Contains the active ingredient, azathioprine (ay-za-THYE-oh-preen)
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What azathioprine is used for
The name of your medicine is GenRx Azathioprine. It contains the active ingredient, azathioprine.
It is used to:
help prevent the body from rejecting transplanted organs (e.g. a heart or kidney)
suppress the body's immune system to treat "autoimmune" conditions like rheumatoid arthritis, and SLE (systemic lupus erythematosus)
treat certain skin, muscle and blood disorders.
How it works
This medicine belongs to a group of medicines called immunosuppressants.
It works by reducing the body's immune responses.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
There is no known evidence to show that this medicine is addictive.
Use in children
There is not enough information to recommend the use of this medicine in children.
Before you take azathioprine
When you must not take it
Do not take this medicine if you have had an allergic reaction to azathioprine, similar medicines such as mercaptopurine or 6-mercaptopurine or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin or fainting.
Do not take this medicine if you are pregnant or intend to become pregnant in the near future.
Azathioprine may affect your developing baby if you take it during pregnancy.
Males: tell your doctor if your partner intends to become pregnant while you are taking GenRx Azathioprine or shortly after you have stopped treatment with GenRx Azathioprine.
Azathioprine may cause birth defects or other complications if either the male or female is taking it at the time of conception.
It is recommended that you use some kind of birth control while you are taking this medicine and for at least 12 weeks after you stop taking it. Your doctor will discuss this with you.
Do not take azathioprine if you have in the past taken medicines called alkylating agents for your rheumatoid arthritis. Examples of alkylating agents include chlorambucil, melphalan and cyclophosphamide).
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
kidney or liver disease
problems with your spleen
a disease affecting the muscles called myasthenia gravis
Crohn's Disease or Ulcerative Colitis
Chicken pox or shingles
Enzyme deficiencies such as Lesch-Nyhan Syndrome or TPMT (thiopurine methyltransferase) deficiency.
3. You have recently been vaccinated or you plan to be vaccinated.
4. You are currently receiving or are planning to receive dental treatment.
5. You are planning to have an operation.
6. You are pregnant or planning to become pregnant.
7. You are breast-feeding or plan to breast-feed.
Taking azathioprine is not recommended whilst breast-feeding. This is because azathioprine passes into breast milk and there is a possibility that your baby may be affected.
Discuss the risks and benefits of breast-feeding whilst taking azathioprine with your doctor.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and azathioprine may interfere with each other. These include:
allopurinol, oxypurinol and thiopurinol, medicines used for gout
warfarin, a medicine used to prevent blood clots
mercaptopurine and cyclophosphamide, used to treat auto immune disorders, certain cancers and to prevent organ rejection
chlorambucil, melphalan and other medicines used to treat cancer
other immunosuppressants such as cyclosporin, and corticosteroids (e.g. dexamethasone, prednisolone) which may sometimes be prescribed by your doctor to add to the effects of azathioprine
penicillamine, a medicine used for rheumatoid arthritis
sulphasalazine, mesalazine or olsalazine, medicines used to treat rheumatoid arthritis, ulcerative colitis or Crohn's disease
medicines used to treat infections such as co-trimoxazole, erythromycin, ketoconazole and rifampicin
some medicines used to treat epilepsy such as phenytoin and phenobarbitone
indomethacin, a medicine used for pain and inflammation
cimetidine, a medicine used for stomach ulcers and reflux
captopril and frusemide, medicines used for the heart or high blood pressure
vaccines
medicines called neuromuscular blocking agents, used by anaesthetists during operations. Examples include tubocurarine and succinycholine.
These medicines may be affected by azathioprine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking azathioprine.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Take GenRx Azathioprine tablets only as directed by your doctor.
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition, your body weight, other medical conditions you may have and whether or not you are taking any other medicines.
How to take it
Swallow the tablets whole with a full glass of water. Do not break, crush or chew the tablets.
Do not handle broken or damaged tablets. Provided that the film coating is undamaged, there is no risk in handling film-coated azathioprine tablets.
When to take it
Take it at about the same time each day.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
Take this medicine with or immediately after food.
GenRx Azathioprine tablets may sometimes cause mild nausea and/or vomiting. This may be prevented by taking them on a full stomach.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Your doctor will discuss with you how long you need to take azathioprine tablets. You could have to take GenRx Azathioprine for some weeks or months before you receive the full effects.
People who are taking azathioprine because they have had an organ transplant will need to take it continuously to reduce the risk of the body rejecting the transplanted organ.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much azathioprine.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much azathioprine, you may get an unexpected infection, ulcers in the throat, and bruising and bleeding.
While you are taking azathioprine
Things you must do
Tell your doctor immediately if you get an infection, unexpected bruising or bleeding, black tarry stools or blood in the urine.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking GenRx Azathioprine.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking azathioprine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
Tell your doctor immediately if you or your partner becomes pregnant.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will perform blood tests every week for the first eight weeks, then at least once a month after that, while you are taking azathioprine. He will do this to make sure the medicine is working and to watch for unwanted side effects.
Tell your doctor if you plan to have any vaccinations or immunisations.
Avoid contact with any person in your household who has had an oral polio vaccine recently.
Try to avoid contact with people who have infectious diseases (such as the 'flu).
Avoid contact with any person who has chickenpox or shingles (herpes zoster), particularly if you have never had chickenpox.
Tell your doctor immediately if you do come into contact with someone who has chickenpox or shingles.
Avoid contact sports or other situations where bruising or injury may occur. Be careful to avoid cutting yourself with sharp objects (e.g. razors).
Protect your skin when you are in the sun, especially between 10am and 3pm. If outdoors, wear protective clothing and use at least a 15+ sunscreen.
Azathioprine suppresses your immune system. Lowering your body's immune defence system increases your risk of skin cancer, cervical cancer, lymphoma and other cancers.
Tell your doctor if you notice any new moles or changes in existing moles.
Tell your doctor if you notice any lumps anywhere in your body or if you feel unwell.
If you are female, tell your doctor if you notice unusual vaginal discharge or bleeding, and make sure to have regular Pap smears.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how azathioprine affects you.
This medicine may cause dizziness and tiredness in some people. If you have any of these symptoms, do not drive, or operate machinery or do anything else that is dangerous.
Side effects of azathioprine
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking azathioprine.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
hair loss (common in kidney transplant patients) - usually reversible
feelings of pins and needles or feeling of ants creeping in or under the skin
change in sense of smell or taste
mild nausea, vomiting and/or diarrhoea.
aching, tender or stiff muscles
sores in the mouth and on the lips
mild skin rash, redness
tiredness and generally feeling unwell
fatty stools.
The above list includes the more common side effects. Mostly, these are mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
headache, dizziness or feeling faint
new moles or changes in existing moles
lumps anywhere in your body
unusual vaginal discharge or bleeding
a worsening of the symptoms of myasthenia gravis (drooping eyes, speech or swallowing problems, weak muscles)
dry cough
any infection (fever chills, shivering, sore throat, spots, mouth ulcers or fungal infections)
unexpected bruising or bleeding, purplish blue spots under the skin
black tarry stools or blood in the urine or stools
severe joint pain
muscle weakness, with or without a skin rash
yellow discoloration of the skin/eyes, pale fatty stools, dark coloured urine and itching all over
tiredness, being short of breath when exercising, feeling dizzy and looking pale
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
If any of the following happen, do not take any more of your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
Symptoms of an allergic reaction, such as cough, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, hay fever, rash, itching or hives on the skin, fainting
diarrhoea with blood and mucous
passing little or no urine, together with drowsiness, nausea and vomiting
severe stomach or severe upper stomach pain, with or without fever, nausea or vomiting
fever, headache, vomiting, stiff neck and extreme sensitivity to bright light
irregular heart beat
a severe skin condition with flaking skin and blisters and blisters or bleeding in the lips, eyes, mouth, nose and/or genitals, sometimes preceded by flu- like symptoms.
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are usually very rare.
Other side effects not listed above may occur in some patients. Some of these side effects can only be found when your doctor does tests from time to time to check your progress (e.g. low blood cell count).
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30 degrees C. Protect them from light and moisture.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, speak to your pharmacist to arrange for safe disposal of any medicine that is left over.
Where to go for further information
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.
Product description
What it looks like
GenRx Azathioprine 50 mg tablets are round, pale yellow film-coated tablets, embossed with AZA, a break line, and 50 on one face. The other face is plain.
The tablets come in blister packs of 100.
Ingredients
Each tablet contains 50 mg of azathioprine as the active ingredient.
It also contains the following inactive ingredients:
microcrystalline cellulose
mannitol
povidone
maize starch
croscarmellose sodium
sodium stearyl fumarate
Opadry™ clear OY-7240 (macrogol 400 and hypromellose).
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
GenRx Azathioprine 50 mg tablets:
Blister packs:
AUST R 80923
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde, NSW 2113
Australia
GenRx is a registered trade mark of Apotex Pty Ltd.
This leaflet was last updated in:
May 2010.
