AZATHIOPRINE TABLETS 50 MG - patient leaflet, side effects, dosage

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PACKAGE LEAFLET: INFORMATION FOR THE USER

AZATHIOPRINE TABLETS 50 MG

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.

• 1. What Azathioprine Tablets are and what they are used for

• 2. What you need to know before you take Azathioprine Tablets

• 3. How to take Azathioprine Tablets

• 4. Possible side effects

• 5. How to store Azathioprine Tablets

• 6. Contents of the pack and other information

• 1. WHAT AZATHIOPRINE TABLETS ARE AND WHAT THEY ARE USED FOR

Azathioprine Tablets 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.

Azathioprine is used for protection against organ transplant rejection.

It can also be used to treat various conditions in which the usual treatment (with steroids) is not working properly, is causing problems or where steroids cannot be used. These conditions include hepatitis, rheumatoid arthritis, systemic lupus erythematosus (SLE), dermatomyositis and polymyositis (conditions which affect the muscles and skin), various blood and bleeding disorders and skin disorders.

2. what you need to know before you take azathioprine tablets

Do not take Azathioprine Tablets if you:

• Are allergic to azathioprine, 6-mercaptopurine or any of the other ingredients of this medicine (listed in section 6)
• Are pregnant or breast-feeding, unless your doctor assess it is necessary (see “Pregnancy, breast-feeding and fertility”)
• Have recently had or are due to have a vaccination (with live bacteria or virus) especially BCG, smallpox or yellow fever
• Have severe infection
• Have severe liver disease or severe bone marrow disease
• Have an inflamed pancreas.

Warnings and precautions

Talk to your doctor or pharmacist before taking Azathioprine Tablets if you have:

• liver or kidney disease or severe bone marrow disease
• a condition where your body produces too little 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, breast-feeding and fertility”).
• 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 Azathioprine Tablets)
• ‘Lesch-Nyhan Syndrome’ (a rare condition that runs in families caused by lack of hypoxanthineguanine-phosphoribosyl­transferase (HPRT))
• ever suffered from chickenpox or shingles.

If you are receiving immunosuppressive therapy, taking Azathioprine Tablets could put you at greater risk of:

• tumours, including skin cancer. Therefore, when taking Azathioprine Tablets, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor.
• lymphoproliferative disorders

– treatment with Azathioprine Tablets increases your risk of getting lymphoproliferative disorder. (a type of cancer). With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death – a combination of multiple immunosuppressants, given concomitantly increases the risk of disorders of the lymph system due to a viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders).

Taking Azathioprine Tablets could put you at greater risk of:

• developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people with certain types of arthritis.

There is an increased risk of developing non Hodgkin’s lym­phomas, such as skin cancers, sarcomas and cervical cancer while taking azathioprine. This is mostly reversible on withdrawal of the product.

You must use contraceptive methods whilst taking these tablets and for up to 3 months after you have finished taking them. Discuss with your doctor for suitable contraception methods.

NUDT15-gene mutation

If you have an inherited mutation in the NUDT15-gene (a gene which is involved in the break-down of Azathioprine Tablets in the body), you have a higher risk for infections and hair loss and your doctor may in this case give you a lower dose.

Other medicines and Azathioprine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Azathioprine Tablets can affect the way some medicines work.

In particular if you are taking any of the following medicines:

• methotrexate (mainly used to treat cancers)
• allopurinol, oxipurinol, thiopurinol or other xanthine oxidase inhibitors, such as febuxostat (mainly used to treat gout)
• tubocurarine or succinylcholine-used during operations
• warfarin or phenprocoumon – used for blood clots
• penicillamine – used for rheumatoid arthritis
• co-trimoxazole or trimethoprim – used for infections
• captopril or furosemide – used for high blood pressure or heart problems
• cimetidine – used for stomach ulcers and indigestion
• indomethacin – used for pain and inflammation
• olsalazine or mesalazine – used for a bowel problem called ulcerative colitis or Infliximab (used in Crohn’s disease)
• sulfasalzine or balsalazide – used for rheumatoid arthritis or ulcerative colitis
• clozapine – used to treat schizophrenia.
• ciclosporin or tacrolimus (used as immunosuppressant medicines)
• cytotoxic medicines (used in chemotherapy).
• Before a surgical procedure tell the anesthesiologist that you are taking azathioprine because muscle relaxants used during anesthesia may interact with azathioprine.

Having vaccines while you are taking Azathioprine

If you are going to have a vaccination speak to your i doctor before having it. As vaccines may not work । properly while you are taking this medicine.

Tests you may have while taking Azathioprine ' Tablets

Your doctor may ask you to have a blood test while you are taking Azathioprine Tablets. This is to check your blood cell count. Your doctor may change your dose of Azathioprine Tablets after the test.

Azathioprine Tablets with food and drink Azathioprine Tablets should only be taken by mouth.

This medicine should be swallowed with a little water with or after meals. Do not chew the tablets.

Pregnancy, breast-feeding and fertility

Do not take this medicine if you are a man trying to have a baby or a woman who is pregnant or think might become pregnant. This is because it may affect the baby. You and your partner must use a reliable method of contraception whilst taking Azathioprine Tablets and for at least 3 months after the treatment is discontinued.

Do not take this medicine if you are breast-feeding. Since small amounts may pass into the mother’s milk. 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.

Azathioprine Tablets and the sun

While taking Azathioprine Tablets you may be more likely to develop some types of cancers such as skin cancer. Some people also become sensitive to sunlight which can cause skin discolouration or a rash. Take care to avoid too much sun.

Chickenpox/Shin­gles infection

Infection with chickenpox or shingles can become severe in patients taking immunosuppressive medicine. Therefore you should avoid contact with anyone suffering from chickenpox or shingles.

Driving and using machines

Do not drive or operate machinery if you feel dizzy while taking this medicine.

Azathioprine Tablets contain lactose monohydrate

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 to take azathioprine tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dose of this medicine you take depends on your illness and how bad it is.

The dose also depends on your age, your weight and how well your liver and kidneys are working. Your doctor will explain this to you.

To stop your body rejecting an organ transplant On the first day

• the recommended dose is up to 5 mg per kg of body weight.

For the rest of your treatment

• you will take between 1 and 4 mg per kg of body weight each day.

For other conditions

At the start of your treatment

• you will take 1 to 3 mg per kg of body weight each day
• your doctor may reduce your dose later.

Use in the elderly

Elderly patients will need to be monitored and doses adjusted accordingly.

These are the recommended doses. Your doctor may prescribe different doses to these. The label on the bottle will tell you what dose you should take and for how long. If you are still not sure ask your doctor or pharmacist.

If you take more Azathioprine 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 or may 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 Azathioprine Tablets

Do not worry. Take the missed dose as soon as you remember. However, if it is almost time for your next dose, leave out the missed dose and take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Azathioprine Tablets

Do not stop taking your medicine unless the doctor tells you because stopping your medicine can make your condition worse or desired effect of the medicine may not achieved.

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

4. possible side effects

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

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

• Allergic reaction, (these are uncommon side effects which may affect upto 1 in 100 people) the signs may include:

• – swelling of the eyelids, face or lips

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

• – high temperature (fever), shivering or chills

• – redness of the skin, skin nodules or a skin rash (including blisters, itching or peeling skin)

• – 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

• Bruise more easily or notice any unusual bleeding
• Have a high temperature (fever) or other signs of an infection
• Notice lumps anywhere on your body
• Feel extremely tired or health suddenly gets worse
• Sudden wheeziness or difficulty in breathing
• You come into contact with anyone who is suffering from chickenpox or shingles.
• Ulcers in throat.

Other side effects include:

Very common (may affect 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 infections more likely
• Feeling sick (nausea) and being sick (vomiting).
• Loss of appetite (anorexia)

Common (may affect upto 1 in 10 people)

• Low blood platelet level, which may cause you to bruise or bleed easily.
• Increased infections in patients with bowel inflammation
• Decrease in red blood cells in the blood (anaemia)
• Decrease in white blood cells in patients with rheumatoid arthritis
• Liver disease
• Certain type of lymphomas (hepatosplenic T-cell lymphoma)
• 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
• Inflammation of the pancreas, which causes severe pain in the abdomen and back

Uncommon (may affect up to 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 and being sick
• Liver problems, which may cause pale stools, dark urine, itchiness and yellowing of your skin and eyes.
• Increased infections in patients suffering from rheumatoid arthritis
• Blood disorder after transplant surgery
• Foul smelling stools which are bulky, loose and greasy
• Allergic reactions including dizziness, confusion, feeling light headed or weak, caused by low blood pressure, low number of white blood cells, fever, feeling cold, diarrhoea, rash, rigors, kidney problems, muscle pain (myalgia), pain in the joint (arthralgia), inflammation of bloodvessels (vasculitis), high number of liver enzymes
• Hair loss (alopecia)
• Liver problems in patients with rheumatoid arthritis

Rare (may affect up to 1 in 1,000 people)

• Problems with your blood and bone marrow not producing enough blood cells (aplastic anaemia) which may cause weakness, tiredness, paleness, headaches, sore tongue, breathlessness, bruising or infections
• Problems with your bowel leading to diarrhoea, abdominal pain, constipation, feeling and being sick, stomach ulcers (which can bleed), stomach discomfort following transplantation
• Hair loss which may get better even though you continue to take this medicine
• Severe liver damage which can be life threatening
• Sensitivity to sunlight which can cause skin discolouration or a rash
• Cough and fever caused by pneumonia or inflammation of the lung
• Blood and bone marrow disorders (including granulocytopenia, pancytopenia, megaloblastic anaemia, erythroid hypoplasia and agranulocytosis).
• Various types of cancers including blood, lymph and skin cancers (see section 2 Warnings and precautions)

Very rare (may affect up to 1 in 10.000 people)

• Inflammation of your lungs causing breathlessness, cough and a fever.
• Blood disorders (including acute myeloid leukaemia and myelo-dysplastic syndromes)
• Life-threatening severe allergic reaction
• Severe skin conditions (Stevens-Johnson syndrome and toxic epidermal necrolysis) which can be life threatening.

Not known (frequency cannot be estimated from the available data)

• You may develop a rash (raised red. pink or purple lumps which are sore to touch), particularly on your arms, hands, fingers, face and neck, which may also be accompanied by a fever (Sweet's syndrome, also known as acute febrile neutrophilic dermatosis).

Azathioprine has been known to cause alterations to chromosomes (the sites of genes) in body cells, which is reversible on withdrawal of the drug.

Check with your doctor or pharmacist if you become unwell or have any other discomfort you do not understand.

Reporting of side effects

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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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. HOWTO STORE AZATHIOPRINETABLETS Keep this medicine out of the sight and reach of children.

6. contents of the pack and other information

What Azathioprine Tablets 50mg contains

The active substance is azathioprine.

The other ingredients are: Maize starch Microcrystalline cellulose

Lactose monohydrate (see section 2)

Magnesium stearate

Talc

Sodium starch glycollate (Type A)

What Azathioprine Tablets 50mg look like

and contents of the pack

Description: Pale yellow biconvex tablets, scored on one side and engraved with a logo on the other side (mortar and pestle).

Contents of pack: Blister pack.

Each blister contains 14 tablets. The tablets are supplied to your pharmacist in packs containing 28, 50. 56. 100 or 250 tablets, who will then provide you with the required number of tablets as prescribed by your doctor (not all pack sizes may be marketed).

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Marketing Authorisation Holder and Manufacturer

Strides Pharma UK Ltd.

Unit 4, Metro Centre. Tolpits Lane.

Watford. Herts. UK. WD18 9SS

Tel: 01923 255580. Fax: 01923 255581

This leaflet was last revised in July 2021

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CHS

Dimension : 150 × 400 mm

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