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IMATINIB DR. REDDYS 100 MG CAPSULES HARD

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the user
Imatinib 50 mg, 100 mg, 400 mg Capsules, Hard
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 capsules 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).

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.

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.

Use in adults

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.



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
Your doctor will tell you exactly how many
capsules of Imatinib to take.

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 capsule of
400 mg) in the morning and a half dose (e.g. 1
capsule 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 capsule of 400 mg plus 2 capsules 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 capsule of 400 mg once a day.



If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as
e.g. 1 capsule of 100 mg once a day. Your
doctor may decide to increase the dose to
400 mg, to be taken as e.g. 1 capsule 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 capsule of 400 mg) in the
morning and a half dose (e.g. 1 capsule of
400 mg) in the evening.

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.

If you are being treated for CML:
The usual starting dose is 600 mg to be
taken as e.g. 1 capsule of 400 mg plus 2
capsules of 100 mg once a day.

Use in children and adolescents
The doctor will tell you how many capsules 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 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






Take Imatinib with a meal. This will help
protect you from stomach problems when
taking Imatinib.
Swallow the capsules whole with a large
glass of water. Do not open or crush the
capsules unless you have difficulty in
swallowing (e.g. in children).
If you are unable to swallow the capsules,
you can open them up and pour the powder
into a glass of still water or apple juice.



If you are a woman who is pregnant or
might get pregnant and are trying to open
the capsules, you should handle the
contents with caution in order to avoid skineye contact or inhalation. You should wash
your hands immediately after opening the
capsules.





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.

How long to take Imatinib

Common side effects (may affect up to 1 in 10
people):
• anorexia, weight loss or a disturbed sense
of taste
If you take more Imatinib than you
• feeling dizzy or weak
should
• difficulty in sleeping (insomnia)
If you have accidentally taken too many
• discharge from the eye with itching, redness
capsules, talk to your doctor straight away. You
and swelling (conjunctivitis), watery eyes or
may require medical attention. Take the
having blurred vision
medicine pack with you.
• nose bleeds
• pain or swelling in your abdomen,
If you forget to take Imatinib
flatulence, heartburn or constipation
• If you forget a dose, take it as soon as you
• itching
remember. However if it is nearly time for
• unusual hair loss or thinning
the next dose, skip the missed dose.
• numbness of the hands or feet
• Then continue with your normal schedule.
• mouth ulcers
• Do not take a double dose to make up a
• joint pain with swelling
forgotten dose.
• dry mouth, dry skin or dry eye
If you have any further questions on the use of
• decreased or increased skin sensitivity
this medicine, ask your doctor, pharmacist or
• hot flushes, chills or night sweats
nurse.
If any of these affect you severely, tell your
doctor.
4. Possible side effects
Keep taking Imatinib every day for as long as
your doctor tells you.

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)
• 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
• 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

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 capsules contain






The active substance is imatinib mesilate.
Each capsule of Imatinib contains either
50 mg, 100 mg or 400 mg imatinib (as
mesilate) for 50 mg, 100 mg or 400 mg
capsules.
The other ingredients are sodium stearyl
fumarate and crospovidone (Type A). The
capsule shell is composed of gelatin,
sodium laurilsulfate and titanium dioxide
(E171); additional for 50 mg capsules: iron
oxide, yellow (E172) additional for 100 mg
capsules: iron oxide, yellow (E172) and iron
oxide, red (E172) additional for 400 mg
capsules: iron oxide, yellow (E172), iron
oxide, red (E172) and iron oxide, black
(E172)
The printing ink is composed of iron oxide,
red (E172), shellac, propylene glycol and
ammonia solution, concentrated.

What Imatinib capsules look like and
contents of the pack
Imatinib 50 mg capsules contain off-white to
brownish yellow colour granular powder in a
light yellow to orange-yellow opaque capsule
imprinted with ‘RDY’ on cap and ‘50’ on body
with red ink.
They are supplied in packs containing 30
capsules.
Imatinib 100 mg capsules contain off-white to
brownish yellow colour granular powder in an
orange to grayish-orange opaque capsule
imprinted with ‘RDY’ on cap and ‘100’ on body
with red ink.
They are supplied in packs containing 24, 30,
48, 60, 96, 120 and 180 capsules, but these
may not all be available in your country.
Imatinib 400 mg capsules contain off- white to
brownish yellow color granular powder in a very
dark yellow to brownish-orange opaque capsule
imprinted with ‘RDY’ on cap and ‘400’ on body
with red ink.
They are supplied in packs containing 10, 30, 60
and 90 capsules, 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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