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PACKAGE LEAFLET: INFORMATION FOR THE USER

Azathioprine 50mg Tablets

Azathioprine

Read this entire 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 your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

Your medicine contains the active substance azathioprine which belongs to a group of medicines called immunosuppressants. This means that they reduce the strength of your immune system.

Immunosuppressant 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).

Azathioprine Tablets are used to:

•    help your body accept a kidney, liver, heart, lung or pancreas transplant. [Azathioprine Tablets are usually used together with other medicines in order to enhance their effect].

•    treat severe rheumatoid arthritis

•    treat severe inflammation of the gut (Crohn's disease or ulcerative colitis)

•    treat some diseases where your immune system is reacting against your own body (autoimmune diseases) including severe inflammatory diseases of the skin, liver, arteries and some blood disorders.

Do not take Azathioprine 50mg Tablets:

•    If you are allergic (hypersensitive) to azathioprine or mercaptopurine

•    If you are allergic to any of the other ingredients in the tablets (see section 6 'Further Information')

•    If you have a severe infection

•    If you have severe liver disease or severe bone marrow disease

•    If you have an inflamed pancreas

•    If you need or are going to have a vaccination such as BCG, smallpox or yellow fever vaccine

•    If you are breast-feeding (see "Pregnancy and breast-feeding”).

Taking other medicines

Tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Azathioprine Tablets:

•    Allopurinol, oxipurinol or thiopurinol (used mainly to treat gout)

•    Ciclosporin or tacrolimus (also used as immunosuppressant medicines)

•    Infliximab (used to treat inflammation of the bowels [Crohn's disease])

•    Olsalazine, mesalazine or sulfasalazine (used mainly to treat ulcers or chronic inflammation of the colon and anal passage)

•    Warfarin or phenprocoumon (used to prevent blood clots)

•    ACE-inhibitors (used to treat high blood pressure and heart failure)

•    Furosemide (used mainly to treat high blood pressure)

•    Trimethoprim/sulfamethoxazole (used to treat bacterial infections)

•    Cimetidine (used to treat stomach ulcers and indigestion)

•    Indometacin (used as a painkiller and to treat inflammation)

•    Cytotoxic medicines - also called "chemotherapy” (used to treat cancer)

•    Vaccines (such as hepatitis B vaccine)

•    Tubocurarine, pancuronium or succinylcholine (used as muscle relaxants during operations)

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

Pregnancy and breast-feeding

Azathioprine Tablets should only be taken if your doctor thinks it is absolutely necessary. Tell your doctor if you are pregnant or think you may be pregnant.

Do not take the tablets if you are breast-feeding.

Driving and using machines

Studies on the effects of azathioprine on the ability to drive and use machines have not been performed. This product may cause dizziness, which could affect a patient's ability to drive.

Take special care with Azathioprine 50mg Tablets

You should tell your doctor if any of the following apply to you:

•    If you have or have ever had any liver or kidney problems

•    If you have a condition where your body produces too little of a natural chemical called thiopurine methyltransferase (TPMT)

•    If you have an infection for which you have not yet received treatment

•    If you are pregnant or trying to become pregnant (see "Pregnancy and breast-feeding”)

•    If you are going to have an operation (this is because medicines including tubocurarine, pancuronium or succinylcholine used as muscle relaxants during operations may interact with your Azathioprine Tablets).

•    If you have a rare genetic disorder called "Lesch-Nyhan syndrome”.

You should take care to avoid too much sun (including sunbeds) whilst taking Azathioprine Tablets.

You must use contraceptive methods whilst taking these tablets and for up to 3 months after you have finished taking them. Suitable methods of contraception should be discussed with your doctor. Women using intra uterine devices (IUDs) should use additional contraceptive methods while taking Azathioprine Tablets.

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

The label on the carton will tell you how many tablets to take and when. The tablets should be swallowed whole with one full glass of water (about 200ml). Take your tablets during meals.

Your doctor will monitor how you respond to your medicine and may change your dose if required.

After organ transplant

A dose of 5mg per kilogram of your bodyweight per day may be given on the 1st day of your treatment. However, the usual maintenance dose is between 1 and 4mg per kilogram of your bodyweight per day. Your doctor may adjust this dose according to your body's response to your medicine.

Patients with chronic active hepatitis

The usual dose is between 1 and 1.5mg per kilogram of your bodyweight per day.

Other conditions

The usual starting dose is between 1 and 3mg per kilogram of your bodyweight per day. Your doctor will adjust the dose until it is right for you.

Children and Adolescents

Where treatment is recommended, the dosage for children and adolescents is the same as the adult dose.

Elderly patients or patients with kidney or liver disease A smaller adult dose may be required.

Whilst you are taking Azathioprine 50mg Tablets, your doctor will want you to have a complete blood test performed, at least once a week, during the first 8 weeks of treatment. After 8 weeks the frequency of the testing may be reduced and your doctor may ask you to repeat the complete blood test every month or at least at intervals of not longer than 3 months.

If you have taken more Azathioprine 50mg Tablets than you should

In the event of overdose the most likely effect is bone marrow suppression reaching its maximum 9-19 days after dosing. You may get a sore throat, fever or infection. You may also feel tired or experience bruising and bleeding. If you have taken too many tablets, contact your doctor or go the nearest hospital casualty department immediately. Remember to take the pack and any remaining tablets with you to show the doctor.

If you forget to take your Azathioprine 50mg Tablets

Do not take a double dose to make up for a forgotten tablet but wait and take your next dose at the usual time. If you have missed more than one dose, contact your doctor for advice.

If you stop taking Azathioprine 50mg Tablets

Do not stop taking your medicine unless the doctor tells you because stopping your medicine can make your condition worse.

If your doctor does not see an improvement in your condition within three to six months, your doctor may wish to gradually reduce your dose and finally stop giving you this medicine.

It is important that you stop your treatment gradually. You should stop taking the tablets slowly, over a period of time.

Like all medicines, Azathioprine Tablets can cause side effects, although not everybody gets them.

You should tell your doctor immediately if you:

•    get any ulcers in the throat, fever, bruises or bleeding, or you think you have an infection.

•    experience any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body).

The following side effects have been reported. Tell your doctor if any of these side effects become troublesome:

Very common side effects (probably affecting more than 1 in 10 patients)

•    infections (in kidney transplant • reduction in number of white

patients)    blood cells which makes

•    feeling and being sick (nausea infections more likely

and vomiting)    • loss of appetite (anorexia).

Uncommon side effects (probably affecting less than 1 in 100 patients)

• allergic reactions including dizziness or feeling unwell, low blood pressure, fever, feeling cold, feeling severely sick and vomiting, diarrhoea, rash, rigors, kidney problems, muscle pain (myalgia), pain in the joint (arthralgia), inflammation of blood vessels (vasculitis), high number of liver enzymes paleness or fatigue or feeling short of breath caused when the body's bone marrow is not producing enough blood cells (aplastic anaemia)

¹ cough and fever caused by pneumonia or inflammation of the lung

Very rare side effects (probably affecting less than 1 in 10,000 patients):

• blood disorders (including acute • very serious allergic reaction. myeloid leukaemia and myelo-dysplastic syndromes)

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

5. HOWTO STORE AZATHIOPRINE 50MG TABLETS

Keep out of the sight and reach of children.

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

Store in the original package in order to protect from light.

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.

What Azathioprine 50mg Tablets contain

The active substance is azathioprine. Each tablet contains 50mg of azathioprine.

The other ingredients are:

Tablet core: Microcrystalline cellulose, Mannitol, Maize starch, Povidone K25, Croscarmellose sodium, Sodium stearyl fumarate. Tablet coat: Hypromellose, Macrogol 400.

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

Azathioprine 50mg Tablets are light yellow, round, biconvex tablets, engraved with "AZA” and "50” separated by a line on one side and plain on the other side.

Common side effects (probably affecting less than 1 in 10 patients):

•    liver disease

•    increased infections in patients with bowel inflammation

•    reduction in blood platelets which increases risk of bleeding or bruising

Certain types of cancer (lymphomas, cancer of the cervix, vulva and skin (especially on areas of the skin exposed to the sun)) are common in patients after kidney transplant.

Azathioprine 50mg Tablets are available in blister packs containing 50, 56 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder:

Actavis Group PTC ehf., Reykjavfkurvegi 76-78, 220 Hafnarfjordur, Iceland Manufacturer:

Juta Pharma GmbH, Gutenbergstrasse 13, 24941, Flensburg, Germany

This leaflet was last revised in October 2013.