Skip to Content

PURINETHOL 50MG TABLETS

Active substance(s): MERCAPTOPURINE

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref: 1378/140116/1/F

Mercaptopurine 50mg Tablets
Patient Information 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.
Your medicine is called Mercaptopurine 50mg tablets but will be referred to
as Mercaptopurine throughout this leaflet.
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
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 2.5mg 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 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.

Ref: 1378/140116/1/B

Mercaptopurine 50mg Tablets
Patient Information Leaflet (continued)
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).
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
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, pharmacist or nurse. 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 store above 25°C. Keep the container tightly closed.
Store in a dry place. Protect from light.
Do not take this medicine after the expiry date shown on the carton or bottle
label. If your doctor tells you to stop taking the medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Mercaptopurine contains
The active ingredient is Mercaptopurine. Each tablet contains 50 mg of
Mercaptopurine.
The other ingredients are lactose, maize starch, maize starch hydrolysed,
stearic acid and magnesium stearate.
What Mercaptopurine looks like and contents of the pack
Mercaptopurine tablets are pale yellow, round, biconvex, scored on one side,
engraved GX above the score and EX2 below the score and plain on the
other side. Mercaptopurine tablets are in bottles of 25 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Excella GmbH, Nurnberger Strasse 12,
Feucht, Germany and is procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1378

Mercaptopurine 50mg Tablets

Revision date: 14/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1378/140116/2/F

Purinethol ® 50mg Tablets
(mercaptopurine)
Patient Information 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.
Your medicine is called Purinethol 50mg tablets but will be referred to as
Purinethol throughout this leaflet.
What is in this leaflet:
1

What Purinethol is and what it is used for

2

What you need to know 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 6-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 fastgrowing 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 Purinethol

Do not take Purinethol:
* if you are allergic (hypersensitive) to 6-mercaptopurine or any of the other
ingredients of Purinethol 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 Purinethol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Purinethol 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.
Other medicines and Purinethol
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 Purinethol there is
a greater chance of side effects, such as breathing problems
* allopurinol, oxipurinol and thiopurinol (used mainly to treat gout) – when
used with Purinethol, only 25 % of the normal dose of Purinethol 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 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, breast-feeding and fertility
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.
Treatment with Purinethol 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 Purinethol. You doctor will
consider the risks and benefits to you and your baby of taking Purinethol.
Do not breast-feed while taking Purinethol. Ask your doctor or midwife for
advice.
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.
* You should take Purinethol 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 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 2.5mg 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 Purinethol 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.

Ref: 1378/140116/2/B

Purinethol ® 50mg Tablets
(mercaptopurine)
Patient Information Leaflet (continued)
The score line is not intended for breaking the tablet.
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.
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, Purinethol 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-purinethol 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 Purinethol) when Purinethol 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, pharmacist or nurse. 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 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 take this medicine after the expiry date shown on the carton or bottle
label. If your doctor tells you to stop taking the medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Purinethol contains
The active ingredient is Purinethol. Each tablet contains 50 mg of
mercaptopurine.
The other ingredients are lactose, maize starch, maize starch hydrolysed,
stearic acid and magnesium stearate.
What Purinethol looks like and contents of the pack
Purinethol tablets are pale yellow, round, biconvex, scored on one side,
engraved GX above the score and EX2 below the score and plain on the
other side. Purinethol tablets are in bottles of 25 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Excella GmbH, Nurnberger Strasse 12,
Feucht, Germany and is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1378

Purinethol 50mg Tablets

Purinethol is a registered trademark of Aspen Global Incorporated.
Revision date: 14/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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