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AZATHIOPRINE 75MG FILM COATED TABLETS

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Ebewe
Immunoprin 75 & 100 mg film-Coated Tablets

PL 14510/00560057

Patient Information Leaflet
09 Demceber 2010

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMMUNOPRIN 75 mg FILM-COATED TABLETS
IMMUNOPRIN 100 mg FILM-COATED TABLETS
(azathioprine)
In this leaflet, the product will be referred to as Immunoprin tablets.
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 Immunoprin tablets is and what it is used for
2.
Before you take Immunoprin tablets
3.
How you take Immunoprin tablets
4.
Possible side effects
5.
How to store Immunoprin tablets
6.
Further information
1.

WHAT IMMUNOPRIN TABLETS IS AND WHAT IT IS USED FOR

Immunoprin tablets contain the active ingredient azathioprine, which belongs to a group of medicines
called immunosupressives. Immunosuppressives reduce the strength of your immune system. Your
doctor has prescribed Immunoprin 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.
Immunoprin 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.

BEFORE YOU TAKE IMMUNOPRIN TABLETS

Do not take Immunoprin tablets if you:
- are allergic (hypersensitive) to azathioprine, mercaptopurine, or any of the ingredients of
Immunoprin tablets (see list of ingredients 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
Take special care with Immunoprin tablets
You will not be given Immunoprin tablets unless you can be monitored for side effects.
PIL.14510.0056-7.002d

V001G – Add Salutas as batch release site
and others – further changes

VM

Ebewe
Immunoprin 75 & 100 mg film-Coated Tablets

PL 14510/00560057

Patient Information Leaflet
09 Demceber 2010

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 Immunoprin 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 Immunoprin tablets.
If the film-coated tablet has to be halved, contact of the skin with tablet dust or the broken area must
be avoided.
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 Immunoprin tablets may cause
birth defects when taken by either the man or woman.
Warning:
Any withdrawal of Immunoprin tablets should be performed under close monitoring. Please ask your
doctor.
Taking 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, 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 sulpfamethoxazole (antibiotics)
- Cimetidine (a treatment for ulcers of the digestive tract)
- 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
You must not take Immunoprin 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).
PIL.14510.0056-7.002d

V001G – Add Salutas as batch release site
and others – further changes

VM

Ebewe
Immunoprin 75 & 100 mg film-Coated Tablets

PL 14510/00560057

Patient Information Leaflet
09 Demceber 2010

You should continue to use a contraceptive for three months after treatment with Immunoprin tablets
has stopped.
You may not breast-feed during treatment with Immunoprin, as metabolic products produced in the
body pass into the breast milk and can damage your child.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
You are safe to drive or operate machinery when taking Immunoprin 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.
Important information about some of the ingredients of Immunoprin tablets
Immunoprin 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 IMMUNOPRIN TABLETS

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.
Children and adolescents:
Immunoprin is not recommended for use in children below18 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 Immunoprin tablets.
The duration of treatment with Immunoprin is determined by your doctor.
Please ask your doctor if you think that the effect of Immunoprin is too strong or too weak.
If you take more Immunoprin 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.

PIL.14510.0056-7.002d

V001G – Add Salutas as batch release site
and others – further changes

VM

Ebewe
Immunoprin 75 & 100 mg film-Coated Tablets

PL 14510/00560057

Patient Information Leaflet
09 Demceber 2010

4.
POSSIBLE SIDE EFFECTS
Like all medicines, Immunoprin tablets 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:
l 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)
PIL.14510.0056-7.002d

V001G – Add Salutas as batch release site
and others – further changes

VM

Ebewe
Immunoprin 75 & 100 mg film-Coated Tablets

-

PL 14510/00560057

Patient Information Leaflet
09 Demceber 2010

severe liver damage which can be life threatening
hair loss which may get better even though you continue to take Immunoprin 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.

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

5.

HOW TO STORE IMMUNOPRIN TABLETS

Keep out of the reach and sight of children.
Store in the original package to protect from light.
Do not use Immunoprin tablets after the expiry date which is stated on the box after "EXP". The
expiry date refers to the last day of that month.
Medicine 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 Immunoprin tablets contain:
Each film-coated tablet contains 75 or 100 mg azathioprine.
The other ingredients are:
Tablet core: Cellulose, microcrystalline (E460), Lactose monohydrate, Maize starch, Povidone K25
(E1201), Croscarmellose sodium, Magnesium stearate, Silica coloidal anhydrous
Tablet coat: Polyvinylalcohol, Talc (E553b), Macrogol 3350, Polysorbate 80 (E433), Purified water

What Immunoprin tablets look like and contents of the pack
Immunoprin 75 mg film-coated tablets are light yellow, round tablets with a break line
Immunoprin 100 mg film-coated tablets are light yellow, oblong tablets with a break line
Splitting of the tablets should be avoided. If splitting of the tablets might be necessary, 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:
Polyethylene plastic container with a PE screw closure containing 50 or 100 film-coated tablets.
Not all packs sizes may be marketed.

Marketing Authorisation Holder:
Ebewe Pharma Ges.m.b.H. Nfg. KG
Mondseestraße 11, 4866 Unterach
Austria
PIL.14510.0056-7.002d

V001G – Add Salutas as batch release site
and others – further changes

VM

Ebewe
Immunoprin 75 & 100 mg film-Coated Tablets

PL 14510/00560057

Patient Information Leaflet
09 Demceber 2010

Manufacturer:
Ebewe Pharma Ges.m.b.H. Nfg. KG
Mondseestraße 11, 4866 Unterach
Austria

Or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany
This leaflet was last approved in 11/2011
-------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
IMMUNOPRIN 75 and 100 mg 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, cytotoxic agents should be handled in strict accordance with the instructions when nursing
staff have halved the 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.

PIL.14510.0056-7.002d

V001G – Add Salutas as batch release site
and others – further changes

VM

Expand Transcript

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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