IMAZAN azathioprine 25mg tablet blister pack

Main information

  • Trade name:
  • IMAZAN azathioprine 25mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IMAZAN azathioprine 25mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184923
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184923

IMAZAN azathioprine 25mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Eris Pharmaceuticals (Australia) Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

5/06/2012

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. IMAZAN azathioprine 25mg tablet blister pack

Product Type

Single Medicine Product

Effective date

17/11/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Azathioprine is used as an immunosuppressant/antimetabolite either alone or, more commonly, in combination with the 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 and chronic refractory idiopathic thromocytopenic purpura.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

1 Years

Store below 30

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

100 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A peach coloured, film coated, circular, biconvex tablet, engraved "AZA 25"

on one face, the other face is plain.

Active Ingredients

Azathioprine

25 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 29.11.2017 at 03:59:19 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

IMAZAN™

Consumer Medicine Information

Azathioprine 25 mg and 50 mg tablets

What is in this leaflet

This leaflet answers some of the common questions about IMAZAN. 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 IMAZAN against

the benefits the 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 IMAZAN is used for

IMAZAN contains azathioprine. This belongs to a group of medicines called immune suppressants which

work by reducing the body’s own natural immunity.

IMAZAN is used to treat patients who have received an organ transplant to help prevent their body from

rejecting the transplanted organs (e.g. a heart or kidney).

IMAZAN is also used to suppress the body’s immunity to treat “autoimmune” conditions like rheumatoid

arthritis, systemic lupus erythematosus or chronic active hepatitis..

IMAZAN may also be used to treat other conditions as determined by your doctor.

IMAZAN is a very powerful medicine. Never let anyone else take your medicine even if his or her

condition seems similar to yours.

Have regular check ups with your doctor.

IMAZAN tablets are not addictive.

Before you take IMAZAN

When you must not take it:

If you are female and you are pregnant or there is a chance that you may become pregnant; or if

you are male and there is a chance that you may father a child.

IMAZAN is not recommended during pregnancy. It may cause birth defects if either the male or

female are using it at the time of conception.

Your partner should take adequate contraceptive precautions while you are taking IMAZAN.

If you are breastfeeding or are planning to breastfeed.

IMAZAN passes into breast milk and may cause serious side effects to your baby.

If you are taking any other medicines or drugs.

If you have ever had an allergy to azathioprine, the active in IMAZAN, any of its ingredients (listed

at the end of this leaflet), or to another immune suppressant medicine (eg. 6-mercaptopurine).

Symptoms of an allergic reaction may be mild or severe. Signs if you are suffering an allergic reaction

usually include some of the following: wheezing, swelling of the lips / mouth, difficulty in breathing,

hayfever, lumpy rash (hives) or fainting.

If you have rheumatoid arthritis which has previously been treated with an alkylating agent (eg.

chlorambucil, melphalan or cyclophosphamide).

If you take IMAZAN after the expiry date (EXP.) printed on the pack. If you take IMAZAN after the

expiry date has passed, it may not work as well.

Do not take IMAZAN if the packaging is torn or shows signs of tampering.

If you're not sure whether you should be taking IMAZAN, talk to your doctor.

All of these factors need to be taken into consideration by your doctor when he/she considers the most

appropriate dose for you.

Before you start to take it:

Tell your doctor if you:

Are allergic to foods, dyes, preservatives or any other medicines;

Have any other medical conditions;

Have liver or kidney disease;

Have been or are considering being vaccinated;

Have been exposed to chickenpox or herpes zoster or have never had chickenpox or herpes

zoster; and

Are currently having or are considering dental treatment.

Taking other medicines:

If you are taking other medicines you must tell your doctor. This includes medicines that you can buy

without a prescription from a pharmacy, supermarket or a health food shop.

Some medicines are affected by others. Your doctor or pharmacist will be able to tell you what you should

do when you have to take other medicines while you are on IMAZAN.

Use in children:

IMAZAN may be used in children. Your doctor will advise the dose to use for children.

How to take IMAZAN

How much to take:

Use IMAZAN only as directed by your doctor. Your doctor has carefully determined your dose of

IMAZAN. Your dose of IMAZAN is determined by the condition being treated, your body weight and any

other medical conditions that you may have. Do not alter the amount you are taking or change your

treatment regime unless directed to do so by your doctor.

How to take it:

IMAZAN should only be taken orally.

Swallow IMAZAN with a glass of water. Do not crush or chew the tablets.

When to take it:

Take IMAZAN at the same time every day. Keeping a regular time for taking IMAZAN will help to remind

you to take them.

IMAZAN may sometimes cause mild nausea and vomiting.

Take your medicine after food or at bedtime to minimise stomach upset.

How long to take it:

Do not stop taking IMAZAN without first checking with your doctor. Your doctor will discuss with you

how long you need to take IMAZAN. You could have to take IMAZAN for some weeks or months before you

will be able to receive the full effects.

Patients that are taking IMAZAN because they have had an organ transplant will need to take IMAZAN

continuously to reduce the risk of the body rejecting the transplanted organ.

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 IMAZAN as you would

normally.

Never take a double dose to make up for the dose that you missed.

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

Do not use IMAZAN if the blister foil is broken or shows signs of tampering.

If you take too much (overdose):

Immediately telephone your doctor or Poisons Information Centre (Australia: 13 11 26) if you think

that you or anyone else may have taken too many IMAZAN. Do this even if there are no signs of

discomfort or poisoning. You may need urgent medical treatment.

While you are using IMAZAN

Things you must do:

You should always tell your doctor about any other medicines that you take, even if you have

bought the medicines, vitamins or herbal products without a doctor’s prescription. Some medicines

can affect the way IMAZAN works.

It is especially important that you tell your doctor if you are taking any of the following:

Allopurinol - may reduce the removal of IMAZAN from your body;

Corticosteroids (cortisone like medicines) these may be prescribed by your doctor to increase the effects

of IMAZAN;

Cytotoxic medicines (eg. mercaptopurine, chlorambucil, cyclosporin, cyclophosphamide); and

Warfarin - IMAZAN inhibits the anticoagulant effect of warfarin.

Make regular visits to your doctor to ensure that IMAZAN is working properly for you and that you are not

suffering any unwanted side effects.

Your doctor may take regular blood tests to check how you are reacting to IMAZAN.

If you have to have or are planning to have an operation, tell your surgeon and anaesthetist that you are

taking IMAZAN.

IMAZAN suppress your immune system, lowering your body’s immune defence system. This increases your

risk of skin cancer and other cancers while taking IMAZAN.

Always protect yourself from the sun, wear sunscreen, a hat and protective clothing.

Tell your doctor:

If you become pregnant or you are trying to become pregnant or you are planning to father a child;

If you plan to have any vaccinations or immunisations;

If you have come into contact with an infected person with chickenpox or herpes zoster;

If you notice any new moles or changes in existing moles; and

If you notice any lumps on your body or if you feel unwell.

Things you must not do:

Do not:

Stop taking IMAZAN or change the dose without first checking with your doctor.

Give this medicine to anyone else, even if their symptoms seem similar to yours.

Have any immunisations without your doctor’s approval. 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, chickenpox or herpes zoster)

Participate in contact sports or other situations where bruising or injury may occur. Be careful to

avoid cutting yourself with sharp objects (eg. razors).

Things to be careful of:

Be careful driving or operating machinery until you know how IMAZAN affects you. IMAZAN generally

does not cause any problems with your ability to drive a car or operate machinery. However, as with many

other medicines, IMAZAN tablets may cause headache or dizziness in some people.

Side effects

Check with your doctor if you experience any problems while taking IMAZAN, even if you do not think that

the problems you are having have anything to do with you taking IMAZAN.

Your doctor will have assessed the risk of possible side effects against the importance of you taking this

medication.

Some side effects may have signs or symptoms that you can see or feel. Your doctor will watch for other

side effects by performing certain tests.

Ensure that you have regular check ups with your doctor.

Side effects commonly found in patients who have received an organ transplant are:

viral, fungal and bacterial infections that include the skin;

hair loss (common in kidney transplant patients);

stomach pain with vomiting and fever;

diarrhoea, usually with blood and mucus;

sores in the mouth and on the lips;

feeling of pins and needles;

change in sense of smell or taste;

skin rash, skin peeling and sores on the mucous membranes; and

tiredness and generally feeling unwell.

Tell the doctor immediately if you notice any of the following:

any infection, unexpected bruising or bleeding, black tarry stools or blood in the urine or stools;

headache, stiff neck and extreme sensitivity to bright light;

muscle pain or stiffness;

severe joint pain;

coughing, difficulty in breathing and wheezing;

muscle weakness, with or without skin rash;

irregular heart beat;

yellow discolouration of the skin and eyes;

fever;

severe abdominal pain;

nausea, vomiting, diarrhoea; and

dizziness or feeling faint.

Immediately contact your doctor or go to the casualty department at your nearest hospital if you

observe any of the following symptoms as you may be having an allergic reaction to IMAZAN:

wheezing;

swelling of the lips / mouth;

difficulty in breathing;

hay fever;

lumpy rash; and

fainting.

This is not a complete list of possible side effects. You may react in a different way.

Contact your Doctor or Pharmacist if you notice anything else that is making you feel unwell, even if

it is not on this list.

After using IMAZAN

Storage:

Keep your tablets in the blister strip until it is time to take them. If you take the tablets out of the blister

strip they may not keep as well.

Keep IMAZAN in a cool dry place where the temperature stays below 30°C. Be sure to protect

IMAZAN from light and moisture.

Do not leave or store IMAZAN in the bathroom, near a sink or stove, on a windowsill or in a car. Heat

and dampness can destroy some medicines.

Keep IMAZAN where children cannot reach them. A locked cupboard at least one-and-a-half metres

above the ground is a good place to store medicines.

Safe handling of IMAZAN:

Azathioprine tablets should not be divided, crushed or broken. Provided that the film coating is intact, there

is no risk in handling film-coated tablets.

Disposal:

Tell your doctor if you stop taking the tablets or the tablets have passed their expiry date. Ask your

pharmacist what to do with any tablets which are left over.

Product description

What IMAZAN looks like:

IMAZAN 25 mg* – Peach coloured, film-coated, circular, biconvex tablet, engraved “AZA 25” on one face,

the other face is plain. They are available in blister packs of 100 tablets.

IMAZAN 50 mg* – Yellow film-coated tablet, embossed AZA, break line 50 on one face, the other face plain.

They are available in blister packs of 100 tablets.

*Some pack sizes and strengths may not be marketed.

Ingredients

:

Active ingredient:

Azathioprine

Other ingredients (excipients):

Microcrystalline cellulose, croscarmellose sodium mannitol, povidone, sodium stearylfumarate and maize

starch.

25 mg only: Opadry Buff OY-3682, Opadry Buff OY-3690 and Opadry OY-1315G

50 mg only: Opadry clear OY-7240

Distributor

Eris Pharmaceuticals (Australia) Pty Ltd

6 Eastern Road,

South Melbourne VIC 3205

www.eris-pharma.com.au

This leaflet was prepared in February 2014

25 mg: AUST R 184923

50 mg: AUST R 184924