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IMATINIB MILPHARM 400 MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESYLATE / IMATINIB MESYLATE

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Package leaflet: Information for the user

Imatinib 100 mg film-coated tablets
Imatinib 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 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 is a treatment for adults and children for:
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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 used to treat a late stage
of Chronic Myeloid Leukaemia called “blast crisis.” In
children and adolescents however it may be used to
treat all stages of the illness.
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.

Imatinib is also a treatment for adults for:
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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).

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 with 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.
If you are a woman who is pregnant or might become
pregnant and is trying to open the HDPE container, you
should handle the rayon and the tablets with caution in
order to avoid skin-eye contact or inhalation. You should
wash your hands immediately after handling the rayon and
the tablets.
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 600 mg, to be taken as 6
tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of
100 mg once a day.
For CML in blast crisis, your doctor may prescribe a higher
or lower dose depending on how you respond to the
treatment. If your daily dose is 800 mg, to be taken as
4 tablets of 100 mg or 1 tablet of 400 mg in the morning
and 4 tablets of 100mg or 1 tablet of 400mg in the evening.
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If you are being treated for Ph-positive ALL:
The starting dose is 600 mg, to be taken as 6 tablets of
100 mg or one tablet of 400 mg plus 2 tablets of
100 mg once a day.

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If you are being treated for MDS/MPD:
The starting dose is 400 mg, to be taken as 4 tablets of
100 mg or one tablet of 400 mg once a day.

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

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If you are being treated for DFSP:
The dose is 800 mg per day (to be taken as 4 tablets
of 100 mg or 1 tablet of 400 mg in the morning and 4
tablets of 100mg or 1 tablet of 400mg 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 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
- 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:
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Use about 50 ml for each 100 mg tablet or 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 for a forgotten
dose.

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.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Children and adolescents
Imatinib 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 and HES/CEL.

Like all medicines, this medicine can cause side effects,
although not everybody gets them. They are usually mild to
moderate.

Some children and adolescents taking Imatinib may have
slower than normal growth. The doctor will monitor the
growth at regular visits.

Very common (may affect more than 1 in 10 people) or
common (may affect up to 1 in 10 people):
-
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).

Black

Some side effects may be serious. Tell your doctor
straight away if you get any of the following:

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).

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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.

4. Possible side effects

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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, darkcoloured 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 (eg.
high potassium, uric acid and calcium levels and low
phosphorous levels in the blood).

100 mg:
Imatinib 100 mg film-coated tablets are brownish , round,
biconvex (approx. 3.5 mm x 7.3 mm), film-coated tablets
embossed with “100” on one side and a score line on the
other side, with “N” on one side of the score line and “I” on
the other side of the score line. The tablet can be divided
into equal doses.
400 mg:
Imatinib 400 mg film-coated tablets are brownish, oval,
biconvex (approx. 5.7 mm x 17.3 mm), film-coated tablets
embossed with “400” on one side and “NI” on the other
side.
Imatinib film-coated tablets are supplied in
Blister pack: Alu/alu (OPA-Al-PVC / Al) blister
And
HDPE container pack: White opaque round HDPE container
with screw type neck finish, having child resistant closure
including purified rayon.
Pack sizes of alu/alu blister:
60 and 120 film-coated tablets (for 100 mg).
30 film-coated tablets (for 400 mg).
Pack sizes of HDPE container:
60 and 120 film-coated tablets (for 100 mg).
30 film-coated tablets (for 400 mg).
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
S.C. POLISANO PHARMACEUTICALS S.R.L.
Alba Iulia Street
No. 156, Sibiu, 550052
Romania
This leaflet was last revised in 01/2017.

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 national reporting system listed in 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 blister, label, carton and bottle after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C.
For 100mg: Use within 135 days after first opening the
HDPE container.
For 400mg: Use within 45 days after first opening the HDPE
container.
After each administration of film-coated tablets, please
reinsert purified rayon into the bottle to prevent film-coated
tablets from physical damage.
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 contains
- The active substance is imatinib mesilate.
Each film-coated tablet contains 100 mg imatinib (as
mesilate).
Each film-coated tablet contains 400 mg imatinib (as
mesilate).

What Imatinib looks like and contents of the pack
Film-coated tablet.

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- The other ingredients are: sodium stearyl fumarate
The tablet coating is made of:
Opadry Brown consisting of hydroxypropylmethyl cellulose,
red iron oxide (E172), yellow iron oxide (E172), talc

Expand Transcript

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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