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KIMATSA 400 MG CAPSULES HARD

Active substance(s): IMATINIB MESILATE

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Package leaflet: Information for the user
Kimatsa 50 mg capsules, hard
Kimatsa 100 mg capsules, hard
Kimatsa 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.
2.
3.
4.
5.
6.

What Kimatsa is and what it is used for
What you need to know before you take Kimatsa
How to take Kimatsa
Possible side effects
How to store Kimatsa
Contents of the pack and other information

1.

What Kimatsa is and what it is used for

Kimatsa 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.
Kimatsa is a treatment for adults and children and adolescents for:
-

Chronic myeloid leukaemia (CML) in blast crisis. 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. Imatinib medac inhibits the growth of these cells. Blast crisis is the most
advanced stage of this disease.

Kimatsa is also a treatment for children and adolescents for:
-

Newly diagnosed CML for whom bone marrow transplantation is not considered as the first line
of treatment;
CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase.
Accelerated phase is an intermediate phase among the chronic phase and the onset of blast
crisis; it is considered as the first manifestation of resistance to therapy.

Kimatsa 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

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white cells (named lymphoblasts) start growing out of control. Kimatsa 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. Kimatsa 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.
Kimatsa 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. Kimatsa 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 Kimatsa works or why this medicine has been prescribed for you,
ask your doctor.

2.

What you need to know before you take Kimatsa

Kimatsa 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 Kimatsa:
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 Kimatsa.
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 Kimatsa:
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 Kimatsa 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 Kimatsa.
During treatment with Kimatsa, tell your doctor straight away if you put on weight very quickly.
Kimatsa may cause your body to retain water (severe fluid retention).
While you are taking Kimatsa, your doctor will regularly check whether the medicine is working. You
will also have blood tests and be weighed regularly.
Children and adolescents
Kimatsa 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 Phpositive ALL.
Some children and adolescents taking Kimatsa may have slower than normal growth. The doctor will
monitor the growth at regular visits.

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Other medicines and Kimatsa
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 Kimatsa
when taken together. They may increase or decrease the effect of Kimatsa, either leading to increased
side effects or making Kimatsa less effective. Kimatsa 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.
Kimatsa 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 Kimatsa during pregnancy.
Women who might become pregnant are advised to use effective contraception during
treatment.
Do not breast-feed during the treatment with Kimatsa as there is limited information on the
distribution of imatinib into the breast milk.
Patients who are concerned about their fertility while taking Kimatsa 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 Kimatsa

Your doctor has prescribed Kimatsa because you suffer from a serious condition. Kimatsa 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 Kimatsa 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 Kimatsa to take
Use in adults
Your doctor will tell you exactly how many capsules of Kimatsa to take.
-

If you are being treated for CML in blast crisis:
The usual starting dose is 600 mg to be taken once a day.

-

If you are being treated for GIST:
The starting dose is 400 mg, to be taken once a day.

For CML and GIST, 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 half your dose in the morning and half in
the evening.
-

If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken once a day.

-

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

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

Use in children and adolescents
The doctor will tell you how many capsules of Kimatsa to give to your child. The amount of Kimatsa
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. 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 Kimatsa
Take Kimatsa with a meal. This will help protect you from stomach problems when taking
Kimatsa.
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 mineral water or apple juice.
If you are a woman who is pregnant or might get pregnant and are trying to open the capsules,
for your children or another patient unable to swallow, you should handle the contents with
caution in order to avoid skin-eye contact or inhalation. You should wash your hands
immediately after opening the capsules.
How long to take Kimatsa
Keep taking Kimatsa every day for as long as your doctor tells you.
If you take more Kimatsa than you should
If you have accidentally taken too many capsules, talk to your doctor straight away. You may require
medical attention. Take the medicine pack with you.
If you forget to take Kimatsa
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. Kimatsa may cause your body to retain water (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Kimatsa 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).
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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).
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).
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.

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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
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 Kimatsa

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 after EXP. The expiry date
refers to the last day of that month.
Do not store above 25°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 Kimatsa contains
The active substance is imatinib (as mesilate). Each capsule contains 50 mg, 100 mg or 400 mg
imatinib (as mesilate).
The other ingredients are:
Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium steryl fumarate, silica
(colloidal hydrophobic and colloidal anhydrous).
Capsule shell:
50 mg capsules: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).
100 mg capsules: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
(E172).
400 mg capsules: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
(E172), black iron oxide (E172).
Printing ink:
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50 mg capsules: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium
hydroxide.
100 mg capsules: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium
hydroxide.
400 mg capsules: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium
Hydroxide 28%.
What Kimatsa looks like and contents of the pack
Kimatsa 50 mg capsules: hard capsule with light yellow cap and light yellow body imprinted with
50 mg in black ink. The capsule contains light yellow powder.
Kimatsa 100 mg capsules: hard capsule with light orange cap and light orange body imprinted with
100 mg in black ink. The capsule contains light yellow powder.
Kimatsa 400 mg capsules: hard capsule with orange opaque cap and orange opaque body imprinted
with 400 mg in black ink. The capsule contains light yellow powder.
Pack sizes:
50 mg: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
100 mg: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
400 mg: The capsules are supplied in aluminium blister packs of 10, 30, 60, or 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DB Ashbourne Limited
The Rectory, Braybrooke Road
Arthingworth, Market Harborough
LE16 8JT, United Kingdom
Telephone: (01858) 525643
Fax: (01858) 525383
Email: enquiries@medinformation.co.uk
Manufacturer
S.C. Sindan-Pharma S.R.L.
11 Ion Mihalache Blvd
Bucharest
Romania
This medicinal product is authorised in the Member States of the EEA under the following
names:
Luxembourg
United Kingdom

Kimatsa 50 mg/100 mg/400 mg gélules dures
Kimatsa 50 mg/100 mg/400 mg capsules, hard

This leaflet was last revised in 04/2016.

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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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