PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed
with a doctor’s prescription only.
Imuran Tablets
25 mg, 50 mg
Each tablet contains: 25 mg or 50 mg azathioprine.
* Inactive ingredients and allergens in the preparation see section 6 in the leaflet.
Read this leaflet carefully in its entirety before using
the medicine. This leaflet contains concise information
about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not
pass it on to others. It may harm them even if it seems
to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Therapeutic activity: Immunosuppression.
This effect is important after an organ transplantation, so
that the immune system will not reject the transplanted
organ. Imuran is also used to treat rheumatoid arthritis
that does not respond to other treatments – only by a
rheumatologist in a hospital or clinic.
Therapeutic group: Immunosuppressants.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•you are sensitive (allergic) to the active ingredient
azathioprine or to any of the other ingredients
included in the medicine (see section 6).
•you are sensitive (allergic) to mercaptopurine
(6-MP).
Special warnings regarding use of the medicine
•Before treatment with Imuran, inform the doctor if
⚪you suffer from a liver or kidney disease.
⚪you suffer from a syndrome called LeschNyhan. This is a rare hereditary condition
of deficiency of an agent called HGPRT
(hypoxanthine-guanine-phosphoribosyltransferase).
⚪your body produces too little TPMT (thiopurine
methyltransferase).
⚪you have suffered from chickenpox or herpes zoster,
since the disease may recur.
⚪you are due to be vaccinated, as the vaccine may
not act as required while taking Imuran.
⚪you are a carrier or have had hepatitis B; since there
is a risk of an outbreak of hepatitis.
While taking Imuran, the doctor will tell you to undergo
regular blood tests to monitor your condition.
Additional warnings:
•While under treatment with Imuran, you are at greater
risk of developing different kinds of cancer, including
skin cancer. Avoid overexposure to the sun; cover
yourself and use sunscreens with a high sun protection
factor.
•There is risk of severe infection of chickenpox or
herpes zoster. Avoid contact with anyone who has
these diseases.
•There is risk of other infections, such as progressive
multifocal leukoencephalopathy (PML). Progressive
multifocal leukoencephalopathy may occur in cases
of an inadequate immune system. If there is a sign of
infection, refer to the doctor.
•The tablets contain lactose. If you have been told that
you have an intolerance to certain sugars, inform the
doctor before commencing treatment with Imuran.
If you are taking or have recently taken other
medicines, including non-prescription medicines
and nutritional supplements, inform the doctor or
pharmacist. It is especially important to inform the doctor
or pharmacist if you are taking or plan to take:
•Vaccinations.
•Ribavirin for treatment of viral diseases.
•Methotrexate.
•Allopurinol, oxipurinol, thiopurinol used to treat gout.
•Penicillamine used to treat rheumatoid arthritis.
•ACE inhibitors for treatment of hypertension (e.g.,
captopril).
•Furosemide for treatment of high blood pressure and
heart problems.
•Warfarin for treatment of blood clots.
•Cimetidine for treatment of gastric ulcers and digestive
problems.
•Indomethacin to relieve pain and inflammation.
•Cytostatic medicines, such as certain antibiotics and
medicines to treat certain types of cancer.
•Aminosalicylates such as olsalazine, mesalazine,
balsalazide and sulfasalazine used to treat rheumatoid
arthritis or intestinal problems called ulcerative colitis
or Crohn’s disease.
•Tubocurarine or succinylcholine used for surgeries.
•Co-trimoxazole an antibiotic for treatment of bacterial
infections.
Use of the medicine and food
Do not take Imuran less than one hour before or less than
three hours after food or drinking milk.
Pregnancy and breastfeeding
•If you are pregnant, think you may become pregnant or
are planning to become pregnant, consult the doctor
before commencing treatment with Imuran.
•Do not take Imuran if you are breastfeeding, as small
quantities of it may pass into the breast milk. Consult
the doctor or pharmacist.
•Imuran may increase fertility of men and women. During
the course of treatment, exercise extra caution and use
proper contraceptives. This applies to a man or woman
under treatment with the medicine.
Driving and use of machines
If you experience any side effect as a result of using
this medicine, be careful and if necessary, abstain from
driving and using machines.
3. HOW SHOULD YOU USE THE MEDICINE?
Always use according to the doctor's instructions. Check
with the doctor or pharmacist if you are unsure.
The dosage and treatment regimen will be determined by
the doctor only, in accordance with the severity of your
disease, age, weight and kidney and liver functions.
The elderly or patients with a kidney or liver disease may
need lower dosages.
Take the tablet with a little water. Do not halve, break or
crush the tablet.
Do not exceed the recommended dose.
If you accidentally took a higher dosage
If you took an overdose or if a child accidentally swallowed
the medicine, immediately refer to a doctor or proceed
to a hospital emergency room and bring the package of
the medicine with you.
The immediate signs of overdose are: nausea, vomiting
and diarrhea, lower white blood cell count, unexplained
infection, throat ulcer, bleeding and bruising.
If you forgot to take the medicine
If you forgot to take the medicine at the designated time,
do not take a double dose. If it is almost time for the
next dose, take the next dose at the regular time and
consult the doctor. If not, take the tablet as soon as you
remember and continue treatment as required.
Adhere to the treatment regimen as recommended by the
doctor. Even if there is an improvement in your health,
do not discontinue or change the treatment regimen of
the medicine without consulting a doctor.
•Do not take medicines in the dark! Check the label and
the dose each time you take medicine. Wear glasses if
you need them.
Tests and follow-up
During the course of treatment with this medicine, and
afterwards, be sure to perform blood tests – in the first
eight weeks of taking the medicine, weekly blood tests
should be performed.
When using a high dosage or if there is liver or kidney
failure, perform blood tests more frequently. Afterwards,
perform blood tests once a month or at least once in
three months.
Perform liver function tests in patients with impaired liver
function.
If you have further questions regarding use of this
medicine, consult the doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Imuran may cause side
effects in some users. Do not be alarmed when reading
the list of side effects. You may not experience any of
them.
Discontinue treatment and refer to the doctor
immediately if you notice the following side effects;
there may be a need for urgent medical care:
•An allergic reaction; the signs may include:
⚪General tiredness, dizziness, nausea, vomiting or
diarrhea
⚪High fever, tremor or chills
⚪Skin rash or redness
⚪Muscle or joint pain
⚪Changes in the amount and color of the urine (kidney
problems)
⚪Confusion, weakness – caused by low blood
pressure
•You bruise more easily or notice unusual bleeding.
•You have fever or any other sign of infection.
•You feel extremely tired.
•You notice lumps anywhere on your body.
•You notice any changes in your skin, such as blisters
or peeling.
•Your health condition suddenly declines.
•You have come into contact with someone who is sick
with chickenpox or herpes zoster.
•In case of hepatitis.
Additional side effects
Occurring very frequently
•An infection caused by a virus, fungus or bacterium
in patients who have undergone an organ
transplantation.
•Reduction in your bone marrow function, which may
cause you to feel unwell or which may show up in your
blood tests.
•Low level of white blood cells in blood tests, which may
cause infection.
Occurring frequently
•Nausea.
•Low levels of platelets, which may cause you to bruise
or bleed easily.
Occurring infrequently
•Effects of hypersensitivity to the medicine (allergic
reactions).
•Anemia, low level of red blood cells, which may cause
tiredness, headache, breathlessness during physical
activity, dizziness, paleness.
•Pancreatitis, which may cause severe upper abdominal
pain with nausea and vomiting.
•Infection caused by a virus, fungus or bacterium in
patients who are not after an organ transplantation.
•Liver problems, which may cause light-colored stool,
dark urine, yellow and itchy skin and eyes, abnormal
liver function test results.
Occurring rarely
•Problems in your blood and bone marrow, which may
cause weakness, tiredness, paleness, headache,
sores on the tongue, breathlessness, hemorrhages or
infections.
•Intestinal problems leading to diarrhea, abdominal pain,
constipation, nausea and vomiting.
•Hair loss (may improve with time, despite continued
treatment with Imuran).
•Severe damage to the liver, which may be
life-threatening.
•Different types of cancer, including: cancer of the blood,
lymph and skin.
Occurring very rarely
•Infection in the lungs, which may cause breathlessness,
cough and fever.
•Intestinal damage, which may cause diarrhea,
abdominal pain, constipation, nausea and vomiting
(can indicate intestinal perforation).
•Skin redness or rash – may develop into a lifethreatening skin reaction which includes a widespread
rash with blisters and skin peeling that occurs primarily
around the mouth, nose, eyes and genitals (StevensJohnson syndrome) or widespread skin peeling (toxic
epidermal necrolysis).
•Progressive multifocal leukoencephalopathy (PML).
•Different clinical syndromes, which are seemingly
a manifestation of hypersensitivity (allergy) to the
medicine, such as acute febrile neutrophilic dermatosis
(Sweet's Syndrome). The clinical characteristics
include: general weakness, dizziness, nausea, vomiting,
diarrhea, fever, tremor, roseola, rash, vasculitis, muscle
pain, joint pain, reduced blood pressure, impaired
kidney function, impaired liver function and cholestasis.
Immediate discontinuation of treatment with Imuran,
and if necessary, support therapy, may lead to recovery
in the vast majority of cases, but rare cases of death
have been reported due to hypersensitivity to Imuran;
therefore, carefully weigh the need for prolonged
treatment with the medicine.
If any of the side effects worsens, or if you suffer from
a side effect not mentioned in this leaflet, consult the
doctor.
5. HOW SHOULD THE MEDICINE BE STORED?
•Avoid poisoning! This medicine and any other medicine
must be kept in a closed place out of the sight and
reach of children and/or infants to avoid poisoning. Do
not induce vomiting without explicit instruction from the
doctor.
•Do not use the medicine after the expiry date
(exp. date) that appears on the package and blister. The
expiry date refers to the last day of that month.
•Store below 25°C. Protect from light.
6. FURTHER INFORMATION
In addition to the active ingredient, the medicine also
contains Lactose monohydrate, pregelatinised starch, maize
starch, magnesium stearate, stearic acid.
The Imuran 25 mg tablet coating contains:
Opadry Orange 06B230003 (Titanium dioxide,
Hypromellose, Iron oxide yellow, Iron oxide red, Macrogol
400).
The Imuran 50 mg tablet coating contains:
Hypromellose, macrogol 400.
Important information regarding some of the ingredients
of the medicine –
Each 25 mg tablet contains 37 mg lactose.
Each 50 mg tablet contains 74 mg lactose.
•What the medicine looks like and the contents of the
package –
The Imuran 25 mg tablet is an orange, round tablet
marked with GX EL5.
The Imuran 50 mg tablet is a yellow, round tablet
marked with GX CH1.
The tablets come in blister packages. Each package
contains 100 tablets.
•Registration holder and importer: Perrigo Israel
Agencies Ltd., 29 Lehi Street, Bnei-Brak 51200.
•Manufacturer: Excella GmbH, Feucht, Germany.
•This leaflet was checked and approved by the Ministry
of Health in September 2013.
•Registration number of the medicine in the National
Drug Registry of the Ministry of Health:
Imuran 25 mg tablets: 3479.25384
Imuran 50 mg tablets: 4265.22964