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PURINETHOL 50 MG TABLETS

Active substance(s): MERCAPTOPURINE

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Package Leaflet: Information for the User

Mercaptopurine 50 mg Tablets

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 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 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 Mercaptopurine
Do not take Mercaptopurine:
• if you are allergic (hypersensitive) to 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

160 mm Measuring Bar

Your medicine is known as Mercaptopurine 50 mg Tablets but will be referred to as
Mercaptopurine throughout the following leaflet.

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.

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.
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 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)

160 mm Measuring Bar

3 How to tak e Mercaptopurine
Mercaptopurine should only be given to you by a specialist doctor who is experienced in
treating blood problems.

Uncommon (may affect up to 1 in 100 people)
• loss of appetite

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, 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 this medicine 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.
• Store in a dry place. Protect from light.
• 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
The active substance is mercaptopurine. Each tablet contains 50 mg of mercaptopurine.
The other ingredients are lactose, maize starch, hydrolysed starch, stearic acid, magnesium
stearate and purified water.
What Mercaptopurine looks like and contents of the pack
Mercaptopurine tablets are a pale yellow colour, are marked with ‘GX’ and ‘EX2’ on either side of
a scoreline and plain on the reverse.
Mercaptopurine tablets come in amber bottles of 25 tablets.
Manufacturer:
Manufactured by EXCELLA GmbH, Nurnberger Strasse 12, 90537 Feucht, Germany.
Procured from within the EU by the Product Licence Holder:
Expono Ltd, Units 8-12 Cornwall Road Industrial Estate, Cornwall Road, Smethwick,
West Midlands, B66 2JT, UK.
Repackaged by N.G.Ltd, West Midlands, B66 2JT, UK.

POM

PL Number: 22961/0123

Leaflet Revision Date: 14.08.2015

Mercaptopurine 50 mg Tablets
Ref 857

160 mm Measuring Bar

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

Package Leaflet: Information for the User

Purinethol® 50 mg Tablets
(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 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. Contents of the pack and other 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 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 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

160 mm Measuring Bar

Your medicine is known as Purinethol 50 mg Tablets but will be referred to as Purinethol
throughout the following leaflet.

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.

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.
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 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 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)

160 mm Measuring Bar

3 How to tak e Purinethol
Purinethol should only be given to you by a specialist doctor who is experienced in
treating blood problems.

Uncommon (may affect up to 1 in 100 people)
• loss of appetite

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, 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 Purinethol
Keep this medicine 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.
Store in a dry place. Protect from light.
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 Purinethol contains
The active substance is mercaptopurine. Each tablet contains 50 mg of mercaptopurine.
The other ingredients are lactose, maize starch, hydrolysed starch, stearic acid, magnesium
stearate and purified water.
What Purinethol looks like and contents of the pack
Purinethol tablets are a pale yellow colour, are marked with ‘GX’ and ‘EX2’ on either side of
a scoreline and plain on the reverse.
Purinethol tablets come in amber bottles of 25 tablets.
Manufacturer:
Manufactured by EXCELLA GmbH, Nurnberger Strasse 12, 90537 Feucht, Germany.
Procured from within the EU by the Product Licence Holder:
Expono Ltd, Units 8-12 Cornwall Road Industrial Estate, Cornwall Road, Smethwick,
West Midlands, B66 2JT, UK.
Repackaged by N.G.Ltd, West Midlands, B66 2JT, UK.

POM

PL Number: 22961/0123

Leaflet Revision Date: 14.08.2015

Purinethol® 50 mg Tablets
Ref 856

Purinethol® is a registered trademark of the GlaxoSmithKline Group of Companies.

160 mm Measuring Bar

Rar e (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

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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