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Azathioprine 50mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Azathioprine 25 mg film-coated tablets Azathioprine 50 mg film-coated tablets


Azathioprine


Read 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 Azathioprine is and what it is used for

2.    Before you take Azathioprine

3.    How to take Azathioprine

4.    Possible side effects

5.    How to store Azathioprine

6.    FuWeaiAzatftonprine is and what it

is used for



Azathioprine belongs to the immunosuppressive group of medicines, medicines suppressing the immune responses of the body.

Azathioprine is used in combination with other immunosuppressives (e.g. adrenocorticotropic hormones) in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants, to prevent rejection of the transplanted organ.

Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids.

Azathioprine is in severe cases also used for the treatment of the following diseases in patients who are intolerant to steroids or who are dependent on steroids and in whom the therapeutic response is inadequate despite treatment with high doses of steroids.

•    Severe active rheumatoid arthritis that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic drugs (DMARDs))

•    Severe or moderately severe inflammatory intestinal diseases (Crohn’s disease or ulcerative colitis)

•    An inflammation-like disease of the skin and/or intestines (systemic lupus erythematosus)

•    A disease of the connective tissue whereby the skin and muscles are affected (dermatomyositis) and non-hereditary muscular disease with inflammatory symptoms (polymyositis)

•    A long-term inflammation of the liver cells where the immune system reacts against the body (auto-immune hepatitis)

•    Infestation of the blood vessels which often results in loss of weight, fatigue and gastrointestinal tract disorders (polyarteritis nodosa)

•    Refractory warm auto-immune haemolytic anaemia

•    A certain form of extravasation of blood in the skin and/or mucous membranes accompanied by a blood platelet deficiency (chronic refractory idiopathic thrombocytopenic purpura).


2 Before you take Azathioprine


Do not take Azathioprine

•    if you are allergic to azathioprine, 6-mercaptopurine (a derivative of azathioprine) or to any of the other ingredients in the tablet.

•    if you suffer from serious infections.

•    if your liver or bone marrow is not functioning properly.

•    if you have an inflammation of the pancreas.

•    if you are pregnant (unless the benefits outweigh the risks, see section “Pregnancy”).

•    if you breast-feed.

When you take azathioprine you cannot be administered a live vaccine, such as TB, smallpox or yellow fever vaccine.

Take special care with Azathioprine

•    You must be under medical supervision during the entire treatment with Azathioprine. Your doctor must do a complete check of your blood on a regular basis. During the first 8 weeks of the treatment this must happen weekly, afterwards once every 3 months.

This check is performed more frequently if:

-    higher dosages are used.

-    the patients are older.

-    the kidneys do not function properly.

-    the liver function is slightly or mildly disturbed (also see the section “Do not take Azathioprine”).

-    if the bone marrow function is slightly or mildly disturbed (also see the section “Do not take Azathioprine”).

-    patients with excessive function of the spleen (hypersplenism).

You should call your doctor immediately if you have ulcers in your mouth, fever, infections, bruises, bleedings or other symptoms which might indicate an inhibiting effect on the bone marrow (myelosuppression).

•    Patients suffering from the Lesch-Nyhan syndrome (a hereditary metabolic disorder in boys with excessive of uronic acid in the blood, excessive liveliness, mental defectiveness) can not use azathioprine as this medicine has no effect on these patients

•    Just like with other medicines that are suppressing the immune system there is a chance of developing tumours, especially if the skin is exposed to the sun. For this reason it is advisable to avoid direct sunlight (ultraviolet rays) on the skin as much as possible and to check your skin on a regular basis (see section “Side effects”)

•    Effects on fertility

Relief of chronic renal insufficiency by renal transplantation involving the administration of azathioprine has been accompanied by increased fertility in both male and female transplant recipients (for contraceptive measures see section “Pregnancy and breast-feeding”).

Azathioprine must be used with care:

•    if you suffer from untreated, suddenly occurring infections (see section “Do not take Azathioprine”).


•    if you also use allopurinol, oxipurinol or thiopurinol (medicines treating gout), mesalazine, olsalazine or sulphasalazine (medicines treating gastroenteritis), ACE inhibitors (a group of hypotensive medicines), trimethoprim/sulphamethoxazole (medicines treating contagious illnesses), cimetidine (treating stomach disorders), indometacin (medicine treating gout, pain and/or inflammations) or substances with a toxic effect or inhibiting effect on the bone marrow.

•    if you seem to have a deficiency of a certain substance (thiopurine methyltransferase), the conversion of azathioprine cannot take place entirely.

•    if you also use medicines that are working on the nerves and muscles (such as curare, pancuronium, tubocurarine or succinylcholine). In case you must undergo a surgery and use these medicines together with Azathioprine, you must inform the doctor (who is giving you anaesthesia) about it (see also “Taking/Using other medicines”).

•    in case you use certain blood-thinning drugs (of the coumarine type). The doctor will examine you more often.

•    if the doctor decides that you can stop using Azathioprine; the doctor will gradually reduce the dosage.

•    if certain vaccines are administered at the same time. The doctor will check your immunoreaction.

•    if you use medicines which inhibit cell growth and cell division (cytostatics; frequently used for cancer). You can only combine these medicines under medical supervision.

Consult your doctor if one of the above-mentioned disorders applies to you, or has applied to you in the past.

Taking/Using other medicines

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

Azathioprine and other medicines can interact with each other (both in their functioning and in their side effects). This holds for the following medicines:

•    Allopurinol, oxipurinol and/or thiopurinol (medicines against gout among other things); the conversion of azathioprine in the body is inhibited

•    Medicines providing complete muscular relaxation (in surgeries), such as curare, pancuronium, tubocurarine or succinylcholine; the effect of these medicines may be affected

•    Cyclosporine and tacrolimus (medicines for transplants etc.); the effect of these medicines will be increased, causing an excessive suppression of the immune system

•    Aminosalicylic acid derivatives such as olsalazine, mesalazine or sulfasalazine (medicines treating Crohn’s disease etc.); it can have an inhibiting effect on the bone marrow

•    Warfarin (blood-thinning medicine); the blood-thinning effect of this medicine may decrease

•    The so-called ACE inhibitors (for heart weakness etc., e.g. captopril), trimethoprim/sulfamethoxazole (medicines against certain infection), cimetidine (medicine for gastrointestinal ulcers etc.), indometacin (medicine against certain rheumatic disorders); there is a greater chance of an inhibiting effect on the bone marrow

•    Medicines that have an inhibiting effect on the bone marrow or medicines against cancer; that the bone marrow function will be suppressed

•    Certain vaccines; the effect of the vaccines can be reduced (see also the section “Do not take Azathioprine”).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

During pregnancy you can only use azathioprine when your doctor has advised it to you and after carefully balancing the benefits and disadvantages against each other.

After Azathioprine has been administered to the mother it can be found, together with its degradation products, in the blood of the foetus and in the amniotic fluid. Some newborn babies, whose mother used azathioprine, show anomalies in the blood. For this reason it is advisable to carefully examine the blood during pregnancy. During treatment and during the first 3 months after stopping the treatment with azathioprine, both male and female patients, who are sexually mature, must take measures to prevent pregnancy. This also holds for patients with decreased fertility as a result of sustained blood poisoning due to improper functioning of the kidneys (uraemia). The fertility can be restored after the transplantation.

Azathioprine can lower the functioning of contraceptives which were applied in the uterus (intrauterine anticonceptives).

Using Azathioprine together with Prednisone (a medicine used against inflammation among other things) during pregnancy can cause a temporary decrease of the immune function. This combination can lead to growth retardation or premature birth. It is not known which effects it has in the long term.

Mercaptopurine (a derivative of azathioprine) is excreted into mother’s milk. Azathioprine cannot be used during the period of breast-feeding (see section “Do not take Azathioprine”).

Driving and using machines

No data is known about the effect of Azathioprine on the ability to drive and on the capacity to use machines.

Important information about some of the ingredients of Azathioprine

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


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3 How to take Azathioprine


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

The usual dose is:

•    Transplantation

The daily dosage usually starts with maximum of 5 mg per kg of bodyweight.

After that the daily dosage can be reduced to 1-4 mg per kg of bodyweight.

•    Other disorders

The daily dosage usually starts with 1-3 mg per kg of body weight. After that the daily dosage may be reduced by your doctor.

For the treatment of auto-immune hepatitis the daily dosage will range between 1 and 1.5 mg per kg of bodyweight.

Patients with kidney and/or liver damage Your doctor will determine a dosage on the low side of the above-mentioned dose-ranges. Azathioprine cannot be used if you suffer from serious liver disorders (see section “Do not take Azathioprine”).

Children and adolescents Insufficient data is available with regard to the treatment of children and young people below the age of 18 concerning:

•    juvenile idiopathic (cause unknown) rheumatic inflammation of the joints

•    rheumatic inflammation of the joints

•    an inflammation-like disease of the skin and/or intestines (systemic lupus erythematosus)

•    a disease of the connective tissue attacking the skin and the muscles (dermatomyositis) and

•    an infestation of the blood vessels which often results in loss of weight, fatigue and gastrointestinal tract disorders (polyarteritis nodosa).

With regard to the other disorders, the same dosages are used as those which are commonly prescribed to adults.

Older patients

Your doctor will determine a dosage on the low side of the above-mentioned dosage ranges. The blood must be checked extra carefully.

If you notice that the effect of Azathioprine is either too strong, or too weak, please consult your doctor or pharmacist.

Method and duration of treatment For oral use.

Azathioprine Film-coated Tablets should be taken with at least a glass of water (200 ml), during meals. If the tablet has to be halved or crushed, contact of the skin with the powder or the broken part of the tablet should be avoided.

Your doctor will tell you how long you must use Azathioprine. It may take weeks or months before you notice the effect of Azathioprine.

However, if there is no effect within 3 to 6 months your doctor might consider to stop the treatment. You cannot stop the treatment yourself, this must always be done gradually and under medical supervision.

If you take more Azathioprine than you should

Immediately consult your doctor or pharmacist if you have taken too much Azathioprine. Following symptoms may indicate an overdose: tiredness, ulcers in the throat, fever, infections, bruises and bleedings.

If you forget to take Azathioprine

Do not take a double dose to make up for a forgotten dose.

Follow the normal dosage schedule. If you have forgotten to take more than one dose, please contact your doctor.

If you stop taking Azathioprine

Stopping treatment with Azathioprine can worsen the following diseases:

•    Systemic lupus erythematosus with nephritis (an inflammatory disease of the skin and/or intestines with an inflammation of the kidneys accompanied by blood in the urine, fever and pain in the flanks)

•    Serious inflammations in the gastrointestinal tract (Crohn’s disease or ulcerative colitis)

•    Inflammation of the liver cells where the immune system reacts against the body (auto-immune disease).

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


•    liver problems, which may cause pale stools, dark urine, itchiness and yellowing of your skin and eyes.

Rare (affects less than 1 in 1,000 people)

•    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)

•    hair loss which may get better even though you continue to take Azathioprine

•    severe liver damage which can be life threatening

•    various types of cancers including blood, lymph and skin cancers

•    sensitivity to sunlight which can cause skin discolouration or a rash.

Very rare (affects less than 1 in 10,000 people)

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

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


5 How to store Azathioprine


Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Azathioprine after the expiry date which is stated on the blister strip and on the carton after “EXP”. The expiry date refers to the last day of that month.

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.


6 Further information


What Azathioprine contains

Active Substance: 25 mg of azathioprine (Azathioprine 25 mg Film-coated Tablets) and 50 mg of azathioprine (Azathioprine 50 mg Film-coated Tablets)

Other ingredients: lactose monohydrate, maize starch, povidone, colloidal silicon dioxide, magnesium stearate, hypromellose, microcrystalline cellulose, polyoxyl-8-stearate, talc.

Colouring agent: titanium dioxide (E171).

What Azathioprine 25 mg looks like and contents of the pack

Azathioprine Film-coated Tablets are white to yellowish-white film-coated tablets, biconvex with no score-line.

Pack sizes: 20, 28, 30, 50 or 100 film-coated tablets.

What Azathioprine 50 mg looks like and contents of the pack

Azathioprine 50 mg Film-coated Tablets are white to yellowish-white film-coated tablets, biconvex with score-line on one side.

Pack sizes: 20, 30, 50, 56 or 100 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,39179 Barleben, Germany.

This leaflet was last approved in 04/2012.


4 Possible side effects


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

The following side effects may happen with this medicine:

Stop taking Azathioprine and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:

•    allergic reaction, the signs may include:

-    general tiredness, dizziness, feeling sick (nausea), being sick (vomiting) or diarrhoea

-    high temperature (fever), shivering or chills

-    redness of the skin or a skin rash

-    pain in the muscles or joints

-    changes in the amount and colour of the urine (kidney problems)

-    dizziness, confusion, feeling light headed or weak, caused by low blood pressure

•    you bruise more easily or notice any unusual bleeding

•    you have a high temperature (fever) or other signs of an infection

•    you feel extremely tired

•    you notice lumps anywhere on your body

•    you notice any changes to your skin, for example blisters or peeling

•    your health suddenly gets worse

•    you come into contact with anyone who is suffering from chickenpox or shingles.

If you notice any of the above, stop taking Azathioprine and see a doctor straight away.

Other side effects include:

Very common (affects more than 1 in 10 people)

•    infections caused by a virus, fungus or bacteria

•    reduction in your bone marrow function, which may make you feel unwell or show up in your blood tests

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

Common (affects less than 1 in 10 people)

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

Uncommon (affects less than 1 in 100 people)

•    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

•    inflammation of the pancreas, which may cause you severe upper stomach pain, with feeling sick (nausea) and being sick (vomiting)


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