PACKAGE LEAFLET: INFORMATION FOR THE USER

Azafalk 50mg film-coated tablets

Azathioprine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Azafalk 50mg tablets is and what it is used for

2.    What you need to know before you take Azafalk 50mg tablets

3.    How you take Azafalk 50mg tablets

4.    Possible side effects

5.    How to store Azafalk 50mg tablets

6.    Contents of the pack and other information

1. What Azafalk 50mg tablets is and what it is used for

Azafalk 50mg tablets contain the active ingredient azathioprine, which belongs to a group of medicines called immunosuppressives. Immunosuppressives reduce the strength of your immune system. Your doctor has prescribed Azafalk 50mg tablets for one of the following conditions:

-    To help your body accept an organ transplant.

-    To control some diseases where your immune system is reacting against your own body.

Azafalk 50mg tablets can also be used alone or in combination with other medicines to treat:

-    severe rheumatoid arthritis

-    severe inflammation of the gut (Crohn’s disease or ulcerative colitis)

or to treat:

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

2. What you need to know before you take Azafalk 50mg tablets Do not take Azafalk 50mg tablets if you

-    are allergic (hypersensitive) to azathioprine, mercaptopurine, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue.

-    have a severe infection

-    have a severe liver or bone marrow disorder

-    have pancreatitis (inflammation of the pancreas)

-    have recently had a vaccination with a live vaccine such as smallpox or yellow fever

-    are pregnant (unless your doctor tells you)

-    are breast-feeding

Warnings and precautions

Talk to your doctor before taking Azafalk 50mg tablets.

You will not be given Azafalk 50mg tablets unless you can be monitored for side effects.

You should tell your doctor straight away if you develop ulcers of the throat, fever, infections, bruising, or bleeding.

Please consult your doctor

- if you are going to have a vaccination while you are taking Azafalk 50mg tablets

- 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.

Patients taking immunosuppressive drugs may be more at risk of cancer, especially non-Hodgkin’s lymphoma, sarcoma (e.g. Kaposi’s and non-Kaposi’s), local cancer in the uterus and skin cancer. You should avoid strong sunlight or UV rays during the treatment with Azafalk 50mg tablets.

Blood tests

You will need a blood test once a week during the first 8 weeks of treatment. You may need blood tests more often if you:

-    are elderly

-    are taking a high dose

-    have a liver or kidney disorder

-    have a bone marrow disorder

-    have an overactive spleen

It is important that you use effective contraception (such as condoms) as Azafalk 50mg tablets may cause birth defects when taken by either the man or woman.

Warning

Any withdrawal of Azafalk 50mg tablets should be performed under close monitoring. Please ask your doctor.

Other medicines and Azafalk 50mg

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, e.g.:

-    Allopurinol, oxipurinol or thiopurinol (treatments for gout)

-    Muscle relaxants such as curare, d-tubocurarine, pancuronium, or succinylcholine

-    Other immunosuppressants such as cyclosporin or tacrolimus

-    Infliximab (a treatment for Crohn’s disease)

-    Olsalazine, mesalazine or sulfasalazine (treatments for ulcerative colitis)

-    Warfarin or phenprocoumon (blood thinners)

-    ACE-inhibitors (treatments for high blood pressure or heart failure)

-    Trimethoprim and sulphamethoxazole (antibiotics)

-    Cimetidine (a treatment for ulcers of the digestive tract)

-    Indomethacin (a treatment for rheumatoid arthritis)

-    Cancer treatments or treatments that slow or stop the production of new blood cells

-    Furosemide (a water tablet for heart failure)

-    Vaccines such as hepatitis B

-    any “live” vaccine

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must not take Azafalk 50mg tablets if you are pregnant unless your doctor tells you to.

Tell your doctor if you are or believe you might be pregnant. Both male and female patients of reproductive age should use a contraceptive other than an interuterine device (e.g. coil, Copper T).

You should continue to use a contraceptive for three months after treatment with Azafalk 50mg tablets has stopped.

You must not breast-feed during treatment with Azafalk 50mg, as metabolic products produced in the body pass into the breast milk and can damage your child.

Driving and using machines

You are safe to drive or operate machinery when taking Azafalk 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.

Azafalk 50mg tablets contain lactose

Azafalk 50mg tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How you take Azafalk 50mg 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 tablets should be taken during meals with a glass of liquid.

Dosage

Patients who have had a transplant:

The usual first day dose is up to 5 mg/kg of body weight per day. The usual dose is then 1-4 mg/kg of body weight per day.

Other conditions:

The usual dosage is 1-3 mg/kg of body weight per day.

Use in children and adolescents:

Azafalk 50mg is not recommended for use in children below 18 years due to insufficient data for the treatment of juvenile chronic arthritis, systemic lupus erythematosus, dermatomyositis and polyarteritis nodosa.

For all other indications, the given dose recommendations apply for children and adolescents as well as for adults.

Elderly:

The elderly may need a reduced dose.

Patients with a liver or kidney disorder may need a reduced dose. Patients with severe liver disorder must not take Azafalk tablets.

The duration of treatment with Azafalk 50mg is determined by your doctor. Please ask your doctor if you think that the effect of Azafalk 50mg is too strong or too weak.

If you take more Azafalk 50mg tablets than you should

Contact your doctor, pharmacist or nearest hospital immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adverse events are listed below by frequency. Frequencies are defined as follows:

Very common:    affects more than 1 user in 10

Common:    affects    1    to    10 users in    100

Uncommon:    affects    1    to    10 users in    1,000

Rare:    affects    1    to    10 users in    10,000

Very rare:    affects    less    than 1 user    in 10,000

Not known:    frequency cannot be estimated from the available data

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects

If you develop any of the following side effects, contact your doctor immediately:

-    Severe sickness

-    Diarrhoea

-    Fever, chills

-    Muscle or bone pain, muscle stiffness

-    Tiredness, dizziness

-    Inflammation of the blood vessels

-    Kidney disorders (symptoms may include changes in the amount of urine passed and changes in its colour)

The following side effects have also been reported:

Very common:

-    infections caused by a virus, fungus or bacteria in transplant patients

-    reduction in your bone marrow function

-    low white blood cell level in your blood tests, which may cause an infection.

-    feeling sick (nausea) and being sick (vomiting), loss of appetite (anorexia).

Common:

-    low blood platelet level, which may cause you to bruise or bleed easily.

Uncommon:

-    infections caused by a virus, fungus or bacteria in all patients except transplant patients

-    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

-    hypersensitivity reactions, which may lead to general discomfort, dizziness, feeling sick, vomiting, diarrhoea, fever, shivering, skin reactions like exanthema and rash, inflammation of the blood vessels, muscle and joint pain, low blood pressure, kidney or liver disorders and problems with your bowel

-    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, and abnormalities in the results of liver function tests.

Rare:

-    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)

-    severe liver damage which can be life threatening

-    hair loss which may get better even though you continue to take Azafalk tablets

-    various types of cancers including blood, lymph and skin cancers.

Very rare:

-    life-threatening allergic reactions leading to severe conditions affecting the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)

-    inflammation of your lungs causing breathlessness, cough and a fever.

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 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 Azafalk 50mg tablets

Keep this medicine out of the sight and reach of children.

Store in the original package to protect from light.

Do not use Azafalk 50mg tablets after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.

Do not use Azafalk 50 mg tablets if you notice any visible signs of deterioration.

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 Azafalk 50mg tablets contain:

The active substance is azathioprine.

Each Azafalk 50mg film-coated tablet contains 50 mg azathioprine.

The other ingredients are:

Tablet core: croscarmellose sodium, colloidal anhydrous silica, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, starch pregelatinized, povidone K25 Tablet coat: Macrogol 3350, Polysorbate 80, Poly(vinyl alcohol), Talc

What Azafalk 50mg tablets look like and contents of the pack

Azafalk 50mg film-coated tablets are yellow, round, biconvex tablets of 9.5 mm marked “50” on one side.

Crushing of the tablets should be avoided. If the film-coating of a tablet is damaged or the tablet is completely crushed, avoid skin contamination and inhalation of tablet particles. For appropriate long-term dosing other medicinal products containing 25 mg should be used, if necessary.

Packaging:

The film-coated tablets are packed in PVC/aluminium blisters in a carton box.

Azafalk 50mg tablets are available in packs of: 20, 30, 50, 60, 90 or 100 film-coated tablets Not all packs sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg Germany

Tel +49 (0) 761 / 1514-0

Fax +49(0) 761 / 1514-321 E-mail: zentrale@drfalkpharma.de

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Germany, Great Britain, Lithuania, The Netherlands, Portugal and Slovenia: Azafalk. This leaflet was last revised in 04/2014

The following information is intended for medical or healthcare professionals only:

AZAFALK 50mg film-coated Tablets Instructions for use and handling and disposal

There are no risks associated with handling tablets with intact coating. In that case no special safety precautions are necessary.

However, Azafalk film-coated tablets should be handled in strict accordance with guidance for handling cytotoxic agents when people have crushed the film-coated tablets.

Surplus medical products as well as contaminated appliances should be temporarily stored in clearly labelled containers. Any unused product or waste material should be disposed of in accordance with local requirements.