethol, tell your doctor or pharmacist if:
 you have a liver problem; your doctor will monitor your liver
function
 you have a condition where your body produces too little of
something called TPMT or ‘thiopurine methyltransferase’.
If you are not sure if any of the above apply to you, talk to your
doctor, nurse or pharmacist before taking Purinethol.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any
of the following:
 other cytotoxic drugs (chemotherapy) - when used with
Purinethol there is a greater chance of side effects, such as
breathing problems
 allopurinol (used to treat gout)
 warfarin (used to thin the blood)
 olsalazine or mesalazine (used for a bowel problem called
ulcerative colitis)
 sulfasalazine (used for rheumatoid arthritis or ulcerative
colitis).
Having vaccines while you are taking Purinethol
If you are going to have a vaccination speak to your doctor or
nurse before you have it. This is because some vaccines (like
polio, measles, mumps and rubella) may give you an infection if
you have them whilst you are taking Purinethol.
Pregnancy and breast-feeding
Do not take Purinethol if you are planning to have a baby.
This applies to both men and women. Purinethol may harm your
sperm or eggs. Reliable contraceptive precautions must be
taken to avoid pregnancy whilst you or your partner are taking
these tablets. Ask your doctor for advice.
If you are already pregnant, it is important to talk to your doctor
before taking Purinethol.
Do not breast-feed while taking Purinethol. Ask your doctor or
midwife for advice.
Important information about some of the ingredients of
Purinethol
Purinethol tablets contain lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact
your doctor before you take Purinethol tablets.

3 HOW TO TAKE PURINETHOL
Purinethol should only be given to you by a specialist doctor
who is experienced in treating blood problems.
Always take Purinethol exactly as your doctor has told you. It is
important to take your medicine at the right times. The label on
your pack will tell you how many tablets to take and how often to
take them. If the label doesn’t say or if you are not sure, ask
your doctor, nurse or pharmacist.






Swallow your tablets whole with a glass of water.
If you need to break your tablet in half, do not inhale any
tablet powder. Wash your hands afterwards.
When you take Purinethol your doctor will take regular blood
tests. This is to check the number and type of cells in your
blood and to ensure your liver is working correctly.
Your doctor may also ask for other blood and urine tests to
monitor your uric acid levels. Uric acid is a natural body
chemical, levels of which can rise while taking Purinethol.
Your doctor may sometimes change your dose of Purinethol
as a result of these tests.

The dose of Purinethol you are given will be worked out by your
doctor based on:
 your body size (surface area)
 the results of your blood tests
 The usual starting dose for adults and children is 2.5 mg per
kilogram of your body weight each day.
 Elderly patients will have their kidney and liver function
tested and if necessary the dose may need to be reduced.

Very common (affects more than 1 in 10 people)
 a drop in the number of white blood cells and platelets
Common (affects less than 1 in 10 people)
 feeling or being sick (nausea or vomiting)
 liver problems - this may show up in your blood tests
Uncommon (affects less than 1 in 100 people)
 a drop in red blood cells which may make you tired, weak or
breathless - called anaemia
 loss of appetite
Rare (affects less than 1 in 1,000 people)
 mouth ulcers
 inflammation of the pancreas which can give you abdominal
pain or make you sick
 hair loss
Very rare (affects less than 1 in 10,000 people)
 leukaemia
 ulcers in the intestines
 in men: low sperm count
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
5 HOW TO STORE PURINETHOL




KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Keep the container tightly closed.
Store in a dry place. Protect from light.
Do not use after the expiry date which is stated on the pack
after ‘EXP’.
If your doctor tells you to stop taking the tablets, it is
important to return any which are left over to your
pharmacist, who will destroy them according to disposal of
dangerous substance guidelines. Only keep the tablets if
your doctor tells you to.
If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.

If you take more Purinethol than you should
If you take more Purinethol than you should, tell your doctor
immediately or go to a hospital straight away. Take the medicine
pack with you.



If you forget to take Purinethol
Tell your doctor. Do not take a double dose to make up for a
forgotten dose.



4 POSSIBLE EFFECTS

6 FURTHER INFORMATIONON

Like all medicines, Purinethol can cause side effects, although
not everybody gets them.

What Purinethol contains
 The active ingredient is mercaptopurine. Each tablet
contains 50mg of mercaptopurine.
 The other ingredients are lactose, maize starch, hydrolysed
starch, stearic acid and magnesium stearate.

If you get any of the following, talk to your specialist doctor
or go to hospital straight away:









allergic reaction, the signs may include:
- skin rashes
- high temperature
- joint pain
- swollen face
any signs of fever or infection (sore throat, sore mouth or
urinary problems)
any unexpected bruising or bleeding, as this could mean
that too few blood cells of a particular type are being
produced
if you suddenly feel unwell (even with a normal
temperature)
any yellowing of the whites of the eyes or skin (jaundice)
if you have diarrhoea
if you feel sick (nausea) or you are sick (vomiting).

Talk to your doctor if you have any of the following side effects
which may also happen with this medicine:

What Purinethol looks like and contents of the pack
 Purinethol tablets are a pale yellow colour, scored on one
side and are marked with 'GX' and 'EX2' on either side of the
score line and they are plain on the other side.
 Purinethol are available in bottles of 25 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Kosei Pharma UK Limited, 956 Buckingham
Avenue, Slough, SL1 4NL.
Manufacturer
This product is manufactured by EXCELLA GmbH, Nürnberger
Strasse 12, Feucht, D-90537, Germany.
POM

PL 39352/0170

Leaflet date: 16.07.2013
Puri-Nethol is a registered trademark of the
GlaxoSmithKline group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER
MERCAPTOPURINE 50mg TABLETS
Your medicine is known as Mercaptopurine 50mg Tablets but
will be referred to as Mercaptopurine throughout the following
leaflet.
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 about your illness or
medicine, 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 get 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 Mercaptopurine is and what it is used for
2 Before you take Mercaptopurine
3 How to take Mercaptopurine
4 Possible side effects
5 How to store Mercaptopurine
6 Further information

Take special care with Mercaptopurine
Before you take Mercaptopurine, tell your doctor or pharmacist
if:
 you have a liver problem; your doctor will monitor your liver
function
 you have a condition where your body produces too little of
something called TPMT or ‘thiopurine methyltransferase’.
If you are not sure if any of the above apply to you, talk to your
doctor, nurse or pharmacist before taking Mercaptopurine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any
of the following:
 other cytotoxic drugs (chemotherapy) - when used with
Mercaptopurine there is a greater chance of side effects,
such as breathing problems
 allopurinol (used to treat gout)
 warfarin (used to thin the blood)
 olsalazine or mesalazine (used for a bowel problem called
ulcerative colitis)
 sulfasalazine (used for rheumatoid arthritis or ulcerative
colitis).

1 WHAT MERCAPTOPURINE IS AND WHAT IT IS USED FOR
Mercaptopurine tablets contain a medicine called
mercaptopurine.
This belongs to a group of medicines called cytotoxics (also
called chemotherapy). Mercaptopurine is used to treat
leukaemia (cancer of the blood). It works by reducing the
number of new blood cells your body makes.
Mercaptopurine is used for:
 Acute myelogenous leukaemia (also called acute myeloid
leukaemia or AML) - a fast-growing disease that increases
the number of white blood cells produced by the bone
marrow. This can cause infections and bleeding.




Acute lymphoblastic leukaemia (also called acute
lymphocytic leukaemia or ALL) - a fast-growing disease
which increases the number of immature white blood cells.
These immature white blood cells are unable to grow and
work properly. They therefore cannot fight infections and
may cause bleeding.
Chronic granulocytic leukaemia (also called chronic
myeloid leukaemia) - a disease that increases the number
of white blood cells. This can cause infections and bleeding.

Ask your doctor if you would like more explanation about these
diseases.
2 BEFORE YOU TAKE MERCAPTOPURINE
Do not take Mercaptopurine if:
 You are allergic (hypersensitive) to mercaptopurine or any of
the other ingredients of Mercaptopurine tablets (See section
6: Further information)
Do not take if the above applies to you. If you are not sure, talk
to your doctor or pharmacist before taking Mercaptopurine.

Having vaccines while you are taking Mercaptopurine
If you are going to have a vaccination speak to your doctor or
nurse before you have it. This is because some vaccines (like
polio, measles, mumps and rubella) may give you an infection if
you have them whilst you are taking Mercaptopurine.
Pregnancy and breast-feeding
Do not take Mercaptopurine if you are planning to have a baby.
This applies to both men and women. Mercaptopurine may
harm your sperm or eggs. Reliable contraceptive precautions
must be taken to avoid pregnancy whilst you or your partner are
taking these tablets. Ask your doctor for advice.
If you are already pregnant, it is important to talk to your doctor
before taking Mercaptopurine.
Do not breast-feed while taking Mercaptopurine. Ask your doctor
or midwife for advice.
Important information about some of the ingredients of
Mercaptopurine
Mercaptopurine tablets contain lactose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before you take Mercaptopurine tablets.

3 HOW TO TAKE MERCAPTOPURINE
Mercaptopurine should only be given to you by a specialist
doctor who is experienced in treating blood problems.
Always take Mercaptopurine exactly as your doctor has told you.
It is important to take your medicine at the right times. The label
on your pack will tell you how many tablets to take and how
often to take them. If the label doesn’t say or if you are not sure,
ask your doctor, nurse or pharmacist.







Swallow your tablets whole with a glass of water.
If you need to break your tablet in half, do not inhale any
tablet powder. Wash your hands afterwards.
When you take Mercaptopurine your doctor will take regular
blood tests. This is to check the number and type of cells in
your blood and to ensure your liver is working correctly.
Your doctor may also ask for other blood and urine tests to
monitor your uric acid levels. Uric acid is a natural body
chemical, levels of which can rise while taking
Mercaptopurine.
Your doctor may sometimes change your dose of
Mercaptopurine as a result of these tests.

The dose of Mercaptopurine you are given will be worked out by
your doctor based on:
 your body size (surface area)
 the results of your blood tests
 The usual starting dose for adults and children is 2.5 mg per
kilogram of your body weight each day.
 Elderly patients will have their kidney and liver function
tested and if necessary the dose may need to be reduced.
If you take more Mercaptopurine than you should
If you take more Mercaptopurine than you should, tell your
doctor immediately or go to a hospital straight away. Take the
medicine pack with you.
If you forget to take Mercaptopurine
Tell your doctor. Do not take a double dose to make up for a
forgotten dose.
4 POSSIBLE EFFECTS
Like all medicines, Mercaptopurine can cause side effects,
although not everybody gets them.
If you get any of the following, talk to your specialist doctor
or go to hospital straight away:









allergic reaction, the signs may include:
- skin rashes
- high temperature
- joint pain
- swollen face
any signs of fever or infection (sore throat, sore mouth or
urinary problems)
any unexpected bruising or bleeding, as this could mean
that too few blood cells of a particular type are being
produced
if you suddenly feel unwell (even with a normal
temperature)
any yellowing of the whites of the eyes or skin (jaundice)
if you have diarrhoea
if you feel sick (nausea) or you are sick (vomiting).

Talk to your doctor if you have any of the following side effects
which may also happen with this medicine:

Very common (affects more than 1 in 10 people)
 a drop in the number of white blood cells and platelets
Common (affects less than 1 in 10 people)
 feeling or being sick (nausea or vomiting)
 liver problems - this may show up in your blood tests
Uncommon (affects less than 1 in 100 people)
 a drop in red blood cells which may make you tired, weak or
breathless - called anaemia
 loss of appetite
Rare (affects less than 1 in 1,000 people)
 mouth ulcers
 inflammation of the pancreas which can give you abdominal
pain or make you sick
 hair loss
Very rare (affects less than 1 in 10,000 people)
 leukaemia
 ulcers in the intestines
 in men: low sperm count
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
5 HOW TO STORE MERCAPTOPURINE







KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Keep the container tightly closed.
Store in a dry place. Protect from light.
Do not use after the expiry date which is stated on the pack
after ‘EXP’.
If your doctor tells you to stop taking the tablets, it is
important to return any which are left over to your
pharmacist, who will destroy them according to disposal of
dangerous substance guidelines. Only keep the tablets if
your doctor tells you to.
If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.

6 FURTHER INFORMATIONON
What Mercaptopurine contains
 The active ingredient is mercaptopurine. Each tablet
contains 50mg of mercaptopurine.
 The other ingredients are lactose, maize starch, hydrolysed
starch, stearic acid and magnesium stearate.
What Mercaptopurine looks like and contents of the pack
 Mercaptopurine tablets are a pale yellow colour, scored on
one side and are marked with 'GX' and 'EX2' on either side
of the score line and they are plain on the other side.
 Mercaptopurine are available in bottles of 25 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Kosei Pharma UK Limited, 956 Buckingham
Avenue, Slough, SL1 4NL.
Manufacturer
This product is manufactured by EXCELLA GmbH, Nürnberger
Strasse 12, Feucht, D-90537, Germany.
POM

PL 39352/0170

Leaflet date: 16.07.2013

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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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