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Imatinib Tablet and Imatinib Capsule are medicines containing the active substance called imatinib. These drugs work through the suppression of the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib tablet 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.
  • 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 tablets inhibit the growth of these cells.

Imatinib tablet 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 tablets inhibit 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 tablets inhibit 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 tablets inhibit 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 tablets work or why this medicine has been prescribed for you, ask your doctor.

What you need to know before taking Imatinib Tablets and Capsules?

Imatinib tablets are prescribed only by doctors who have experience in the use of drugs for the treatment of cancer or solid tumors.

Follow the doctor's instructions carefully, even if they are different from the general information contained in this brochure.

Do not take Imatinib tablets:

  • If you are allergic to imatinib or any other ingredient of this medicine. If this applies to you, tell your doctor without taking the tablets.

If you think you can be allergic, but not sure, ask your doctor for advice.

Warnings and Precautions

Talk to your doctor before taking Imatinib:

  • if you have or have ever had liver, kidney or heart problems.
  • if you are taking levothyroxine because your thyroid gland has been removed.
  • if you have ever had or could now have an infection with hepatitis B. This is due to the fact that imatinib tablets may cause new hepatitis B activity, which may be fatal in some cases. Patients will be thoroughly checked by a doctor about the presence of signs of this infection before treatment.

If any of these apply to you, tell your doctor before taking Imatinib.

During treatment with Imatinib tablets, tell your doctor straight away if you put on weight very quickly. Imatinib tablets may cause your body to retain water (severe fluid retention).

While you are taking Imatinib tablets, your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Other medicines and Imatinib Tablets and Capsules

If you are taking, have recently taken or could take any other medicines, including over-the-counter medicines (for example, paracetamol) and including herbal medicines (for example, St. John's wort), tell your doctor or pharmacist. Some medicines may affect the effects of imatinib tablets while taking it at the same time. They can increase or decrease the effect of imatinib tablets, which results in increased side effects or decreased efficacy of imatinib tablets. Imatinib tablets may do the same for some other medicines.

Tell your doctor if you are using medicines to 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 tablets are 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 tablets during pregnancy.
  • Women who might become pregnant are advised to use effective contraception during treatment.
  • Do not breast-feed during the treatment with Imatinib tablets.
  • Patients who are concerned about their fertility while taking Imatinib tablets are advised to consult with their doctor.

Possible side effects of Imatinib

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

  • Rapid weight gain. Imatinib tablets may cause your body to retain water (severe fluid retention).
  • Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib tablets 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

  • 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.
  • 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 (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, during Imatinib tablets treatment or after you have stopped taking Imatinib tablets.
  • 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.

How to store Imatinib Tablets

  • 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.
  • This medicinal product does not require any special storage conditions.
  • 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.

Imatinib Tablet and Capsule Brands In India

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Brand Name : ImatibActive Ingredients : Imatinib MesylateManufactured by: Cipla Ltd.Strength: 400 mgForm: TabletsPacking: Pack of 10 Tablets

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