PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorambucil 2mg Tablets

(chlorambucil)

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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.

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 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.

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

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.

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 breast-milk. Ask your doctor or midwife for advice.

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

■    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

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.

irreversible bone marrow failure - your body may stop producing blood cells

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

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.

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.

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

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

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

■    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

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

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.    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.

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