Patient leaflet - IMATINIB 100 MG CAPSULES HARD
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:
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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.
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- 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.
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- 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.
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- 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:
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– 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:
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– if you have or have ever had a liver, kidney or heart problem.
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– if you are taking the medicine levothyroxine because your thyroid has been removed.
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– if you have ever had or might now have a hepatitis B infection. This is because imatinib capsules 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.
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– if you experience bruising, bleeding, fever, fatigue and confusion when taking imatinib capsule, contact you doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
If any of these apply to you, tell your doctor before taking imatinib capsules.
You may become more sensitive to the sun while taking imatinib. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.
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. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST 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
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– 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.
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– 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.
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– Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.
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– Do not breast-feed during the treatment with imatinib and for 15 days after ending treatment, as it may harm your baby.
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– 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 and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
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
The recommended doses are:
Use in adults
Your doctor will tell you exactly how many capsules of imatinib to take.
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– If you are being treated for CML:
Depending on your condition the usual starting dose is either 400 mg or 600 mg:
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- 400 mg to be taken as 4 capsules once a day.
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- 600 mg to be taken as 6 capsules 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 (8 capsules), you should take 4 capsules in the morning and 4 capsules 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 capsules 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 capsules 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 capsule of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules 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 (8 capsules), to be taken as 4 capsules in the morning and 4 capsules 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
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- Take imatinib capsules with a meal. This will help protect you from stomach problems when taking imatinib capsules.
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- 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. children).
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– 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.
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– 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
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– 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.
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– Then continue with your normal schedule.
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– 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):
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– Rapid weight gain. Imatinib may cause your body to retain water (severe fluid retention).
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– 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.
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– 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):
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– Chest pain, irregular heart rhythm (signs of heart problems).
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– Cough, having difficulty breathing or painful breathing (signs of lung problems).
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– Feeling light-headed, dizzy or fainting (signs of low blood pressure).
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– Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
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– 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).
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– Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
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– Severely decreased urine output, feeling thirsty (signs of kidney problems).
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– Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
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– 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).
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– Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
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– Eye pain or deterioration in vision, bleeding in the eyes.
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– Pain in your hips or difficulty walking.
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– Numb or cold toes and fingers (signs of Raynaud’s syndrome).
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– Sudden swelling and redness of the skin (signs of a skin infection called cellulites).
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– Difficulty hearing.
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– Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
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– Bruising.
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– Stomach pain with feeling sick (nausea).
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– Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
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– 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).
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– Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg. high/low potassium, high uric acid and calcium levels and low phosphorous levels in the blood).
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– Blood clots in small blood vessels (thrombotic microangiopathy)
Not known (frequency cannot be estimated from the available data):
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– 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).
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– Chronic renal failure.
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– 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).
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– 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.
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– 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).
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– Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
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– Bleeding into the eyeball (vitreous haemorrhage).
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– Blood clot, usually in a leg, which causes pain swelling or redness (Thrombosis)
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– Respiratory failure occurs when the respiratory system fails in oxygenation (Acute respiratory failure)
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– Inflammation of the lungs, which can cause shortness of breath and difficulty breathing (Interstitial lung disease)
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– Death of tissue (Avascular necrosis)
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– Gastrointestinal bleeding (Gastric antral vascular ectasia (GAVE))
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):
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– Headache or feeling tired.
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– Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
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– Rash.
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– Muscle cramps or joint, muscle or bone pain, during imatinib capsules treatment or after you have stopped taking imatinib capsules.
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– Swelling such as round your ankles or puffy eyes.
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– Weight gain.
If any of these affects you severely, tell your doctor.
Common (may affect up to 1 in 10 people):
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– Anorexia, weight loss or a disturbed sense of taste.
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– Feeling dizzy or weak.
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– Difficulty in sleeping (insomnia).
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– Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
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– Nose bleeds.
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– Pain or swelling in your abdomen, flatulence, heartburn or constipation.
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– Itching.
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– Unusual hair loss or thinning.
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– Numbness of the hands or feet.
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– Mouth ulcers.
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– Joint pain with swelling.
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– Dry mouth, dry skin or dry eye.
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– Decreased or increased skin sensitivity.
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– 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):
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– 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.
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– Painful and/or blistering skin lesions.
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– 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 in United Kingdom via Yellow Card Scheme at
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store imatinib capsules
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– Keep this medicine out of the sight and reach of children.
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– 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.
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– Store below 25°C. Store in the original package to protect from moisture.
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– Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
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– 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
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– The active substance is imatinib. Each capsule contains 100mg of imatinib (as mesilate)
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– The other ingredients are lactose anhydrous, crospovidone (Type B), silica, colloidal anhydrous and magnesium stearate
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– 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 100 mg, hard capsule are light yellow granules filled in size “3” hard gelatin capsule with brown cap and white body.
Capsule length: 15.8 mm.
Blister consisting of PVC/PE/PVDC-Aluminium.
They are supplied in packs containing 20, 60, 120 and 180 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder/Manufacturer
Marketing Authorisation Holder:
Cipla (EU) Limited,
Dixcart House, Addlestone Road,
Bourne Business Park, Addlestone,
Surrey, KT15 2LE,
United Kingdom.
Manufacturer:
Cipla (EU) Limited
Dixcart House, Addlestone Road,
Bourne Business Park, Addlestone,
Surrey, KT15 2LE,
United Kingdom.
This medicinal product is authorized in the Member States of the EEA under the following names:
| United Kingdom | Imatinib 100 mg capsules, hard |
| Denmark | Imatinib ”Cipla” 100 mg harde kapsler |
| Finland | Imatinib Orion 100 mg kovat kapselit |
| France | Imatinib Cipla 100 mg gelule |
| Germany | Imatinib Cipla 100 mg Hartkapsel |
| Norway | Imatinib Cipla 100 mg kapsler, harde |
| Spain | Imatinib Cipla 100 mg Capsulas Duras |
| Sweden | Imatinib Cipla 100 mg kapslar, harda |
This leaflet was last revised in Month of variation approval
Cipla
Date: 19/01/2021