Imatinib 100 mg Film-Coated Tablets

IMATINIB ZYDUS contains the active ingredient imatinib. This medicine works by inhibiting the uncontrollable growth of abnormal cells in the diseases listed below. These include some types of cancer. IMATINIB ZYDUS 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 your body to fight infection. Chronic myeloid leukaemia is a form of leukaemia.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph - positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help your body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia.

IMATINIB ZYDUS is also a treatment for adults for:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). IMATINIB ZYDUS inhibits the growth of these cells in a certain subtype of these diseases.
• Systemic mastocytosis (SM) and eosinophilia. Systemic mastocytosis (SM) is a rare disease in which too many mast cells (immune cells) are found in your skin, bones, joints, lymph nodes, liver, spleen, and the gastrointestinal tract. Eosinophilia represents an increased number of white blood cells (named eosinophils) in your tissues and/or blood.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). IMATINIB ZYDUS 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.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin.

Do not take IMATINIB ZYDUS:

• if you are hypersensitive (allergic) to imatinib or to any of the other ingredients of IMATINIB ZYDUS listed in section 6 of this leaflet;
• if you are pregnant or breastfeeding (see ‘Pregnancy and breastfeeding’).

Warnings and precautions

Take special care with IMATINIB ZYDUS if you or a child in your care:

• are taking other medicines that may increase or decrease the amount of IMATINIB ZYDUS in your blood or influence its effect. See ‘Other medicines and IMATINIB ZYDUS’;
• are taking the medicine levothyroxine because your thyroid has been removed;
• have liver, kidney or heart problems;
• have ever had or might now have a hepatitis B infection. This is because IMATINIB ZYDUS could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will check for signs of this infection before treatment is started;
• experience bruising, bleeding, fever, fatigue and confusion when taking IMATINIB ZYDUS, contact your doctor. This may be a sign of damage to your blood vessels known as thrombotic microangiopathy (TMA).

You may become more sensitive to the sun while taking IMATINIB ZYDUS. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with IMATINIB ZYDUS, tell your doctor straight away if you put on weight very quickly. IMATINIB ZYDUS may cause your body to retain water (severe fluid retention). While you are taking IMATINIB ZYDUS, your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents

There is no experience with the use of IMATINIB ZYDUS in children below 2 years of age. There is very limited experience with the use of IMATINIB ZYDUS in children below 3 years of age in the other diseases. Some children and adolescents taking IMATINIB ZYDUS may have slower than normal growth. The doctor will monitor their growth at regular visits.

Other medicines and IMATINIB ZYDUS

Always tell your health care provider if you or a child in your care are taking any other medicine. (This includes all complementary or traditional medicines.) Some medicines can interfere with the effect of IMATINIB ZYDUS when taken together. They may increase or decrease the effect of IMATINIB ZYDUS, either leading to increased side effects or making IMATINIB ZYDUS less effective. IMATINIB ZYDUS may do the same to some other medicines.

Tell your doctor or pharmacist if you are using:

• medicines used in the treatment of HIV (human immunodeficiency virus) and AIDS (acquired immune deficiency syndrome) (indinavir, lopinavir/ritonavir, ritonavir, saquinavir, nelfinavir);
• medicines used to treat Hepatitic C (telaprevir, boceprevir);
• medicines used to treat fungal infections (ketoconazole, itraconazole, posaconazole, voriconazole);
• antibiotic medicines used to treat infections (erythromycin, clarithromycin and telithromycin);
• dexamethasone (used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders);
• St. John's Wort (used to treat depression);
• medicines used to treat tuberculosis (TB) (rifampicin);
• medicines used to treat epilepsy (carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone);
• medicines used to treat high cholesterol (simvastatin);
• medicines used to prevent organ rejection (ciclosporin, tacrolimus, sirolimus);
• medicines used to treat psychosis, a severe mental disorder;
• medicines used to treat migraines (ergotamine, diergotamine);
• medicines used to treat severe pain (fentanyl, alfentanil);
• antihistamines used to treat allergies (terfenadine);
• medicines used to treat certain types of cancer (bortezomib, docetaxel, L-asparaginase);
• medicines used to treat heart rhythm disorders (quinidine);
• medicines used to treat anxiety, panic disorders and depression (triazolo-benzodiazepines);
• medicines used to treat high blood pressure (dihydropyridine calcium channel blockers, metoprolol);
• medicines that prevent the formation of blood clots (warfarin);
• paracetamol (used to treat mild or moderate pain and fever);
• medicines used to treat an underactive thyroid (levothyroxine).

IMATINIB ZYDUS with food and drink

There are no known interactions between IMATINIB ZYDUS and food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking IMATINIB ZYDUS. If you are pregnant or breastfeeding your baby, you should not use IMATINIB ZYDUS as it may harm your baby. Women who might become pregnant are advised to use effective contraception during treatment. Patients who are concerned about their fertility while taking IMATINIB ZYDUS are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking IMATINIB ZYDUS. If this happens, do not drive a vehicle or use any tools or machines until you are feeling well again.

Do not share medicines prescribed for you or a child in your care with any other person. Always take or give IMATINIB ZYDUS exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

IMATINIB ZYDUS should be taken with food and a large glass of water to minimise the risk of gastrointestinal disturbances. Your doctor will advise you on the dose to be taken for your specific condition.

If you or a child in your care are unable to swallow the film-coated tablets, the tablets may be dissolved in a glass of water or apple juice. The required number of tablets should be placed in the appropriate volume of liquid (approximately 50 mL for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon. Take the suspension immediately after complete disintegration of the tablet(s).

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 a child in your care. Your doctor will tell you how long your treatment with IMATINIB ZYDUS will last. Do not stop treatment with IMATINIB ZYDUS unless your doctor tells you to.

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

If you take more IMATINIB ZYDUS than you should

In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre. You or a child in your care may require medical attention. Take the medicine pack with you.

If you forget to take IMATINIB ZYDUS

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 for a forgotten dose.

If you stop taking IMATINIB ZYDUS

It is important to keep taking or receiving IMATINIB ZYDUS every day, as long as your doctor prescribes it for you or a child in your care. If you have any further questions on the use of IMATINIB ZYDUS, ask your doctor or pharmacist.

IMATINIB ZYDUS can have side effects. Not all side effects reported for IMATINIB ZYDUS are included in this leaflet. Should your or a child in your care’s general health worsen or if you experience any untoward effects while taking IMATINIB ZYDUS, please consult your health care provider for advice.

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

• swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• rash, hives or itching;
• fainting.

These are all very serious side effects. If you or a child in your care have them, you may have had a serious reaction to IMATINIB ZYDUS. 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:

• signs of infection such as fever, severe chills, sore throat or mouth ulcers;
• unexpected bleeding or bruising (when you have not hurt yourself);
• rapid weight gain because of severe fluid retention;
• difficulty in breathing;
• severe abdominal pain, blood in your vomit, stools or urine, black stools;
• pneumonia (fever, chills, shortness of breath, cough – you may cough up greenish or yellow mucus or even bloody mucus);
• sepsis (often called blood poisoning, a severe infection which can lead to death);
• 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 your skull/brain);
• seizures (fits);
• heart problems which can cause shortness of breath or ankle swelling;
• changes in the way your heart beats (beating faster, slower) or irregular;
• heart attack;
• chest pain, pressure or discomfort;
• severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders);
• inflammation of your pancreas (abdominal pain that radiates to your back and feels worse after eating, tenderness when touching your abdomen);
• yellow of your skin or eyes (signs of liver problems);
• painful, blistering or peeling skin rash (such as Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme);
• rhabdomyolysis (rapid breakdown of muscle tissue causing muscle pain or weakness, dark coloured urine, fever);
• blood in your urine, increased need to urinate;
• renal failure (reduced amount of urine, swelling of your legs, ankles, and feet from fluid retention caused by the failure of your kidneys to eliminate water waste, drowsiness or fatigue);
• blood clots in small blood vessels (thrombotic microangiopathy);
• recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection);
• acute respiratory failure (your body does not get enough oxygen from your lungs causing a severe shortness of breath, drowsiness, low blood pressure, blue lips or nails);
• intestinal obstruction (crampy abdominal pain that comes and goes, loss of appetite, inability to have a bowel movement or pass gas, swelling of your abdomen);
• gastrointestinal perforation (a hole in the wall or part of your gastrointestinal tract causing severe pain in your stomach area that worsens when moving.

Tell your doctor if you notice any of the following:

Frequent side effects:

• pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells);
• anorexia (lack or loss of appetite);
• difficulty in sleeping (insomnia);
• headaches, dizziness;
• tingling or numbness of your hands and feet (pins and needles);
• disturbed sense of taste;
• diminished sense of touch;
• puffy eyes, dry eyes, discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision;
• hot flushes;
• nose bleeds;
• cough;
• nausea (feeling sick), diarrhoea, vomiting (being sick), indigestion, pain in your stomach area, flatulence (wind), bloating, reflux, constipation, dry mouth;
• increased liver enzymes when blood tests are done;
• dry skin, swelling of your face, eyelid swelling, redness of your skin;
• hair loss (temporarily);
• night sweats;
• decreased or increased skin sensitivity;
• muscle spasms or cramps, muscle pain, bone or joint pain, joint swelling;
• feeling tired or weak;
• fever or chills;
• increased or decreased weight.

Less frequent side effects:

• runny or stuffy nose, postnasal drip, sinus headache, sneezing, scratchy or sore throat;
• sudden swelling and redness of the skin (signs of a skin infection called cellulitis);
• burning feeling when you urinate, cloudy urine, frequent urge to urinate (signs of a urinary tract infection);
• fungal infection;
• increased or decreased appetite;
• abnormal laboratory test results when blood tests are done (e.g. low phosphorus, sodium and magnesium levels or high uric acid and calcium levels);
• dehydration;
• high blood sugar levels;
• gout;
• muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood);
• feeling depressed, anxious or confused;
• migraine;
• drowsiness, fainting;
• peripheral neuropathy (tingling or numbness in your hands or feet, dropping things from your hands regularly, feeling of weakness or heaviness in your arms and legs, sharp stabbing pains);
• difficulty remembering things;
• pain in your hips or difficulty walking;
• an uncontrollable urge to move your legs (restless legs syndrome (RLS));
• shakiness (tremors);
• deterioration of vision, eye pain or irritation, bleeding eyes, red, swollen eyelids, flaking of the skin around your eyes, crusted eyelashes upon awakening;
• vertigo (sensation of spinning or swaying);
• ringing in your ears, hearing loss;
• high or low blood pressure;
• numb or cold toes and fingers (signs of Raynaud’s syndrome);
• inflammation of your mouth and lips, mouth ulcer, stomach ulcer;
• burping;
• difficulty and or painful swallowing;
• increased sweating;
• bruising more easily;
• unusual hair loss or thinning;
• patchy skin color - irregular skin color with lighter or darker areas;
• brittle nails, nail discolouration;
• rash, red skin with blisters on your lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems);
• painful, swollen and red joints, joint and muscle stiffness;
• nipple pain, breast enlargement in men and women;
• sexual problems, including the inability to develop or maintain an erection in men;
• irregular or heavy menstruation in women;
• 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);
• scrotal swelling in men;
• generally feeling unwell;
• increased liver enzymes when blood tests are done.

Frequency unknown side effects:

slowing of growth in children and adolescents. 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. This includes any possible side effects not listed in this leaflet. 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 IMATINIB ZYDUS.

• Store at or below 25 °C.

• Keep the blister strips in the outer carton until required for use.

• Protect from moisture.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton or container.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).