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MERCAPTOPURINE 50 MG TABLETS

Active substance(s): MERCAPTOPURINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Puri-Nethol®

50mg Tablets

(mercaptopurine)

Your medicine is available using the name Puri-Nethol 50mg
Tablets but will be referred to as Puri-Nethol throughout this
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, 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.

Taking Puri-Nethol 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.

Pregnancy and breast-feeding

Infections
When you are treated with Puri-Nethol 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).

Treatment with Puri-Nethol 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 Puri-Nethol for you.

Blood tests


What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Puri-Nethol is and what it is used for
What you need to know before you take Puri-Nethol
How to take Puri-Nethol
Possible side effects
How to store Puri-Nethol
Contents of the pack and other information

1. What Puri-Nethol is and what it is used for
Puri-Nethol contains the active substance called
mercaptopurine. Mercaptopurine belongs to a group of
medicines called cytotoxics (also called chemotherapy) and
works by reducing the number of new blood cells your body
makes. Puri-Nethol is used to treat cancer of the blood
(leukaemia) in adults, adolescents and children.

2. What you need to know before you take
Puri-Nethol
Do not take Puri-Nethol:

If you are allergic to 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 Puri-Nethol:

If you have recently received, or are due to receive, a
vaccination (vaccine). If you take Puri-Nethol, 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 Puri-Nethol

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
Puri-Nethol could put you at greater risk of:

tumours, including skin cancer. Therefore, when taking
Puri-Nethol, avoid excessive exposure to sunlight, wear
protective clothing and use protective sunscreen with a
high protection factor.

lymphoproliferative disorders:

treatment with Puri-Nethol 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).

Treatment with Puri-Nethol 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


Puri-Nethol is toxic to your liver. Therefore, your doctor
will carry out weekly liver function tests when you are
taking Puri-Nethol. 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

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

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

Breast-feeding

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

Driving and using machines

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

Puri-Nethol contains 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.

3. How to take Puri-Nethol
Puri-Nethol should only be prescribed to you by a specialist
doctor who is experienced in treating cancers of the blood.


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 how your kidneys are working and to
measure uric acid levels. Uric acid is a natural substance
made in your body and levels of uric acid can rise while
you are taking Puri-Nethol. High levels of uric acid may
damage your kidneys
Your doctor may sometimes change your dose of
Puri-Nethol as a result of these tests.

Low blood sugar levels (sweating more than usual, nausea,
dizziness, confusion, etc.) have been reported in some
children receiving Puri-Nethol; 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 Puri-Nethol.



Other medicines and Puri-Nethol

Always take Puri-Nethol exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure. 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 does not say
or if you are not sure, ask your doctor, nurse or pharmacist.

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 Puri-Nethol

If you are going to have a vaccination speak to your doctor or
nurse before you have it.
If you take Puri-Nethol, 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 Puri-Nethol.

Puri-Nethol with food and drink

You can take Puri-Nethol 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.

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The usual dose for adults and children is 2.5mg per kilogram
of your body weight each day (or alternatively 50 to 75mg
per m2 of your body surface area each day). Your doctor will
calculate and adjust your dose based on your body weight,
results of your blood tests, whether or not you are taking
other chemotherapy medicines and your kidney and liver
function.


Swallow your tablets whole. Do not chew the tablets.
The tablets should not be broken or crushed. If you or
your caregiver does handle broken tablets, wash the
hands immediately.

You can take your medicine 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.

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 stop taking Puri-Nethol

If you stop taking Puri-Nethol, tell your doctor immediately.
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, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following side effects, talk to your
specialist doctor or go to hospital immediately:

An allergic reaction with swelling of the face and
sometimes mouth and throat (this is a very rare side
effect).

An allergic reaction with joint pain, skin rashes, high
temperature (fever) (this is a rare side effect).

Yellowing of the skin and whites of the eyes. If you get
such symptoms, you should stop taking Puri-Nethol.

Any signs of fever or infection (sore throat, sore mouth
or urinary problems) or any unexplained bruising or
bleeding. Treatment with Puri-Nethol affects your bone
marrow and will cause a reduction in your white blood
cells and platelets (this is a very common side effect).
Talk to your doctor if you have any of the following side
effects, which may also happen with this medicine:

6. Contents of the pack and other
information
What Puri-Nethol contains

Each tablet contains 50mg of the active ingredient
mercaptopurine.
The other (inactive) ingredients are: lactose, maize starch,
hydrolysed starch, stearic acid, magnesium stearate.

What Puri-Nethol looks like and contents of the
pack

The tablets are pale yellow, round tablets that are plain on
one side and marked on the reverse with ‘GX’ above a
scoreline and ‘EX2’ underneath.
Puri-Nethol is packed in bottles of 25 tablets.

Manufacturer

Puri-Nethol is manufactured by:
EXCELLA GmbH, Nurnberger Strasse 12, 90537 Feucht,
Germany.

Common (may affect up to 1 in 10 people)

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Uncommon (may affect up to 1 in 100 people)

Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster,
DN3 1QR.





Nausea (you feel sick) or vomiting (being sick)
Low red blood cell count (anaemia)
Loss of appetite

Rare (may affect up to 1 in 1,000 people)







Mouth ulcers
Inflammation of the pancreas (pancreatitis); symptoms
may include abdominal pain or feeling or being sick
Damage to your liver (hepatic necrosis)
Hair loss
Various types of cancers including blood, lymph and skin
cancers

Very rare (may affect up to 1 in 10,000 people)







Blood cancer
Cancer of the spleen and liver (in patients with a
condition called Inflammatory Bowel Disease)
Ulcers in the intestines; symptoms may include
abdominal pain and bleeding
Low sperm count in men

Not known (frequency cannot be estimated from
the available data)


Increased sensitivity to sunlight and UV light

Additional side effects in children

Low blood sugar levels (sweating more than usual, nausea,
dizziness, confusion, etc.) have been reported in some
children receiving Puri-Nethol; 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 or
search for MHRA Yellow Card in the Google Play or Apple
App Store.

PL No: 08929/0402

POM

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 01302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Puri-Nethol 50mg Tablets
Reference No: 08929/0402
Leaflet revision & issue date (ref): 14.12.17
Puri-Nethol® is a registered trademark of the Aspen Global
Incorporated.

By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Puri-Nethol











Keep out of the sight and reach of children.
Do not store above 25°C.
Keep the bottle tightly closed.
Do not take any tablets after the expiry date printed on
the carton and bottle label. This refers to the last day of
that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away any medicines you no longer use. These measures
will help protect the environment.
If your doctor tells you to stop taking the tablets, please
return any which are left over to your pharmacist for
safe disposal. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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