Azathioprine 50mg Film-Coated Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.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 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 50mg Tablets and what are they used for
2. Before you take Azathioprine 50mg Tablets
3. How to take Azathioprine 50mg Tablets
4. Possible side effects
5. Howto store Azathioprine 50mg Tablets
6. Further information
I. WHAT ARE AZATHIOPRINE 50MGTABLETS AND WHAT ARE THEY USED FOR
Azathioprine 50mg Tablets belong to a group of medicines cal led immunosuppressives. This means that they reduce 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).
2. BEFORE YOU TAKE AZATHIOPRINE 50MG TABLETS
Do not take Azathioprine 50mg Tablets
• If you are allergic (hypersensitive) to azathioprine, mercaptopurine or any of the other ingredients of Azathioprine 50mg Tablets.
• if you are pregnant or breast-feeding
• if you are planning to have a baby (This applies to both men and women).
• if you are being treated for a severe infection
• if you have severe liver problems
• if you have an inflamed pancreas (pancreatitis)
• if you suffer from a weak immune system.
Take special care with Azathioprine 50mg Tablets Please consult your doctor
• if you are going to have a vaccination while you are taking Azathioprine 50 mg Tablets
• if you suffer from liver or kidney disease
• if you have a condition where your body produces too little of a natural chemical called thiopurine methyltransferase (TPMT)
• if you suffer from a condition known as Lesch-Nyhan Syndrome Takingother medicines
It is important that you tell your doctor if you are taking or likely to be taking any of the following medicines before taking Azathioprine 50mg Tablets as they may harm you:
• allopurinol (used mainly to treat gout)
• tubocurarine, succinylcholine (used mainly during surgical operations)
• penicillamine (used mainly in the treatment of rheumatoid arthritis)
• captopril,furosemide (used mainly to treat high blood pressure)
• warfarin (used to prevent blood clots)
• cimetidine (used to treat stomach ulcers and indigestion)
• indometacin (used as a pain killer and anti-inflammatory)
• cytostatic drugs (includes some antibiotics and also medicinal products used to treat various types of cancer)
• balsalazide, mesalazine, olsalazine or sulfasalazine (used mainly to treat ulcerative colitis)
• co-trimoxazole (an antibiotic)
Please also tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Azathioprine 50mg Tablets with food and drink
You should swallow your tablets with some water.
Pregnancy and breast-feeding
Do not take Azathioprine 50mg Tablets if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You are safe to drive or operate machinery when taking Azathioprine 50mg Tablets, unless you experience dizziness. Dizziness maybe made worse by alcohol and you should not drive or operate machinery if you have been drinking alcohol.
Important information about some of the ingredients of Azathioprine 50mg Tablets
These tablets contain Mannitol which may have a mild laxative effect.
3. HOW TO TAKE AZATHIOPRINE 50MG TABLETS
Always take Azathioprine 50mg Tablets exactly as your doctor has told you. It is important to take your medicine at the right times. The label on your pack will tell you how many tablets to take and how often to take them. You should check with your
doctor or pharmacist if you are not sure.The number of Azathioprine 50mg Tablets people take can be very different. Your doctor may change your dose from time to time.The usual dose for adults is I -5mg per kilogram body weight per day and for children, I-3 mg per kilogram of body weight 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 many tablets to take, or if the dose on the label has changed for no reason, ask your doctor.
From time to time, while you are taking Azathioprine 50mg Tablets, 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 more Azathioprine 50mg Tablets than you should
If you take too many tablets, or if someone else takes your medicine by mistake, tell your doctor immediately.
If you forget to take Azathioprine 50mg Tablets
If you forget to take a dose, tell your doctor. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Azathioprine 50mg Tablets
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 tel Is you to.
If you have any further questions on the use of this product, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azathioprine 50mg Tablets can cause side effects, although not everybody gets them.
Patients receiving immunosupressives such as Azathoprine may be more likely to develop different types of cancers including skin cancers. You should take care to avoid too much sun and wear protective clothing and sunscreen. A few people may be allergic to Azathioprine 50mg Tablets. See your doctor immediately if you develop any of the following symptoms:
• Feeling sick and/or being sick
• Diarrhoea
• Fever, shivering/chill and skin rash
• Muscle and bone pain
• Kidney problems (symptoms may include changes in the amount of urine passed and changes in the colour of the urine).
• Tiredness
• Dizziness.
Tell your doctor immediately if any of the following happen to you while you are taking Azathioprine 50mg Tablets:
• You startto notice any signs ofafever oran infection
• You have any unexpected bruising or bleeding
• You develop bad diarrhoea and/or abdominal pain
• You develop jaundice (skin or whites of the eyes turn yellow)
• You develop a chest infection (pneumonitis)
• If you develop lumps on the body or patches on the skin.
You may notice some hair loss while taking Azathioprine 50mg Tablets. This is a rare side effect of Azathioprine that could happen in less than I in 1,000 patients. Often hair does grow again, even if you carry on taking Azathioprine 50mg Tablets. If you are worried askyour doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOWTO STORE AZATHIOPRINE 50MG TABLETS
Store in the outer carton in order to protect from light.
Keep out of the reach and sight of children.
Do not use Azathioprine 50mg Tablets after the expiry date which is stated on the carton and blister foil.
Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Azathioprine 50mg Tablets contain
• The active substance is Azathioprine.
• Each tablet contains 50mg of azathioprine.
• The other ingredients are Microcrystalline cellulose, Mannitol, Maize starch, Povidone K25, Croscarmellose sodium, Sodium stearyl fumarate, Hypromellose and Macrogol.
What Azathioprine 50mg Tablets look like and contents of the pack
Azathioprine 50mg Tablets are pale yellow, circular coated tablets. On one side of each tablet are the letters AZA', then a score line and the number “50”.
Your Azathioprine 50mg Tablets come in blister packs of 56 and 100 tablets
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:-Relonchem Limited
27 Old Gloucester Street, London, WC I 3XX, United Kingdom The Manufacturer is:-
Actavis Nordic A/S, ornegrardsvej 16, 2820 Gentofte, Denmark.
This leaflet was last approved in March 2011.