Imatinib Lek-am

Leaflet attached to the packaging: information for the user

Imatinib LEK-AM, 400 mg, hard capsules

Imatinib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Imatinib LEK-AM and what is it used for
• 2. Important information before taking Imatinib LEK-AM
• 3. How to take Imatinib LEK-AM
• 4. Possible side effects
• 5. How to store Imatinib LEK-AM
• 6. Contents of the packaging and other information

1. What is Imatinib LEK-AM and what is it used for

Imatinib LEK-AM is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the course of the diseases listed below. These include certain types of cancer.

Imatinib LEK-AM is indicated for the treatment of adult patients and children with:

• Chronic myeloid leukemia(English: Chronic Myeloid Leukaemia,CML). Leukemia is a cancer that originates from white blood cells. Normally, white blood cells help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Acute lymphoblastic leukemia with Philadelphia chromosome(English: Ph-positive ALL). Leukemia is a cancer that originates from white blood cells. Normally, white blood cells help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to multiply uncontrollably. Imatinib LEK-AM inhibits the growth of these cells.

Imatinib LEK-AM is also indicated for the treatment of adult patients with:

• Myelodysplastic/myeloproliferative syndromes(English: myelodysplastic/myeloproliferate,MDS/MPD). These are blood disorders in which certain white blood cells begin to multiply uncontrollably. Imatinib LEK-AM inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome(English: Hypereosinophilic Syndrome, HESand (or) Chronic Eosinophilic Leukemia(English: Chronic Eosinophilic Leukemia, CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably.

in an uncontrolled manner. Imatinib LEK-AM 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 begin to multiply uncontrollably. Imatinib LEK-AM inhibits the growth of these cells.

In the rest of the leaflet, abbreviations of the names of the diseases listed above will be used. If you have any questions about how Imatinib LEK-AM works or why it has been prescribed, you should consult your doctor.

2. Important information before taking Imatinib LEK-AM

Imatinib LEK-AM is prescribed to patients only by doctors with experience in using medicines for the treatment of blood cancers or solid tumors. You should strictly follow the doctor's instructions, even if they differ from the general information contained in this leaflet.

When not to take Imatinib LEK-AM:

they should tell their doctor before taking the medicine.

Imatinib LEK-AM.

In case of suspected allergy, but uncertainty, medical advice should be sought.

Warnings and precautions

Before starting treatment with Imatinib LEK-AM, you should discuss it with your doctor:

they should tell their doctor before taking Imatinib LEK-AM.

While taking Imatinib LEK-AM, the patient 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.

The patient should immediately tell their doctor if, during treatment with Imatinib LEK-AM,

there is a very rapid weight gain. Imatinib LEK-AM may cause water retention in the body (severe fluid retention). During treatment with Imatinib LEK-AM, the patient's health will be regularly assessed by their doctor to determine if treatment with Imatinib LEK-AM is effective. Blood tests and weight measurements will be regularly performed while taking this medicine.

Children and adolescents

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

Imatinib LEK-AM and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may affect the action of Imatinib LEK-AM if taken at the same time. They may increase or decrease the action of Imatinib LEK-AM, which can lead to increased side effects or make Imatinib LEK-AM less effective. Similarly, Imatinib LEK-AM may affect some other medicines. The patient should tell their doctor if they are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• Imatinib LEK-AM is not recommended for pregnant women unless it is absolutely necessary, as it may harm the baby. The doctor will discuss the possible risks that may occur during treatment with Imatinib LEK-AM during pregnancy.
• Women who may become pregnant should use effective contraception during treatment with Imatinib LEK-AM and for 15 days after the end of treatment.
• Women should not breastfeed while taking Imatinib LEK-AM and for 15 days after the end of treatment, as it may harm the baby.
• Patient concerned about their fertility during treatment with Imatinib LEK-AM should consult their doctor.

Driving and using machines

While taking this medicine, dizziness or drowsiness, or vision disturbances may occur. In such cases, the patient should not drive vehicles or operate any tools or machines until they feel better.

3. How to take Imatinib LEK-AM

The doctor has prescribed Imatinib LEK-AM because of the patient's serious condition. Imatinib LEK-AM may help improve this condition. However, this medicine should always be taken according to the doctor's or pharmacist's instructions. It is essential to take the medicine for as long as the doctor or pharmacist has prescribed. If the patient has any doubts, they should consult their doctor or pharmacist. The patient should not stop taking Imatinib LEK-AM unless their doctor advises them to do so. If the patient cannot take the prescribed medicine or thinks they do not need it, they should immediately contact their doctor.

What dose of Imatinib LEK-AM to take

Use in adult patients

The doctor will determine the exact number of Imatinib LEK-AM capsules to be taken.

• In the case of CML treatment:

Depending on the patient's condition, the initial 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.

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

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

Use in children and adolescents

The doctor will determine the number of Imatinib LEK-AM capsules to be given to the child. The dose of the medicine will depend on the child's condition, weight, and height. The total daily dose in children should not exceed 800 mg in the treatment of CML and 600 mg in the treatment of Ph-positive ALL. The dose can be given to the child 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 Imatinib LEK-AM

• Imatinib LEK-AM should be taken with foodto protect the stomach while taking Imatinib LEK-AM.
• Capsules should be swallowed whole, with a large glass of water. Do not open, crush, or chew the capsules unless the patient has swallowing problems (e.g., in children).
• If the patient is unable to swallow the capsules, they can be opened and the powder poured into a glass of still mineral water or apple juice.
• Women who are pregnant or may become pregnant and who open the capsules should handle the contents carefully: avoid skin and eye contact and do not inhale the powder. Hands should be washed immediately after opening the capsules.

How long to take Imatinib LEK-AM

Imatinib LEK-AM should be taken every day for as long as the doctor has prescribed.

Taking more than the prescribed dose of Imatinib LEK-AM

Patient who has taken too many capsules by mistake should immediately telltheir doctor, as they may require medical attention. The patient should take the packaging of the medicine with them.

Missing a dose of Imatinib LEK-AM

• If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose.
• The patient should then continue with their usual dosing schedule.
• The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

Some side effects can be serious. The patient should immediately tell their doctor

if they 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. Imatinib LEK-AM may cause water retention in the body (severe fluid retention).
• Infection symptoms, such as fever, severe chills, sore throat, and mouth ulcers. Imatinib LEK-AM may reduce the number of white blood cells in the blood, which can increase the risk of infection.
• Unexpected 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 or irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or chest pain (symptoms of lung problems).
• 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 of the skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular 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, stool, or urine, black stools (symptoms of stomach and intestine disorders).
• Significantly reduced urine output, feeling of thirst (symptoms of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestinal 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 skull/brain).
• Pale skin, feeling of tiredness, and shortness of breath, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or vision disturbances, bleeding in the eye.
• Hip or walking difficulties.
• Numbness or feeling of cold in the 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 cramps with irregular heartbeat (symptoms of changes in the patient's blood potassium levels).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine, pain, and weakness of the patient's muscles (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 accompanying 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 (symptoms of allergic reaction related to treatment) with shortness of breath, chest pain/discomfort, and significantly reduced urine output, and feeling of thirst, etc. (symptoms of allergic reaction).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who have had this disease in the past.

If the patient experiences any of the above side effects, they should immediately telltheir doctor.

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 taking Imatinib LEK-AM.
• Swelling, such as swelling of the ankles or around the eyes.
• Weight gain. If any of the above side effects worsen, the patient should tell their 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, the patient should tell their 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, the patient should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 Tel.: +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 authorization holder. By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Imatinib LEK-AM

• The medicine should be stored out of the sight and reach of children.
• The medicine should not be used after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
• The medicine should not be stored at temperatures above 30°C.
• The medicine should not be used if the packaging is damaged or shows signs of opening.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Imatinib LEK-AM contains

• The active substance of the medicine is imatinib. One hard capsule of 400 mg Imatinib LEK-AM contains 400 mg of imatinib (in the form of imatinib mesylate).
• The other ingredients are: crospovidone, magnesium stearate, and colloidal silicon dioxide. The capsule shell consists of gelatin, water, titanium dioxide (E 171), and yellow iron oxide (E 172).

What Imatinib LEK-AM looks like and contents of the pack

Imatinib LEK-AM, hard capsules 400 mg: capsules size "00", containing a white to cream-colored granulate, consisting of a body and a cap in a caramel color. OPA/Aluminum/PVC/Aluminum blisters containing 10 capsules are placed in a cardboard box. The packaging contains 10, 20, 30, 60, 90, 100, 120, or 180 capsules.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd. ul. 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 leaflet:

• 14.07.2022