Imarem 100 mg Film-Coated Tablets

IMAREM is a medicine containing an active substance called imatinib which belongs to a class of medicines known as protein-tyrosine kinase inhibitors. It is used to treat various types of cancers by inhibiting the growth of abnormal cells.

Do not take IMAREM:

• lf you know that you are hypersensitive (allergic) to the active substance in the tablet or any of the other ingredients of IMAREM (listed in section 6).
• lf you are pregnant or breastfeeding your baby.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking IMAREM.

Warnings and precautions

Tell your healthcare professional if you:

• 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 you have ever had or might now have a hepatitis B infection. This is because IMAREM 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.
• if you experience bruising, bleeding, fever, fatigue, and confusion when taking IMAREM, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
• Experience weakness or numbness in the face, arm, or leg, usually on just one side. Difficulty speaking, blurred vision, loss of balance or dizziness and a severe headache. You may be experiencing a stroke and your doctor might discontinue treatment.

Do not share medicines prescribed for you with any other person. Always take IMAREM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Therapy should be started by a doctor experienced in the treatment of patients with these conditions. The usual dose for use in adults is 100 mg 400 mg or 600 mg once a day or 800 mg, taken as 400 mg in the morning and 400 mg in the evening. The usual dose for children is 340 mg/m2. Your doctor will advise you on the dose to be taken depending on the type of cancer you have. During the course of the treatment your doctor may adjust the dose to suit your individual needs. Your doctor will advise you on the dose specific for children.

• IMAREM, tablets should be taken with a meal and large glass of water.
• For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of water or apple juice. The required number of tablets should be placed in the appropriate volume of liquid and stirred with a spoon. The suspension should be taken immediately after complete disintegration of the tablet(s).

To benefit from your medicine, you must take IMAREM tablets every day. Your doctor will tell you how long your treatment with IMAREM will last. Do not stop treatment early because your condition may get worse and you may start to feel sick.

If you have the impression that the effect of IMAREM is too strong or too weak, tell your doctor or pharmacist.

If you take more IMAREM than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

IMAREM can have side effects. You may tend to see side effects more frequently when you start your medication or increase to a higher dose. In most cases, side effects will gradually disappear as your body becomes used to the medicine.

Not all side-effects reported for IMAREM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IMAREM, please consult your healthcare provider for advice.

If any of the following happens, stop taking IMAREM and tell your doctor immediately or go to the casualty department at your nearest hospital.

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to IMAREM. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• 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 and fever (signs of skin problems e.g., acute generalised exanthematous pustulosis AGEP).
• Signs of infection such as fever, severe chills, sore throat, or mouth ulcers
• IMAREM 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).
• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling sick (nausea), with loss of appetite, light-coloured urine, yellow skin or eyes (signs of liver problems).
• Severely decreased urine output, feeling thirsty (signs of kidney 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).
• Loss of appetite, nausea and vomiting, weakness and fatigue, yellowing of your skin and the whites of your eyes (jaundice) (possible indication of a recurrence (reactivation) of a Hepatitis B infection when you have had hepatitis B in the past (a liver infection)).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• Headache or feeling tired.
• Being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain.
• Swelling such as round your ankles or puffy eyes.
• Weight gain.
• 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.
• Less frequent:
• Feeling light-headed, dizzy, or fainting (signs of low blood pressure).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel 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, 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 cellulites).
• 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 rhabdomyolysis and myopathy).
• 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).
• Burping or belching
• Nausea, vomiting, diarrhoea, muscle cramps or twitches, weakness, numbness or tingling, fatigue, decreased urination, irregular heart rate, seizures (signs that you may be suffering with tumour lysis syndrome)

• 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.
• Black/red tarry stools, fatigue, weak and blood loss (signs you are suffering with a condition called gastric antral vascular ectasia (GAVE))
• Chronic renal failure
• recurrent episodes of high-grade fever, pain and inflammation (signs of tumour necrosis)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse drug Reaction reporting Form”, found online under SAHPRA’s publications : https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of IMAREM.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN

Store at or below 25 ° C in the original pack

Protect from moisture. The blisters should not be removed from the carton until required for use. Keep out of the reach of children.