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IMATINIB ACTAVIS GROUP 100MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the user

Imatinib 100mg
Film-coated Tablets
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,
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.
•  The full name of this medicine is Imatinib 100mg
Film-coated Tablets but within the leaflet it will be
referred to as Imatinib Tablets.

Warnings and precautions

Talk to your doctor before taking Imatinib Tablets:
• 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 Tablets.
During treatment with Imatinib Tablets, tell your
doctor straight away if you put on weight very quickly.
Imatinib Tablets may cause your body to retain water
(severe fluid retention).
While you are taking Imatinib Tablets, your doctor will
regularly check whether the medicine is working. You will
also have blood tests and be weighed regularly.

What is in this leaflet:
1 What Imatinib Tablets are and what they are
used for
2 What you need to know before you take
Imatinib Tablets
3 How to take Imatinib Tablets
4 Possible side effects
5 How to store Imatinib Tablets
6 Contents of the pack and other information

Children and adolescents

1  What Imatinib Tablets are and what they are

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 Tablets when taken together. They
may increase or decrease the effect of Imatinib Tablets,
either leading to increased side effects or making Imatinib
Tablets less effective. Imatinib Tablets may do the same to
some other medicines.

used for

Imatinib 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 Tablets is a treatment 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 Tablets is intended for use in
the most advanced phase of the disease (blast crisis). In
children and adolescents, Imatinib Tablets can be used in
different phases of the disease (chronic, accelerated phase
and blast crisis).

Imatinib Tablets is also a treatment for adults for:
• 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 Tablets inhibits the
growth of these cells.
•M
 yelodysplastic/myeloproliferative diseases (MDS/
MPD). These are a group of blood diseases in which
some blood cells start growing out of control. Imatinib
Tablets inhibits the growth of these cells in a certain
subtype of these diseases.
•H
 ypereosinophilic 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 Tablets inhibits
the growth of these cells in a certain subtype of these
diseases.
•D
 ermatofibrosarcoma protuberans (DFSP). DFSP is a
cancer of the tissue beneath the skin in which some cells
start growing out of control. Imatinib Tablets 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 Tablets
work or why this medicine has been prescribed for you,
ask your doctor.
Imatinib Tablets may also be prescribed to treat conditions
not listed in this leaflet. If you have any questions, ask your
doctor or pharmacist.

2 What you need to know before you take

Imatinib Tablets

Imatinib Tablets 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 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 Tablets.
If you think you may be allergic but are not sure, ask your
doctor for advice.

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Imatinib Tablets is also a treatment for children and
adolescents with CML. There is no experience in children
with CML below 2 years of age. There is limited experience
in children and adolescents with Ph-positive ALL and very
limited experience in children and adolescents with MDS/
MPD, DFSP and HES/CEL.
Some children and adolescents taking Imatinib Tablets
may have slower than normal growth. The doctor will
monitor the growth at regular visits.

Other medicines and Imatinib Tablets

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 Tablets are 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 Tablets during pregnancy.
• Women who might become pregnant are advised to use
effective contraception during treatment.
• Do not breast-feed during the treatment with Imatinib
Tablets.
• Patients who are concerned about their fertility while
taking Imatinib Tablets 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.

Imatinib 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 to take Imatinib Tablets
Your doctor has prescribed Imatinib Tablets because you
suffer from a serious condition. Imatinib Tablets 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 Tablets 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 in blast crisis:
The usual starting dose is 600mg to be taken as 6 tablets
once a day.
Your doctor may prescribe a higher or lower dose
depending on how you respond to the treatment. If your
daily dose is 800mg (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 600mg to be taken as 6 tablets once
a day.
• If you are being treated for MDS/MPD:
The starting dose is 400mg to be taken as 4 tablets once
a day.

Continued over page

• If you are being treated for HES/CEL:
The starting dose is 100mg, to be taken as one tablet
once a day. Your doctor may decide to increase the dose
to 400mg, to be taken as 4 tablets once a day, depending
on how you respond to treatment.

• 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 phosphorous levels
in the blood).

• If you are being treated for DFSP:
The dose is 800mg per day (8 tablets), to be taken as
4 tablets in the morning and 4 tablets in the evening.

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.

Use in children and adolescents

The doctor will tell you how many tablets of Imatinib
to give to your child. The amount of Imatinib Tablets
given will depend on your child’s condition, body
weight and height. The total daily dose in children and
adolescents must not exceed 800mg with CML. 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 Tablets

• Take Imatinib Tablets with a meal. This will help protect
you from stomach problems when taking Imatinib
Tablets.
• S wallow the tablets whole with a large glass of water.
If you are unable to swallow the tablets, you can dissolve
them in a glass of still or mineral water or apple juice:
• Use about 50ml for each 100mg 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 Tablets

Keep taking Imatinib Tablets every day for as long as your
doctor tells you.

If you take more Imatinib 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 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) side effects:
• Rapid weight gain. Imatinib Tablets may cause your body
to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or
mouth ulcers. Imatinib Tablets 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) side effects:
• Chest pain, irregular heart rhythm (signs of heart
problems).
• Cough, having difficulty breathing or painful breathing
(signs of lung problems).
• Feeling lightheaded, 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).
• B ruising.
• 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).
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If you get any of the above, tell your doctor straight
away.

Other side effects may include:
Very common side effects (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 affect you severely, tell your doctor.
Common side effects (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.
• I tching.
• 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, 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 Tablets
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 after EXP. The expiry date refers to the
last day of that month.
This medicine does not require any special storage
conditions.
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 Tablets contain

• The active substance is imatinib (as mesilate). Each
film-coated tablet contains 119.5mg imatinib mesilate
corresponding to 100mg of imatinib.
• The other ingredients are hypromellose (E464), cellulose
microcrystalline, lactose monohydrate, crospovidone,
silica (colloidal anhydrous), magnesium stearate,
macrogol (E1521), talc (E553b), yellow iron oxide (E172)
and red iron oxide (E172).

What Imatinib Tablets look like and contents of
the pack

Brownish-orange, round, 10.5mm in diameter, biconvex,
film-coated tablets with no scorings or markings.
Pack sizes:
The film-coated tablets are supplied in blister packs of 60.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
This leaflet was last revised in September 2015

If you would like a
leaflet with larger text,
please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

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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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