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• leaflet MAH BRAND_PLPI 18980-0851
• leaflet MAH BRAND_PLPI 18980-0862
• leaflet MAH BRAND_PLPI 18980-0863
• leaflet MAH BRAND_PLPI 19065-0325

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PURI-NETHOL® 50 mg tablets / Mercaptopurine 50 mg tablets

(mercaptopurine)

PATIENT INFORMATION LEAFLET

This medicine can be known by either of the above names but will be referred to as Puri-Nethol through the remainder of this leaflet.

What is in this leaflet:

1)    What Puri-Nethol is and what it is used for

2)    What you need to know before you take Puri-Nethol

3)    How to take Puri-Nethol

4)    Possible side effects

5)    How to store Puri-Nethol

6)    Contents of the pack and other information

1) WHAT PURI-NETHOL IS AND WHAT IT IS USED|

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) WHAT YOU NEED TO KNOW BEFORE YOU| TAKE PURI-NETHOL^^^^^^^^H

Do not take Puri-Nethol:

•    if you are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of Puri-Nethol 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 Puri-Nethol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Puri-Nethol 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 Puri-Nethol.

Other medicines and Puri-Nethol

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 Puri-Nethol there is a greater chance of side effects, such as breathing problems

•    allopurinol, oxipurinol and thiopurinol (used mainly to treat gout) - when used with Puri-Nethol, only 25 % of the normal dose of Puri-Nethol 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 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, breast-feeding and fertility

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 are taking these tablets. Ask your doctor for advice.

Treatment with Puri-Nethol 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 Puri-Nethol. Your doctor will consider the risks and benefits to you and your baby of taking Puri-Nethol.

Do not breast-feed while taking Puri-Nethol. Ask your doctor or midwife for advice.

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.

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.

•    You should take Puri-Nethol 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 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.

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.

•    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 Puri-Nethol 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 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.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

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). 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 Puri-Nethol)

•    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)

-    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 Puri-Nethol) when Puri-Nethol 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.

•    Keep out of the sight and reach of children.

•    Do not store    above 25°C.

•    Keep the bottle tightly closed.

•    Protect from    moisture.

•    Protect from    light.

•    Do not use Puri-Nethol 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 tablets show any signs of deterioration seek the advice of your pharmacist.

6) CONTENTS OF THE PACK AND OTHER| INFORMATION^^^^^^^^H

What Puri-Nethol contains

The active ingredient is mercaptopurine.

Each tablet contains 50 mg of mercaptopurine.

The other ingredients are lactose, starch, modified starch, magnesium stearate and stearic acid.

What Puri-Nethol looks like and contents of the pack

Puri-Nethol tablets are pale yellow, circular, biconvex tablets, scored on one side and engraved ‘GX' above the score and ‘EX2' below the score and plain on the reverse.

Your Puri-Nethol tablets are in bottles of 25 tablets.

Manufacturer

This product is manufactured by EXCELLA GmbH, Nurnberger Strasse 12, Feucht, Germany. Procured from within the EU and repackaged by Mediwin Limited. Product Licence Holder: Mediport Limited. 13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, United Kingdom.

PL: 18980/0862

PURI-NETHOL is a registered trademark of Aspen Global Incorporated.

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

Date of leaflet preparation: 15/06/2015

To request a copy of this leaflet in Braille. Large print or audio Please call 0800 198 5000 (UK only).

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