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IMATINIB ACTAVIS GROUP 300MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the user
Imatinib 300mg 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 300mg Film-coated Tablets but within the leaflet it
will be referred to as Imatinib Tablets.

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

1.

What Imatinib Tablets are and what they are 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.
Myelodysplastic/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.
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 Tablets inhibits the growth of these cells in a certain subtype of these diseases.

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-

Dermatofibrosarcoma 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 works 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.
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.
Children and adolescents
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 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 Actavis Group,
either leading to increased side effects or making Imatinib Tablets less effective. Imatinib Tablets may
do the same to some other medicines.
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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 2 tablets once a day.

Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your
daily dose is 800mg (2 tablets of 300mg and 2 tablets of 100mg), you should take one 300mg tablet
and one 100mg tablet in the morning and the same in the evening.
-

If you are being treated for Ph-positive ALL:
The starting dose is 600mg to be taken as 2 tablets once a day.

-

If you are being treated for MDS/MPD:
The starting dose is 400mg to be taken as one 300mg tablet and one 100mg tablet once a day.

-

If you are being treated for HES/CEL:
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The starting dose is 100mg, to be taken as one tablet of 100mg once a day. Your doctor may
decide to increase the dose to 400mg, to be taken as one 300mg tablet and one 100mg tablet
once a day, depending on how you respond to treatment.
-

If you are being treated for DFSP:
The dose is 800mg per day (2 tablets of 300mg and 2 tablets of 100mg), to be taken as
one tablet of 300mg and one tablet of 100mg in the morning and the same 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
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 Actavis Group.
Swallow the tablets whole with a large glass of water. Imatinib 300mg film-coated tablets
have a score line on one side. The score line is not intended for breaking the tablet.
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 150ml for each 300mg 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.
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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).
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 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.
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.
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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.
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 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 358.5mg
imatinib mesilate corresponding to 300mg 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, ovaloid, 19mm in length and 9mm in width, biconvex, film-coated tablets with a
score line on one side and “300” on the other side.

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Pack sizes:
The film-coated tablets are supplied in blister packs of 30, 60, 90 and 120..
Not all pack sizes may be marketed.
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.

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK

Pil Spec no

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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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