Imatinib Mesylate Tablets

Taj-Ando-Imatinib Mesylate Tablets
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What Imatinib? and is used for?

Imatinib is used to treat adults and children/adolescents who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells.
Imatinib kills the abnormal cells while leaving normal cells alone.

Imatinib is also used to treat adults for:
* myelodysplastic / myeloproliferative diseases (MDS/MPD).
These are a group of blood diseases in which some blood cells start growing out of control.

* Aggressive systemic mastocytosis (ASM).
It is a cancer in which certain blood cells, called “mast” cells, grow out of control.

* 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.

* gastro-intestinal stromal tumours (GIST).
This is a type of cancer of the stomach and bowels. This cancer affects the tissue
that surrounds the stomach and bowels and the cells grow uncontrollably.

* dermatofibrosarcoma protuberans (DFSP).
DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.

Imatinib works by slowing the growth of abnormal cells.
Imatinib kills the abnormal cells while leaving normal cells alone.

Imatinib is only available with a doctor’s prescription.
It is not addictive.
There is not enough information to recommend the use of Imatinib in children under 3 years of age for most uses.
For use in CML, there is no experience with the use of Imatinib in children below 2 years of age.
For acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL), there is no experience with the use of Imatinib in children below 1 year of age.Imatinib Mesylate Tablets – Taj Ando Pharmaceuticals, South Africa | Imatinib is used to treat adults and children/adolescents who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells.
Imatinib Mesylate Tablets – Taj Ando Pharmaceuticals, South Africa | Imatinib is used to treat adults and children/adolescents who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells.

Side effects

  • Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Imatinib.
  • Tell your doctor if you notice any of the following side effects and they worry you:

* swelling of fingers, eyelids, face or lower legs due to fluid build up (see your doctor immediately if fluid build up is severe)
* indigestion, upset stomach, wind, feeling of bloating
* nausea (feeling sick) or vomiting
* diarrhoea
* constipation
* dry mouth
* swelling, aching, cramping or stiffness in joints or muscles
* pain in the bones or along veins
* headache
* dizziness, light-headedness or vertigo (spinning sensation)
* tiredness, weakness, feeling generally unwell
* numbness, coldness or tingling in fingers and toes
* difficulty sleeping, feeling anxious, depressed, confused or forgetful
* change in sense of taste
* rash, eczema, itching, dry skin, darkening or lightening of skin
* symptoms of sunburn (such as redness, itching, swelling or blistering of the skin) which happens more quickly than normal
* irritated, red, runny or itchy eyes, blurred vision
* ringing in the ears
* changes in appetite and weight
* hair loss
* sweating during the night
* throat pain
* cough or cold symptoms
* loss of interest in sex, problems with sexual function
* breast enlargement, nipple pain, painful periods
* 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
Tell your doctor immediately if you get any of the following side effects:
* severe allergic reaction that can result in difficulty breathing, dizziness.
* rapid weight gain, swelling of the extremities (calves, ankles),
* generalised swelling such as swelling of the face (signs of water retention)
* weakness, spontaneous bleeding or bruising, frequent infections with signs such as fever, chills, swollen glands, sore throat or mouth ulcers (signs of low level of blood cells)
* pale skin, tiredness, breathlessness, dark urine (signs of breakdown of red blood cells).
* pain and having difficulty walking
* cough, difficult or painful breathing, wheezing, pain in chest when breathing (signs of lung infections/disorders).
* muscle weakness, muscle spasms, abnormal heart rhythm (signs of changes in level of potassium in the blood).
* muscle spasms, fever, red-brown urine, kidney disorders, pain or weakness in muscles (signs of muscle disorders)
* severe abdominal pain, vomiting blood, black or bloody stools, swelling of the abdomen/fluid within the abdomen, constipation, stomach pain (signs of gastrointestinal disorders)
* thirst, weight loss and severely decreased urine output (signs of low intake of drinks/fluids)
* nosebleeds or any other unusual bleeding
* vision impairment, blurred vision, blood in eye
* nausea, loss of appetite, dark- coloured urine or yellowing of your skin or eyes (signs of liver disorders).
* nausea, diarrhoea, vomiting, abdominal pain, fever (signs of inflammatory bowel disease).
* severe rash, red skin, blistering of the lips, eyes, skin or mouth, skin peeling, fever, red raised or purple skin patches, itching, burning, pustular eruption (signs of skin disorder).
* inflammation of the skin caused by an infection (sign of cellulitis)
* blood in the urine
* severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system disorder such as bleeding or swelling in the brain)
* seizures (fits)
* swelling and pain in one part of the body (signs of clots in blood vessels)
* crushing chest pain, fever, tiredness, irregular heart beat (signs of heart disorders such as heart attack, angina).
* muscle weakness, muscle spasms, abnormal heart rhythm (signs of changes in level of potassium in the blood)
* pelvic pain sometimes accompanied by nausea and vomiting, unexpected vaginal bleeding, (signs of gynaecological disorder)
* nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory (such as high potassium, uric acid, and phosphorous levels and low calcium levels in the blood)
* severe headache, dizziness, blurred vision (signs of increased pressure inside skull).

Storage
* Keep your medicine in the original container until it is time to take it.
* Store it in a cool dry place.
* Do not store Imatinib or any other medicine in the bathroom or near a sink.
* Do not leave it in the car or on window sills.
* Keep the medicine where young children cannot reach it.
* A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.
Disposal
* If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.

Before you take Imatinib

When you must not take it

  • Do not take Imatinib if you have ever had an allergic reaction to imatinib (the active ingredient)
  • Some of the symptoms of an allergic reaction may include:
    – shortness of breath, wheezing or difficulty breathing;
    -swelling of the face, lips, tongue or other parts of the body;
    – rash, itching or hives on the skin.
  • Do not take Imatinib after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
  • In that case, return the medicine to your pharmacist.

Before you start to take it

  • Tell your doctor if you are pregnant or planning to become pregnant.
  • This medicine may be harmful to your unborn baby.
  • If it is necessary for you to take it during pregnancy, your doctor will discuss with you the risks and benefits involved.
  • Tell your doctor if you are breast- feeding.
  • It is not known if the active ingredient, imatinib, passes into the breast milk.
  • Because this medicine could affect your baby, breast- feeding is not recommended.
  • Tell your doctor if you have ever had any of the following medical problems or procedures:
    * kidney or liver problems
    * problems with your heart
    * you have had your thyroid gland removed

Taking other medicines

  • Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
  • Some medicines and Imatinib may interfere with each other.
  • These include many medicines that are eliminated from the body through the liver:
    * St. John’s wort, a herbal medicine found in many products that you can buy without a prescription
    * paracetamol, a medicine found in many common pain relievers and cold remedies which are known to be associated with liver toxicity.
    * A patient, who was taking paracetamol regularly for fever, died of acute liver failure. Although the cause is currently unknown, special caution should be exercised when using paracetamol and Imatinib.
    * antibiotic medicines such as rifampicin, ketoconazole, erythromycin, clarithromycin, itraconazole
    * antiviral medicines used to treat HIV/AIDS
    * dexamethasone, a steroid medicine
    * medicines for high cholesterol, such as simvastatin
    * medicines used to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone
    * warfarin, a medicine used to prevent blood clots
    * some medicines used to treat mental disorders and depression
    * some medicines used to treat high blood pressure and heart problems
    * cyclosporine
  • You may need to take different amounts of these medicines or you may need to take different medicines.