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IMATINIB 600 MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the user
Imatinib 600 mg film-coated tablets
Imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Imatinib 600 mg film-coated tablets is and what it is used for
What you need to know before you take Imatinib 600 mg film-coated tablets
How to take Imatinib 600 mg film-coated tablets
Possible side effects
How to store Imatinib 600 mg film-coated tablets
Contents of the pack and other information

What Imatinib 600 mg film-coated tablets is and what it is used for

Imatinib 600 mg film-coated tablets is a medicine containing an active substance called imatinib.
This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These
include some types of cancer.
Imatinib 600 mg film-coated tablets is a treatment for adults and children for:
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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 600 mg is used to treat a late stage of Chronic Myeloid
Leukaemia called “blast crisis”. In children and adolescents however it may be used to treat
all stages of the illness.

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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 600 mg inhibits the
growth of these cells.

Imatinib 600 mg film-coated tablets is also a treatment for adults for:

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Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood
diseases in which some blood cells start growing out of control. Imatinib 600 mg 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 600 mg 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 600 mg 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 600 mg works or why this medicine has been
prescribed for you, ask your doctor.
Imatinib which is contained in Imatinb 600 mg may also be authorised to treat other conditions
which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

2.

What you need to know before you take Imatinib 600 mg film-coated tablets

Imatinib 600 mg 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 600 mg film-coated tablets:
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 600 mg film-coated tablets.
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 600 mg:
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 you have ever had or might now have a hepatitis B infection. This is because Imatinib 600
mg could cause hepatitis B to become active again, which can be fatal in some cases.
Patients will be carefully checked by their doctor for signs of this infection before treatment
is started.
If any of these apply to you, tell your doctor before taking Imatinib 600 mg film-coated tablets.
During treatment with Imatinib 600 mg film-coated tablets, tell your doctor straight away if
you put on weight very quickly. Imatinib 600 mg may cause your body to retain water (severe fluid
retention).

While you are taking Imatinib 600 mg, your doctor will regularly check whether the medicine is
working. You will also have blood tests and be weighed regularly.
Children and adolescents
Imatinib 600 mg 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, DFSPand HES/CEL.
Some children and adolescents taking Imatinib 600 mg may have slower than normal growth. The
doctor will monitor the growth at regular visits.
Other medicines and Imatinib 600 mg film-coated tablets
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 600 mg when taken together. They may increase or decrease the effect of Imatinib 600 mg,
either leading to increased side effects or making Imatinib 600 mg less effective. Imatinib 600 mg
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 600 mg 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 600
mg during pregnancy.
Women who might become pregnant are advised to use effective contraception during
treatment.
Do not breast-feed during the treatment with Imatinib 600 mg.
Patients who are concerned about their fertility while taking Imatinib 600 mg 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 600 mg film-coated tablets

Your doctor has prescribed Imatinib 600 mg because you suffer from a serious condition. Imatinib
600 mg can help you to fight this condition.
However, 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 600 mg 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 600 mg film-coated tablets to take
With the 600 mg tablets, doses of 300 mg (half tablet) and 600 mg can be realized. Tablets of 100
mg and 400 mg are available on the market to realize doses of 100 mg, 200 mg (half tablet of 400
mg) and 400 mg.
Use in adults
Your doctor will tell you exactly how many tablets of Imatinib 600 mg to take.
If you are being treated for CML:
Depending on your condition the usual starting dose is either 400 mg or 600 mg:
400 mg to be taken as one tablet of 400 mg once a day,
600 mg to be taken as one tablet 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 (2 tablets of 400 mg), you should take one tablet in the
morning and a second tablet in the evening.
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If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as one tablet once a day.

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If you are being treated for MDS/MPD:
The starting dose is 400 mg to be taken as one tablet of 400 mg once a day.

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If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day. Your doctor
may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day,
depending on how you respond to treatment.

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If you are being treated for DFSP:
The dose is 800 mg per day (2 tablets of 400 mg), to be taken as one tablet in the morning
and a second tablet in the evening.

Use in children and adolescents
The doctor will tell you how many tablets of Imatinib 600 mg to give to your child. The amount of
Imatinib 600 mg given will depend on your child’s condition, body weight and height. The total
daily dose in children must not exceed 800 mg with CML 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 600 mg film-coated tablets
Take Imatinib 600 mg film-coated tablets with a meal. This will help protect you from
stomach problems when taking Imatinib 600 mg.
Swallow the tablets whole with a large glass of water.
The tablet can be divided into two 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 200 ml for each 600 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 600 mg film-coated tablets
Keep taking Imatinib 600 mg every day for as long as your doctor tells you.
If you take more Imatinib 600 mg film-coated tablets 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 600 mg film-coated tablets
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, pharmacist or nurse.

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 600 mg may cause your body to retain water (severe fluid
retention).

Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib 600 mg
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 cellulitis).
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 (eg. high potassium, uric acid
and calcium levels and low phosphorous levels in the blood).

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).

Chronic renal failure

Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past
(a liver infection).
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 round your ankles or puffy eyes.

Weight gain.
If any of these affects 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.

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 affects 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 affects you severely, tell your
doctor.
Reporting of side effects
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. Website: 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 600 mg film-coated tablets

Do not store above 30°C. Store in the original packaging in order to protect from light.
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.
Do not use any pack that is damaged or shows signs of tampering.
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 600 mg film-coated tablets contains
The active substance is imatinib mesilate. Each tablet of Imatinib 600 mg contains 600 mg
imatinib (as mesilate).
The other ingredient is magnesium stearate.
The tablet coating is made of hypromellose (E464), titanium dioxide (E171), macrogol
(E1521) and talc (E553b).
What Imatinib 600 mg film-coated tablets looks like and contents of the pack
Imatinib 600 mg are white to off white, capsule shaped, biconvex film-coated tablets, with a
dimension of 16.5x8.0 mm, debossed with H on one side and I1 on the other side, I and 1 separated
by a score line.
The tablets are packaged in blisters containing 10, 20, 30, 60, 90, 120 or 180 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hetero Europe, S.L.
Viladecans Business Park
C/ Catalunya 83-85
08840 Viladecans (Barcelona)
Spain
Manufacturer
Pharmadox Healthcare LtD.
KW20A Kordin Industrial Park
PLA 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following
names:
The Netherlands:
Germany:
Spain:
United Kingdom:

Imatinib Hetero 600 mg, filmomhulde tabletten
Imatinib Hetero 600 mg Filmtabletten
Imatinib Hetero 600 mg comprimidos recubiertos con película
Imatinib 600 mg film-coated tablets

This leaflet was last revised in May 2017

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