Purinethol 50mg Tablets
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PURINETHOL® 50mg TABLETS
(mercaptopurine)
Your medicine is known as Purinethol 50mg Tablets but will be referred to as Purinethol throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine 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 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, nurs e 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)
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
3 KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C. Keep the container tightly closed. Store in a dry place. Protect from light.
• Do not use after the expiry date which is stated on the pack after 'EXP'.
• If your doctor tells you to stop taking the tablets, it is important to return any which are left over to your pharmacist, who will destroy them according to disposal of dangerous substance guidelines. Only keep the tablets if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6 Contents of the pack and other information
What Purinethol contains
• The active ingredient is mercaptopurine. Each tablet contains 50mg of mercaptopurine.
• The other ingredients are lactose, maize starch, hydrolysed starch, stearic acid and magnesium stearate.
What Purinethol looks like and contents of the pack
• Purinethol tablets are a pale yellow colour, scored on one side and are marked with 'GX' and 'EX2' on either side of the score line and they are plain on the other side.
• Purinethol are available in bottles of 25 tablets.
Product Licence holder:
Procured from within the EU and repackaged by the Product Licence holder:
Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough, SL1 4NL.
Manufacturer:
This product is manufactured by EXCELLA GmbH, Nurnberger Strasse 12, Feucht, D-90537, Germany. _
PURINETHOL® 50mg TABLETS POM
PL 39352/0170 Leaflet date: 17.04.2015
Puri-NethoP is a registered trademark of the GlaxoSmithKline group of companies.
Package Leaflet: Information for the User
MERCAPTOPURINE 50mg TABLETS
Your medicine is known as Mercaptopurine 50mg Tablets but will be referred to as Mercaptopurine throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine 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
T ell 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.
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.
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)
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 use after the expiry date which is stated on the pack after 'EXP'.
• If your doctor tells you to stop taking the tablets, it is important to return any which are left over to your pharmacist, who will destroy them according to disposal of dangerous substance guidelines. Only keep the tablets if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Mercaptopurine contains
• The active ingredient is mercaptopurine. Each tablet contains 50mg of mercaptopurine.
• The other ingredients are lactose, maize starch, hydrolysed starch, stearic acid and magnesium stearate.
What Mercaptopurine looks like and contents of the pack
• Mercaptopurine tablets are a pale yellow colour, scored on one side and are marked with 'GX' and 'EX2' on either side of the score line and they are plain on the other side.
• Mercaptopurine are available in bottles of 25 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough, SL1 4NL.
Manufacturer
POM
This product is manufactured by EXCELLA GmbH, Nurnberger Strasse 12, Feucht, D-90537, Germany.
Leaflet date: 17.04.2015
MERCAPTOPURINE 50mg TABLETS PL 39352/0170