MedicineX 100 mg hard capsules (Package Leaflet)

ProductX CompanyY is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

ProductX CompanyY 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. ProductX CompanyY inhibits the growth of these cells.

ProductX CompanyY 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. ProductX CompanyY inhibits 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. ProductX CompanyY 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. It arises from uncontrolled cell growth of the supporting tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. ProductX CompanyY inhibits 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 ProductX CompanyY works or why this medicine has been prescribed for you, ask your doctor.

ProductX CompanyY 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.

Your doctor has prescribed ProductX CompanyY because you suffer from a serious condition. ProductX CompanyY can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking ProductX CompanyY unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

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 (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):

• Rapid weight gain. ProductX CompanyY may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. ProductX CompanyY 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 (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• 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 bones or joints (signs of osteonecrosis).
• Blisters on skin or mucous membranes (signs of pemphigus).
• 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 (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

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 treatment with ProductX CompanyY or after you have stopped taking ProductX CompanyY.
• 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.

Uncommon (may affect up to 1 in 100 people):

• Cough, runny or stuffy nose, feeling of heaviness or pain on pressing the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache felt as a throbbing pain or pulsing sensation, usually on one side of the head and often accompanied by nausea, vomiting and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation while passing urine, increased body temperature, pain in groin or pelvic area, red- or brown-coloured or cloudy urine (signs of urinary tract infection).
• Pain and swelling of your joints (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which stops you carrying out your normal activities (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as pounding heart, sweating, trembling, dry mouth (signs of anxiety).
• Sleepiness/drowsiness/excessive sleep.
• Trembling or shaky movements (tremor).
• Memory impairment.
• Overwhelming urge to move the legs (restless leg syndrome).
• Hearing noises (e.g. ringing, humming) in the ears that have no external source (tinnitus).
• High blood pressure (hypertension).
• Burping/belching.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Skin discolouration.
• Brittle nails.
• Red bumps or white-headed pimples around the roots of the hair, possibly with pain, itching or burning sensation (signs of inflammation of the hair follicles, also called folliculitis).
• Skin rash with flaking or peeling (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain during urination, sexual intercourse or ejaculation, blood in urine (signs of oedema of the testicles).
• Inability to get or keep an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving/maintaining sexual arousal.
• Decreased sexual desire.
• Nipple pain.
• Generally feeling unwell (malaise).
• Viral infection such as cold sore.
• Lower back pain resulting from kidney disorder.
• Increased frequency of passing urine.
• Increase in appetite.
• Pain or burning sensation in upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, black-coloured stools (signs of stomach ulcer).
• Joint and muscle stiffness.
• Abnormal laboratory test results.
• Painful red lumps on the skin, skin pain, skin reddening (inflammation of fatty tissue under the skin).

If any of these affects you severely, tell your doctor.

Rare (may affect up to 1 in 1,000 people):

• Confusion.
• Nail discolouration.

If any of these affects you severely, tell your doctor.

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.

If any of these affects you severely, tell your doctor.

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 and blister after EXP. The expiry date refers to the last day of the month.

This medicine 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.