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IMATINIB TEVA UK 400 MG FILM COATED TABLETS

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the patient
Imatinib Teva UK 400 mg 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.
What is in this leaflet:
1. What Imatinib Teva UK is and what it is used for
2. What you need to know before you take Imatinib Teva UK
3. How to take Imatinib Teva UK
4. Possible side effects
5. How to store Imatinib Teva UK
6. Contents of the pack and other information

1.

What Imatinib Teva UK is and what it is used for

Imatinib Teva UK 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 Teva UK 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 Teva UK is used to treat a late stage of Chronic Myeloid Leukaemia called “blast
crisis.” In children however it may be used to treat all stages of the illness.

Imatinib Teva UK is a treatment for adults and children 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 Teva UK inhibits the growth of these cells.

Imatinib Teva UK 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 Teva UK inhibits the growth of these
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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
Teva UK inhibits the growth of these cells in a certain subtype of these diseases.
Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises
from uncontrolled cell growth of the supporting tissues of these organs.
Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in
which some cells start growing out of control. Imatinib Teva UK 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 Teva UK works or why this medicine has been prescribed for
you, ask your doctor.

2.

What you need to know before you take Imatinib Teva UK

Imatinib Teva UK 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 Teva UK
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 Teva UK.
If you think you may be allergic but are not sure, ask your doctor for advice.
Warning and precautions
Talk to your doctor before taking Imatinib Teva UK:
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 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 Teva UK
During treatment with Imatinib Teva UK, tell your doctor straight away if you put on weight very
quickly. Imatinib Teva UK may cause your body to retain water (severe fluid retention).
While you are taking Imatinib Teva UK your doctor will regularly check whether the medicine is working.
You will also have blood tests and be weighed regularly.
Children and adolescents
Imatinib Teva UK 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 Teva UK may have slower than normal growth. The doctor
will monitor the growth at regular visits.
Other medicines and Imatinib Teva UK
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 Teva UK when taken
together. They may increase or decrease the effect of Imatinib Teva UK, either leading to increased side
effects or making Imatinib Teva UK less effective. Imatinib Teva UK 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 Teva UK 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 Teva UK during
pregnancy.
Women who might become pregnant are advised to use effective contraception during treatment.
Do not breast-feed during the treatment with Imatinib Teva UK.
Patients who are concerned about their fertility while taking Imatinib Teva UK 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 Teva UK

Your doctor has prescribed Imatinib Teva UK because you suffer from a serious condition. Imatinib Teva
UK 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 Teva UK 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 Teva UK to take
Use in adults
Your doctor will tell you exactly how many tablets of Imatinib Teva UK to take.
If you are being treated for CML:
The usual starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
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If you are being treated for GIST:
The starting dose is 400 mg, to be taken as one tablet once a day.

For CML and GIST, 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), you should take one tablet in the morning and a
second tablet in the evening.
If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.
-

If you are being treated for MDS/MPD:
The starting dose is 400 mg, to be taken as 1 tablet once a day.

-

If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day. Your doctor may decide to
increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you
respond to treatment.

If you are being treated for DFSP:
The dose is 800 mg per day (2 tablets), to be taken as 1 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 Teva UK to give to your child. The amount of
Imatinib Teva UK 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 Teva UK
Take Imatinib Teva UK with a meal. This will help protect you from stomach problems when
taking Imatinib Teva UK.
Swallow the tablets with a large glass of water.
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 400 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.
The tablet can be divided into equal doses by breaking it through the score line in case your doctor has
prescribed you or your child a dose where half of a tablet is needed.
How long to take Imatinib Teva UK
Keep taking Imatinib Teva UK every day for as long as your doctor tells you.
If you take more Imatinib Teva UK 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 Teva UK
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 Teva UK may cause your body to retain water (severe fluid retention).

Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva UK 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 or 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 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 Teva UK

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 and blister after EXP. The expiry
date refers to the last day of the month.
This medicine does not require any special storage conditions.
Bottles:
The in-use storage time after first opening is 3 months.
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 Teva UK contains

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The active substance is imatinib mesilate. Each tablet of Imatinib Teva UK contains 400 mg imatinib
(as mesilate).
The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium
stearate.
The tablet coating is made of macrogol, poly(vinyl alcohol), talc, titanium dioxide (E171), iron oxide
yellow (E172) and iron oxide red (E172).

What Imatinib Teva UK looks like and contents of the pack
Imatinib Teva UK 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets
with a score line on one side. The tablet is debossed with “IT” and “4” at each side of the score line.
Imatinib Teva UK is available in packs of 30 or 90 film-coated tablets in blisters.
Imatinib Teva UK is available in packs of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters
Imatinib Teva UK is available in HDPE bottles of 100 or 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic
*OR
Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
*OR
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
*OR
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80. 31-546, Krakow, Poland
*OR
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary

*OR
TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
*OR
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
*OR
PLIVA Croatia Ltd., Prilaz baruna Filipovića 25, 10000, Zagreb, Croatia

This leaflet was last revised in 04/2016
PL 00289/1517
* Only the actual site of batch release will appear on the printed version of the leaflet

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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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