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CHLORAMBUCIL 2MG TABLETS

Active substance(s): CHLORAMBUCIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorambucil 2mg Tablets

(chlorambucil)
Not printable space
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.







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.

2. 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: Further information)
Do not take Chlorambucil if the above applies to you. If you are
not sure, talk to your doctor or pharmacist before taking
Chlorambucil.


Take special care with Chlorambucil

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

You have had radiotherapy or chemotherapy, now or
recently

You have a liver or kidney problem

You have nephrotic syndrome (a kidney problem) or ever
had a fit or convulsion. You may have an increased risk of
fits when taking Chlorambucil.
If you are not sure if any of the above apply to you, talk to your
doctor, nurse or pharmacist before taking Chlorambucil.

Taking other medicines

In this leaflet:

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.

1. What Chlorambucil is and what it is used
for

In particular, tell your doctor or pharmacist 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) – Chlorambucil can make
your body less able to fight infections.

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 medicines
used during chemotherapy or radiotherapy treatment for the
treatment of haematological malignancies (types of cancer
that affect blood, bone marrow and lymph nodes.

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

What Chlorambucil is and what it is used for
Before you take Chlorambucil
How to take Chlorambucil
Possible side effects
How to store Chlorambucil
Further information

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-Hodgkins Lymphoma.
Together, these form a group of diseases called lymphomas.
They are cancers formed from cells of the lymphatic system.

Chronic lymphocytic leukaemia. A disease where the
bone marrow produces a large number of abnormal white
cells.

Waldenstrom’s macroglobulinaemia is a rare blood
condition involving the release of an abnormal protein into
the blood.
Ask your doctor if you would like more explanation about these
diseases.

Important information about some of the
ingredients of Chlorambucil

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
Chlorambucil should only be given to you by a specialist doctor
who is experienced in treating cancer.
Always take Chlorambucil 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.

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 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 elderly or have a kidney or liver
problems.

When you take Chlorambucil your doctor will take regular
blood tests. This is to check the number of cells in your
blood. Your doctor may sometimes change your dose as a
result.

Hodgkin’s Disease


Non-Hodgkin’s Lymphoma


Fertility

Do not take Chlorambucil if you are planning to have a baby.
This applies to both men and women. Chlorambucil can affect
ovaries or sperm, which may cause infertility (inability to have a
baby). Use a reliable form of contraception to avoid pregnancy if
either you or your partner is taking Chlorambucil. Ask your doctor
for advice.

Pregnancy and breast-feeding

Treatment with Chlorambucil is not recommended during
pregnancy because it may cause permanent damage to a foetus.
If you are pregnant, if you think you could be pregnant, or if you
are planning to become pregnant, check with your doctor before
you take Chlorambucil. 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.

Page 1 of 2

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

If you take more Chlorambucil 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 Chlorambucil

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

4. Possible side effects



Like all medicines, Chlorambucil 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:

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










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.

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 blood cells and platelets.

irreversible bone marrow failure – your body may stop
producing blood cells
scarring and thickening in the lungs with shortness of breath
lung disease.

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 haematological malignancy
include tiredness, fever, infection and bruising. These side effects
may also show up in your blood tests.
Tell your doctor as soon as possible if you have any of these
symptoms. You may need to stop taking Chlorambucil, but only
your doctor can tell you if that is the case.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.

Common (affects less than 1 in 10 people)

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



5. How to store Chlorambucil






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

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.

Uncommon (affects less than 1 in 100 people)

Store in a refrigerator between 2°C and 8°C.

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

If your doctor decides to stop your treatment, take any leftover
tablets back to the pharmacy.











rash.

yellowing of the whites of the eyes or skin (jaundice)
allergy symptoms such as skin lumps, hives or swelling of
the tissues (oedema)
on rare occasions, 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. Patients are more at risk of having fits or
convulsions if they have epilepsy and/or if they are being
prescribed high doses.

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

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. Further 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.
Page 2 of 2

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.
PL No: 21828/0544

POM

Other Formats

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.
Leaflet issue and revision date: 05.02.15

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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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