Imatinib IPI 100 and 400 mg

1. Dosage:
- 100 mg
- 400 mg

2. What Imatinib IPI is and what is it used for:
Imatinib IPI is a medicine containing an active substance called imatinib. Imatinib IPI is a treatment for adults and children for Chronic Myeloid Leukaemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia. It is also a treatment for adults for Myelodysplastic and Myeloproliferative Diseases, Hypereosinophilic Syndrome and Chronic Eosinophilic Leukaemia, Gastrointestinal Stromal Tumours, and Dermatofibrosarcoma Protuberans.

3. What you need to know before you take Imatinib IPI:
Imatinib IPI 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 IPI: If you are allergic to imatinib or any of the other ingredients of this medicine.
Children and Adolescents:
- Imatinib IPI 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 IPI may have slower than normal growth. The doctor will monitor the growth at regular visits.
Other Medicines and Imatinib IPI:
- Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, Breastfeeding, and Fertility:
- If you are pregnant or breastfeeding, think you may be pregnant, or planning to have a baby, ask your doctor for advice before taking this medicine.
- Imatinib IPI 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 IPI during pregnancy.
- Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.
- Do not breastfeed during the treatment with Imatinib IPI and for 15 days after ending treatment, as it may harm your baby.
- Patients who are concerned about their fertility while taking Imatinib IPI 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 feel well again.

4. Warnings and Precautions:
Talk to your doctor before taking Imatinib IPI:
- If you have or have ever had liver, kidney, or heart problems.
- If you take levothyroxine medicine because your thyroid has been removed.
- If you have ever had or might now have a hepatitis B infection.
- If you experience bruising, bleeding, fever, fatigue, and confusion when taking Imatinib IPI, contact your doctor.

You may become more sensitive to the sun while taking Imatinib IPI.
During treatment with Imatinib IPI, tell your doctor straight away if you put on weight very quickly.

5. How and when to take Imatinib IPI:
- Take Imatinib IPI with a meal.
- 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 water or apple juice:
- Use about 50 ml for each 100 mg tablet or 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.
How long to take to take Imatinib IPI:
- Keep taking Imatinib IPI every day for as long as your doctor tells you.
If you take more Imatinib IPI 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.
If you forget to take Imatinib IPI:
- 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.

6. Possible Side Effects:
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.
- Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
- Unexpected bleeding or bruising.
Uncommon (May Affect Up to 1 in 100 People) or Rare (May Affect up to 1 in 1000 People):
- Chest pain, and irregular heart rhythm.
- Cough, having difficulty breathing, or painful breathing.
- Feeling light-headed, dizzy, or fainting.
- Feeling sick with loss of appetite, dark-coloured urine, or yellow skin or eyes.
- Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, or pustular eruption.
- Severe abdominal pain, blood in your vomit, stools, urine, or black stools.
- Severely decreased urine output, feeling thirsty.
- Feeling sick with diarrhoea and vomiting, abdominal pain, or fever.
- Severe headache, weakness or paralysis of limbs or face, difficulty speaking, or sudden loss of consciousness.
- Pale skin, feeling tired and breathless, and having dark urine.
- Eye pain, deterioration in vision, or bleeding in the eyes.
- Pain in your hips or difficulty walking.
- Numb or cold toes and fingers.
- Sudden swelling and redness of the skin.
- Difficulty hearing.
- Muscle weakness and spasms with an abnormal heart rhythm.
- Bruising.
- Stomach pain with feeling sick.
- Muscle spasms with a fever, red-brown urine, or pain or weakness in the muscles.
- Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy, or fainting due to low blood pressure.
- Nausea, shortness of breath, irregular heartbeat, clouding or urine, tiredness, or joint discomfort associated with abnormal laboratory test results.
- Blood clots in small blood vessels.
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 with breathlessness, chest pain and discomfort, and severely decreased urine output and feeling thirsty.
- Chronic renal failure.
- Recurrence of hepatitis B infection when you have had hepatitis B in the past.
Other Side Effects May Include:
Very Common (May Affect More Than 1 in 10 People):
- Headache or feeling tired.
- Feeling sick, being sick, diarrhoea, or indigestion.
- Rash.
- Muscle cramps or joint, muscle or bone pain, during Imatinib IPI treatment or after you have stopped taking Imatinib IPI.
- Swelling such as around your ankles or puffy eyes.
- Weight gain.
Common (May Affect Up to 1 in 10 People);
- Anorexia, weight loss, or disturbed sense of taste.
- Feeling dizzy or weak.
- Difficulty sleeping.
- Discharge from the eye with itching, redness, swelling, watery eyes, or blurred vision.
- Nose bleeds.
- Pain or swelling in the 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.
Uncommon (May Affect Up to 1 in 100 People):
- Painful red lumps on the skin, skin pain, and skin reddening.
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.
- Painful and/or blistering skin lesions.
- Slowing of growth in children and adolescents.