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IMATINIB 400 MG CAPSULES HARD

Active substance(s): IMATINIB MESYLATE

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Package Leaflet – Information for the patient
Imatinib 400mg capsules, hard
imatinib
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. You can help by reporting any side effects you may get. See section 4 for how to report side
effects
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 capsules is and what it is used for
2. What you need to know before you take imatinib capsules
3. How to take imatinib capsules
4. Possible side effects
5. How to store imatinib capsules
6. Contents of the pack and other information

1. What imatinib capsules is and what it is used for
Imatinib capsule 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:
- 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:
- 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 capsules
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 capsules:
- 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 capsules.
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 capsules:
- 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 capsules.
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 with CML. There is no experience in children with CML below 2
years of age and in children with Ph-positive ALL below 1 years of age. There is very limited experience in
children 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 capsules 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.
Imatinib capsules contains lactose anhydrous
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. How to take imatinib capsules
Your doctor has prescribed imatinib capsules because you suffer from a serious condition. Imatinib capsules
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 capsules 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 capsules to take
Use in adults
Your doctor will tell you exactly how many capsules of imatinib to take.
- If you are being treated for CML:
Depending on your condition the usual starting dose is 600 mg:
- 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg once a day.
For CML your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a second capsule in
the evening.
- If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as one 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 one capsule once a day.
- If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day. Your doctor may decide to
increase the dose to 400 mg, to be taken as one 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 (2 capsules), to be taken as one capsule in the morning and a second capsule
in the evening.
Use in children and adolescents
The doctor will tell you how many capsules of imatinib to give to your child. The amount of imatinib
capsules 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 capsules
- Take imatinib capsules with a meal. This will help protect you from stomach problems when taking
imatinib capsules.
- 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 and pour the powder into a glass of still
water or apple juice.
- If you are a women 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 skin-eye contact or inhalation. You should wash your
hands immediately after opening the capsules.
How long to take imatinib capsules
Keep taking imatinib capsules every day for as long as your doctor tells you.
If you take more imatinib capsules 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 imatinib capsules
- 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.

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Imatinib 400mg capsules, hard

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Imatinib 400mg capsules, hard

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.

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4. Possible side effects

Date : 29-02-16 (01-06-16)

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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).
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.
- Inflammation of the sac around the heart. May manifest as chest pain that varies with each breath. Pain
often increases when lying down and decreases upon sitting up. Fever, cough, and palpitations are
common as well. May be serious and require medical intervention (Pericarditis).
- Cardiac tamponade is caused by the accumulation of blood, fluid, pus, clots, or gas in the pericardial
space, resulting in reduced ventricular filling and subsequent haemodynamic compromise. Cardiac
tamponade is a medical emergency.
- Extensive peeling of the skin (Toxic epidermal necrolysis) or extended rashes with liver, blood and other
body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms).
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.
- Bleeding into the eyeball (vitreous haemorrhage).
- Blood clot, usually in a leg, which causes pain swelling or redness (Thrombosis)
- Respiratory failure occurs when the respiratory system fails in oxygenation (Acute respiratory failure)
- Inflammation of the lungs, which can cause shortness of breath and difficulty breathing (Interstitial lung
disease)
- Death of tissue (Avascular necrosis)
- Gastrointestinal bleeding (Gastric antral vascular ectasia (GAVE))
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 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 imatinib capsules
- 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 and blister after EXP. The
expiry date refers to the last day of the month.
- Store below 25ºC. Store in the original package to protect from moisture.
- Do not use this medicine if you notice that the pack 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 contains
- The active substance is imatinib. Each capsule contains 400mg of imatinib (as mesilate).
- The other ingredients are lactose anhydrous, crospovidone (Type B), silica, colloidal anhydrous and
magnesium stearate
- The capsule shell is made of gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide
(E171) and sodium laurilsulfate.
What imatinib capsules looks like and contents of the pack
Imatinib 400 mg, hard capsule are light yellow granules filled in size “00EL” hard gelatin capsule with
brown cap and brown body.
Capsule length: 25.5 mm.
Blister consisting of PVC/PE/PVDC-Aluminium.
They are supplied in packs containing 10, 30 and 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Cipla (EU) Limited,
Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer:
S&D Pharma CZ,
spol. s r.o. Theodor 28, 273 08 Pchery (Pharmos a.s. facility), Czech republic.
Cipla (EU) Limited
20 Balderton Street, London W1K 6TL, United Kingdom.
Cipla Europe NV
Uitbreidingstraat 80, 2600 Antwerp, Belgium
Pharmadox Healthcare Limited
KW20A Corradino Industrial Estate, Paola PLA 3000, Malta

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This leaflet was last revised in 06/2016

Date : 29-02-16 (01-06-16)

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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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