Active ingredient
- azathioprine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL39699/0004.
Imuran Tablets
Package leaflet: Information for the patient
Imuran 25mg and 50mg Film-coated Tablets
azathioprine
Read all of this leaflet carefully before you start taking this medicine because it contains -important information for you.
What is in this leaflet
1. What Imuran Tablets are and what they are used for
2. What you need to know before you take Imuran
3. How to take Imuran
4. Possible side effects
5. How to store Imuran
6. Contents of the pack and other information
1. What Imuran Tablets are and what they are used for
Imuran tablets contain the active substance azathioprine. They belong to a group of medicines called immunosuppressives. This means that they reduce the strength of your immune system.
Imuran Tablets may be used to help your body accept an organ transplant, such as a new kidney, heart or liver, or to treat some diseases where your immune system is reacting against your own body (autoimmune diseases).
Autoimmune diseases may include:
Imuran Tablets may also be used to treat inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Your doctor has chosen this medicine to suit you and your condition.
Imuran Tablets may be used on its own, but it is more often used in combination with other medicines.
2. What you need to know before you take Imuran Tablets
Do not take Imuran Tablets:
Warnings and precautions
Talk to your doctor or pharmacist before taking Imuran Tablets:
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before taking Imuran Tablets.
Your doctor will want to take regular blood samples while you are taking Imuran Tablets, to check for any changes (see section 3 “How to take Imuran Tablets. The frequency of your blood tests will usually decrease the longer you continue to take Imuran Tablets.
If you are receiving immunosuppressive therapy, taking Imuran could put you at greater risk of:
Other medicines and Imuran Tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines. This is because Imuran Tablets can affect the way some medicines work. Also some other medicines can affect the way Imuran works. In particular tell your doctor if you are taking, or are planning to take:
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Imuran Tablets.
Having vaccines while you are taking Imuran Tablets
If you are due to receive a vaccination (vaccine) speak to your doctor or nurse before you do so. If you take Imuran Tablets, you should not have a live vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe to do so by your doctor. This is because some vaccines may give you an infection if you receive them while you are taking Imuran Tablets.
Imuran Tablets with food and drink
You should take your medicine at least 1 hour before or 2 hours after having milk or dairy products.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Pregnancy
Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner is taking Imuran Tablets.
If you are pregnant your doctor will carefully consider whether you should take this medicine, based on the risks and benefits of treatment.
Breast-feeding
Small amounts of Imuran may pass into the breast milk. It is recommended that women receiving Imuran should avoid breastfeeding unless the benefits outweighs the potential risks to the child. Ask your doctor for advice before breastfeeding.
Fertility
The effects of Imuran Tablets on fertility are not known.
Driving and using machines
Imuran Tablets are not known to affect your ability to drive or use machinery. If you experience any side effect from this medicine, you may not be able to drive or operate machinery.
Imuran Tablets contain lactose
Imuran Tablets contain lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Imuran Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The quantity of Imuran Tablets taken may vary from patient to patient and will be prescribed by your doctor. The dose depends on the condition for which you are being treated.
You can take Imuran Tablets with food or on an empty stomach but the choice of method should be consistent from day to day. Some patients feel nausea (sick) when first given Imuran Tablets, this may be relieved by taking the tablets after food.
Your doctor may sometimes change your dose of Imuran Tablets as a result of these tests.
Swallow your tablets whole. Do not chew the tablets. The tablets should not be broken or crushed.
It is important that carers are aware of the need for safe handling of this medicine. If you or your caregiver does handle broken tablets, wash your hands immediately. Please consult your doctor or pharmacist for advice.
The recommended dose is:
Adults who have had an organ transplant: On the first day of treatment, the usual dose is up to 5 mg per kilogram of body weight, then a usual daily dose of 1 mg to 4 mg per kilogram of body weight. During treatment your doctor will adjust the dose depending on your reaction to the medicine.
Adults with other conditions: The usual starting dose is 1 mg to 3 mg per kilogram of body weight, then a usual daily dose of less than 1 mg to 3 mg per kilogram of body weight During treatment your doctor will adjust the dose depending on your reaction to the medicine.
Elderly patients may need a reduced dose.
Patients with kidney or liver problems may need a reduced dose.
Use in children
Children who have had organ transplant: The dosing for children who have had an organ transplant is the same as adults.
Children with other conditions: The dosing for children with other conditions is the same as adults.
Children who are considered overweight may require a higher dose.
If you take more Imuran Tablets than you should
If you take too many tablets, contact your doctor or pharmacist immediately.
If you forget to take Imuran Tablets
Do not take a double dose to make up for the dose that you missed. Inform your doctor if you do miss a dose.
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, then go back to taking it as you would normally.
If you stop taking Imuran Tablets
Before you stop taking Imuran Tablets, consult with your doctor or pharmacist. Do not stop taking Imuran Tablets until your doctor tells you it is safe to do so.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Imuran Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Stop taking Imuran Tablets and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:
If you get any of the following serious side effects, talk to your doctor or specialist doctor immediately, you may need urgent medical treatment:
If you notice any of the above, stop taking Imuran Tablets and see a doctor straight away.
Other side effects include:
Very Common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very Rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Imuran
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Imuran contains
What Imuran looks like and contents of the pack
Imuran tablets come in packs of 28, 30, 56, 60 and 100 tablets.
The 50 mg tablets are also available in packs of 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Imuran 25 mg
PL 39699/0004
Imuran 50 mg
PL 39699/0005
Manufacturer:
This leaflet was last revised in June 2021.
3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
0800 0087 392