Imatilek

Package Leaflet: Information for the User

Imatilek, 400 mg, Hard Capsules

Imatinib

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Imatilek and what is it used for
• 2. Before you take Imatilek
• 3. How to take Imatilek
• 4. Possible side effects
• 5. How to store Imatilek
• 6. Contents of the pack and other information

1. What is Imatilek and what is it used for

Imatilek is a medicine that contains the active substance imatinib. It works by stopping the growth of abnormal cells in certain diseases, including some types of cancer.

Imatilek is indicated for the treatment of adult and pediatric patients with:

• Chronic Myeloid Leukemia (CML)(also known as Chronic Myeloid Leukaemia, CML). Leukemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infection. In CML, certain abnormal white blood cells (called myeloid cells) start to grow out of control.
• Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph-positive ALL). Leukemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infection. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatilek stops the growth of these cells.

Imatilek is also indicated for the treatment of adult patients with:

• Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)(also known as myelodysplastic/myeloproliferative, MDS/MPD). These are blood diseases in which certain white blood cells start to grow out of control. Imatilek stops the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic Syndrome (HES) and (or) Chronic Eosinophilic Leukemia (CEL). These are blood diseases in which certain blood cells (called eosinophils) start to grow out of control. Imatilek stops the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a skin cancer and a cancer of the tissue under the skin, in which certain cells start to grow out of control. Imatilek stops the growth of these cells.

In the rest of this leaflet, the abbreviations for the diseases listed above will be used.
If you have any questions about how Imatilek works or why it has been prescribed for you, ask your doctor.

2. Before you take Imatilek

Imatilek is prescribed to patients only by doctors who are experienced in the use of anticancer medicines.
Follow the doctor's instructions carefully, even if they differ from the general information in this leaflet.

When not to take Imatilek:

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

Imatilek.

If you suspect an allergy but are not sure, consult your doctor.

Warnings and precautions

Before starting treatment with Imatilek, discuss the following with your doctor:

• if you have or have ever had liver, kidney, or heart disease.
• if you are taking levothyroxine after thyroid removal.
• if you have had or may have a hepatitis B infection; this is because Imatilek can cause the hepatitis B virus to become active again, which can be life-threatening in some cases; you will be closely monitored by your doctor for signs of this infection before starting treatment.
• if you experience bruising, bleeding, fever, fatigue, and confusion while taking Imatilek, contact your doctor. This could be a sign of a condition called thrombotic microangiopathy (TMA). If any of the above apply to you, tell your doctor before taking Imatilek.

While taking Imatilek, you may become more sensitive to the sun. It is important to cover exposed skin areas and use sunscreens with a high sun protection factor (SPF). These precautions should also be taken by children.
Tell your doctor immediately if you experience a sudden increase in weight during treatment with Imatilek.Imatilek can cause fluid retention in the body (severe fluid retention).
Your doctor will regularly check your health to see if treatment with Imatilek is effective. Blood tests and weight checks will be done regularly while you are taking this medicine.

Children and adolescents

Imatilek is also used to treat children with CML. There is limited experience in children with CML under 2 years of age. Experience in children with Ph-positive ALL is limited, and experience in children with MDS/MPD, DFSP, and HES/CEL is very limited.
Some children and adolescents taking Imatilek may grow more slowly than normal. Your doctor will monitor growth during regular check-ups.

Imatilek and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines can affect the way Imatilek works, or Imatilek can affect the way other medicines work, which can lead to increased side effects or make Imatilek less effective. Imatilek can also affect the way other medicines work.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Imatilek is not recommended during pregnancy unless clearly necessary, as it may harm the baby. Your doctor will discuss the potential risks with you.
• Women who may become pregnant should use effective contraception during treatment with Imatilek and for 15 days after stopping treatment.
• Do not breastfeed while taking Imatilek and for 15 days after stopping treatment, as it may harm the baby.
• Patients concerned about their fertility during treatment with Imatilek should consult their doctor.

Driving and using machines

While taking this medicine, you may experience dizziness or drowsiness, or have vision problems.
Do not drive or operate any tools or machines until you feel well.

3. How to take Imatilek

Your doctor has prescribed Imatilek for your condition. Imatilek can help improve your condition.
However, you should always take Imatilek exactly as your doctor or pharmacist has told you. It is important to take Imatilek for as long as your doctor tells you to. If you are unsure, ask your doctor or pharmacist.

What dose of Imatilek to take

Adult patients

Your doctor will decide the exact number of Imatilek capsules you should take.

• For CML treatment:The starting dose is usually 400 mg or 600 mg:
• 400 mgtaken as 1 capsule oncea day,
• 600 mgtaken as 1 capsule of 400 mg plus 2 capsules of 100 mg oncea day.

For CML treatment, your doctor may prescribe a higher or lower dose depending on your response to treatment. If the daily dose is 800 mg (2 capsules), take 1 capsule in the morning and 1 capsule in the evening.

• - For Ph-positive ALL treatment:The starting dose is 600 mg, taken as 1 capsule of 400 mg plus 2 capsules of 100 mg oncea day.
• - For MDS/MPD treatment:The starting dose is 400 mg, taken as 1 capsule of 400 mg oncea day.
• - For HES/CEL treatment:The starting dose is 100 mg, taken as 1 capsule of 100 mg oncea day. Your doctor may decide to increase the dose to 400 mg, taken as 1 capsule of 400 mg oncea day, depending on your response to treatment.
• - For DFSP treatment:The daily dose is 800 mg (2 capsules), taken as 1 capsule in the morning and 1 capsule in the evening.

Children and adolescents

Your doctor will decide the number of Imatilek capsules to give to your child. The dose will depend on the child's condition, weight, and height. The total daily dose in children should not exceed 800 mg for CML treatment and 600 mg for Ph-positive ALL treatment. The dose can be taken once a day or divided into two doses (half the dose in the morning and half the dose in the evening).

When and how to take Imatilek

• Take Imatilek with foodto protect your stomach while taking Imatilek.
• Swallow the capsules whole, with a large glass of water. Do not open, crush, or chew the capsules unless you have problems swallowing (e.g., in children).
• If you cannot swallow the capsules, you can open them and pour the powder into a glass of still water or apple juice.
• Pregnant women or women who may become pregnant who open the capsules should handle the contents carefully: avoid contact with the skin and eyes and do not inhale the powder. Wash your hands immediately after handling the capsules.

How long to take Imatilek

Take Imatilek every day for as long as your doctor tells you to.

Taking too much Imatilek

If you have taken too many capsules, tell your doctor immediately, as you may need medical attention. Bring the medicine pack with you.

Missing a dose of Imatilek

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Imatilek can cause side effects, although not everybody gets them.
They are usually mild to moderate.

Some side effects may be serious. You should tell your doctor immediately if you experience any of the following:

Very common(may affect more than 1 in 10 people) or common(may affect less than 1 in 10 people):

• Rapid weight gain. Imatilek can cause fluid retention in the body (severe fluid retention).
• Infection symptoms, such as fever, chills, sore throat, and mouth ulcers. Imatilek can reduce the number of white blood cells in your blood, making you more prone to infection.
• Unexplained bleeding or bruising (even without injury).

Uncommon(may affect less than 1 in 100 people) or rare(may affect less than 1 in 1000 people):

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or chest pain (symptoms of lung problems).
• Feeling faint, dizziness, or fainting (symptoms of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms of liver problems).
• Rash, redness of the skin with blisters on the lips, around the eyes, on the skin, or in the mouth, peeling skin, fever, red or purple spots on the skin, itching, burning sensation, blistering rash (symptoms of skin problems).
• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin).
• Severe abdominal pain, blood in vomit, stools, or urine, black stools (symptoms of stomach and intestine problems).
• Significantly reduced urine output, feeling thirsty (symptoms of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestine problems).
• Severe headache, weakness, or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (symptoms of nervous system problems, such as bleeding or swelling in the brain).
• Pale skin, feeling tired and short of breath, and dark urine (symptoms of anemia).
• Eye pain or vision problems, bleeding in the eye.
• Hip or walking difficulties.
• Numbness or feeling cold in fingers and toes (symptoms of Raynaud's syndrome).
• Sudden swelling and redness of the skin (symptoms of skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and muscle cramps with irregular heartbeat (symptoms of changes in potassium levels in your blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine, muscle pain, or weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (symptoms of ovarian or uterine problems).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and (or) joint problems with abnormal laboratory test results (e.g., high potassium, uric acid, and calcium levels and low phosphorus levels in your blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Frequency not known(cannot be estimated from the available data):

• Combination of widespread, severe rash, nausea, fever, high levels of certain white blood cells, or yellowing of the skin or eyes (jaundice) with shortness of breath, chest pain/discomfort, and significantly reduced urine output and thirst (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Reactivation of hepatitis B virus infection (liver infection) in patients who have had the disease in the past.

If you experience any of the above side effects, tell your doctor immediately.

Other side effects may include:

Very common(may affect more than 1 in 10 people):

• Headache or fatigue.
• Nausea, vomiting, diarrhea, indigestion.
• Rash.
• Muscle cramps or joint pain, muscle pain, or bone pain during or after treatment with Imatilek.
• Swelling, such as swelling of the ankles or around the eyes.
• Weight gain. If any of the above side effects get worse, tell your doctor.

Common(may affect less than 1 in 10 people):

• Lack of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep disturbances (insomnia).
• Eye discharge with itching, redness, and swelling, increased tearing, or blurred vision (conjunctivitis), nasal bleeding.
• Abdominal pain or swelling, bloating with gas, heartburn, or constipation.
• Itching.
• Excessive hair loss or thinning.
• Numbness of hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats. If any of the above side effects get worse, tell your doctor.

  Frequency not known(cannot be estimated from the available data):

  • Redness or swelling of the palms and soles, which may be accompanied by tingling and burning pain.
  • Skin changes with pain and (or) blistering.
  • Slowed growth in children and adolescents. If any of the above side effects get worse, tell your doctor.

  Reporting side effects

  If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Imatilek

  • 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 after EXP. The expiry date refers to the last day of that month.
  • Do not store above 30°C.
  • Do not use any pack that is damaged or shows signs of tampering.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

  6. Contents of the pack and other information

  What Imatilek contains

  • The active substance is imatinib. One hard capsule of Imatilek 400 mg contains 400 mg of imatinib (as imatinib mesilate).
  • The other ingredients are: crospovidone, magnesium stearate, and colloidal anhydrous silica. The capsule shell contains gelatin, water, titanium dioxide (E 171), and yellow iron oxide (E 172).

  What Imatilek looks like and contents of the pack

  Imatilek, hard capsules 400 mg: size "00" capsules containing a white to cream-colored granule, with a caramel-colored body and cap.
  OPA/Aluminum/PVC/Aluminum blisters, each containing 10 capsules, are packaged in a cardboard box.
  The pack contains 10, 20, 30, 60, 90, 100, 120, or 180 capsules.

  Marketing authorization holder and manufacturer

  LEK-AM Pharmaceutical Company Ltd.
  Ostrzykowizna 14A
  05-170 Zakroczym
  Tel.: +48 22 785 27 60
  Fax: +48 22 785 27 60 ext. 106

  Date of last revision of the package leaflet:

  • 14.07.2022