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IMATINIB HELM AG 100 MG FILM-COATED TABLETS

Active substance(s): IMATINIB MESYLATE / IMATINIB MESYLATE / IMATINIB MESYLATE

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Imatinib Tablets - UK - PIL

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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

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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.
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 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.

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.

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 do. Check with your doctor
or pharmacist if you are not sure.

Imatinib is a treatment for children for:
- Chronic myeloid leukaemia (CML):
- and where bone marrow transplantation is not
considered as the first line of treatment. 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.
- Philadelphia chromosome (bcr-abl) positive (Ph+)
chronic myeloid leukaemia (CML) in chronic phase
after failure of interferon-alpha therapy, or in
accelerated phase or blast crisis.
- newly diagnosed Philadelphia chromosome positive
acute lymphoblastic leukaemia (Ph-positive ALL)
integrated with chemotherapy.

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.

Imatinib is a treatment for adults for:
- Philadelphia chromosome (bcr-abl) positive (Ph+)
chronic myeloid leukaemia (CML) in blast crisis
- 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.

Use in adults:
Your doctor will tell you exactly how many tablets of Imatinib to
take.

In the rest of this leaflet, we will use the abbreviations when
talking about these diseases.
Imatinib, which is contained in Imatinib, may also be authorised
to treat other conditions which are not mentioned in this leaflet.
Ask your doctor or pharmacist if you have further questions.
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 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 a treatment for children with CML. There is no
experience in children with CML below 2 years of age and with
Ph-positive ALL below 1 year of age.
There is very limited experience in children with MDS/MPD, DFSP
and HES/CEL.

Imatinib packed in HDPE bottles contains purified rayon. After
each opening of the HDPE bottle, the rayon should be removed
and kept in a clean and dry place. Following removal of the
tablet(s), the rayon should be carefully re-inserted into the bottle.
If you are a woman who is pregnant or might become pregnant
and is trying to open the HDPE bottle, 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

If you are being treated for CML in blast crisis:
- The starting dose is 600 mg to be taken as 6 tablets of
100 mg once a day
- The starting dose is 600 mg to be taken as 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 (8 tablets), you should take 4 tablets in
the morning 4 tablets in the evening. If your daily dose is 800 mg,
you should take 1 tablet of 400 mg in the morning and a second
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 6 tablets once a
day.
- 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 4 tablets once a
day.
- The starting dose is 400 mg, to be taken as 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 once
a day. Your doctor may decide to increase the dose to
400 mg, to be taken as 4 tablets once a day, depending on
how you respond to the treatment.
- 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 the treatment.
If you are being treated for DFSP:
- The dose is 800 mg per day (8 tablets), to be taken as
4 tablets in the morning and 4 tablets in the evening.
- The dose is 800 mg per day, to be taken as 1 tablet of
400 mg in the morning and a second 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 must not exceed 800mg, to be taken as 8 tablets of
100mg to be taken as 2 tablets of 400 mg. 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 tablet 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
- 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.
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.

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

Pil Size: 180 x 560 mm, Pantone: Black
Date: 01/02/17

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Imatinib Tablets - UK - PIL

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):
• 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):
• 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 cellulites).
• 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).

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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 25°C.
• 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 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).
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
What Imatinib looks like and contents of the pack
Imatinib 100 mg film-coated tablets are brownish , round,
biconvex, film-coated tablets debossed 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 halves.
Imatinib 400 mg film-coated tablets are brownish , oval,
biconvex, film-coated tablets debossed with "400" on one side
and "NI" on the other side.
Imatinib film-coated tablets are supplied in alu/alu blister or HDPE
bottles.
Pack sizes alu/alu blister
20, 60, 90, 120 and 180 film-coated tablets (for 100 mg).
10, 30 and 90 film-coated tablets (for 400 mg).
Pack sizes HDPE bottles:
60, 90, 120 and 180 film-coated tablets (for 100 mg).
30 and 90 film-coated tablets (for 400 mg).
Not all pack sizes may be available in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorsation Holder:
Helm AG
Nordkanalstr. 28
20097 Hamburg
Germany
Maufacturer:
S.C. POLISANO PHARMACEUTICALS, S.R.L.
Alba Iulia Street, no.156
550052 Sibiu
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).
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
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.

Pil Size: 180 x 560 mm, Pantone: Black
Date: 01/02/17

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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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