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:
-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.
Imatinib 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 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.
-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. 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.
||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.
||-if you are allergic (hypersensitive) to imatinib .
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.
|Drug Special Care
||Before taking Imatinib, tell your doctor:
- 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. 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. There is no experience in children with GIST. Some children and adolescents taking Imatinib may have slower than normal growth. The doctor will monitor the growth at regular visits.
|Drug Drug Interactions
||Please tell your doctor or pharmacist if you are taking or have recently taken 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.
|Drug Pregnancy Interaction
||-Talk to your doctor before taking Imatinib if you are pregnant, might become pregnant or are breast-feeding.
-Imatinib is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the possible risks of taking Imatinib during pregnancy
|Drug Breast feeding Interaction
||-Women who might become pregnant are advised to use effective contraception during treatment.
-Do not breast-feed during the treatment with Imatinib.
|Drug Machinery Interaction
||You may feel dizzy 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.
|Drug More Information
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|How to take the
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||Use in adults
Your doctor will tell you exactly how many tablets of Imatinib to take.
-If you are being treated for CML:
Depending on your condition the usual starting dose is either 400 mg or 600 mg:
-400 mg to be taken as one tablet once a day,
-600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
-If you are being treated for GIST:
The starting dose is 400 mg, to be taken as one tablet once a day. For CML and GIST, 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 tablets), you should take one tablet in the morning and a second tablet in the evening.
-If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as one 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 one tablet once a day.
-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 one tablet 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 tablets), to be taken as one tablet in the morning and a second tablet in the evening.
Use in children
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. 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).
||-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:
•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.
|Excess Drug Consumption
||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.
|Forgot Drug Consumption
||-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 product, ask your doctor or pharmacist.
|Stop Drug Consumption
||Keep taking Imatinib every day for as long as your doctor tells you.
||•Headache or feeling tired.
•Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
•Muscle cramps or joint, muscle or bone pain.
•Swelling such as round your ankles or puffy eyes.
•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).
|Common Drug Side Effects
||•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.
•Pain or swelling in your abdomen, flatulence, heartburn or constipation.
•Unusual hair loss or thinning.
•Numbness of the hands or feet.
•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:
•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.
|Rare Drug Side Effects
||•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, light-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.
•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).
•Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
•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 phosphorous levels and low calcium levels in the blood).
|Very Rare Drug Side Effects
||no data available
|Drug Side Effects Symptoms
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|How to Store the
|How to Store the Medicine
||•Keep out of the reach and sight of children.
•Do not use after the expiry date which is stated on the carton.
•Do not store above 30°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.