AZATHIOPRINE 50MG TABLETS

Active substance: AZATHIOPRINE

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PIL-623UK_AZA_V2.qxp

14/01/2012

02:36

A R R O W

Page 1

G E N E R I C S

L I M I T E D

• tel: 01438 737 630 • email: geoff.corrin@arrowgenerics.com

Distributor:

Not applicable - generic component

Product:

Azathioprine 50mg Tablets

Reference:

PIL-623UK_AZA_V2

MA number:

PL 18909/0093

A/W version

Version 2

Dimensions:

210 x 297 mm

Inks used:

Black

Date:

14/01/2012

Software:

QuarkXpress 6.5

Pages:

2 (not including this one)

APPROVED BY
Technical:

Sales:

Regulatory:

(Details & date)
Health Authority:

Confirm PDF saved to fileserver (sign& date):
Comments:

The printed PIL will state the primary site of batch release, which will be one of the following Selamine Limited T/A Arrow Generics Limited, Unit 4, Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh,
Dublin 17, Ireland
Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate, Birzebbugia BBG 06, Malta
This PIL states Arrow Pharm (Malta) Limited as an example
Item and pharmacodes will be inserted before printing.

PIL-623UK_AZA_V2.qxp

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Page 2

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 symptoms 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.
In this leaflet:
1. What Azathioprine 50mg Tablets are and what they are used for
2. Before you take Azathioprine 50mg Tablets
3. How to take Azathioprine 50mg Tablets
4. Possible side effects
5. How to store Azathioprine 50mg Tablets
6. Further information
1. WHAT AZATHIOPRINE 50MG TABLETS ARE AND WHAT THEY
ARE USED FOR
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.
2. BEFORE YOU TAKE AZATHIOPRINE 50MG TABLETS
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”).
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.

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.
3. HOW TO TAKE AZATHIOPRINE 50MG 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.

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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.
4. POSSIBLE SIDE EFFECTS
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).
Common side effects (probably affecting less than 1 in 10 patients):
• liver disease
• decrease in red blood cells in
• increased infections in patients
the blood (anaemia)
with bowel inflammation
• inflammation of the pancreas,
• reduction in blood platelets
which causes severe pain in the
which increases risk of bleeding
abdomen and back.
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.

Uncommon side effects (probably affecting less than 1 in 100 patients):
• allergic reactions including
• increased infections in patients
dizziness or feeling unwell, low
suffering from rheumatoid
blood pressure, fever, feeling
arthritis
cold , feeling severely sick and
• blood disorder after transplant
vomiting, diarrhoea, rash, rigors,
surgery
kidney problems, muscle pain
• foul smelling stools which are
(myalgia), pain in the joint
bulky, loose and greasy
(arthralgia), inflammation of
• hair loss (alopecia).
blood vessels (vasculitis), high
number of liver enzymes
Rare side effects (probably affecting less than 1 in 1000 patients):
• paleness or fatigue or feeling
• stomach ulcer and disease
short of breath caused when the
which may cause heartburn,
body’s bone marrow is not
vomiting, general discomfort in
producing enough blood cells
the stomach.
(aplastic anaemia)
• 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 myelodysplastic 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. HOW TO 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.
6. FURTHER INFORMATION
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.
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:
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage,
Hertfordshire SG1 4SZ, United Kingdom
Manufacturer:
Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate,
Birzebbugia BBG 06, Malta
This leaflet was last approved in 01/2012.
Code

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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