Imatilek

Package Leaflet: Information for the User

Imatilek, 100 mg, Hard Capsules

Imatinib

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

• Keep this package 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 experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 1. What is Imatilek and what is it used for
• 2. Important information before taking 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. This medicine works by inhibiting the growth of abnormal cells in the following diseases. These include certain types of cancer.

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

• Chronic Myeloid Leukaemia(English: Chronic Myeloid Leukaemia,CML). Leukaemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infection. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) start to multiply out of control.
• Philadelphia chromosome positive Acute Lymphoblastic Leukaemia(English: Ph-positive ALL). Leukaemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infection. Acute lymphoblastic leukaemia is a type of leukaemia in which certain abnormal white blood cells (called lymphoblasts) start to multiply out of control. Imatilek inhibits the growth of these cells.

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

• Myelodysplastic/Myeloproliferative Syndromes(English: myelodysplastic/myeloproliferative,MDS/MPD). These are blood disorders in which certain white blood cells start to multiply out of control. Imatilek inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic Syndrome(English: Hypereosinophilic Syndrome, HES) and (or) Chronic Eosinophilic Leukaemia(English: Chronic Eosinophilic Leukemia, CEL). These are blood disorders in which certain blood cells (called eosinophils) start to multiply out of control.

out of control. Imatilek inhibits the growth of these cells in certain subtypes of these diseases.

• Dermatofibrosarcoma protuberans(English: dermatofibrosarcoma protuberans, DFSP). DFSP is a skin and subcutaneous tissue cancer in which certain cells start to multiply out of control. Imatilek inhibits the growth of these cells.

In the rest of the package leaflet, abbreviations for the names of the diseases mentioned 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. Important information before taking Imatilek

Imatilek is prescribed to patients only by doctors experienced in the use of medicines for the treatment of blood cancers or solid tumours.
Follow the doctor's instructions carefully, even if they differ from the general information contained in this package 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 ever had or may currently have a hepatitis B virus infection; this is because Imatilek may cause the hepatitis B virus to become active again, which can be life-threatening in some cases; patients will be closely monitored by their doctor to detect signs of this infection before starting treatment.
• if, while taking Imatilek, you experience bruising, bleeding, fever, fatigue, and confusion, contact your doctor. This may be a sign of a blood vessel disorder called thrombotic microangiopathy (TMA). If any of the above applies to you, tell your doctor before taking Imatilek.

While taking Imatilek, you may become more sensitive to the sun. It is important to cover areas of skin exposed to the sun 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 very rapid increase in weightwhile taking Imatilek. Imatilek may cause water retention in the body (severe fluid retention).
While taking Imatilek, your health will be regularly monitored by your doctor to determine if the treatment is effective. Blood tests and weight measurements will be regularly performed while taking this medicine.

Children and adolescents

Imatilek is also used to treat children with CML. There is no experience with the use of Imatilek in children with CML under 2 years of age. Experience with the use of Imatilek in children with Ph-positive ALL is limited, and experience with the use of Imatilek in children with MDS/MPD, DFSP, and HES/CEL is very limited.
In some children and adolescents taking Imatilek, growth may be slower than normal. The doctor will monitor growth during regular visits.

Imatilek and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may affect the action of Imatilek if taken at the same time. They may increase or decrease the action of Imatilek, which can lead to increased side effects or make Imatilek less effective. Imatilek may also affect some other medicines.
Tell your doctor if you are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 possible risks and benefits of taking Imatilek during pregnancy.
• Women who may become pregnant should use effective contraception while taking 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 while taking Imatilek should consult their doctor.

Driving and using machines

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

3. How to take Imatilek

Your doctor has prescribed Imatilek because of your serious condition. Imatilek may help improve your condition.
However, this medicine should always be taken as directed by your doctor or pharmacist. It is important to take the medicine for as long as your doctor tells you to. If you are unsure, ask your doctor or pharmacist.
Do not stop taking Imatilek unless your doctor tells you to. If you cannot take the prescribed dose or think you do not need it, contact your doctor immediately.

What dose of Imatilek to take

Adult patients

Your doctor will determine the exact number of Imatilek capsules to take.

• In the case of CML treatment:

Depending on your condition, the initial dose is usually 400 mg or 600 mg:

• 400 mgtaken as 4 capsules oncea day,
• 600 mgtaken as 6 capsules oncea day.

In the case of CML treatment, your doctor may prescribe a higher or lower dose depending on your response to treatment. If the daily dose is 800 mg (8 capsules), take 4 capsules in the morning and 4 capsules in the evening.

• - In the case of Ph-positive ALL treatment:The initial dose is 600 mg, taken as 6 capsules oncea day.
• - In the case of MDS/MPD treatment:The initial dose is 400 mg, taken as 4 capsules oncea day.
• - In the case of HES/CEL treatment:The initial dose is 100 mg, taken as 1 capsule oncea day. Your doctor may decide to increase the dose to 400 mg taken as 4 capsules oncea day, depending on your response to treatment.
• - In the case of DFSP treatment:The daily dose is 800 mg (8 capsules), taken as 4 capsules in the morning and 4 capsules in the evening.

Children and adolescents

Your doctor will determine the amount of Imatilek to give to your child. The dose will depend on your child's condition, weight, and height. The total daily dose in children should not exceed 800 mg in CML treatment and 600 mg in Ph-positive ALL treatment. The dose can be given 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

• Imatilek should be taken with foodto protect the stomach while taking Imatilek.
• Swallow the capsules whole with a large glass of water. Do not open or crush the capsules unless you have difficulty swallowing (e.g., in children).
• If you are unable to swallow the capsules, you can open them and pour the powder into a glass of still mineral water or apple juice.
• Pregnant or potentially pregnant women who open the capsules should handle the contents carefully: avoid skin and eye contact and do not inhale the powder. Wash your hands immediately after opening the capsules.

How long to take Imatilek

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

Taking more than the prescribed dose of Imatilek

Patient who have taken too many capsules should immediately tell their doctor, as they may need medical attention. Bring the package leaflet 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 regular dosing schedule.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about taking 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 can be serious. Tell your doctor immediately if you experience any of the following side effects:

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

• Rapid weight gain. Imatilek may cause fluid retention in the body (severe fluid retention).
• Infection symptoms, such as fever, chills, sore throat, and mouth ulcers. Imatilek may reduce the number of white blood cells in the blood, which can increase the risk of 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 (signs of heart problems).
• Cough, difficulty breathing, or chest pain (signs of lung problems).
• Feeling faint, dizziness, or fainting (signs of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (signs 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, pustular rash (signs 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 (signs of stomach and intestine problems).
• Significantly reduced urine output, feeling thirsty (signs of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (signs of intestine 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).
• Pale skin, feeling tired and short of breath, and dark urine (signs of red blood cell deficiency).
• Eye pain or vision changes, bleeding in the eye.
• Hip or walking difficulties.
• Numbness or cold sensation in fingers and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (signs of skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and muscle cramps with irregular heartbeat (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine, muscle pain, or weakness (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (signs of ovary or uterus problems).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and (or) joint problems with laboratory test abnormalities (e.g., high potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

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

• Co-occurrence 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, significantly reduced urine output, and thirst, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure.
• Reactivation (recurrence) 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 while taking or after stopping Imatilek.
• Swelling, such as swelling of the ankles or around the eyes.
• Weight gain. If any of the above side effects worsen, 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 (conjunctivitis), increased tearing, or blurred vision.
• Nosebleeds.
• 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 worsen, 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 worsen, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation 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 stated on the carton after EXP. The expiry date refers to the last day of the month stated.
• Do not store above 30°C.
• Do not use the medicine if the packaging is damaged or shows signs of opening.
• 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 100 mg contains 100 mg of imatinib (as imatinib mesylate).
• The other ingredients are: crospovidone, magnesium stearate, and colloidal anhydrous silica. The capsule shell consists of gelatin, water, titanium dioxide (E 171), and yellow iron oxide (E 172). The ink used for printing on the capsule contains shellac, potassium hydroxide, and red iron oxide (E 172).

What Imatilek looks like and contents of the pack

Imatilek, hard capsules 100 mg: size "1" capsules containing a white to cream-coloured granulate, consisting of a caramel-coloured body and cap. There is a red stripe on the cap and body of the capsule.
OPA/Aluminium/PVC/Aluminium blisters containing 10 capsules, placed in a cardboard box.
The pack contains 10, 20, 30, 60, 90, 100, 120, or 180 capsules.

Marketing authorisation holder and manufacturer

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

Date of last revision of the package leaflet:

• 14.07.2022