Consumer Medicine Information
What is in this leaflet?
Please read this leaflet carefully before you start Myleran tablets.
This leaflet answers some common questions about Myleran tablets. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Myleran tablets against the benefits this medicine is expected to have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Myleran tablets are used for Myleran belongs to a group of medicines called cytotoxics. It is used to treat certain blood disorders. Myleran works by reducing the amount of certain types of blood cells in your body. Your doctor may have prescribed Myleran for another reason. Ask your doctor if you have any questions about why Myleran has been prescribed for you. Myleran is not addictive. Before you take Myleran When you must not take it
Do not take Myleran if you have ever had an allergic reaction to busulphan or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.
Unless your doctor says you should, do not take Myleran if you are pregnant, trying to become pregnant, breastfeeding or likely to father a child.
Myleran may harm the sperm, eggs and/or baby so reliable contraceptive methods MUST be taken to avoid pregnancy whilst you or your partner are taking these tablets.
Your doctor will discuss the risks and benefits of using Myleran if you are pregnant or breastfeeding
Do not take Myleran after the expiry date (EXP) printed on the pack.
If you take it after the expiry date has passed, it may not work as well.
Do not take Myleran if the packaging is torn or shows signs of tampering.
If you're not sure whether you should be taking Myleran, talk to your doctor. Before you start to take it
You must tell your doctor if:
You have recently received, or are receiving, radiotherapy
You have recently been vaccinated, or are planning to be vaccinated
You are taking, or likely to be taking phenytoin, itraconazole, thioguanine or other cytotoxic drugs
You suffer from liver or kidney disease
You are planning, or likely to have surgery
You are allergic to foods, dyes, preservatives or any other medicines.
You suffer from gout
Make sure that your doctor is aware of any of the above before you start taking Myleran tablets.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking Myleran with other medicines. Use in children
Do not use Myleran in children unless your doctor tells you to.
How to take Myleran The Pharmacist's label on the pack will tell you how to take Myleran. If there is something you do not understand, ask your doctor or pharmacist. How much to take
The dosage is very variable and it may be changed from time to time by your doctor. If you are unsure or the dosage on the label has changed for no apparent reason, ask your doctor.
From time to time while you are taking Myleran, your doctor will want you to have a blood test. This is to check your blood cell count and to change your dose if necessary. How to take it
Swallow your tablets whole with water. Do not break, crush or chew the tablets.
It is helpful to drink extra fluids while taking Myleran to help keep your kidneys working well. When to take it
It is important to take your medicine at the right times. The pharmacist's label on the 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 or pharmacist.
It is best to take the tablets at the same time each day. How long to take it
It is important to take your Myleran tablets until your doctor tells you to stop.
If you forget to take it
If you forget to take a dose tell your doctor.
Do not take a double dose to make up for the dose that you missed. If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you taken too much Myleran, or if someone else takes your medicine by mistake, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy. If you are not sure what to do, contact your doctor. While you are taking Myleran Things you must do
It is important that you visit your doctor regularly, so your doctor can check your progress and make sure your medicine is working.
Tell your doctor or pharmacist that you are taking Myleran if you are about to be started on any new medicines, immunisations, vaccinations or radiotherapy. Tell your doctor if you become pregnant, are trying to become pregnant, or trying to father a child. Tell your doctor that you are taking Myleran tablets if you need surgery. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily. Things you must not do
Do not stop taking Myleran, or change the dose without first checking with your doctor.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours. Do not use Myleran to treat any other complaints unless your doctor says to. Things to be careful of
Be careful driving or operating machinery until you know how Myleran affects you.
Myleran generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Myleran may cause dizziness/drowsiness/tiredness in some people. Side-Effects Check with your doctor as soon as possible if you have any problems while taking Myleran, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like other medicines, Myleran can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
In women, periods may stop.
In men, sperm production may be reduced or stop
In girls, the onset of puberty may be delayed or stop.
Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor immediately if any of the following happen to you while you are taking Myleran:
If you feel sick, vomit, develop diarrhoea or mouth ulcers.
If you notice any signs of jaundice (yellowing of the whites of the eyes or the skin).
If you start to lose weight, feel weaker or more tired than usual.
If you notice any signs of a skin rash, excessive skin dryness or itching, darker areas of skin pigmentation, or hair loss,
Effects on the blood may occur. Your doctor will do regular blood tests, but you should tell him at once if you notice any signs of fever or infection such as cystitis.
If you have any unexpected bruising or bleeding or signs of blood in your urine.
If you have a fit or convulsion.
If you become breathless and are known to have thalassaemia.
If you develop a persistent cough or breathlessness.
If you notice any weakness of your muscles.
If you have any problems with your eyesight.
If you are a man and you experience breast tenderness and/or breast enlargement.
Tell your pharmacist or doctor if you notice any other symptoms or discomfort which are not mentioned here. If you think you are having an allergic reaction to Myleran, TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital. Symptoms usually include some or all of the following:
swelling of the lips/mouth
difficulty in breathing
lumpy rash ("hives")
This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Because of the way this medicine works there is a chance it might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukaemia. Discuss these possible effects with your doctor. Ask your doctor or pharmacist if you don't understand anything in this list. Do not be alarmed by this list of possible side-effects. You may not experience any of them. After taking Myleran Storage
Keep this medicine where young children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines. Keep Myleran tablets in a cool, dry place where it stays below 25 °C. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Keep your Myleran in its pack until it is time to take it. If you take Myleran out of its pack it may not keep well. Disposal
If your doctor tells you to stop taking Myleran, or Myleran has passed its expiry date, ask your pharmacist what to do with any tablets left over.
Product description What Myleran looks like
Myleran tablets are white, film-coated, round and engraved "GX EF3"on one side and "M" on the other.
Myleran tablets are supplied in amber glass bottles with a child resistant closure containing 100 tablets. Ingredients
Myleran contains the active ingredient busulfan. Myleran also contains anhydrous lactose, pregelatinised starch, magnesium stearate, hypromellose, titanium dioxide and triacetin.
Your Myleran Tablets are supplied by:
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia Victoria 3155
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.
Do not throw this leaflet away.
You may need to read it again.
This leaflet was prepared on 11 December 2006. The information provided applies only to: Myleran ®. ® Myleran is a registered trade mark of the GlaxoSmithKline group of companies. Myleran Tablets 2mg: AUSTR 68028 © 2006 GlaxoSmithKline (Myleran Issue No. 6)