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IMATINIB 100MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESILATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Imatinib 100mg film-coated tablets
Imatinib 400mg film-coated tablets
imatinib mesilate
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.
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.
What is in this leaflet:
1. What imatinib is and what it is used for
2. What you need to know before you take
imatinib
3. How to take imatinib
4. Possible side effects
5. How to store imatinib
6. Contents of the pack and other information
1. WHAT IMATINIB IS AND WHAT IT IS
USED FOR
Imatinib is a medicine containing an active
substance called imatinib mesilate. This 
medicine works by  inhibiting the growth of
abnormal cells in the diseases listed below.
These include some types of cancer.
Imatinib is a treatment for adults and
children for:
– Chronic myeloid leukaemia (CML).
Leukaemia is a cancer of white blood cells.
These white cells usually help the body to
fight infection. Chronic myeloid leukaemia
is a form of leukaemia in which certain
abnormal white cells (named myeloid cells)
start growing out of control. In adult
patients, imatinib is used to treat a late
stage of CML called “blast crisis”. In
children and adolescents however it may
be used to treat all stages of the illness.
– Philadelphia chromosome positive
acute
lymphoblastic
leukaemia
(Ph-positive ALL). Leukaemia is a cancer
of white blood cells. These white cells
usually help the  body to fight infection.
Acute lymphoblastic leukaemia is a form of
leukaemia in which certain abnormal white
cells (named lymphoblasts) start growing
out of control. Imatinib inhibits the growth
of these cells.
Imatinib is also a treatment for adults for:
– Myelodysplastic/myeloproliferative
diseases (MDS/MPD). These are a group
of blood diseases in  which some blood
cells start growing out of control. Imatinib
inhibits the growth of these cells in a certain
subtype of these diseases.
– Hypereosinophilic syndrome (HES)
and/or chronic eosinophilic leukaemia
(CEL). These are blood diseases in which
some blood cells (named eosinophils) start
growing out of control. Imatinib inhibits the 
growth of these cells in a certain subtype of
these diseases.
– Dermatofibrosarcoma
protuberans
(DFSP). DFSP is a cancer of the tissue
beneath the skin in which some cells start
growing out of control. Imatinib inhibits the
growth of these cells.
In the rest of this leaflet, we will use the
abbreviations when talking about these
diseases.
If you have any questions about how imatinib
works or why this medicine has been prescribed
for you, ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE IMATINIB
Imatinib will only be prescribed to you by a
doctor with experience in medicines to treat
blood cancers or solid tumours.
Follow all your doctor’s instructions carefully,
even if they differ from the general information
contained in this leaflet.
Do not take imatinib
– if you are allergic to imatinib or any of the
other ingredients of this medicine listed in
section 6.
If this applies to you, tell your doctor without
taking imatinib.
If you think you may be allergic but are not sure,
ask your doctor for advice.
Warnings and precautions
Talk to your doctor before taking imatinib
– if you have or have ever had a liver, kidney
or heart problem.
– if you are taking the medicine levothyroxine
because your thyroid has been removed.
If any of these apply to you, tell your doctor
before taking imatinib.
During treatment with imatinib, tell your
doctor straight away if you put on weight very
quickly. Imatinib may cause your body to retain
water (severe fluid retention).
While you are taking imatinib, your doctor will
regularly check whether the medicine is working.
You will also have blood tests and be weighed
regularly.
Children and adolescents
Imatinib is also a treatment for children with
CML. There is no experience in children with
CML below 2 years of age. There is limited
experience in children with Ph-positive ALL and
very limited experience in children with
MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking imatinib
may have slower than normal growth. The doctor
will monitor the growth at regular visits.
Other medicines and imatinib
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription (such as paracetamol) and
including herbal medicines (such as St. John’s
Wort). Some medicines can interfere with the
effect of imatinib when taken together. They may
increase or decrease the effect of imatinib, either
leading to increased side effects or making
imatinib less effective. Imatinib may do the same
to some other medicines.
Tell your doctor if you are using medicines that
prevent the formation of blood clots.
Pregnancy, breast-feeding and fertility
– If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor for advice
before taking this medicine.
– Imatinib is not recommended during
pregnancy unless clearly necessary as it
may harm your baby. Your doctor will
discuss with you the possible risks of
taking imatinib during pregnancy.
– Women who might become pregnant are
advised to use effective contraception
during treatment.
– Do not breast-feed during the treatment
with imatinib.
– Patients who are concerned about their
fertility while taking imatinib are advised to
consult with their doctor.
Driving and using machines
You may feel dizzy or drowsy or get blurred
vision while taking this medicine. If this happens,
do not drive or use any tools or machines until
you are feeling well again.
3. HOW TO TAKE IMATINIB
Your doctor has prescribed imatinib because
you suffer from a serious condition. Imatinib can
help you to fight this condition.
Always take this medicine exactly as your doctor
or pharmacist has told you. It is important that
you do this as long as your doctor or pharmacist
tells you to. Check with your doctor or 
pharmacist if you are not sure.
Do not stop taking imatinib unless your doctor
tells you to. If you are not able to take the 
medicine as your doctor prescribed or you feel
you do not need it anymore, contact your doctor
straight away.
How much imatinib to take
Use in adults
Your doctor will tell you exactly how many
tablets of imatinib to take.
– If you are being treated for CML:
The usual starting dose is 600 mg to be
taken as 6 tablets once a day.
For CML, your doctor may prescribe a higher or
lower dose depending on how you respond to
the treatment. If your daily dose is 800 mg
(8 tablets), you should take 4 tablets in  the
morning and 4 tablets in the evening.
– If you are being treated for Ph-positive
ALL:
The starting dose is 600 mg to be taken as
6 tablets once a day.
– If you are being treated for MDS/MPD:
The starting dose is 400 mg to be taken as
4 tablets once a day.
– If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as
1 tablet once a day. Your doctor may decide
to increase the dose to 400 mg, to be taken as
4 tablets once a day, depending on how you
respond to treatment.
– If you are being treated for DFSP:
The dose is 800 mg per day (8 tablets), to
be taken as 4 tablets in the morning and 
4 tablets in the evening.
Use in children and adolescents
The doctor will tell you how many tablets of
imatinib to give to your child. The  amount of 
imatinib given will depend on your child’s
condition, body weight and height. The total
daily dose in children must not exceed 800 mg
and 600 mg with Ph+ALL. The treatment can
either be given to your child as a once-daily dose
or alternatively the daily dose can be  split into
two administrations (half in the morning and half
in the evening).
When and how to take imatinib
– Take imatinib with a meal.
This will help protect you from stomach
problems when taking imatinib.
– Swallow the tablets whole with a large
glass of water.
– The tablet can be divided into equal doses.
If you are unable to swallow the tablets, you
can dissolve them in a glass of still water or 
apple juice.
– Use about 50 ml for each 100 mg tablet.
– Stir with a spoon until the tablets have
completely dissolved.
– Once the tablet has dissolved, drink
everything in the glass straight away.
Traces of the dissolved tablets may be left
behind in the glass.
How long to take imatinib
Keep taking imatinib every day for as long as
your doctor tells you.
If you take more imatinib than you should
If you have accidentally taken too many tablets,
talk to your doctor straight away. You may
require medical attention. Take the medicine
pack with you.

If you forget to take imatinib
– If you forget a dose, take it as soon as you
remember. However if it is nearly time for 
the next dose, skip the missed dose.
– Then continue with your normal schedule.
– Do not take a double dose to make up a
forgotten dose.
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. They
are usually mild to moderate.
Some side effects may be serious. Tell your
doctor straight away if you get any of  the 
following:
Very common (may affect more than 1 in
10 people) or common (may affect up to 1 in
10 people):
– Rapid weight gain. Imatinib may cause
your body to retain water (severe fluid
retention).
– Signs of infection such as fever, severe
chills, sore throat or mouth ulcers. Imatinib
can reduce the number of white blood
cells, so you might get infections more
easily.
– Unexpected bleeding or bruising (when
you have not hurt yourself).
Uncommon (may affect up to 1 in 100 people)
or rare (may affect up to 1 in 1,000 people):
– Chest pain, irregular heart rhythm (signs of
heart problems).
– Cough, having difficulty breathing or painful
breathing (signs of lung problems).
– Feeling light-headed, dizzy or fainting
(signs of low blood pressure).
– Feeling sick (nausea), with loss of appetite,
dark-coloured urine, yellow skin or eyes
(signs of liver problems).
– Rash, red skin with blisters on the lips,
eyes, skin or mouth, peeling skin, fever,
raised red or purple skin patches, itching,
burning sensation, pustular eruption (signs
of skin problems).
– Severe abdominal pain, blood in your
vomit, stools or urine, black stools (signs of 
gastrointestinal disorders).
– Severely decreased urine output, feeling
thirsty (signs of kidney problems).
– Feeling sick (nausea) with diarrhoea and
vomiting, abdominal pain or fever (signs of 
bowel problems).
– Severe headache, weakness or paralysis of
limbs or face, difficulty speaking, sudden
loss of  consciousness (signs of nervous
system problems such as bleeding or
swelling in skull/brain).
– Pale skin, feeling tired and breathlessness
and having dark urine (signs of low levels of 
red blood cells).
– Eye pain or deterioration in vision, bleeding
in the eyes.
– Pain in your hips or difficulty walking.
– Numb or cold toes and fingers (signs of
Raynaud’s syndrome).
– Sudden swelling and redness of the skin
(signs of a skin infection called cellulites).
– Difficulty hearing.
– Muscle weakness and spasms with an
abnormal heart rhythm (signs of changes in 
the amount of potassium in your blood).
– Bruising.
– Stomach pain with feeling sick (nausea).
– Muscle spasms with a fever, red-brown
urine, pain or weakness in your muscles
(signs of muscle problems).
– Pelvic pain sometimes with nausea and
vomiting,
with
unexpected
vaginal
bleeding, feeling dizzy or  fainting due to
low blood pressure (signs of problems with
your ovaries or womb).
– Nausea, shortness of breath, irregular
heartbeat, clouding of urine, tiredness
and/or joint discomfort associated with
abnormal laboratory test results (e.g. high
potassium, uric acid and calcium levels
and low phosphorus levels in the blood).

– Unusual hair loss or thinning.
– Numbness of the hands or feet.
– Mouth ulcers.
– Joint pain with swelling.
– Dry mouth, dry skin or dry eye.
– Decreased or increased skin sensitivity.
– Hot flushes, chills or night sweats.
If any of these affect you severely, tell your
doctor.
Not known (frequency cannot be estimated from
the available data):
– Reddening and/or swelling on the palms of
the hands and soles of the feet which may
be accompanied by tingling sensation and
burning pain.
– Slowing of growth in children and
adolescents.
If any of these affect you severely, tell your
doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE IMATINIB
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What imatinib contains:
– The active substance is imatinib mesilate.
Each tablet of imatinib contains imatinib
mesilate equivalent to 100 mg or 400 mg
imatinib.
– The other ingredients are microcrystalline
cellulose
(E460),
low
substituted
hydroxypropyl cellulose (E463), povidone
(E1201), crospovidone (Type A) (E1201),
silica colloidal anhydrous, magnesium
stearate (E572).
– The tablet coating is made of hypromellose
(E464), Macrogol 400, talc (E553b), red
iron oxide (E172), yellow iron oxide (E172).
What imatinib looks like and contents of the
pack:
Imatinib 100 mg film-coated tablets are dark
yellow to brownish-orange, round shaped,
film-coated tablets of 10.1 mm (± 5%) diameter
with a break-line on one side and  ‘100’ on the
other side. The tablet can be divided into equal
doses.
Imatinib 400 mg film-coated tablets are dark
yellow to brownish-orange, ovaloid shaped,
film-coated tablets, 21.6 mm long and 10.6 mm
wide (± 5%) wide with a break-line on one side
and ‘400’ on the other side. The tablet can be
divided into equal doses.
Imatinib film-coated tablets are available in
packs of 60 tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK.
The manufacturer is: Remedica LTD, Aharnon
Street, Limassol Industrial Estate, 3056
Limassol, Cyprus
This leaflet was last updated in April 2016
‘Zentiva’ is a registered trademark. © 2016
Zentiva.

Not known (frequency cannot be estimated
from the available data):
− Combination of a widespread severe rash,
feeling sick, fever, high level of certain
white blood cells or yellow skin or eyes
(signs of jaundice) with breathlessness,
chest pain/discomfort, severely decreased
urine output and feeling thirsty etc. (signs
of a treatment-related allergic reaction).
If you get any of the above, tell your doctor
straight away.
Other side effects may include:
Very common (may affect more than 1 in
10 people):
– Headache or feeling tired.
– Feeling sick (nausea), being sick (vomiting),
diarrhoea or indigestion.
– Rash.
– Muscle cramps or joint, muscle or bone
pain.
– Swelling such as around your ankles or
puffy eyes.
– Weight gain.
If any of these affect you severely, tell your
doctor.
Common (may affect up to 1 in 10 people):
– Anorexia, weight loss or a disturbed sense
of taste.
– Feeling dizzy or weak.
– Difficulty in sleeping (insomnia).
– Discharge from the eye with itching,
redness and swelling (conjunctivitis),
watery eyes or having blurred vision.
– Nose bleeds.
– Pain or swelling in your abdomen, flatulence,
heartburn or constipation.
– Itching.
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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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