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Azathioprine 50mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Azathioprine 50mg Tablets

This product is available using the above name but will be referred to as Azathioprine Tablets throughout the following leaflet.

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, nurse 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, nurse or pharmacist.

In this leaflet:

1.    What Azathioprine Tablets are and what they are 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 AZATHIOPRINE TABLETS ARE AND WHAT THEY ARE USED FORl

Azathioprine Tablets belong to a group of medicines called immunosuppressants. These medicines reduce the activity of your body's immune system.

Azathioprine Tablets are used to:

•    stop your body rejecting an organ transplant

•    treat diseases where your immune system reacts against your own body (called autoimmune diseases, such as rheumatoid arthritis).

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

2. BEFORE YOU TAKE AZATHIOPRINE TABLETS

Do not take Azathioprine Tablets if:

•    you are allergic (hypersensitive) to azathioprine, mercaptopurine or any of the other ingredients of Azathioprine Tablets (listed in section 6).

Do not take Azathioprine Tablets if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before taking Azathioprine Tablets.

Take special care with Azathioprine Tablets

Check with your doctor, nurse or pharmacist before taking Azathioprine Tablets if:

•    you have liver or kidney disease

•    you have 'Lesch-Nyhan Syndrome'. This is a rare condition that runs in families caused by a lack of something called HPRT or 'hypoxanthine- guanine-phosphoribosyltransferase'

•    you have a condition where your body produces too little of something called TPMT or 'thiopurine methyltransferase'

•    you have ever suffered from chickenpox or shingles.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Azathioprine Tablets.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Azathioprine Tablets can affect the way some medicines work. Also some other medicines can affect the way Azathioprine Tablets work.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

•    allopurinol - used for gout

•    tubocurarine or succinylcholine - used during operations

•    warfarin - used for blood clots

•    penicillamine - used for rheumatoid arthritis

•    co-trimoxazole - used for infections

•    captopril - used for high blood pressure or heart problems

•    cimetidine - used for stomach ulcers and indigestion

•    indomethacin - used for pain and inflammation

•    furosemide - used for high blood pressure and heart problems

•    olsalazine or mesalazine - used for a bowel problem called ulcerative colitis

•    sulfasalzine or balsalazide - used for rheumatoid arthritis or ulcerative colitis.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Azathioprine Tablets.

Having vaccines while you are taking Azathioprine Tablets

If you are going to have a vaccination speak to your doctor or nurse before you have it. This is because vaccines may not work properly while you are taking Azathioprine Tablets.

Tests you may have while taking Azathioprine Tablets

Your doctor may ask you to have a blood test while you are taking Azathioprine Tablets. This is to check your blood cell count. Your doctor may change your dose of Azathioprine Tablets after the test.

Trying for a baby, pregnancy and breast-feeding

•    Do not take Azathioprine Tablets if you are a man trying to have a baby. This is because it may affect the baby.

•    Do not take Azathioprine Tablets if you are a women who is pregnant or think you might become pregnant. This is because it may affect the baby.

•    Do not take Azathioprine Tablets if you are breast-feeding. This is because small amounts may pass into the mother's milk.

Ask your doctor, midwife or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Azathioprine Tablets and the sun

While taking Azathioprine Tablets 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.

3. HOW TO TAKE AZATHIOPRINE TABLETS

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

The dose of Azathioprine Tablets you take depends on your illness and how bad it is. The dose also depends on your age, your weight and how well your liver and kidneys are working. Your doctor will explain this to you.

To stop your body rejecting an organ transplant On the first day

•    the usual dose is up to 5 mg per kg of body weight.

For the rest of your treatment

•    you will take between 1 and 4 mg per kg of body weight each day.

For other conditions

At the start of your treatment

•    you will take 1 to 3 mg per kg of body weight each day

•    your doctor may reduce your dose later.

If you take more Azathioprine Tablets than you should

If you take more Azathioprine Tablets than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Azathioprine Tablets

•    If you forget to take Azathioprine Tablets, tell your doctor.

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

If you have any further questions about Azathioprine Tablets and how to take it, ask your doctor, nurse or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Stop taking Azathioprine Tablets 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

•    you bruise more easily or notice any unusual bleeding

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

•    you feel extremely tired

•    you notice lumps anywhere on your body

•    you 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 Azathioprine Tablets 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 Azathioprine Tablets

•    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 breathlessness, cough and a fever.

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

Reporting of side effects

If you get any side effects, talk to your doctor or 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

•    Do not store above 25°C.

•    Protect from light.

•    Keep out of the sight and reach of children.

•    Do not use Azathioprine Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

•    If your doctor tells you to stop taking the tablets, please return any which are left over to your pharmacist. Only keep them if your doctor tells you to.

•    Medicines should not be disposed of via wastewater 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 contain

•    Each tablet contains 50mg of the active ingredient azathioprine.

•    The other ingredients are lactose, pregelatinised starch, maize starch, stearic acid, magnesium stearate, hypromellose and macrogol 400, purified water.

•    There is no colouring in the yellow tablets.

What Azathioprine Tablets look like and contents of the pack

•    Azathioprine Tablets are covered by a thin coating.

•    The yellow tablets are marked with 'GX CH1' with a breakline on one side and plain on the reverse. Azathioprine Tablets come in blister packs of 50 and 100 tablets.

PL: 15814/0904 Azathioprine 50mg Tablets    |POM|

Manufactured by Excella GmbH, Nurnberger Strasse 12, D-90537, Feucht, Germany and is procured from within the EU and repackaged by the Product Licence Holder: OPD Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.) 02.06.2015.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.