Puri-Nethol 50mg Tablets
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PURI-NETHOL® 50mg TABLETS /
MERCAPTOPURINE 50mg TABLETS (mercaptopurine)
Patient Information Leaflet
This product is known as any of the above names but will usually be referred to as Puri-Nethol throughout this 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.
In this leaflet:
1. What Puri-Nethol is and what it is used for
2. Before you take Puri-Nethol
3. How to take Puri-Nethol
4. Possible side effects
5. How to store Puri-Nethol
6. Further information
1. What Puri-Nethol is and what it is used for:
Puri-Nethol tablets contain a medicine called mercaptopurine. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Puri-Nethol is used to treat leukaemia (cancer of the blood). It works by reducing the number of new blood cells your body makes.
Puri-Nethol is used for:
• Acute myelogenous leukaemia (also called acute myeloid leukaemia or AML) - a
fast-growing disease that increases the number of white blood cells produced by the bone marrow. This can cause infections and bleeding.
• Acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL) - a fast-growing disease which increases the number of immature white blood cells.
These immature white blood cells are unable to grow and work properly. They therefore cannot fight infections and may cause bleeding.
• Chronic granulocytic leukaemia (also called chronic myeloid leukaemia) - a disease that increases the number of white blood cells. This can cause infections and bleeding.
Ask your doctor if you would like more explanation about these diseases.
2. Before you take Puri-Nethol:
Do not take Puri-Nethol if:
• You are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of Puri-Nethol 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 Puri-Nethol.
Take special care with Puri-Nethol
Before you take Puri-Nethol, 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 or pharmacist before taking Puri-Nethol.
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 Puri-Nethol 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 Puri-Nethol
If you are going to have a vaccination speak to your doctor or nurse before you have it. This is because some vaccines (like polio, measles, mumps and rubella) may give you an infection if you have them whilst you are taking Puri-Nethol.
Pregnancy and breast-feeding
Do not take Puri-Nethol if you are planning to have a baby. This applies to both men and women. Puri-Nethol may harm your sperm or eggs. Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner is taking these tablets. Ask your doctor for advice.
If you are already pregnant, it is important to talk to your doctor before taking Puri-Nethol.
Do not breast-feed while taking Puri-Nethol. Ask your doctor or midwife for advice.
Important information about some of the ingredients of Puri-Nethol
Puri-Nethol tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take Puri-Nethol tablets.
3. Howto take Puri-Nethol:
Puri-Nethol should only be given to you by a specialist doctor who is experienced in treating blood problems.
Always take Puri-Nethol exactly as your doctor has told you. It is important to take your medicine at the right times. The label on your pack will tell you how many tablets to take and how often to take them. If the label doesn’t say or if you are not sure, ask your doctor, nurse or pharmacist.
• 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 Puri-Nethol your doctor will take regular blood tests. This is to check the number and type of cells in your blood and to ensure your liver is working correctly.
• Your doctor may also ask for other blood and urine tests to monitor your uric acid levels.
Uric acid is a natural body chemical, levels of which can rise while taking Puri-Nethol.
• Your doctor may sometimes change your dose of Puri-Nethol as a result of these tests.
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
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The dose of Puri-Nethol you are given will be worked out by your doctor based on:
• Your body size (surface area)
• The results of your blood tests
• The usual starting dose for adults and children is 2.5 mg per kilogram of your body weight each day.
• Elderly patients will have their kidney and liver function tested and if necessary the dose may need to be reduced.
If you take more Puri-Nethol than you should
If you take more Puri-Nethol than you should, tell your doctor immediately or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Puri-Nethol
Tell your doctor. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects:
Like all medicines, Puri-Nethol can cause side effects, although not everybody gets them.
If you get any of the following, talk to your specialist doctor or go to hospital straight away:
• allergic reaction, the signs may include:
- skin rashes
- high temperature -joint pain
- swollen face
• any signs of fever or infection (sore throat, sore mouth or urinary problems)
• 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
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.
5. Howto store Puri-Nethol:
• Keep out of the reach and sight of children.
• Do not use Puri-Nethol after the expiry date which is stated on the pack after ‘EXP’.
• Do not store your Puri-Nethol tablets above 25°C. Keep the container tightly closed.
• Store in the original packaging. 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.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist.
6. Further information:
Your medicine is called Puri-Nethol 50mg tablets/Mercaptopurine 50mg tablets.
Each tablet contains 50mg of the active ingredient mercaptopurine.
Puri-Nethol 50mg tablets/Mercaptopurine 50mg tablets are pale yellow, round tablets marked ‘GX’ and ‘EX2’ either side of a breakline on one side and plain on the reverse.
Puri-Nethol 50mg tablets/Mercaptopurine 50mg tablets also contain the following:
Lactose monohydrate, maize starch, hydrolysed starch, magnesium stearate and stearic acid.
Puri-Nethol 50mg tablets/Mercaptopurine 50mg tablets are available in bottles of 25 tablets.
POM] PL No: 06464/2815
This product is manufactured by EXCELLA GmbH, Nurnberger Strasse 12, 90537 Feucht, Germany and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 12.07.2010
Puri-Nethol is a registered trademark of The Wellcome Foundation Limited
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
000-0000D