Thioprine 50
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
THIOPRINE 50
azathioprine film-coated tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Thioprine 50. 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 risks of you taking this medicine against the benefits they expect it will 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 Thioprine 50 is used for
Thioprine 50 contains azathioprine as the active ingredient. Azathioprine belongs to a group of medicines called immunosuppressants.
This medicine is used to help prevent the rejection of a transplanted organ such as a kidney, liver or heart. It works by suppressing the body’s immune defence system.
Thioprine 50 can also be used to treat other diseases called autoimmune diseases where your immune system is reacting against your own body.
These may include:
severe rheumatoid arthritis
systemic lupus erythematosus (SLE)
chronic active hepatitis
certain skin, muscle and blood diseases.
Thioprine 50 is usually taken in combination with other medicines such as corticosteroids or other immunosuppressive drugs.
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 not addictive.
This medicine is available only with a doctor’s prescription.
Before you take Thioprine 50
When you must not take it
Do not take this medicine if you have an allergy to:
azathioprine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
any other similar medicines such as 6-mercaptopurine (Puri-Nethol®).
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine if you have been previously treated with alkylating agents (such as chlorambucil, melphalan or cyclophosphamide) for rheumatoid arthritis.
Do not take this medicine if you are pregnant, may be pregnant, intend to become pregnant or to father a child.
It may cause birth defects if either the male or female is taking it at the time of conception. It may also affect your developing baby if you take it during pregnancy. You and your partner should take adequate contraceptive precautions while you are taking Thioprine 50.
Do not take this medicine if you are breastfeeding unless you and your doctor have discussed the risks and benefits involved.
It is not recommended for use while breastfeeding as it may cause serious side effects to your baby.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
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.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney disease
liver disease
spleen disorder
a history of chickenpox or shingles
hepatitis B
a condition where your body produces too little of the natural chemical called thiopurine methyltransferase (TPMT)
Lesch-Nyhan syndrome
any other medical conditions.
Tell your doctor if you have recently been vaccinated or immunised, or plan to do so.
Thioprine 50 may affect the way the vaccine works or your reaction to the vaccine.
Tell your doctor if you are pregnant, may be pregnant, plan to become pregnant or intending to father a child.
You or your partner should take adequate contraceptive precautions while you are taking Thioprine 50.
Tell your doctor if you are breastfeeding or planning to breastfeed.
Thioprine 50 is not recommended for use while breastfeeding as it may cause serious side effects to your baby.
Tell your dentist that you are taking Azathioprine.
Dental work, whenever possible, should be completed before you start taking Thioprine 50 or delayed until your blood cell counts are normal.
If you have not told your doctor about any of the above, tell him/her before you start taking Thioprine 50.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Thioprine 50 may interfere with each other. These include:
penicillamine, a medicine used to treat rheumatoid arthritis
captopril, a medicine used to treat high blood pressure and heart failure
cimetidine, a medicine used to treat stomach ulcers and indigestion
indomethacin, used as painkiller and anti-inflammatory
co-trimoxazole and erythromycin, medicines used to treat bacterial infections
allopurinol, oxipurinol or thiopurinol, medicines used to treat gout
succinylcholine or tubocurarine, medicines used to relax muscles during surgery
frusemide, a diuretic medicine
warfarin, a medicine used to prevent blood clots
aminosalicylates such as sulfasalazine, mesalazine and olsalazine, medicines used to treat inflammation of the bowel
phenytoin and phenobarbital, medicines used to treat epilepsy
rifampicin, a medicine used to treat tuberculosis
ketoconazole, a medicine used to treat fungal infections
methotrexate, used in the treatment of cancer
ribavirin, used to treat a type of respiratory infection.
These medicines may be affected by Thioprine 50 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 have more information on medicines to be careful with or avoid while taking this medicine.
How to take Thioprine 50
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Thioprine 50 may not work as well and your problem may not improve.
Your dose will depend on your body weight and how you respond to the medicine. Your doctor will determine the right dose for you. Your doctor may change the number of tablets you need to take, particularly at the beginning of treatment.
How to take it
Swallow the tablets whole with a full glass of water.
Do not break, chew or crush the tablets.
When to take it
Take your medicine at about the same time each day, preferably after a meal.
Taking it at the same time each day will help you remember when to take it. Take it at least one hour before or three hours after food or milk.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Your doctor will discuss with you for how long you need to take your medicine. It could take some weeks or months for Thioprine 50 to take full effect.
Transplant patients will need to take Thioprine 50 continuously to reduce the risk of organ rejection.
If you forget to take it
Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
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 (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Thioprine 50. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking Thioprine 50
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Thioprine 50.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, including any dental work, tell the surgeon, anaesthetist or dentist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, are trying to become pregnant or planning to father a child, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may order regular blood tests to make sure the medicine is working and to prevent unwanted side effects.
Tell your doctor if you plan to have any immunisations or vaccinations.
If you come into contact with anyone who is suffering from chickenpox or shingles, tell your doctor immediately.
Always protect yourself from the sun while you are taking Thioprine 50.
If you go out in the sun, wear a hat, protective clothing and use sunscreen.
Tell your doctor immediately if you notice any new moles or changes in existing moles, any lumps on your body, or if you feel unwell.
Thioprine 50 lowers your body’s immune system and may increase your risk of skin and other cancers while you are taking this medicine.
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 take Thioprine 50 to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
Your doctor may want you to gradually reduce the amount you are taking before stopping completely.
Do not break, chew or crush the tablets.
Things to be careful of
Be careful driving or operating machinery until you know how Thioprine 50 affects you.
This medicine may cause dizziness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness may be worse.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Thioprine 50.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist immediately if you notice any of the following:
any infection or fever
unexpected bruising or bleeding
new marks on skin or any change to marks that may have been there previously
headache, stiff neck and extreme sensitivity to bright light
nausea and vomiting
tiredness, dizziness or generally unwell
irregular heart beat
you come into contact with anyone who is suffering from chickenpox or shingles
sores in the mouth and on the lips
feeling of ants creeping in or under the skin
changes in sense of smell or taste
black tarry stools or blood in the urine or stools
Azathioprine could cause your hepatitis B to become active again.
Side effects reported particularly in organ transplant patients are:
viral, fungal and bacterial infections
hair loss (particularly following a kidney transplant)
diarrhoea, usually with blood and mucus
stomach pain with fever and vomiting.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
allergic type reactions e.g. skin rash, itching and difficulty breathing, wheezing or coughing
muscle weakness, with or without a skin rash
muscle pain or stiffness
severe joint pain
kidney problems
feeling faint especially when standing up
severe abdominal pain
diarrhoea
yellowing of the skin and/or eyes (jaundice)
serious skin reactions such as blistering or peeling
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell even if you think the problems are not connected with this medicine and are not referred to in this leaflet.
Other side effects not listed above may also occur in some people.
Some side effects, such as low blood cell count, can only be found when your doctor does tests from time to time to check your progress.
Do not be alarmed by this list of possible side-effects.
You may not experience any of them.
After taking Thioprine 50
Storage
Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Thioprine 50 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 tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Thioprine 50 50 mg – round, biconvex white to yellowish-white film-coated tablets, with one-sided breaking notch.
Available in blisters of 100 tablets.
Ingredients
Active ingredients:
Thioprine 50 – 50 mg azathioprine.
Inactive ingredients:
lactose monohydrate
maize starch
povidone
colloidal anhydrous silica
magnesium stearate
hypromellose
microcrystalline cellulose
PEG-8 stearate
purified talc
titanium dioxide.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Supplier
Alphapharm Pty Ltd (A Mylan Company)
Level 1, 30 The Bond
30 – 34 Hickson Road
Millers Point NSW 2000
Australia
This leaflet was prepared in October 2018.
Australian Register Number
50 mg film-coated tablets: AUST R 221962
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