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CHLORAMBUCIL 2MG TABLETS

Active substance(s): CHLORAMBUCIL / CHLORAMBUCIL / CHLORAMBUCIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorambucil 2mg Tablets
(chlorambucil)
Your medicine is available using the name Chlorambucil 2mg
Tablets but will be referred to as Chlorambucil 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 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 or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

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

1. What Chlorambucil is and what it is used
for
Chlorambucil contains a medicine called chlorambucil.
This belongs to a group of medicines called cytotoxics (also
called chemotherapy). Chlorambucil is used to treat some
types of cancer and certain blood problems. It works by
reducing the number of abnormal cells your body makes.
Chlorambucil is used for:

Hodgkin’s disease and Non-Hodgkin’s Lymphoma.
Together, these form a group of diseases called
lymphomas. They are cancers formed from cells of the
lymphatic system.

Chronic lymphocytic leukaemia. A type of white
blood cell cancer where the bone marrow produces a
large number of abnormal white cells.

Waldenstrom’s macroglobulinaemia. A rare
lymphoma associated with an uncontrolled increase of
B-cells, a type of white blood cell, resulting in the
release of an abnormal protein into the blood.
Ask your doctor if you would like more explanation about
these diseases.
You must talk to a doctor if you do not feel better or if you
feel worse.

2. What you need to know before you take
Chlorambucil
Do not take Chlorambucil:


If you are allergic (hypersensitive) to chlorambucil or
any of the other ingredients of Chlorambucil tablets (See
section 6).

If you are not sure, talk to your doctor or nurse before taking
Chlorambucil.

Warnings and precautions

Before you take Chlorambucil, tell your doctor or nurse if:

you have been recently vaccinated, or planning to be
vaccinated with a live vaccine (see Other medicines and
Chlorambucil). Chlorambucil can make your body less
able to fight infections

you are a potential candidate for bone marrow
transplantation (autologous stem cell transplantation) as
the long term use of Chlorambucil may reduce the
amount of stem cells

you have had radiotherapy or chemotherapy, now or
recently

you have a liver or kidney problem

you have a kidney problem (nephrotic syndrome), had
high pulse dosing regimen or ever had a fit or
convulsion. If you had ever had fits or convulsions, you
might be more at risk of having fits or convulsions when
taking Chlorambucil.
It is possible that the use of Chlorambucil, particularly long
term use, may increase the risk of developing a secondary
blood cancer. In many cases, patients who develop this have
also received another type of chemotherapy or some form of
radiation therapy. Symptoms of a secondary blood cancer
include tiredness, fever, infection and bruising. Tell your
doctor as soon as possible if you have any of these symptoms
(see section 4).

Other medicines and Chlorambucil

Please tell your doctor 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 if you are taking or have
recently taken any of the following:

Vaccines which contain live organisms (such as oral polio
vaccine, measles, mumps, rubella).

Phenylbutazone (a medicine used to treat fever, pain,
and inflammation in the body) - you may require a lower
dose of Chlorambucil.

Fludarabine, Pentostatin or Cladribine, which are other
chemotherapy medicines that may be used for the
treatment of haematological malignancies (types of
cancer that affect blood, bone marrow and lymph
nodes).

Chlorambucil with food

Chlorambucil should be taken on an empty stomach. See
section 3.
Page 1 of 2

Pregnancy, breast-feeding and fertility
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.
Do not take Chlorambucil if you are planning to have a baby.
This applies to both men and women.
Treatment with Chlorambucil is not recommended during
pregnancy because it may cause permanent damage to a
foetus. Your doctor will consider the risks and benefits to you
and your baby of taking Chlorambucil.
Do not breast-feed while taking Chlorambucil. There have
been reports indicating that Chlorambucil and its ingredients
can be passed into breast-milk. Ask your doctor or midwife
for advice.

Fertility

Chlorambucil can affect ovaries or sperm, which may cause
infertility (inability to have a baby). In women menstruation
can stop (amenorrhoea) and in men, a complete lack of
sperm can be observed (azoospermia). Use a reliable form of
contraception to avoid pregnancy if either you or your partner
is taking Chlorambucil. Ask your doctor for advice.

Driving and using machines

No information on the effects of Chlorambucil on the ability to
drive and use machines is available.

Chlorambucil contains lactose anhydrous

Chlorambucil tablets contain lactose anhydrous. If you have
been told by your doctor that you have an intolerance to
some sugars, contact your doctor before you take
Chlorambucil tablets.

3. How to take Chlorambucil
Always take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
Chlorambucil should only be given to you by a specialist
doctor who is experienced in treating cancer. The duration of
the treatment will be decided by your doctor based on your
disease.

Chlorambucil is administrated orally and should be taken
daily on an empty stomach (at least one hour before
meals or three hours after meals).

Swallow your tablets whole with a glass of water.

Do not break, crush or chew the tablets.

The dose of Chlorambucil depends on the type of your blood
problem or cancer (see section 1).

Your doctor may change your dose during your
treatment depending on your needs. The dose can
sometimes be changed if you are an older person or
have liver problems. Your kidney or liver functions may
be monitored during treatment, if you are an elderly
person.

When you take Chlorambucil your doctor will take
regular blood tests to check the number of cells in your
blood and your drug dose may be adjusted as a result.

Talk to your doctor if you have any of the following side
effects, which may also happen with this medicine:

Hodgkin’s Disease





The usual dose is 0.2mg per kilogram of your body
weight each day for adults and children.

Non-Hodgkin’s Lymphoma


The usual dose is 0.1 to 0.2mg per kilogram of your
body weight each day for adults and children.

Chronic Lymphocytic Leukaemia


The usual starting dose is 0.15mg per kilogram of your
body weight each day.

Waldenstrom’s macroglobulinaemia


The usual starting dose is 6 to 12mg each day. Some
people have to take Chlorambucil long term. If you have
to take it long term, the usual dose is 2 to 8mg each
day. Follow your doctor’s instructions carefully.

If you take more Chlorambucil than you should
Tell your doctor immediately or go to a hospital straight
away. Ensure to take the medicine pack with you.

If you forget to take Chlorambucil

Tell your doctor. Do not take a double dose to make up
for a forgotten dose.

If you stop taking Chlorambucil

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

4. Possible side effects
Like all medicines, Chlorambucil can cause side effects,
although not everybody experiences them.

If you experience any of the following, talk to your
specialist doctor or go to hospital straight away:








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),
if you start feeling extremely tired,
if you notice numbness or weakness of your muscles,
if you experience skin rashes, blisters on the skin, sore
mouth or eyes and have a high temperature.

Very Common (affects more than 1 in 10 people)


a drop in the number of blood cells, or bone marrow
suppression.

Common (affects less than 1 in 10 people)





feeling sick (nausea), being sick (vomiting), diarrhoea or
mouth ulcers (sores),
secondary blood cancers (acute secondary haematologic
malignancies),
fits (convulsions) in children with a kidney problem
known as nephrotic syndrome,
a drop on red blood cells or anaemia which may make
you feel tired or weak or breathless.

Uncommon (affects less than 1 in 100 people)


rash.

Rare (affects less than 1 in 1,000 people)








yellowing of the whites of the eyes or skin (jaundice)
allergy symptoms such as skin lumps, hives (urticaria)
or swelling of the tissues (oedema)
skin rash has been reported to progress to serious
conditions including Stevens-Johnson syndrome and
toxic epidermal necrolysis. These two forms of the same
serious skin disease cause rash, skin peeling and stores
on the mucous membranes
fever
fit or convulsion
liver damage/injury (hepatotoxicity).

Very rare (affects less than 1 in 10,000 people)







abnormal and repetitive shaking movement of the body
or twitching, without fits or convulsions,
inflammation of the bladder called cystitis,
irreversible bone marrow failure – your body may stop
producing blood cells transiently,
scarring and thickening in the lungs with shortness of
breath,
lung disease,
condition affecting nerves leading to impairment of
sensation, movement and organ function (peripheral
neuropathy).

5. How to store Chlorambucil
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Chlorambucil after the expiry date which is stated
on the pack after ‘Exp’. The expiry date is the last day of that
month.
Store in a refrigerator between 2°C and 8°C.
If your doctor decides to stop your treatment, take any
leftover tablets back to the pharmacy.
If your tablets appear to be discoloured or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
Medicines should not be disposed of via household
wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will
help to protect the environment.

6. Contents of the pack and other
information
What Chlorambucil contains

The active ingredient is chlorambucil.
Each film-coated tablet contains 2mg chlorambucil.
Also contains: microcrystalline cellulose, lactose anhydrous,
colloidal anhydrous silica, stearic acid, hypromellose,
titanium dioxide, synthetic yellow iron oxide,
synthetic red iron oxide and macrogol.

What Chlorambucil looks like and contents of the
pack

Chlorambucil are brown, film-coated, round, biconvex tablets
engraved ‘GX EG3’ on one side and ‘L’ on the other.
Chlorambucil is available in bottles of 25 tablets.

Manufacturer

Chlorambucil is manufactured by: Excella GmbH,
Nurnberger Strasse 12, Feucht, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

Not known: frequency cannot be estimated from the
available data

PL No: 21828/0544




To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory
Department.

absence of menstruation (amenorrhoea),
absence of sperm (azoospermia).

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the reporting system:
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.
Page 2 of 2

POM

Other Formats

Please be ready to give the following information:
Product name:
Chlorambucil 2mg Tablets
Reference number:
21828/0544
Leaflet issue and revision date: 18.10.16

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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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