Consumer Medicine Information

IMURAN™

Azathioprine tablets 50mg, injection 50mg

What is in this leaflet

Please read this leaflet carefully before you start taking IMURAN tablets or receiving IMURAN injections.

This leaflet answers some common questions about IMURAN. It does not contain all 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 expected benefits of you taking IMURAN against the risks this medicine could have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What IMURAN is used for

IMURAN contains the active ingredient azathioprine.

IMURAN belongs to a group of medicines called immunosuppressive antimetabolites. IMURAN is used to suppress the immune system and prevent rejection of transplanted organs, most often the heart, kidney and liver. It is also used to treat diseases where the immune system does not recognise certain types of normal healthy body tissue and tries to destroy them. They include:

• Severe rheumatoid arthritis
• Systemic lupus erythematosus
• Dermatomyositis and polymyositis
• Autoimmune chronic active hepatitis
• Pemphigus vulgaris
• Polyarteritis nodosa
• Autoimmune haemolytic anaemia
• Chronic refractory idiopathic thrombocytopenic purpura
• Ulcerative colitis
• Crohn's disease

IMURAN is often used to treat the above diseases when they have not responded well to anti-inflammatory medicines called corticosteroids. IMURAN can boost the effects of these medicines, often allowing lower corticosteroid doses to be used. In some people corticosteroids can be replaced by IMURAN.

Your doctor may have prescribed IMURAN for another purpose.

Ask your doctor if you have any questions about why IMURAN has been prescribed for you.

IMURAN is available only with a doctor's prescription.

Before you take IMURAN

When you must not take it

Do not take IMURAN if:

• You have had an allergic reaction to azathioprine before or to any of the ingredients in IMURAN listed at the end of this leaflet.
• You have ever had an allergic reaction to a medicine called mercaptopurine (Puri-Nethol™).
• The package is torn or shows signs of interference. If you are taking tablets, they should not be discoloured or damaged. If you are being given the injection, it should not be discoloured or cloudy.
• The expiry date on the tablet or injection packaging has passed. If you take this medicine after the expiry date has passed, it may not work as well. If the pharmacist has repacked the medicine, there may not be an expiry date on the pack.
• You are pregnant or likely to become pregnant in the near future.

Before you start taking IMURAN

Tell your doctor if:

• You are pregnant or plan to become pregnant.
  
  IMURAN may be harmful to an unborn baby when taken by a pregnant woman. You should avoid becoming pregnant while taking IMURAN.
  If you are already pregnant, your doctor will weigh up the expected benefits of IMURAN to you against the possible risks to your unborn baby.
  
• You are breastfeeding or planning to breastfeed.
  
  The active ingredient in IMURAN, azathioprine, may pass into breast milk, so mothers taking IMURAN should not breastfeed.
  
• You have any other health problems, especially:
  
  • Liver disease
  • Kidney disease
• You are allergic to any other medicines, foods, dyes or preservatives.
  
• You have one of the following rare enzyme disorders:
  
  • Thiopurine methyltransferase (TPMT) deficiency
  • Lesch-Nyhan syndrome

If you have not told your doctor about any of the above, please do so before taking IMURAN.

Taking other medicines

Some medicines may affect the way others work.

Tell your doctor if you are taking any other medicines, including the oral contraceptive pill or medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

If you are taking any of the following medicines, please let your doctor know before starting treatment with IMURAN:

• Drugs used to treat gout, such as allopurinol (Zyloprim™, Z300™, Apo-Allopurinol™, Allorin™, Progout™)
• Nerve blockers/muscle relaxants
• Warfarin anticoagulants (Marevan™, Coumadin™) to thin the blood
• Medicines used to treat cancer, such as D-penicillamine (D-Penamine™)
• Drugs known as ACE inhibitors, such as captopril (Capoten™), used to lower blood pressure
• An antibiotic called co-trimoxazole (Bactrim™, Septrin™, Trimel™, Trisul™)
• Cimetidine (Apo-Cimetidine™, Cytine™, Duomet™, Tagamet™), used for stomach ulcers and heartburn
• A non-steroidal anti-inflammatory drug called indomethacin (Arthrexin™, Indocid™, Indocid-R™, Rheumacin™, Rheumacin-R™)
• Some drugs used to treat rheumatoid arthritis, including olsalazine (Dipentum™), mesalazine (Pentasa™, Asacol™), sulphasalazine (Colizine™, Colizine E™, Salazopyrin, Salazopyrin-EN™)
• Frusemide (Apo-Frusemide™, Diurin™, Frusid™, Frusid Forte™, Lasix™), a drug used to lower blood pressure

If you are planning to have a vaccination of any sort, please discuss this with your doctor or pharmacist first.

Your doctor will be able to tell you more about what to do when taking IMURAN with other medicines.

Taking IMURAN

How much to take

The amount of azathioprine, the active ingredient in IMURAN, contained in one tablet is the same as in one injection (50mg).

Your doctor may have prescribed IMURAN for you to be given by injection or as tablets to swallow.

IMURAN injection will only be given if you are too sick to swallow tablets e.g. while you are in hospital recovering after an organ transplant. As soon as you are well enough, you will be switched to IMURAN tablets.

If you are taking IMURAN tablets, your doctor will tell you how many tablets to take each day.

Never take more IMURAN tablets than your doctor has prescribed.

Your doctor will calculate your IMURAN dose based on your weight and the condition you are receiving IMURAN for. Your doctor will then adjust your IMURAN dose depending on how you respond to this medicine. If you have liver or kidney problems, your doctor may decide to reduce your IMURAN dose.

IMURAN is usually given in doses ranging from 1mg to 6mg per kilogram of body weight daily. Treatment with IMURAN may be long term for some conditions.

Doses based on body weight in children are similar to those used in adults. A reduced dose is often needed in the elderly who may be more sensitive to IMURAN and are more likely to get its side effects.

Your doctor may do regular blood tests to make sure that IMURAN is working safely and effectively for you.

How to take it

If you have been prescribed tablets, swallow them whole once daily with a glass of water, preferably after food.

If you are receiving IMURAN by injection, it will be given to you by a doctor or nurse in hospital.

If you forget to take it

Do not take an extra dose. Wait until the next dose and take your normal dose then.

Do not try to make up for the dose that you missed by taking more than one dose at a time.

If you are not sure what to do, ask your doctor or pharmacist.

In case of an overdose

Immediately telephone your doctor or the National Poisons Information Centre [Ph (03) 474-7000] for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much IMURAN. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep phone numbers for these places handy.

Too much IMURAN may cause nausea, vomiting and diarrhoea, followed later by abnormal liver function and a reduction in the number of white cells in your blood.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking IMURAN

Things you must do

Tell all doctors, dentists and pharmacists treating you that you are taking IMURAN.

Tell your doctor if you become pregnant while taking IMURAN.

Tell your doctor if, for any reason, you have not taken IMURAN exactly as prescribed if you have been given tablets. Otherwise, your doctor may think they are not working for you and change your IMURAN dose unnecessarily.

Tell your doctor if you get an infection or you have experienced bleeding or bruising unexpectedly. This could be a sign that your bone marrow is not functioning properly.

Tell your doctor if you feel that IMURAN is not helping your condition.

You should use reliable contraception when taking IMURAN, whether you are male or female. Discuss this with your doctor if you need more information.

Things you must not do

Do not stop taking IMURAN or change the dose without first checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not give IMURAN to anyone else even if they appear to have the same condition as you.

Do not take any other medicines whether they require a prescription or not without first asking your doctor or a pharmacist.

Do not drive or operate machinery until you know how IMURAN affects you.

Side-Effects

All medicines can have unwanted side effects. Sometimes they may be serious, but often they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Be sure that your doctor or pharmacist knows as soon as possible if you do not feel well while you are taking IMURAN.

If you think IMURAN is causing you to have an allergic (hypersensitivity) reaction, TELL YOUR DOCTOR IMMEDIATELY. Symptoms include:

• Diarrhoea
• Nausea (feeling as if you are about to vomit), vomiting
• Dizziness
• Fever
• Shivering
• Skin rash
• Sore muscles
• Sore joints
• Low blood pressure (feeling dizzy and faint)
• Difficulty passing urine
• Tiredness

Also tell your doctor if you notice any of the following:

• Stomach upset and pain including nausea (feeling as if you are about to vomit), vomiting and severe diarrhoea, caused by colitis (an inflammation of the gut)
• Weakness/fatigue
• Unusual bleeding/bruising
• Jaundice (yellowing of the skin/eyes) caused by hepatic veno-occclusive disease (a liver problem)
• Rash
• Fever/chills
• Breathing difficulties
• Susceptibility to infection
• Hair loss

Your doctor can prescribe helpful medication for many of the above side effects.

Your doctor may also recommend that you change your dose of IMURAN if you experience any of these side effects.

This is not a complete list of all possible side effects.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you do not understand anything on this list.

Do not be alarmed by the above list of possible side effects. Many of them are uncommon. You might not experience any of them.

After taking IMURAN

Storage

IMURAN for injection is stored in a hospital ward or pharmacy.

If you are taking IMURAN tablets, keep them in their bottle until it is time to take them.

If you take the tablets out of the bottle they may not keep well.

Keep IMURAN tablets in a cool dry place where the temperature stays below 30°C.

Do not store it, or take any other medicine, in a bathroom or near a sink.

Do not leave it in a car or on a windowsill.

Heat and dampness can destroy some medicines.

Keep IMURAN 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.

Disposal

If your doctor tells you to stop taking IMURAN, or the medicine has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What IMURAN looks like

• IMURAN 50mg tablets are round and yellow. They are engraved with WELLCOME K7A on one side and are unmarked on the other side.
• IMURAN 50mg injection is made up from a yellow to brownish freeze-dried powder contained in a colourless glass vial.

Ingredients

IMURAN tablets
Azathioprine, Lactose, Starch, Stearic acid, Magnesium stearate, Methylhydroxypropylcellulose

IMURAN injection
Azathioprine, Sodium hydroxide

Further information

Your doctor is the best person to give you advice on the treatment of your illness. You may also be able to find general information about its treatment from other sources, for example, from books in public libraries and on the Internet.

Manufacturer

IMURAN is supplied by:

GlaxoWellcome (New Zealand) Ltd
Quay Tower
Cnr Albert & Customs Sts
Private Bag 106600
Downtown, Auckland
NEW ZEALAND

Ph (09) 367-2900
Fax (09) 367-2910

This leaflet was prepared in October 2000, Issue 1. It is copyrighted to GlaxoWellcome (New Zealand) Ltd and may be reproduced but not altered in any way.

IMURAN is a trademark of the GlaxoWellcome Group of Companies.