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PACKAGE LEAFLET: INFORMATION FOR THE USER

AZATHIOPRINE TABLETS 50 MG

[Azathioprine]

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor, health care provider or pharmacist.

•    This medicine has been prescribed for you.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What are Azathioprine Tablets and what are they used for

2.    Before you take Azathioprine Tablets

3.    How to take Azathioprine Tablets

4.    Possible side effects

5.    How to store Azathioprine Tablets

6.    Further information

1.    WHAT ARE AZATHIOPRINE TABLETS AND WHAT ARE THEY USED FOR

Azathioprine belongs to a group of medicines called immunosuppressants, which work by reducing the immune response.

Azathioprine is used for protection against organ transplant rejection.

It can also be used to treat various conditions in which the usual treatment (with steroids) is not working properly, is causing problems or where steroids cannot be used. These conditions include hepatitis, rheumatoid arthritis, systemic lupus erythematosus (SLE), dermatomyositis and polymyositis (conditions which affect the muscles and skin), various blood and bleeding disorders and skin disorders.

2.    BEFORE YOU TAKE AZATHIOPRINE TABLETS Do not take Azathioprine if you:

•    Are allergic to azathioprine or another drug called mercaptopurine or any of the other tablet ingredients

•    Have recently had or are due to have a vaccination

Take special care with Azathioprine

If the answer to any of these questions is yes, tell your doctor or pharmacist before taking Azathioprine Tablets.

•    Are you pregnant or trying to become pregnant?

•    Are you breast feeding?

•    Do you have liver or kidney disease or problems with your spleen?

•    Do you have the inherited deficiency of enzyme thiopurine methyl-transferase (TPMT) or Lesch Nyhan Syndrome (hypoxanthine-guaninephosph ribosyltransferase deficiency)

•    If you have ever suffered from chickenpox or shingles

•    An increase in fertility has been seen in both male and female renal transplant patients

•    If you have been told by your doctor that you have an intolerance to some sugars, as this medicine contains lactose.

There is an increased risk of developing non Hodgkin's lymphomas, such as skin cancers, sarcomas and cervical cancer while taking azathioprine. This is mostly reversible on withdrawal of the product.

Your doctor will monitor your treatment carefully and you will have to have blood tests at least once a week for the first eight weeks of your treatment. You should tell your doctor immediately if you have an infection or unexpected bleeding or bruising.

Azathioprine and the sun

While taking azathioprine you may be more likely to develop some types of cancers such as skin cancer. Some people also become sensitive to sunlight which can cause skin discolouration or a rash. Take care to avoid too much sun, cover up and use sunscreen.

Chickenpox /Shingles infection

Infection with chickenpox or shingles can become severe in patients taking immunosuppressive medicine. Therefore you should avoid contact with anyone suffering from chickenpox or shingles.

You should tell your doctor if you are over 65 years of age.

Withdrawal of this medicine should be gradual and under the supervision of your doctor.

Taking other medicines

Are you taking any of the following medicines?

•    Allopurinol and related medicines such as oxipurinol and thiopurinol (to treat gout)

•    Co-trimoxazole or trimethoprim (to treat bacterial infections)

•    Captopril (to treat high blood pressure)

•    Aminosalicylates e.g. olsalazine, mesalazine, sulphasalazine (to treat bowel disorders such as ulcerative colitis)

•    Warfarin (to prevent blood clotting)

•    Penicillamine (mainly used to treat rheumatoid arthritis)

•    Muscle relaxants (e.g. curare, Dtubocurarine or pancuronium)

•    Other bone marrow suppressant drugs (e.g. mycophenolate mofetil, ciclosporin, tacrolimus and sirolimus)

•    Clozapine - used to treat schizophrenia

•    Furosemide- used for high blood pressure and heart problems

Having vaccines while you are taking Azathioprine

If you are going to have a vaccination speak to your doctor before having it. This is because vaccines may not work properly while you are taking this medicine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Azathioprine with food and drink

Azathioprine Tablets should only be taken by mouth. Azathioprine Tablets should be swallowed with a little water with or after meals. Do not chew the tablets.

Pregnancy and breast-feeding

Do not take this medicine if you are a man trying to have a baby. This is because it may affect the baby. Do not take this medicine if you are a women who is pregnant or think you might become pregnant. This is because it may affect the baby.

Driving and using machines

Ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO TAKE AZATHIOPRINE TABLETS

Always take Azathioprine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose which the doctor prescribes for different people may differ according to their weight, medical condition, and perhaps the results of a blood test. The usual dose for adults and children is 1 to 5 mg per kg body weight. Elderly patients will need to be monitored and doses adjusted accordingly.

These are the usual doses. Your doctor may prescribe different doses to these. The label on the bottle will tell you what dose you should take and for how long. If you are still not sure ask your doctor or pharmacist.

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If you take more Azathioprine Tablets than you should

Too many tablets at once may make you unwell. Contact your doctor or your nearest casualty department at once.

If you forget to take Azathioprine Tablets

Do not worry. Take the missed dose as soon as you remember. However, if it is almost time for your next dose, leave out the missed dose and take your next dose at the right time.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Azathioprine can cause some side-effects although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Azathioprine and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:

•    Allergic reaction, the signs may include:

-    general tiredness, dizziness, feeling sick (nausea), being sick (vomiting) or diarrhoea

-    high temperature (fever), shivering or chills

-    redness of the skin or a skin rash

-    pain in the muscles or joints

-    changes in the amount and colour of the urine (kidney problems)

-    dizziness, confusion, feeling light headed or weak, caused by low blood pressure

•    Bruise more easily or notice any unusual bleeding

•    Have a high temperature (fever) or other signs of an infection

•    Feel extremely tired

•    Notice lumps anywhere on your body

•    Notice any changes to your skin, for example blisters or peeling

•    Your health suddenly gets worse

•    You come into contact with anyone who is suffering from chickenpox or shingles.

If you notice any of the above, stop taking this medicine and see a doctor straight away.

Other side effects include:

Very common (affects more than 1 in 10 people)

•    Infections caused by a virus, fungus or bacteria

•    Reduction in your bone marrow function, which may make you feel unwell or show up in your blood tests

•    Low white blood cell level in your blood tests, which may cause an infection.

Common (affects less than 1 in 10 people)

•    Low blood platelet level, which may cause you to bruise or bleed easily.

Uncommon (affects less than 1 in 100 people)

•    Low red blood cell level, which may cause you to be tired, get headaches, be short of breath when exercising, feel dizzy and look pale

•    Inflammation of the pancreas, which may cause you severe upper stomach pain, with feeling sick (nausea) and being sick (vomiting)

•    Liver problems, which may cause pale stools, dark urine, itchiness and yellowing of your skin and eyes.

Rare (affects less than 1 in 1,000 people)

•    Problems with your blood and bone marrow which may cause weakness, tiredness, paleness, headaches, sore tongue, breathlessness, bruising or infections

•    Problems with your bowel leading to diarrhoea, abdominal pain, constipation, feeling sick (nausea) and being sick (vomiting)

•    Hair loss which may get better even though you continue to take this medicine

•    Severe liver damage which can be life threatening

•    Various types of cancers including blood, lymph and skin cancers

•    Sensitivity to sunlight which can cause skin discolouration or a rash.

Very rare (affects less than 1 in 10,000 people)

•    Inflammation of your lungs causing breath lessness, cough and a fever.

Azathioprine has been known to cause alterations to chromosomes (the sites of genes) in body cells, which is reversible on withdrawal of the drug. Further advice should be obtained from your doctor. Since azathioprine can cause changes in your blood, your doctor will probably want to take regular blood samples whilst you are taking this medicine to look out for any such changes.

Check with your doctor or pharmacist if you become unwell or have any other discomfort you do not understand.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE AZATHIOPRINE TABLETS

Keep out of the sight and reach of children.

Store in a dry place below 25°C. Protect from light. Do not use Azathioprine Tablets 50mg after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Azathioprine Tablets 50mg if you notice visible signs of deterioration.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Azathioprine Tablets 50mg contains

The active substance(s) is azathioprine.

The other ingredients are: Maize starch

Microcrystalline cellulose

Lactose monohydrate

Magnesium Stearate

Talc

Sodium starch glycollate (Type A)

What Azathioprine Tablets 50mg looks like and contents of the pack

Description: Pale yellow biconvex tablets, scored on one side and engraved with a logo on the other side (mortar and pestle).

Contents of pack: Blister pack.

Each blister contains 14 tablets. The tablets are supplied to your pharmacist in packs containing 28, 50, 56, 100 or 250 tablets, who will then provide you with the required number of tablets as prescribed by your doctor (not all pack sizes may be marketed).

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Marketing Authorisation Holder and

Manufacturer

Co-Pharma Limited

Unit 4, Metro Centre, Tolpits Lane,

Watford, Herts, UK, WD 18 9SS Tel: 01923 255580 Fax: 01923 255581

This medicinal product is authorised in the Member States of the EEA under the following

names: Not applicable

This leaflet was last revised in April 2015.

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