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PURI-NETHOL 50 MG TABLETS

Active substance(s): MERCAPTOPURINE

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501126/PL1d

Mercaptopurine 50 mg Tablets

Patient Information Leaflet
The name of your medicine is Mercaptopurine 50 mg Tablets,
throughout this leaflet it will be referred to as Mercaptopurine.
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) What Mercaptopurine is and what it is used for
2) What you need to know before you take
Mercaptopurine
3) How to take Mercaptopurine
4) Possible side effects
5) How to store Mercaptopurine
6) Contents of the pack and other information
1) WHAT MERCAPTOPURINE IS AND WHAT IT IS USED
FOR
Mercaptopurine
tablets
contain
a
medicine
called
6-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) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MERCAPTOPURINE
Do not take Mercaptopurine:
• if you are allergic (hypersensitive) to 6-mercaptopurine
or any of the other ingredients of Mercaptopurine
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Mercaptopurine 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.
Other medicines and Mercaptopurine
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 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, only 25
% of the normal dose of Mercaptopurine 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 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, breast-feeding and fertility
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.
Treatment with Mercaptopurine 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. You
doctor will consider the risks and benefits to you and your
baby of taking Mercaptopurine.
Do not breast-feed while taking Mercaptopurine. Ask your
doctor or midwife for advice.
Mercaptopurine tablets contain lactose monohydrate
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.
• You should take Mercaptopurine 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 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.
• 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 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 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.
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 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 6-mercaptopurine
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).

Continued overleaf

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
Mercaptopurine)
• 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) when
Mercaptopurine is taken with other drugs called antiTNF 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 MERCAPTOPURINE
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the pack after ‘EXP’.
• Do not store above 25°C. Keep the container tightly
closed.
• If you notice any sign of deterioration or discolouration
of the tablets, please tell your pharmacist immediately.
• 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.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Mercaptopurine contains
Each tablet contains 50 mg of mercaptopurine.
The other ingredients are lactose, maize starch, hydrolysed
maize starch, stearic acid and magnesium stearate.
What Mercaptopurine looks like and contents of the pack
Pale yellow, round, bi-convex tablets, scored on one side,
engraved with GX above the score line and EX2 below the
score line and plain on the other side.
Your Mercaptopurine tablets are in bottles of 25 tablets.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder: Ginova
Ltd and repackager: Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by EXCELLA GmbH, Nurnberger Strasse 12,
Feucht, D-90537, Germany.
Mercaptopurine 50 mg Tablets
PL No: 18067/0347
POM
th

This leaflet was last revised on 13 September 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

501126/PL1d

501124/PL1d

®

®

Puri-Nethol 50 mg Tablets
(mercaptopurine)

Patient Information Leaflet
®
The name of your medicine is Puri-Nethol 50 mg Tablets,
®
throughout this leaflet it will be referred to as Puri-Nethol .
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) What Puri-Nethol is and what it is used for
®
2) What you need to know before you take Puri-Nethol
®
3) How to take Puri-Nethol
4) Possible side effects
®
5) How to store Puri-Nethol
6) Contents of the pack and other information
®

1) WHAT PURI-NETHOL IS AND WHAT IT IS USED FOR
®
Puri-Nethol
tablets
contain
a
medicine
called
6-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 :
• if you are allergic (hypersensitive) to 6-mercaptopurine
®
or any of the other ingredients of Puri-Nethol 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 Puri-Nethol .
Warnings and precautions
®
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 .

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 .
®

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

Puri-Nethol 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 Puri-Nethol tablets.
®

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 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 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 Puri-Nethol .
• Your doctor may sometimes change your dose of Puri®
Nethol 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
2.5 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.
• 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 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 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.

®

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 .

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 6-mercaptopurine
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).

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.
Continued overleaf

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
Mercaptopurine)
• 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 use this medicine after the expiry date which is
stated on the pack after ‘EXP’.
• Do not store above 25°C. Keep the container tightly
closed.
• If you notice any sign of deterioration or discolouration
of the tablets, please tell your pharmacist immediately.
• 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.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Puri-Nethol contains
Each tablet contains 50 mg of 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
Pale yellow, round, bi-convex tablets, scored on one side,
engraved with GX above the score line and EX2 below the
score line and plain on the other side.
®

Your Puri-Nethol tablets are in bottles of 25 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder: Ginova
Ltd and repackager: Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
EXCELLA GmbH, Nurnberger Strasse 12, Feucht, D-90537,
Germany.
®

Puri-Nethol 50 mg Tablets
PL No: 18067/0347
POM
®

Puri-Nethol is a registered trademark of Aspen Global
Incorporated.
th

This leaflet was last revised on 13 September 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

501124/PL1d

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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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