THIOPRINE

Main information

  • Trade name:
  • THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221962
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221962

THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

24/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

5/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which

influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing

the toxicity associated with high dosage and prolonged usage of corticosteroids. Azathioprine, in combination with corticosteroids and/or other

immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. Azathioprine, either alone or more

usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or

discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus,

dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic

refractory idiopathic thrombocytopenic purpura.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PP/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

100 tablets

(S4) Prescription Only Medicine

Components

1. THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Round, biconvex white to yellowish white film-coated tablets, with one-sided

breaking notch.

Active Ingredients

Azathioprine

50 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:18:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

AZATHIOPRINE ALPHAPHARM

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

This medicine is used to prevent the

body from rejecting transplanted

organs.

Thioprine 50 can also be used to treat

diseases involving the body's

immune defence system such as:

severe rheumatoid arthritis

systemic lupus erythematosus

(SLE)

chronic active hepatitis

certain skin, muscle and blood

diseases.

It contains the active ingredient

azathioprine.

Azathioprine belongs to a group of

medicines called

immunosuppressants.

It works by reducing the body's own

natural immunity.

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 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 breastfeed if you are taking

this medicine.

The active ingredient in Thioprine 50

passes into breast milk and there is a

possibility that your baby may be

affected.

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

THIOPRINE 50

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

currently having or planning to

have dental treatment.

Any dental work should be done

before treatment with Thioprine 50 is

started 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:

allopurinol, oxypurinol or

thiopurinol, medicines used to

treat gout

succinylcholine or tubocurarine,

medicines used to relax muscles

during surgery

other medicines used to suppress

the body's immune defence

system

warfarin, a medicine used to

prevent blood clots

aminosalicylates such as

sulfasalazine, mesalazine and

olsalazine, medicines used to treat

inflammation of the bowel

cimetidine, a medicine used to

treat heartburn or stomach ulcers

penicillamine, a medicine used to

treat rheumatoid arthritis

co-trimoxazole and erythromycin,

medicines used to treat bacterial

infections

rifampicin, a medicine used to

treat tuberculosis

ketoconazole, a medicine used to

treat fungal infections

indomethacin, a non-steroidal

anti-inflammatory drug

frusemide, a diuretic medicine

phenytoin and phenobarbital,

medicines used to treat epilepsy

methotrexate, used in the

treatment of cancer

ribavirin, used to treat a type of

respiratory infection

captopril, a medicine used to treat

high blood pressure.

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.

These tablets have a special coating

to stop them dissolving until they

have gone through the stomach and

into the intestines, where they can

start to work. If you break, chew or

crush them, the coating is destroyed.

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. If you

take it on an empty stomach, it may

increase the likelihood of vomiting,

nausea (feeling sick) and stomach

upsets.

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.

THIOPRINE 50

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.

Wear sunscreen, a hat and protective

clothing.

Tell your doctor immediately if

you notice any lumps on your

body, any new moles or changes in

existing moles 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 if

you notice any of the following and

they worry you:

sores in the mouth and on the lips

feeling of pins and needles

changes in smell or taste

dizziness or feeling faint

tiredness and generally feeling

unwell.

Tell your doctor or pharmacist

immediately if you notice any of

the following:

THIOPRINE 50

any infection or fever

unexpected bruising or bleeding

black tarry stools or blood in the

urine or stools

nausea, vomiting or diarrhoea

stomach discomfort or severe

abdominal pain

muscle weakness, tenderness,

pain or stiffness

severe joint pain

yellowing of the skin and/or eyes

(jaundice)

irregular heart beat

coughing, difficulty breathing and

wheezing

new marks on skin or any change

to marks that may have been

there previously

feeling of ants creeping in or

under the skin

headache, stiff neck and extreme

sensitivity to bright light.

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), which is

reversible in most cases

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:

swelling of the face, lips, mouth

or throat which may cause

difficulty in swallowing or

breathing

rash, itching or hives on the skin

shortness of breath or wheezing

fainting.

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.

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.

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 50mg - white to

yellowish white, round, biconvex,

film-coated tablets with a one-sided

score notch.

Available in blisters of 100 tablets.

Ingredients

Active ingredients:

Thioprine 50 - 50mg

azathioprine.

Inactive ingredients:

lactose monohydrate

starch - maize

povidone

silica - colloidal anhydrous

magnesium stearate

hypromellose

cellulose - microcrystalline

PEG-8 stearate

talc -purified

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 August

2016.

Australian Register Number

50mg film-coated tablets: AUST R

221962