Aspen

Patient Information Leaflet

Imuran™ Film-coated Tablets 25mg or 50mg

(azathioprine)

Please read this carefully before you start to take medicine. Keep it safe as you may want to read it again.

This leaflet contains important information about your Imuran Tablets. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is in Imuran Tablets?

Imuran Tablets are film-coated tablets and come in two strengths and colours. Imuran 50mg Tablets contain 50mg of the active ingredient, azathioprine and are yellow and marked with ‘GX CH1’. Imuran 25mg Tablets contain 25mg of the active ingredient, azathioprine and are orange and marked with ‘GX EL5’. There are also some excipients in Imuran Tablets. These are lactose monohydrate*, maize starch, pregelatinised starch, stearic acid, magnesium stearate, hypromellose and macrogol 400. There are no colourings in the yellow tablets. The colourings in the orange tablets are titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

* If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

Your Imuran Tablets come in blister packs of 100 film-coated tablets. Your doctor will prescribe an appropriate amount for you.

Who makes Imuran?

Imuran Tablets are manufactured by

The Product Authorisation is held by

What is Imuran for?

Imuran belongs to a group of medicines called immunosuppressives. This means that is reduces the strength of your immune system.

Immunosuppressive medicines are sometimes necessary to help your body accept an organ transplant, or to treat some diseases where your immune system is reacting against your own body (autoimmune diseases).

Who can take Imuran Tablets?

This medicines suits most people but there are a few people who should not take it. Ask yourself these questions to check whether Imuran is right for you:

• Have you ever had an allergy (e.g. rash, itchiness, shortness of breath) or bad reaction to Imuran, azathioprine or mercaptopurine or any of the other ingredients listed above?
• Are you pregnant or breast-feeding?
• Are you planning to have a baby? This question is for both men and women. As Imuran can damage the foetus, adequate contraceptive precautions should be taken if either partner is taking Imuran.
• This is to prevent the possibility of a pregnancy during treatment.
• Are you taking or likely to be taking any of the following medicines (Please check with your doctor if you are not sure):
  • allopurinol, oxipurinol or thiopurinol (used mainly to treat gout),
  • tubocurarine, succinylcholine (used mainly during surgical operations),
  • penicillamine (used mainly in the treatment of rheumatoid arthritis),
  • captopril (used mainly to treat high blood pressure – hypertension),
  • frusemide (used mainly to help reduce body fluids – diuretics),
  • warfarin (used to prevent blood clots),
  • cimetidine (used to treat stomach ulcers and indigestion),
  • indomethacin (used as a pain killer and anti-inflammatory),
  • cytostatic drugs (includes some antibiotics and also drugs used to treat various types of cancer).
  • olsalazine, mesalazine or sulphasalazine (used mainly in the treatment of ulcerative colitis).
• Do you need, or are going to have, a vaccination while you are on Imuran Tablets?
• Do you suffer from liver or kidney disease?
• Do you have a rare hereditary condition, where you have too little of the natural body chemical thiopurine methyltransferase (TPMT) enzyme in your body? If you are unsure, ask your doctor.
• Do you suffer from the condition known as Lesch-Nyhan Syndrome?
• Have you ever suffered from chickenpox or shingles?
• Do you have an intolerance to some sugars? Imuran Tablets contain lactose.

If you answer “YES” to any of these questions, check with your doctor first, before you take any tablets.

How do you take Imuran Tablets?

• Do not break the tablets before you take them. If you or your carer handle broken or uncoated dusty tablets make sure you wash your hands immediately. It is important that carers are aware of the need for safe handling of this medicine. Please consult your pharmacist or doctor for advice.
• It is important to take your medicine at the right times. You must take it in the way your doctor has told you to. The label on your pack will tell you how many tablets to take and how often to take them. If the label doesn’t say or if you are not sure, ask your doctor or pharmacist.
• The amount of Imuran people take can be very different. Your doctor may change your dose from time to time. The usual daily dose of Imuran is for adults 1 – 5 mg per kilogram/bodyweight per day and for children, 1-3 mg per kilogram of the bodyweight per day. The usual dosage for elderly patients should be at the lower end of the dosage range for adults. If you are not sure how may tablets to take or if the dose on the label has changed for no reason, ask your doctor.
• You should swallow your tablets with some water.
• If you forget to take a dose tell your doctor. DO NOT DOUBLE YOUR NEXT DOSE.
• From time to time while you are taking Imuran, your doctor will want you to have a blood test. This is to check your blood cell count and to change your dose if necessary.
• If you take too many Imuran Tablets or if someone else takes your medicine by mistake, tell your doctor immediately.

Do Imuran Tablets have side effects?

This medicine may cause side effects in some people. Some people can be allergic to medicines.

If you have any of the following symptoms soon after taking Imuran, STOP taking this medicine and tell your doctor immediately or go to the nearest hospital casualty (accident and emergency) department.

• You develop muscle and bone pain
• You develop kidney problems
• You start feeling faint especially on standing up.
• You develop bad diarrhoea and/or abdominal pain.
• You develop jaundice (skin or whites of the eyes turn yellow).
• You develop a serious skin reaction (e.g. blistering and/or peeling).

Patients taking immunosuppressive medicines may have an increased risk of developing tumours including skin cancer. Therefore while taking Imuran Tablets you should avoid too much exposure to sunlight. You are advised to wear protective clothing and to use a sunscreen with a high protection factor. 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.

Tell your doctor immediately if any of the following happen to you while you are taking Imuran:

• You start to notice any signs of a fever or an infection.
• You have any unexpected bruising or bleeding.
• You develop any new marks on your skin or any change to marks that you have had previously.
• You develop a cough or difficulty breathing similar to a chest infection.
• You have nausea and vomiting
• You feel tired, dizzy or generally unwell.
• You come into contact with anyone who is suffering from chickenpox or shingles.

You may notice some hair loss while taking Imuran. Often hair does grow again, even if you carry on taking Imuran. If you are worried ask your doctor.

Tell your pharmacist or doctor if you notice any other side effects from your medicine which are not mentioned here.

Look after your Imuran Tablets

• Keep your tablets out of reach and sight of children. Do not store your tablets above 25°C and keep the blister pack in the outer carton.
• Do not take any tablets after the “use by” date printed on the foil strip or carton.
• 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.
• Disposal: Imuran Tablets should be disposed of in a manner appropriate to the prevailing local regulatory requirements for the destruction of dangerous substances.

Remember

This medicine is for YOU. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Further Information

This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has the information you need and will advise you.

You may need to read this leaflet again. Please do not throw it away until you have finished your medicine.

The information in this leaflet applies only to Imuran Tablets.