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IMATINIB DR. REDDYS 100 MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the user
Imatinib 100 mg, 400 mg Film-Coated Tablets
Imatinib
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 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 tablets are 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 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 is intended for use in the most advanced phase of the disease (blast crisis). In
children and adolescents, Imatinib can be used in different phases of the disease (chronic, accelerated
phase and blast crisis).
Imatinib 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 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 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 you have ever had or might now have a hepatitis B infection. This is because Imatinib 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.
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 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 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 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.
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 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 e.g. 1 tablet of 400 mg plus 2 tablets of 100 mg once a
day.
Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your
daily dose is 800 mg, you should take a half dose (e.g. 1 tablet of 400 mg) in the morning and a half dose
(e.g. 1 tablet of 400 mg) in the evening.
 If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as e.g. 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 e.g. 1 tablet of 400 mg 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 e.g. 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, to be taken as a half dose (e.g. 1 tablet of 400 mg) in the morning and a
half dose (e.g. 1 tablet of 400 mg) 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 and
adolescents must not exceed 800 mg with CML. The treatment can either be given to your child as a oncedaily 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.
 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 and 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.

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, 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 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) side effects:
 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)

ifficulty 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
 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 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
 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








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 store above 30°C.
Store in the original package in order to protect from moisture.
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 mesilate. Each tablet of Imatinib contains either 100 mg imatinib (as
mesilate) for 100 mg film-coated tablets or 400 mg imatinib (as mesilate) for 400 mg film-coated
tablets.
 The other ingredients are sodium stearyl fumarate, anhydrous colloidal silica, crospovidone,
microcrystalline cellulose, anhydrous lactose and magnesium stearate.
 The tablet coating is made of red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171),
macrogol, sodium laurilsulfate and hypromellose.
What Imatinib tablets look like and contents of the pack
Imatinib 100 mg Film-Coated Tablets are yellow to brownish orange, round film coated tablets debossed
with "1" on one side and score line on the other side
They are supplied in packs containing 20, 30, 60, 120 or 180 tablets, but these may not all be available in
your country.
Imatinib 400 mg Film-Coated Tablets are yellow to brownish orange, ovaloid film coated tablets debossed
with "4" on one side and score line on the other side
They are supplied in packs containing 10, 30, 60 or 90 tablets, but these may not all be available in your
country.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD,
United Kingdom
This leaflet was last revised in 06/2016

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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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