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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. 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

Do not take Mercaptopurine:

If you are allergic to 6-mercaptopurine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Mercaptopurine:

• If you have recently received, or are due to receive, a vaccination (vaccine). If you take Mercaptopurine, you should not have a live organism vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe to do so by your doctor. This is because some vaccines may give you an infection if you receive them while you are taking Mercaptopurine
• If you have reduced liver function or liver damage
• If you have a genetic condition called TPMT (thiopurine methyltransferase) deficiency
• If you have an inherited mutation in the NUDT15-gene (a gene which is involved in the break-down of Mercaptopurine in the body), you have a higher risk of infections and hair loss and your doctor may in this case give you a lower dose.
• If you have an allergy to a medicine called azathioprine (also used to treat cancer)
• If you have a kidney problem.
• Tell your doctor whether you have, or have not, had chicken pox, shingles or hepatitis B (a liver disease caused by a virus).
• If you have a genetic condition called Lesch-Nyhan Syndrome

If you are receiving immunosuppressive therapy, taking Mercaptopurine could put you at greater risk of:

• tumours, including skin cancer. Therefore, when taking Mercaptopurine, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor.
• lymphoproliferative disorders:
  
  • treatment with Mercaptopurine increases your risk of getting a type of cancer called lymphoproliferative disorder. With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death.
  • a combination of multiple immunosuppressants, given concomitantly increases the risk of disorders of the lymph system due to a viral infection (Epstein-Barr virus (EBV) - associated lymphoproliferative disorders).

Taking Mercaptopurine could put you at greater risk of:

• developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis.

Infections

When you are treated with Mercaptopurine the risk of viral, fungal and bacterial infections is increased and the infections may be more serious. See also section 4.

Tell your doctor before starting treatment whether or not you have had chickenpox, shingles or hepatitis B (a liver disease caused by a virus).

Blood tests

• Treatment with Mercaptopurine may affect your bone marrow. This means you may have a reduced number of white blood cells, platelets and (less commonly) red blood cells in your blood. Your doctor will carry out blood tests daily when you are at the beginning of your treatment (induction) and at least weekly when you are further along into your treatment (maintenance). This is in order to monitor the levels of these cells in your blood. If you stop treatment early enough, your blood cells will return to normal.

Other laboratory tests

• Additional laboratory tests (urine, blood, etc.) may also be carried out as directed by your doctor.

Liver function

• Mercaptopurine is toxic to your liver. Therefore, your doctor will carry out weekly liver function tests when you are taking Mercaptopurine. If you already have liver disease, or if you are taking other medications which may affect your liver, your doctor will carry out more frequent tests. If you notice the whites of your eyes or your skin turn yellow (jaundice) tell your doctor immediately as you may need to stop your treatment immediately.

Children and adolescents

Low blood sugar levels (sweating more than usual, nausea, dizziness, confusion, etc.) have been reported in some children receiving Mercaptopurine; however, most of the children were under the age of six years old and had a low body weight.

If you are not sure if any of the above applies to you, talk to your doctor 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.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• Ribavirin (used to treat viruses)
• Other cytotoxic medicines (chemotherapy – used to treat cancer)
• Allopurinol, thiopurinol, oxipurinol or febuxostat (used to treat gout)
• Olsalazine (used to treat a bowel problem called ulcerative colitis)
• Mesalazine (used to treat Crohn’s Disease and ulcerative colitis)
• Sulfasalazine (used to treat rheumatoid arthritis or ulcerative colitis)
• Methotrexate (used to treat rheumatoid arthritis or severe psoriasis)
• Infliximab (used to treat Crohn’s Disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or severe psoriasis)
• Warfarin or acenocoumarol (used to ‘thin’ the blood)

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. If you take Mercaptopurine, you should not have a live vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe to do so by your doctor. This is because some vaccines may give you an infection if you have them whilst you are taking Mercaptopurine.

Mercaptopurine with food and drink

You can take Mercaptopurine with food or on an empty stomach but the choice of method should be consistent from day to day. You should take your medicine at least 1 hour before or 2 hours after having milk or dairy products.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Treatment with Mercaptopurine is not recommended during pregnancy, particularly in the first trimester (three months) because it may cause damage to the foetus. If you are pregnant your doctor will consider the risks and benefits to you and your baby before prescribing Mercaptopurine for you.

If you or your partner are taking Mercaptopurine, you must use a reliable form of contraception to avoid pregnancy for the whole course of Mercaptopurine treatment and for at least 3 months after receiving the last dose of Mercaptopurine. This applies to both men and women.

Breast-feeding

It is recommended that you do not breast-feed when you are taking Mercaptopurine.

Driving and using machines

It is not expected that Mercaptopurine will affect your ability to drive or use machines, but no studies have been done to confirm this.

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.

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 stop taking Mercaptopurine

If you stop taking Mercaptopurine, tell your doctor immediately.

Additional side effects in children

Low blood sugar levels (sweating more than usual, nausea, dizziness, confusion, etc.) have been reported in some children receiving Mercaptopurine; however, most of the children were under the age of six years old and had a low body weight.

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.

What Mercaptopurine contains

The active substance is 6-mercaptopurine. Each tablet contains 50mg of 6-mercaptopurine. The other ingredients are lactose, maize starch, modified maize starch, stearic acid and magnesium stearate.

What Mercaptopurine looks like and contents of the pack

Mercaptopurine tablets are a pale yellow colour and are marked with ‘PT / 50’. Your Mercaptopurine tablets are in bottles of 25 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Manufacturer: