Imatinib Accord: detailed information

Package leaflet: Information for the user

Imatinib Accord 100 mg film-coated tablets, 400 mg film-coated tablets

imatinib
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Imatinib Accord is and what it is used for
What you need to know before taking Imatinib Accord
How to take Imatinib Accord
Possible side effects
How to store Imatinib Accord
Contents of the pack and other information

1. What Imatinib Accord is and what it is used for

Imatinib Accord is a medicine containing an active substance called imatinib. In the conditions listed below, this medicine works by inhibiting the growth of abnormal cells, including certain types of cancer.
Imatinib Accord is indicated in adult patients and in children and adolescents for the treatment of:

Chronic myeloid leukaemia (CML). Leukaemia is a tumour of white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.
Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a tumour of white blood cells. White blood cells normally help the body fight infections. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells.

Imatinib Accord is indicated in adult patients for the treatment of:

Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of haematological diseases in which certain blood cells begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells in certain subtypes of these diseases.
Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells in a specific subtype of these diseases.
Malignant gastrointestinal stromal tumours (GIST). GIST is a tumour of the stomach and intestine. It arises from uncontrolled growth of cells supporting the tissues of these organs.
Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the subcutaneous tissue in which certain cells begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells. In the remainder of this patient information leaflet, the abbreviations will be used when referring to these conditions.

If you have any questions about how Imatinib Accord works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before taking Imatinib Accord

Imatinib Accord will only be prescribed by doctors experienced in medicines for the treatment of
blood cancers and solid tumors.
Carefully follow all instructions given by your doctor, even if they differ from the general information
contained in this leaflet.
Do not take Imatinib Accord:

if you are allergic to imatinib or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, consult your doctor before taking Imatinib Accord.

If you think you may be allergic but are unsure, ask your doctor for advice.
Warnings and precautions
Talk to your doctor before taking Imatinib Accord:

if you have or have had liver, kidney, or heart problems.
if you are taking the medicine levothyroxine because your thyroid gland has been removed.
if you have ever had or may currently have hepatitis B infection. This is because Imatinib Accord can cause reactivation of hepatitis B, which in some cases can be fatal. Your doctor will carefully monitor you for signs of this infection before starting treatment.
if you develop bruising, bleeding, fever, fatigue, or confusion while taking Imatinib Accord, contact your doctor. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

If you are in any of these situations, consult your doctor before taking Imatinib Accord.
While taking Imatinib Accord, you may become more sensitive to sunlight. It is important to cover
exposed areas of skin and use sunscreen with a high sun protection factor (SPF). These precautions apply also to children.
During treatment with Imatinib Accord, inform your doctor immediately if you gain weight rapidly. Imatinib Accord may cause your body to retain fluid (severe fluid retention).
While taking Imatinib Accord, your doctor will regularly monitor whether the medicine is working. You will also have regular blood tests and be weighed regularly.
Children and adolescents
Imatinib Accord is also a treatment for children and adolescents with CML. There is no experience in children and adolescents with CML under 2 years of age. Experience is limited in children and adolescents with Ph+ ALL and very limited in children and adolescents with MDS/MPD, DFSP, GIST, and HES/LEC.
Some children and adolescents taking Imatinib Accord may experience slower than normal growth. Your doctor will monitor growth at regular intervals.
Other medicines and Imatinib Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (such as paracetamol), and including herbal medicines (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Accord when taken together. They may increase or decrease the effect of Imatinib Accord, leading to an increase in side effects or making Imatinib Accord less effective. Imatinib Accord may have similar effects on other medicines.
Inform your doctor if you are using medicines that prevent blood clots from forming.
Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Imatinib Accord is not recommended during pregnancy unless strictly necessary, as it may harm the unborn baby. Your doctor will discuss with you the potential risks of taking Imatinib Accord during pregnancy.
Women who can become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
Do not breastfeed during treatment with Imatinib Accord and for 15 days after stopping treatment, as it may harm the baby.
Patients concerned about fertility during treatment with Imatinib Accord are advised to consult their doctor.

Driving and using machines
Dizziness, drowsiness, or blurred vision may occur while taking this medicine. If this happens, do not drive or operate tools or machinery until you feel well again.

3. How to take Imatinib Accord

Your doctor has prescribed Imatinib Accord because you suffer from a serious condition. Imatinib Accord
can help you fight this condition.
However, take this medicine exactly as instructed by your doctor or pharmacist. It is important that you
do so until your doctor or pharmacist tells you otherwise. If you have any doubts, consult your doctor or
pharmacist.
Do not stop taking Imatinib Accord unless your doctor tells you to. If you are unable to take the medicine as
prescribed or feel you no longer need it, contact your doctor immediately.

How much Imatinib Accord to take

Use in adults
Your doctor will tell you exactly how many Imatinib Accord tablets you should take.

If you are being treated for CML: Depending on your condition, the usual starting dose is 400 mg or 600 mg:
- 400 mg to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once daily
- 600 mg to be taken as 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once daily.
If you are being treated for GIST: The starting dose is 400 mg, to be taken once daily.

For both CML and GIST, your doctor may prescribe a higher or lower dosage depending on your response
to treatment. If the daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg), you should take
4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.

If you are being treated for Ph+ ALL: The starting dose is 600 mg, to be taken as 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once daily.
If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once daily.
If you are being treated for HES/CEL: The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once daily. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once daily, based on your response to treatment.
If you are being treated for DFSP: The dose is 800 mg daily, to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.

Use in children and adolescents
Your doctor will tell you how many Imatinib Accord tablets should be given to the child. The amount of
Imatinib Accord administered will depend on the child's condition, weight, and height. The total daily dose must not exceed 800 mg in children and adolescents with CML and 600 mg in children and adolescents with Ph+ ALL. The treatment may be given to the child as a single daily dose or, alternatively, the daily dose may be divided into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Accord

Take Imatinib Accord with food. This will help protect your stomach when taking Imatinib Accord.
Swallow the tablets whole with a glass of water.

If you are unable to swallow the tablets, you may dissolve them in a glass of still water or apple juice:

Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
Stir the liquid with a spoon until the tablets are completely dissolved.
Once the tablets are dissolved, drink the entire contents of the glass at once. Traces of the dissolved tablets may remain in the glass.

How long to take Imatinib Accord
Continue taking Imatinib Accord every day for as long as your doctor tells you to.

If you take more Imatinib Accord than you should
If you accidentally take too many tablets, contact your doctor immediately. You may need medical
assistance. Bring the medicine pack with you.

If you forget to take Imatinib Accord

If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Then continue with your regular dosing schedule.
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These are generally mild to moderate.
Some side effects may be serious. Inform your doctor immediately if you experience
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. Imatinib Accord may cause your body to retain water (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Accord may reduce the number of white blood cells, so you may get infections more easily.
Unexpected bleeding or bruising (when you have not injured yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

Chest pain, irregular heartbeat (signs of heart problems).
Cough, difficulty breathing or painful breathing (signs of lung problems).
Feeling of emptiness in the head, dizziness or fainting (signs of low blood pressure).
Feeling unwell (nausea), with loss of appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
Skin rash, redness of the skin with blisters on the lips, eyes, skin or mouth, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
Severe abdominal pain, presence of blood in vomit, faeces or urine, black stools (signs of gastrointestinal disorders).
Marked decrease in urine output, feeling thirsty (signs of kidney problems).
Feeling unwell (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of intestinal 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 the skull/brain).
Paleness, feeling tired and short of breath and dark-coloured urine (signs of low red blood cell levels).
Eye pain or deterioration in vision, bleeding in the eyes.
Bone or joint pain (signs of osteonecrosis).
Blisters on the skin or mucous membranes (signs of pemphigus).
Numbness or coldness in fingers or toes (signs of Raynaud's syndrome).
Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Hearing problems.
Muscle weakness and muscle cramps with an abnormal heartbeat (signs of changes in blood potassium levels).
Bruising (bruises).
Stomach pain with feeling unwell (nausea).
Muscle cramps with fever, red-brown urine, muscle pain or weakness (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 ovaries and uterus).
Nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness and/or joint problems associated with abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium and low levels of phosphorus 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 skin reaction, feeling unwell, fever, increase in number of certain types of white blood cells or yellowing of the skin or eyes (signs of jaundice, i.e. a liver problem) with shortness of breath, chest pain/discomfort, marked decrease in urine production and feeling thirsty, etc. (signs of a treatment-related allergic reaction).
Chronic kidney failure.
Reactivation (recurrence) of hepatitis B infection if you have previously had hepatitis B (a liver infection).

If you experience any of the above effects, inform your doctor immediately.
Other side effects may include
Very common (may affect more than 1 in 10 people):

Headache or feeling tired.
Feeling unwell (nausea), vomiting, diarrhoea or indigestion.
Skin rash.
Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Accord or after stopping Imatinib Accord.
Swelling, for example around the ankles or puffy eyes.
Weight gain. If any of these effects becomes severe, inform your doctor.

Common (may affect up to 1 in 10 people):

Loss of appetite, weight loss or taste disturbances.
Feeling dizzy or weak.
Sleep disturbances (insomnia).
Eye discharge with itching, redness and swelling (conjunctivitis), increased tearing or blurred vision.
Nosebleeds.
Abdominal pain or swelling, flatulence, heartburn or constipation.
Itching.
Unusual hair loss or thinning.
Numbness of hands or feet.
Mouth ulcers.
Joint pain with swelling.
Dry mouth, dry skin or dry eyes.
Reduced or increased skin sensitivity.
Hot flushes, chills or night sweats. If any of these effects becomes severe, inform your doctor.

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

Painful red nodules on the skin, skin pain, skin redness (inflammation of subcutaneous fat tissue).
Cough, runny or stuffy nose, feeling of pressure or pain when 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 pulsating pain or pulsating 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 during urination, increased body temperature, pain in the groin or pelvic area, red, brown or cloudy urine

(signs of urinary tract infection).

Joint pain and swelling (signs of arthralgia).
Persistent feeling of sadness and loss of interest, preventing you from carrying out your normal activities (signs of depression).
A feeling of apprehension and worry together with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
Drowsiness/lethargy/excessive sleepiness.
Tremor or shaky movements (tremor).
Memory problems.
Uncontrollable urge to move the legs (restless legs syndrome).
Hearing noises in the ears (e.g. ringing, buzzing) that have no external source (tinnitus).
High blood pressure (hypertension).
Belching.
Inflammation of the lips.
Difficulty swallowing.
Increased sweating.
Change in skin colour.
Brittle nails.
Red bumps or boils with white tips around hair roots, possibly with pain, itching or burning sensation (signs of inflammation of hair follicles, also called folliculitis).
Skin rash with peeling or exfoliation (exfoliative dermatitis).
Breast enlargement (can occur in men or women).
Dull and/or heavy feeling in testicles or lower abdomen, pain during urination, sexual intercourse or ejaculation, blood in urine (signs of testicular oedema).
Inability to achieve or maintain an erection (erectile dysfunction).
Heavy or irregular menstrual periods.
Difficulty achieving/maintaining sexual arousal.
Decreased sexual desire.
Nipple pain.
General feeling of being unwell (malaise).
Viral infection such as cold sores.
Back pain due to kidney disease.
Increased frequency of urination.
Increased appetite.
Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, dark-coloured stools (signs of stomach ulcer).
Stiffness of joints and muscles.
Abnormal laboratory test results.

If any of these effects becomes severe, inform your doctor.
Rare (may affect up to 1 in 1,000 people):

Confusion.
An episode of seizure(s) and reduced consciousness (convulsions).
Change in nail colour.

Not known (frequency cannot be estimated from the available data):

Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and painful burning.
Painful and/or ulcerative skin lesions.
Slowed growth in children and adolescents.

If any of these effects becomes severe, inform your doctor.
Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of the month.
For PVC/PVdC/aluminium blisters: Do not store above 30°C.
For aluminium/aluminium blisters: This medicine does not require any special storage conditions.
Do not use if the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imatinib Accord contains

The active substance is imatinib mesilate. Each 100 mg film-coated tablet of Imatinib Accord contains 100 mg of imatinib (as mesilate). Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg of imatinib (as mesilate).
The other components are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica. The tablet coating contains polyvinyl alcohol (E1203), talc (E553b), polyethylene glycol (E1521), yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Imatinib Accord and contents of the pack
Imatinib Accord 100 mg film-coated tablets are biconvex, brownish-orange, round, film-coated tablets, with 'IM' engraved on one side and 'T1' on both sides of the breakline on the other side.
Imatinib Accord 400 mg film-coated tablets are biconvex, brownish-orange, oval, film-coated tablets, with 'IM' engraved on one side and 'T2' on both sides of the breakline on the other side.
Imatinib Accord 100 mg film-coated tablets are supplied in packs containing 20, 60, 120 or 180 tablets, although not all pack sizes may be available in your country.
Additionally, Imatinib Accord 100 mg tablets are also available in cartons with perforated unit dose blisters (PVC/PVdC/Aluminium) or aluminium/aluminium in packs of 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Imatinib Accord 400 mg film-coated tablets are supplied in packs containing 10, 30 or 90 tablets, although not all pack sizes may be available in your country.
Additionally, Imatinib Accord 400 mg tablets are available in cartons with perforated unit dose blisters (PVC/PVdC/Aluminium) or aluminium/aluminium in packs of 30x1, 60x1 or 90x1 film-coated tablets.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu