• 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.

1. What Chlorambucil is and what it is used for
2. What you need to know before you take Chlorambucil
3. How to take Chlorambucil
4. Possible side effects
5. How to store Chlorambucil
6. Contents of the pack and other information

• 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.

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 problems
• 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).

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 should be taken on an empty stomach. See section 3.

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 woman 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.

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

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.

Tell your doctor immediately or go to a hospital straight away. Ensure to take the medicine pack with you.

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

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

• 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, 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).

Not known: frequency cannot be estimated from the available data

• 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.

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 national 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.

• The active substance is chlorambucil. Each Chlorambucil tablet contains 2 mg of chlorambucil.
• The other ingredients are microcrystalline cellulose, anhydrous lactose, colloidal anhydrous silica, stearic acid, hypromellose, titanium dioxide (E171), synthetic yellow iron oxide (E172), synthetic red iron oxide (E172) and macrogol.

Chlorambucil tablets are brown, round, biconvex, film-coated tablets, one side engraved with ‘L’ on the other side engraved “GX EG3”. Your Chlorambucil tablets are in bottles of 25 tablets.

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Manufacturer:

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Product name Chlorambucil Tablets 2 mg

Reference number PL 39699/ 0041

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