Package Leaflet: Information for the User

Imatinib Accord 100 mg Film-Coated Tablets

Imatinib Accord 400 mg Film-Coated Tablets

imatinib

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4

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

2.What you need to know before you start taking Imatinib Accord

3.How to take Imatinib Accord

4.Possible side effects

5.Storage of Imatinib Accord

6.Contents of the pack and additional information

Imatinib Accord is a medication that contains an active ingredient called imatinib. This medication acts by inhibiting the growth of abnormal cells in the diseases described below. These include some types of cancer.

Imatinib Accord is a treatment for adults and children and adolescents for:

• Chronic Myeloid Leukemia (CML). Leukemia is a cancer of the white blood cells. These white blood cells normally help the body fight infections. Chronic myeloid leukemia is a form of leukemia in which abnormal white blood cells (called myeloid cells) start to grow uncontrollably.

• Ph+ Acute Lymphoblastic Leukemia (ALL). Leukemia is a cancer of the white blood cells. These white blood cells normally help the body fight infections. Acute lymphoblastic leukemia is a form of leukemia in which abnormal white blood cells (called lymphoblasts) start to grow uncontrollably. Imatinib Accord inhibits the growth of these cells.

Imatinib Accord is also a treatment for adults for:

• Myeloproliferative/Myelodysplastic Syndromes (MPMDS). These are a group of blood disorders in which some blood cells start to grow uncontrollably. Imatinib Accord inhibits the growth of these cells in a certain subtype of these disorders.
• Systemic Mastocytosis (SM) and/or Chronic Eosinophilic Leukemia (CEL). These are blood disorders in which some blood cells (called eosinophils) start to grow uncontrollably. Imatinib Accord inhibits the growth of these cells in a certain subtype of these disorders.
• Gastrointestinal Stromal Tumors (GIST). GIST is a cancer of the stomach and intestine. It originates from uncontrolled cellular growth of the supportive tissues of these organs.
• Dermatofibrosarcoma Protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start to grow uncontrollably. Imatinib Accord inhibits the growth of these cells.

In the rest of this prospectus, these abbreviations are used when referring to these diseases.

If you have any questions about how Imatinib Accord works or why this medication has been prescribed to you, ask your doctor.

Only a doctor with experience in medications for treating blood cell cancers or solid tumors will prescribe Imatinib Accord.

Follow carefully all the instructions from your doctor, even if they are different 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 components of this medication (listed in section6).

If this applies to you,inform your doctor and do not take Imatinib Accord.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Consult your doctor before starting to take Imatinib Accord:

-if you have or have had any liver, kidney, or heart problems.

-if you are taking a medication that contains levotiroxine because your thyroid gland has been removed.

• if you have ever had or may have a hepatitis B infection at this time. This is because Imatinib Accord may cause hepatitis B to become active again, which can be fatal in some cases. The doctor should carefully check for signs of this infection before starting treatment.

• if while taking Imatinib Accord you develop bruises, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of a blood vessel damage called microangiopathic thrombosis (MAT).

If any of these cases apply to you,inform your doctor before taking Imatinib Accord.

It is possible that you may become more sensitive to the sun while taking Imatinib Accord. It is essential to cover areas of the skin exposed to the sun and use high-protection sunscreen. These precautions also apply to children.

Inform your doctor immediately during treatment with Imatinib Accordif you gain weight very quickly. Imatinib Accord may cause severe fluid retention in the body.

While taking Imatinib Accord, your doctor will regularly check if the medication is working. Blood tests and regular weighing will also be performed.

Children and adolescents

Imatinib Accord is also a treatment for children and adolescents with LMC. There is no experience with children and adolescents with LMC under 2years of age. The experience with children and adolescents with LLA Ph-positive is limited, and the experience with children and adolescents with SMD/SMP, DFSP, GIST, and SHE/LEC is very limited.

Some children and adolescents taking Imatinib Accord may experience slower-than-normal growth. The doctor will monitor growth during regular visits.

Interaction of Imatinib Accord with other medications

Inform your doctor or pharmacist if you are using, have taken recently, or may need to take any other medication, including those purchased without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medications may interfere with the effect of Imatinib Accord when taken together. These 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 also produce the same effect on other medications.

Inform your doctor if you are using medications that prevent blood clotting.

Pregnancy, breastfeeding, and fertility

-If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

• It is not recommended to use Imatinib Accord during pregnancy except when clearly necessary, as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Accord during pregnancy.
• Women who may become pregnant are advised to use an effective contraceptive method during treatment and for 15days after completing treatment.

-Do not breastfeed your baby during treatment with Imatinib Accord or for 15days after completing treatment, as it may harm your baby.

-Patients concerned about their fertility while taking Imatinib Accord should consult their doctor.

Driving and operating machinery

You may experience dizziness, drowsiness, or blurred vision while taking this medication. If you experience these symptoms, do not drive or operate tools or machinery until you feel better again.

Your doctor has prescribed Imatinib Accord because you have a serious disease. Imatinib Accord may help you fight this disease.

However, follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. It is important that you do it for the time that your doctor or pharmacist tells you. In case of doubt, consult your doctor or pharmacist again.

Do not stop taking Imatinib Accord unless your doctor tells you to. If you cannot take the medication as prescribed by your doctor or think you do not need to take it for a longer time, 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 LMC

Depending on your situation, the initial normal dose is 400 mg or 600 mg:

- 400 mg, that is 4 tablets of 100 mg or 1 tablet of 400 mg once a day,

- 600 mg, that is 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.

• If you are being treated for GIST:

The initial dose is 400 mg, taken once a day.

For LMC and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your 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 LLA Ph-positive

The initial dose is 600 mg, that is 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.

• If you are being treated for SMD/SMP

The initial dose is 400 mg, that is 4 tablets of 100 mg or 1 tablet of 400 mg once a day.

• If you are being treated for SHE/LEC

The initial dose is 100 mg, that is 1 tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, that is 4 tablets of 100 mg or 1 tablet of 400 mg once a day, depending on how you respond to treatment.

• If you are being treated for DFSP

The dose is 800 mg per day, that is 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 to administer to the child. The amount of Imatinib Accord administered will depend on the child's situation, weight, and height. The total daily dose in children and adolescents should not exceed 800 mg in LMC and 600 mg in LLA Ph+. The treatment may be given to the child once a day or, alternatively, the dose may be divided into two doses (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 you from stomach problems when taking Imatinib Accord.
• Swallow the tablets with a large glass of water.

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

• Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
• Stir until the tablets have completely dissolved.
• Once the tablet has dissolved, drink the entire glass immediately. You may be left with remnants of the dissolved tablets in the glass.

For how long to take Imatinib Accord

Continue taking Imatinib Accord every day for the time your doctor tells you.

If you take more Imatinib Accord than you should

If you have accidentally taken too many tablets, talk to your doctor immediately. You may need medical attention. Bring the medication packaging.

If you forget to take Imatinib Accord

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the one you forgot.
• Then continue with the normal schedule.
• Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These are usually mild to moderate.

Some side effects can be serious. Inform your doctor immediately if you experience any of the following

Frequent side effects(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 in your blood, making you more susceptible to infections.

• Bleeding or unexpected bruising (when you have not suffered any injury).

Less frequent side effects(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, difficulty breathing, or painful breathing (signs of lung problems).
• Dizziness, lightheadedness, or fainting (signs of low blood pressure).
• Nausea, loss of appetite, dark urine, yellow skin or eyes (signs of liver problems).

• Rash, skin redness, blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin patches, itching, burning sensation, rash with pustules (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stool, or urine, black stool (signs of gastrointestinal problems).
• Significant decrease in urine output, feeling thirsty (signs of kidney problems).
• Nausea, diarrhea, and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the brain or skull).
• Pale skin, feeling tired, and difficulty breathing, dark urine (signs of low red blood cell count).
• Eye pain or vision problems.
• Hip pain or difficulty walking.
• Numbness or cold sensation in the feet and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and muscle spasms, abnormal heart rhythm (signs of changes in potassium levels in the blood).
• Bruises.
• Stomach pain with nausea.
• Muscle spasms with fever, urine that is reddish-brown, muscle or joint pain (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, unexpected vaginal bleeding, dizziness or fainting due to low blood pressure (signs of ovarian or uterine problems).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal laboratory test results (e.g., elevated potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
• Small blood clots in small blood vessels (microangiopathic thrombosis).

Unknown frequency(cannot be estimated from available data)

• A combination of widespread generalized rash, feeling unwell, fever, elevated levels of certain blood cells, or yellow skin or eyes (signs of jaundice) with difficulty breathing, chest pain, decreased urine output, and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney disease.
• Recurrence (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

If you experience any of the above changes,inform your doctor immediately.

Other side effects may include

Frequent side effects(may affect more than 1 in 10 people)

• Headache or feeling tired.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the muscles, joints, or bones, during treatment with Imatinib Accord or when stopping treatment.
• Inflammations such as swollen ankles or eyes.
• Weight gain.

If any of these affect you significantly,inform your doctor.

Common side effects(may affect up to 1 in 10 people)

• Loss of appetite, weight loss, or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Runny eyes with itching, redness, and swelling (conjunctivitis), watery eyes, or blurred vision.
• Nasal bleeding.
• Abdominal pain, bloating, heartburn, or constipation.
• Itching.
• Unusual hair loss or weakness.
• Numbness in the hands or feet.
• Mouth ulcers.
• Pain in the joints with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

If any of these affect you significantly,consult your doctor.

Unknown frequency(cannot be estimated from available data)

• Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and burning sensation.
• Painful skin lesions with blisters
• Delayed growth in children and adolescents.

If any of these affect you significantly,consult your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and the blister pack after "CAD" or “EXP”. The expiration date refers to the last day of the month.

• For PVC/PVdC/aluminum blisters

Do not store at a temperature above30°C.

• For aluminum/aluminum blisters

This medication does not require any special storage conditions.

• Do not use any packaging if you observe that it is damaged or shows signs of manipulation.
• Medications should not be thrown away through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Imatinib Accord

• The active ingredient is imatinib mesylate.

Each film-coated tablet of 100 mg of Imatinib Accord contains 100 mg of imatinib (as mesylate).

Each film-coated tablet of 400 mg of Imatinib Accord contains 400 mg of imatinib (as mesylate).

• The other components are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate, and anhydrous colloidal silica. The tablet coating is composed of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the package

Imatinib Accord 100 mg film-coated tablets have a brown-orange color, round biconvex shape, and are marked on one side with "IM" and "T1" on either side of the notch and smooth on the other side.

Imatinib Accord 400 mg film-coated tablets have a brown-orange color, oval shape, biconvex, marked on one side with "IM" and "T2" on either side of the notch and smooth on the other side.

Imatinib Accord 100 mg film-coated tablets are presented in packages containing 20, 60, 120, or 180 tablets, but it is possible that not all are available in your country.

In addition, Imatinib Accord 100 mg tablets are also available in a blister pack of PVC/PVdC/aluminum in packages of 30x1, 60x1, 90x1, 120x1, or 180x1 film-coated tablets.

Imatinib Accord 400 mg film-coated tablets are presented in packages containing 10, 30, or 90 tablets, but it is possible that not all are available in your country.

In addition, Imatinib Accord 400 mg tablets are available in a blister pack of PVC/PVdC/aluminum in packages of 30x1, 60x1, 90x1 film-coated tablets.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6th floor,

08039 Barcelona,

Spain

Responsible for manufacturing

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Last revision date of this leaflet:

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