• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• You are allergic (hypersensitive) to busulfan or any of the other ingredients of this medicine (listed in section 6).
• You have taken Busulfan before and it did not work.

Do not take Busulfan if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Busulfan.

Talk to your doctor or pharmacist before taking Busulfan, if:

• You have had radiotherapy or any other chemotherapy, now or recently, or if you have ever had a stem cell transplant. This is because patients taking busulfan can develop serious liver problems (hepatic veno-occlusive disease). There is an increased risk of developing hepatic veno-occlusive disease if you have had radiotherapy, more than three cycles of chemotherapy or if you have had a stem cell transplant
• You have an inherited blood problem called thalassaemia.
• You have ever had gout (painful and swollen joints caused by uric acid crystals). You may need treatment for your gout before you start taking Busulfan.
• You have a liver, kidney or lung problem.

Busulfan may cause impaired fertility in both males and females. Before starting your treatment you should talk to your doctor. Men who are planning to have children should discuss with the doctor about preserving their sperm before starting treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Busulfan.

Tell your doctor or pharmacist 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 or pharmacist if you are taking any of the following:

• Other cytotoxic drugs (chemotherapy) - when used with Busulfan there is a greater chance of side effects, such as breathing problems.
• Phenytoin (used to treat and prevent fits) - your doctor may need to change your phenytoin to a different medicine.
• Vaccines which contain live organisms (such as oral polio, measles, mumps and rubella) - Busulfan can make your body less able to fight infections.
• Itraconazole (for fungal infections) or metronidazole (for bacterial infections) - they can cause serious side effects if used with Busulfan.
• Cyclophosphamide (used for certain types of blood disorders) - if used with Busulfan, it is best that your first cyclophosphamide dose is given 24 hours or longer after the last Busulfan dose. This will reduce the chance of any possible side effects.
• An anaesthetic for an operation at the hospital or dentist. If so, tell your doctor or dentist that you are taking Busulfan.
• The use of Paracetamol during Busulfan administration should be used with caution.
• Deferasirox (a medicine used to remove excess iron from your body).
• Melphalan (used to treat certain cancers) – in children, it has been reported that treatment with melphalan less than 24 hours after the last busulfan treatment given by mouth may cause more problems (toxicity).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This applies to both men and women. Busulfan may harm your sperm or eggs. Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner are taking these tablets. Ask your doctor for advice.

If you are already pregnant, it is important to talk to your doctor before taking Busulfan.

Do not breast-feed while taking Busulfan. Ask your doctor or midwife for advice.

If you have been told by your doctor that you have intolerance to some sugars contact your doctor before taking this medicinal product.

• The usual dose is 4 to 6 mg each day.
• The course is usually 4 to 6 weeks. This course can be repeated.
• Some people have to take Busulfan long term. If you have to take it long term, the usual dose is 2 to 3 mg each day. Follow your doctor’s instructions carefully.

• The usual dose is 2 to 4 mg each day.

• The medicine is usually taken on days 7, 6, 5, 4 and 3 before your transplant day (Imagine your transplant day is day 0, and that you count down the days before).
• Two days before your transplant, you will also get a medicine called cyclophosphamide. The cyclophosphamide should not be given until 24 hours have passed since your last dose of Busulfan.
  • Adults – The usual dose is 1 mg per kilogram of your body weight. This is taken every 6 hours.
  • Children – The dose is worked out according to the surface area of your body. This is taken every 6 hours.

If you take more Busulfan than you should, tell your doctor immediately or go to a hospital straight away. Take the medicine pack with you.

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

• 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)

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
• feeling sick (nausea), being sick (vomiting), diarrhoea and mouth ulcers - with high doses of Busulfan
• yellowing of the whites of the eyes or skin (jaundice) and liver damage - with high doses of Busulfan
• in women, periods may stop, fertility may be affected and the menopause may start early - with high doses of Busulfan
• in girls, the start of puberty may be delayed or prevented
• in boys and men, sperm production may be delayed, reduced or stopped and your testicles may reduce in size
• inflammation of the lung with no sign of infection - called pneumonia syndrome - with high doses of Busulfan

Common (affects less than 1 in 10 people)

• your heart may not be able to beat properly - especially if you have an inherited blood problem called thalassaemia
• inflammation of the lungs which causes breathlessness, cough and raised temperature – called pneumonitis
• hair loss (with high doses of Busulfan)
• appearance of patches of dark skin
• signs of blood in your urine and pain when passing water (bladder inflammation) - with high doses of Busulfan at the same time as taking a medicine called cyclophosphamide
• leukaemia

Uncommon (affects less than 1 in 100 people)

• in women, periods may stop and fertility may be affected and menopause may start early - with usual doses of Busulfan

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

• a severe drop in red blood cells which can cause tiredness, weakness, bruising and make you more likely to get infections – called aplastic anaemia
• fits or seizures - with high doses of Busulfan
• cataracts or other eye problems - after bone marrow transplantation and with high doses of Busulfan
• feeling or being sick (nausea or vomiting), diarrhoea and mouth ulcers - with usual doses of Busulfan. This can be improved by splitting the dose through the day
• jaundice (yellowing of the whites of eyes or skin) and liver damage - with usual doses of Busulfan
• hair loss (with normal doses of Busulfan)
• dry mouth and lips or other skin changes including very dry skin, itching or rash

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

• muscle weakness commonly leading to drooping eye lids and difficulty in speaking or using your arms and legs – called Myasthenia gravis
• enlargement of breasts in men
• weakness, feeling very tired, weight loss, feeling sick, being sick and dark skin patches – which resembles Addison’s disease (but with the adrenal glands working correctly)

Not known (frequency cannot be estimated from the available data)

• Incomplete development of teeth

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:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The active ingredient is busulfan. Each Busulfan tablet contains 2 mg of busulfan.

The other ingredients are lactose anhydrous, pregelatinised starch, magnesium stearate, hypromellose, titanium dioxide (E171) and triacetin.

Busulfan tablets are white, film-coated tablets and are marked with ‘GX EF3’ on one side and 'M' on the other. Your Busulfan tablets are in bottles of 25 or 100 tablets.

Marketing Authorisation holder:

Manufacturer: