Myleran tablets 2 mg
busulfan
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 Myleran is and what it is used for
2 Before you take Myleran
3 How to take Myleran
4 Possible side effects
5 How to store Myleran
6 Further information
What Myleran is and what it is used for
Myleran tablets contain a medicine called busulfan. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Myleran is used for certain blood problems and cancers of the blood. It works by reducing the number of new blood cells your body makes.
Myleran is used for:
Chronic granulocytic leukaemia (also called chronic myeloid leukaemia) - a disease that increases the number of white blood cells. This can cause infections and bleeding
Polycythaemia vera a disease which increases the number of red cells in your blood. This makes the blood thicken and causes blood clots. This leads to headaches, dizziness and shortness of breath
Thrombocythaemia a disease which affects platelets (blood cells which help blood to clot). There may be an increase in platelets - which causes blood clots. Or the platelets do not work properly - which causes bleeding such as nose bleeds, bleeding gums and bruising easily
Myelofibrosis a disease where bone marrow (where blood cells are made) is replaced by scar (fibrous) tissue. This causes red and white blood cells to be made wrongly. This can cause tiredness, bloated stomach, bleeding, and bruising- Preparing you before haematopoietic progenitor cell transplantation. This is where blood cells growing in a healthy donor’s bone marrow are transferred to your bone marrow to help you produce healthy cells.
Ask your doctor if you would like more explanation about these diseases.
Before you take Myleran
Do not take Myleran if:
- You are allergic (hypersensitive) to busulfan or any of the other ingredients of Myleran tablets (See section 6: Further information)
- You have taken Myleran before and it did not work.
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Myleran.
Take special care with Myleran
Before you take Myleran, tell your doctor or pharmacist if:
- You have had radiotherapy, now or recently
- 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 Myleran.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Myleran.
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 any of the following:
- Other cytotoxic drugs (chemotherapy) - when used with Myleran 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) - Myleran 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 Myleran
- Cyclophosphamide (used for certain types of blood disorders) - if used with Myleran, it is best that your first cyclophosphamide dose is given 24 hours or longer after the last Myleran 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.
Pregnancy and breast-feeding
Do not take Myleran if you are planning to have a baby. This applies to both men and women. Myleran 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 Myleran.
Do not breast-feed while taking Myleran. Ask your doctor or midwife for advice.
How to take Myleran
Myleran should only be given to you by a specialist doctor who is experienced in treating blood problems.
Always take Myleran 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.
- Swallow your tablets whole with a glass of water.
Do not break, crush or chew the tablets.
The dose of Myleran depends on your blood problem or blood cancer (see section 1)
- Your doctor may also change your dose during your treatment, depending on your needs.
- The dose can sometimes be changed if you are over-weight.
- If you take a high-dose of Myleran, your doctor may also prescribe another medicine called a benzodiazepine. This will help to stop you having a fit.
- When you take Myleran 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.
Chronic granulocytic leukaemia (also called chronic myeloid leukaemia)
- The usual first dose is up to 4 mg, given as a single dose. Your doctor will then decide on the size of the next doses, based on your weight.
- The treatment is normally a course which lasts for 12 to 20 weeks. You may have more than one course of treatment.
- Some people have to take Myleran long term. If you have to take it long term, the usual dose is 0.5 mg to 2 mg each day. If your dose is less than 2 mg each day, your doctor might ask you to take tablets only on certain days. Follow your doctor’s instructions carefully.
- Chronic myeloid leukaemia is rare in children and there is no recommended dose of Myleran.
Polycythaemia vera
- 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 Myleran 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.
Myelofibrosis and essential thrombocythaemia
- The usual dose is 2 to 4 mg each day.
Haematopoietic progenitor cell transplantation
- 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 Myleran.
- 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.
- Adults - The usual dose is 1 mg per kilogram of your body weight.
If you take more Myleran than you should
If you take more Myleran 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 Myleran
Tell your doctor. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, Myleran 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).
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 Myleran
- yellowing of the whites of the eyes or skin (jaundice) and liver damage - with high doses of Myleran
- in women, periods may stop, fertility may be affected and the menopause may start early - with high doses of Myleran
- 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 Myleran.
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 Myleran)
- appearance of patches of dark skin
- signs of blood in your urine and pain when passing water (bladder inflammation) - with high doses of Myleran 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 Myleran.
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 Myleran
- cataracts or other eye problems - after bone marrow transplantation and with high doses of Myleran
- feeling or being sick (nausea or vomiting), diarrhoea and mouth ulcers - with usual doses of Myleran. 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 Myleran
- hair loss (with normal doses of Myleran)
- 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).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Myleran
- Keep out of the reach and sight of children.
- Do not use Myleran after the expiry date which is stated on the pack after ‘Exp’.
- Do not store your Myleran tablets above 25°C.
- If your doctor tells you to stop taking the tablets, it is important to return any which are left over to your pharmacist, who will destroy them according to disposal of dangerous substance guidelines. Only keep the tablets if your doctor tells you to.
Further information
What Myleran contains:
The active ingredient is busulfan. Each Myleran tablet contains 2 mg of busulfan. The other ingredients are anhydrous lactose, pregelatinised starch, magnesium stearate, hypromellose, titanium dioxide (E171) and triacetin.
What Myleran looks like and contents of the pack
Myleran tablets are white, film-coated tablets and are marked with ‘GX EF3’ on one side and ‘M’ on the other. Your Myleran tablets are in bottles of 25 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Manufacturer:
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0800 198 5000 (UK only)
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Product name: Myleran 2 mg Reference number: 00003/5112R
This is a service provided by the Royal National Institute of Blind People.
Leaflet date: September 2008
Myleran is a registered trademark of the GlaxoSmithKline group of companies
© 2008 GlaxoSmithKline group of companies
7037898-0144
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