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CHLORAMBUCIL 2MG FILM-COATED TABLETS

Active substance(s): CHLORAMBUCIL

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Chlorambucil 2mg Film-coated Tablets
(chlorambucil)
Package Leaflet: Information for the User
Your medicine is known by the above name 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.
In this leaflet:
1) What Chlorambucil is and what it is used for
2) Before you take Chlorambucil
3) How to take Chlorambucil
4) Possible side effects
5) How to store Chlorambucil
6) Further information

1) What Chlorambucil is and what it is used for
Chlorambucil contains
group of medicines
Chlorambucil is used
problems. It works by
makes.

a medicine called chlorambucil. This belongs to a
called cytotoxics (also called chemotherapy).
to treat some types of cancer and certain blood
reducing the number of abnormal cells your body

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.

This includes herbal medicines.
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.
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 breastmilk. Ask your doctor or midwife for advice.
Important information about some of the ingredients of Chlorambucil
Chlorambucil 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 Chlorambucil tablets.

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

2) Before you take Chlorambucil
Do not take Leukeran 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.

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.

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.

 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.

Taking other medicines
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.

Hodgkin’s Disease
 The usual dose is 0.2 mg per kilogram of your body weight each day for
adults and children.

 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

Non-Hodgkin’s Lymphoma
 The usual dose is 0.1 to 0.2 mg per kilogram of your body weight each
day for adults and children.

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
 scarring and thickening in the lungs with shortness of breath
 lung disease

Chronic Lymphocytic Leukaemia
 The usual starting dose is 0.15 mg per kilogram of your body weight each
day.
Waldenstrom’s macroglobulinaemia
 The usual starting dose is 6 to 12 mg each day. Some people have to
take Chlorambucil long term. If you have to take it long term, the usual
dose is 2 to 8 mg 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:
 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
Common (affects less than 1 in 10 people)
 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
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 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

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.
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.

5) How to store Chlorambucil
 Keep all medicines out of the sight and reach of children.
 Do not use Chlorambucil after the expiry date which is stated on the pack
after ‘EXP’.
 Store in a refrigerator between 2 and 8°C.
 If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep the tablets if your doctor tells
you to. Do not throw them away with your normal household water or
waste. This will help to protect the environment.
 If the tablet become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist before taking them.

6) Further information
What Chlorambucil contains
The active ingredient is chlorambucil.
Each film-coated tablet contains 2mg of chlorambucil.
The other ingredients are microcrystalline cellulose, anhydrous lactose,
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 tablets are brown, film-coated, round, biconvex tablets
engraved ‘GX EG3’ on one side and ‘L’ on the other.
Chlorambucil tablets are in bottles of 25 tablets.
PL 10383/1909

Chlorambucil 2mg Film-coated Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by EXCELLA GmbH, Nurnberger Strasse
12, Feucht, Germany. Procured from within the EU and repackaged by the
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 21.08.2013

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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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