Purinethol 50mg Tablets
Out of date information, search anotherMercaptopurine 50mg Tablets Ref: 1378/031213/1/F
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Your medicine is called Mercaptopurine 50mg tablets but will be referred to as Mercaptopurine throughout this leaflet.
In this leaflet:
What Mercaptopurine is and what it is used for [a Before you take Mercaptopurine How to take Mercaptopurine i4 Possible side effects
How to store Mercaptopurine .6 Further information
^ 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 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.
^ Before you take Mercaptopurine
Do not take Mercaptopurine if:
* You are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of Mercaptopurine tablets (See section 6: Further information)
Do not take if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Mercaptopurine.
Take special care with Mercaptopurine
Before you take Mercaptopurine, tell your doctor or pharmacist 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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:
* other cytotoxic drugs (chemotherapy) - when used with Mercaptopurine there is a greater chance of side effects, such as breathing problems
* allopurinol (used to treat gout)
* warfarin (used to thin the blood)
* olsalazine or mesalazine (used for a bowel problem called ulcerative colitis)
* sulfasalazine (used for rheumatoid arthritis or ulcerative colitis).
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 and breast-feeding
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 is taking these tablets. Ask your doctor for advice.
If you are already pregnant, it is important to talk to your doctor before taking Mercaptopurine.
Do not breast-feed while taking Mercaptopurine. Ask your doctor or midwife for advice.
Important information about some of the ingredients of Mercaptopurine
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.
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.
* Swallow your tablets whole with a glass of water.
* If you need to break your tablet in half, do not inhale any tablet powder. Wash your hands afterwards.
* 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.
Patient Information Leaflet (continued)
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.
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.
[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)
* 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 (affects more than 1 in 10 people)
* a drop in the number of white blood cells and platelets
Common (affects less than 1 in 10 people)
* feeling or being sick (nausea or vomiting)
* liver problems - this may show up in your blood tests
Uncommon (affects less than 1 in 100 people)
* a drop in red blood cells which may make you tired, weak or breathless - called anaemia
* loss of appetite
Rare (affects less than 1 in 1,000 people)
* mouth ulcers
* inflammation of the pancreas which can give you abdominal pain or make you sick
* hair loss
Very rare (affects less than 1 in 10,000 people)
* leukaemia
* ulcers in the intestines
* in men: low sperm count
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.
[p Further 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.
[POMl PL 15184/1378 Mercaptopurine 50mg Tablets
Revision date: 03/12/13
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Purinethol® 50mg Tablets
(mercaptopurine)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Your medicine is called Purinethol 50mg tablets but will be referred to as Purinethol throughout this leaflet.
In this leaflet:
[4 What Purinethol is and what it is used for 3 Before you take Purinethol [4 How to take Purinethol [4 Possible side effects How to store Purinethol ^4 Further information
^ 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 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.
Before you take Purinethol
Do not take Purinethol if:
* You are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of Purinethol tablets (See section 6: Further information)
Do not take if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Purinethol.
Take special care with Purinethol
Before you take Purinethol, tell your doctor or pharmacist 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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:
* other cytotoxic drugs (chemotherapy) - when used with Purinethol there is a greater chance of side effects, such as breathing problems
* allopurinol (used to treat gout)
* warfarin (used to thin the blood)
* olsalazine or mesalazine (used for a bowel problem called ulcerative colitis)
* sulfasalazine (used for rheumatoid arthritis or ulcerative colitis).
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 and breast-feeding
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 is taking these tablets. Ask your doctor for advice.
If you are already pregnant, it is important to talk to your doctor before taking Purinethol.
Do not breast-feed while taking Purinethol. Ask your doctor or midwife for advice.
Important information about some of the ingredients of Purinethol
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.
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.
* Swallow your tablets whole with a glass of water.
* If you need to break your tablet in half, do not inhale any tablet powder. Wash your hands afterwards.
* 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.
Purinethol® 50mg Tablets
(mercaptopurine)
Patient Information Leaflet (continued)
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 2.5 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.
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.
[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)
* 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 (affects more than 1 in 10 people)
* a drop in the number of white blood cells and platelets
Common (affects less than 1 in 10 people)
* feeling or being sick (nausea or vomiting)
* liver problems - this may show up in your blood tests
Uncommon (affects less than 1 in 100 people)
* a drop in red blood cells which may make you tired, weak or breathless - called anaemia
* loss of appetite
Rare (affects less than 1 in 1,000 people)
* mouth ulcers
* inflammation of the pancreas which can give you abdominal pain or make you sick
* hair loss
Very rare (affects less than 1 in 10,000 people)
* leukaemia
* ulcers in the intestines
* in men: low sperm count
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/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
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 Further 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: 03/12/13