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MERCAPTOPURINE 50MG TABLETS

Active substance(s): MERCAPTOPURINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PURI-NETHOL® 50MG TABLETS
(mercaptopurine)

Your medicine is available using the name Puri-Nethol 50mg
Tablets, but will be referred to as Puri-Nethol throughout this
leaflet.

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 about your illness or
your medicine, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If you get any side effects talk to your doctor, nurse or
pharmacist. This includes any possible side effects not
listed in the leaflet. See section 4.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Puri-Nethol is and what it is for
What you need to know before you take Puri-Nethol
How to take Puri-Nethol
Possible side effects
How to store Puri-Nethol
Contents of the pack and other information

1. What Puri-Nethol is and what it is used for
Puri-Nethol contains a medicine called mercaptopurine. This
belongs to a group of medicines called cytotoxics (also called
chemotherapy). Puri-Nethol is used to treat leukaemia
(cancer of the blood). It works by reducing the number of
new blood cells your body makes.
Puri-Nethol 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. What you need to know before you take
Puri-Nethol
Do not take Puri-Nethol:

Treatment with Puri-Nethol is not recommended during
pregnancy, particularly in the first three months, because it
may cause permanent damage to a foetus. If you think you
could be pregnant, or if you are planning to become
pregnant, check with your doctor before taking Puri-Nethol.
You doctor will consider the risks and benefits to you and
your baby of taking Puri-Nethol.

if you are allergic (hypersensitive) to mercaptopurine or
any of the other ingredients of Puri-Nethol
(listed in section 6)
Do not take if the above applies to you. If you are not sure,
talk to your doctor or pharmacist before taking Puri-Nethol.

Do not breast-feed while taking Puri-Nethol. Ask your doctor
or midwife for advice.

Warnings and precautions

Puri-Nethol contain lactose



Talk to your doctor or pharmacist before taking Puri-Nethol 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 Puri-Nethol.

Other medicines and Puri-Nethol

Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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:

methotrexate (used mainly to treat cancers)

other cytotoxic drugs (chemotherapy) - when used with
Puri-Nethol there is a greater chance of side effects,
such as breathing problems

allopurinol, oxipurinol and thiopurinol (used mainly to
treat gout) – when used with Puri-Nethol, only 25 % of
the normal dose of Puri-Nethol should be taken

anticoagulants such as warfarin (used to thin the blood
and prevent blood clots)

olsalazine or mesalazine (used for a bowel problem
called ulcerative colitis)

sulfasalazine (used for rheumatoid arthritis or ulcerative
colitis) ribavirin (used to treat viral infections)

Having vaccines while you are taking Puri-Nethol

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 Puri-Nethol.

Pregnancy, breast-feeding and fertility

Do not take Puri-Nethol if you are planning to have a baby.
This applies to both men and women. Puri-Nethol 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.

Page 1 of 2

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before you
take Puri-Nethol.

3. How to take Puri-Nethol
Puri-Nethol should only be given to you by a specialist doctor
who is experienced in treating blood problems.
Always take Puri-Nethol 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.

You should take Puri-Nethol at least 1 hour before or 3
hours after food or milk.

Swallow your tablets whole with a glass of water.

When you take Puri-Nethol 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 Puri-Nethol 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 2.5mg
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.

Overweight children may have to take doses at the
higher end of the recommended dose range. Their
doctor will closely assess how they respond to
treatment.

Children with acute lymphoblastic leukaemia may be
asked by their doctor to take Puri-Nethol in the evening
as this may lower the risk of the leukaemia getting
worse again in the future.

Patients with kidney or liver problems may need to have
their dose reduced.



If you have a condition where your body produces too
little of something called TPMT or ‘thiopurine
methyltransferase’, your dose may be reduced.

The score line is not intended for breaking the tablet.

If you take more Puri-Nethol than you should

If you take more Puri-Nethol 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 Puri-Nethol

Tell your doctor. Do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the use of this medicine,
ask your doctor, nurse or pharmacist.

4. Possible side effects
Like all medicines, Puri-Nethol 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). Treatment with Puri-Nethol causes
a lowering of the white blood cell count. White blood
cells fight infection, and when there are too few white
blood cells, infections can occur.

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 (may affect more than 1 in 10
people)


a drop in the number of white blood cells and platelets

Common (may affect up to 1 in 10 people)





feeling or being sick (nausea or vomiting)
inflammation of the pancreas, which can give you
abdominal pain or make you sick, for patients with
Inflammatory Bowel Disease (an unlicensed use of PuriNethol)
liver problems – this may show up in your blood tests



yellow discolouration of your skin and/or pain under
your ribs and around the area of your stomach (biliary
stasis)

Uncommon (may affect up to 1 in 100 people)


loss of appetite

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






mouth ulcers
inflammation of the pancreas which can give you
abdominal pain or make you sick
hair loss
severe damage to liver cells (hepatic necrosis)
allergic reaction (hypersensitivity) with:

skin rash

persistent fever

joint pain

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

leukaemia
lymphoma in patients with Inflammatory Bowel Disease
(an unlicensed use of Puri-Nethol) when Puri-Nethol is
taken with other drugs called anti-TNF agents.

ulcers in the intestines

in men: low sperm count

allergic reaction (hypersensitivity) with:

facial swelling
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.



Reporting of side effects

If you get any side effects, talk to your doctor, nurse or
pharmacist. 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 Puri-Nethol








Keep out of the sight and reach of children.
Do not store above 25°C.
Keep container tightly closed in order to protect from
moisture and light.
Do not take any tablets after the expiry date printed on
the carton and bottle label.
If your doctor tells you to stop taking the tablets, please
return any which are left over to your pharmacist for
safe disposal. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you.

Page 2 of 2

6.

Contents of the pack and other
information

What Puri-Nethol contains

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

What Puri-Nethol looks like and contents of the
pack

Puri-Nethol are pale yellow, round tablets that are plain on
one side and marked on the reverse with ‘GX’ above a
scoreline and ‘EX2’ underneath.
Puri-Nethol is packed in bottles of 25 tablets.

Manufacturer

Puri-Nethol is manufactured by: Excella GmbH,
Nurnberger Strasse 12, Feucht, D-90537, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM

PL No: 08929/0547

Leaflet revision & issue date (ref): 23.02.16
Puri-Nethol® is a registered trademark of the GlaxoSmithKline
group of companies.

Other formats:

To listen to or request a copy of this leaflet in Braille, large
print or audio please call: 01302 365000
Please be ready to give the following information:
Product name: Puri-Nethol 50mg Tablets
Reference number: 08929/0547

PACKAGE LEAFLET: INFORMATION FOR THE USER

MERCAPTOPURINE 50MG TABLETS
Your medicine is available using the name Mercaptopurine
50mg Tablets, but will be referred to as Mercaptopurine
throughout this leaflet.

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 about your illness or
your medicine, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If you get any side effects talk to your doctor, nurse or
pharmacist. This includes any possible side effects not
listed in the leaflet. See section 4.

What is in this leaflet:
1.

2.
3.
4.
5.
6.

What Mercaptopurine 50mg Tablets are and what they
used for
What you need to know before you take Mercaptopurine
50mg Tablets
How to take Mercaptopurine 50mg Tablets
Possible side effects
How to store Mercaptopurine 50mg Tablets
Contents of the pack and other information

1. What Mercaptopurine 50mg Tablets are
and what they are used for
Mercaptopurine 50mg Tablets contain a medicine called
mercaptopurine. This belongs to a group of medicines called
cytotoxics (also called chemotherapy). Mercaptopurine 50mg
Tablets are used to treat leukaemia (cancer of the blood). It
works by reducing the number of new blood cells your body
makes.
Mercaptopurine 50mg Tablets are 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. What you need to know before you take
Mercaptopurine 50mg Tablets
Do not take Mercaptopurine 50mg Tablets:

if you are allergic (hypersensitive) to mercaptopurine or
any of the other ingredients of Mercaptopurine 50mg
Tablets
(listed in section 6)
Do not take if the above applies to you. If you are not sure,
talk to your doctor or pharmacist before taking
Mercaptopurine 50mg Tablets.



Warnings and precautions

Talk to your doctor or pharmacist before taking
Mercaptopurine 50mg Tablets 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 50mg Tablets.

Other medicines and Mercaptopurine 50mg Tablets

Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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:

methotrexate (used mainly to treat cancers)

other cytotoxic drugs (chemotherapy) - when used with
Mercaptopurine 50mg Tablets there is a greater chance
of side effects, such as breathing problems

allopurinol, oxipurinol and thiopurinol (used mainly to
treat gout) – when used with Mercaptopurine 50mg
Tablets, only 25 % of the normal dose of
Mercaptopurine 50mg Tablets should be taken

anticoagulants such as warfarin (used to thin the blood
and prevent blood clots)

olsalazine or mesalazine (used for a bowel problem
called ulcerative colitis)

sulfasalazine (used for rheumatoid arthritis or ulcerative
colitis) ribavirin (used to treat viral infections)

Page 1 of 2

Having vaccines while you are taking
Mercaptopurine 50mg Tablets

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 50mg
Tablets.

Pregnancy, breast-feeding and fertility

Do not take Mercaptopurine 50mg Tablets if you are planning
to have a baby. This applies to both men and women.
Mercaptopurine 50mg Tablets 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.
Treatment with Mercaptopurine 50mg Tablets is not
recommended during pregnancy, particularly in the first three
months, because it may cause permanent damage to a
foetus. If you think you could be pregnant, or if you are
planning to become pregnant, check with your doctor before
taking Mercaptopurine 50mg Tablets. You doctor will consider
the risks and benefits to you and your baby of taking
Mercaptopurine 50mg Tablets.
Do not breast-feed while taking Mercaptopurine 50mg
Tablets. Ask your doctor or midwife for advice.

Mercaptopurine 50mg 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 50mg Tablets.

3. How to take Mercaptopurine 50mg Tablets
Mercaptopurine 50mg Tablets should only be given to you by
a specialist doctor who is experienced in treating blood
problems.
Always take Mercaptopurine 50mg Tablets 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.

You should take Mercaptopurine 50mg Tablets at least 1
hour before or 3 hours after food or milk.

Swallow your tablets whole with a glass of water.

When you take Mercaptopurine 50mg Tablets 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 50mg Tablets.

Your doctor may sometimes change your dose of
Mercaptopurine 50mg Tablets as a result of these tests.

The dose of Mercaptopurine 50mg Tablets 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 2.5mg
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.

Overweight children may have to take doses at the
higher end of the recommended dose range. Their
doctor will closely assess how they respond to
treatment.

Children with acute lymphoblastic leukaemia may be
asked by their doctor to take Mercaptopurine 50mg
Tablets in the evening as this may lower the risk of the
leukaemia getting worse again in the future.

Patients with kidney or liver problems may need to have
their dose reduced.

If you have a condition where your body produces too
little of something called TPMT or ‘thiopurine
methyltransferase’, your dose may be reduced.
The score line is not intended for breaking the tablet.

If you take more Mercaptopurine 50mg Tablets than
you should
If you take more Mercaptopurine 50mg Tablets 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 50mg Tablets

Tell your doctor. Do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the use of this medicine,
ask your doctor, nurse or pharmacist.

4. Possible side effects
Like all medicines, Mercaptopurine 50mg Tablets 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). Treatment with Mercaptopurine
50mg Tablets cause a lowering of the white blood cell
count. White blood cells fight infection, and when there
are too few white blood cells, infections can occur.
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:

By reporting side effects you can help provide more
information on the safety of this medicine.

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







a drop in the number of white blood cells and platelets

5. How to store Mercaptopurine






Common (may affect up to 1 in 10 people)






feeling or being sick (nausea or vomiting)
inflammation of the pancreas, which can give you
abdominal pain or make you sick, for patients with
Inflammatory Bowel Disease (an unlicensed use of
Mercaptopurine 50mg Tablets)
liver problems – this may show up in your blood tests
yellow discolouration of your skin and/or pain under
your ribs and around the area of your stomach (biliary
stasis)

Uncommon (may affect up to 1 in 100 people)


loss of appetite

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






mouth ulcers
inflammation of the pancreas which can give you
abdominal pain or make you sick
hair loss
severe damage to liver cells (hepatic necrosis)
allergic reaction (hypersensitivity) with:

skin rash

persistent fever

joint pain

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

leukaemia
lymphoma in patients with Inflammatory Bowel Disease
(an unlicensed use of Mercaptopurine 50mg Tablets)
when Mercaptopurine 50mg Tablets is taken with other
drugs called anti-TNF agents.

ulcers in the intestines

in men: low sperm count

allergic reaction (hypersensitivity) with:

facial swelling
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.



Reporting of side effects

If you get any side effects, talk to your doctor, nurse or
pharmacist. 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
Page 2 of 2



6.

Keep out of the sight and reach of children.
Do not store above 25°C.
Keep container tightly closed in order to protect from
moisture and light.
Do not take any tablets after the expiry date printed on
the carton and bottle label.
If your doctor tells you to stop taking the tablets, please
return any which are left over to your pharmacist for
safe disposal. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you.

Contents of the pack and other
information

What Mercaptopurine contains

Each tablet contains 50mg of the active ingredient
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 are pale yellow, round tablets that are plain
on one side and marked on the reverse with ‘GX’ above a
scoreline and ‘EX2’ underneath.
Mercaptopurine is packed in bottles of 25 tablets.

Manufacturer

Mercaptopurine is manufactured by: Excella GmbH,
Nurnberger Strasse 12, Feucht, D-90537, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM

PL No: 08929/0547

Leaflet revision & issue date (ref): 23.02.16

Other formats:

To listen to or request a copy of this leaflet in Braille, large
print or audio please call: 01302 365000
Please be ready to give the following information:
Product name: Mercaptopurine 50mg Tablets
Reference number: 08929/0547

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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