Imatinib lek-am

Package leaflet: Information for the user

Imatinib LEK-AM, 400 mg, hard capsules
Imatinibum

Please read all of this leaflet carefully before 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Imatinib LEK-AM is and what it is used for
2. What you need to know 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 pack and other information

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

Imatinib LEK-AM is a medicine containing the active substance called imatinib. This medicine works
by inhibiting the growth of abnormal cells in the diseases listed below.
These include certain types of cancer.
Imatinib LEK-AM is indicated for the treatment of adults and children with:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer originating from white blood cells. Normally, white blood cells help the body fight infections. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer originating from white blood cells. Normally, white blood cells help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia 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 diseases (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 (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply
  uncontrollably. Imatinib LEK-AM inhibits the growth of these cells in certain
  subtypes of these disorders.

• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the skin and subcutaneous tissues in which certain cells begin to multiply uncontrollably. Imatinib LEK-AM inhibits the growth of these cells.

In the remainder of this leaflet, the abbreviated names of the diseases listed above will be used.
If you have any questions regarding the mechanism of action or the rationale for using Imatinib LEK-AM, please consult your doctor.

2. Important information before using Imatinib LEK-AM

Imatinib LEK-AM is prescribed to patients only by physicians experienced in the use of drugs used in the treatment of hematological malignancies or solid tumors.
It is essential to strictly follow the physician's instructions, even if they differ from the general information contained in this leaflet.
When not to use Imatinib LEK-AM:

• if the patient is allergic to imatinib or to any of the other ingredients of this medicine (listed in section 6). If this applies to the patient, the patient should inform the doctor before taking Imatinib LEK-AM.

If an allergy is suspected but not certain, medical advice should be sought.
Warnings and precautions
Before starting treatment with Imatinib LEK-AM, discuss the following with the doctor:

• if the patient has or has ever had liver, kidney, or heart disease.
• if the patient is taking levothyroxine after thyroid removal.
• if the patient has ever had or may currently have hepatitis B virus infection; this is because Imatinib LEK-AM may cause reactivation of hepatitis B virus, which in some cases may be fatal; patients will be closely monitored by the doctor for signs of this infection before starting treatment.
• if, while taking Imatinib LEK-AM, the patient develops bruising, bleeding, fever, fatigue, or disorientation, the patient should contact the doctor immediately. These may be symptoms of a blood vessel disorder called thrombotic microangiopathy (TMA). If any of the above points apply to the patient, the patient should inform the doctor before taking Imatinib LEK-AM.

While taking Imatinib LEK-AM, the patient may become more sensitive to sunlight.
It is important to cover skin areas exposed to the sun and to use sunscreen products with a high sun protection factor (SPF). These precautions should also be applied to children.
The patient should immediately inform the doctor if there is a very rapid weight gain during treatment with Imatinib LEK-AM.
Imatinib LEK-AM may cause fluid retention (severe fluid retention).
While taking Imatinib LEK-AM, the patient's health status will be regularly monitored by the doctor to assess whether treatment with Imatinib LEK-AM is effective.
Blood tests and body weight measurements will be performed regularly during treatment with this medicine.
Children and adolescents
Imatinib LEK-AM is also used in the treatment of children with CML. There is no experience with use 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 Imatinib LEK-AM may experience slower than normal growth. The doctor will monitor growth during regular visits.
Imatinib LEK-AM and other medicines
The patient should inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take, including those 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 when taken at the same time. They may increase or decrease the effect of Imatinib LEK-AM, potentially leading to increased adverse reactions or causing Imatinib LEK-AM to be less effective. In the same way, Imatinib LEK-AM may affect certain other medicines.
The patient should inform the doctor if they are taking medicines to prevent blood clots.
Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
• Imatinib LEK-AM is not recommended for pregnant women unless absolutely necessary, as it may harm the unborn child. The doctor will explain the potential risks associated with taking Imatinib LEK-AM during pregnancy.
• Women of childbearing potential are advised to use effective contraception during treatment with Imatinib LEK-AM and for 15 days after treatment ends.
• Breastfeeding must be avoided during treatment with Imatinib LEK-AM and for 15 days after treatment ends, as it may harm the infant.
• Patients concerned about fertility during treatment with Imatinib LEK-AM should consult their doctor.

Driving and operating machinery
While taking this medicine, dizziness, drowsiness, or visual disturbances may occur.
In such cases, the patient should not drive or operate tools or machinery until feeling well again.

3. How to use Imatinib LEK-AM

Your doctor has prescribed Imatinib LEK-AM because of your serious medical condition. Imatinib LEK-AM
may help improve this condition.
However, this medicine should always be taken exactly as directed by your doctor or pharmacist. It is important to
continue taking the medicine for as long as your doctor or pharmacist has instructed. If you have any doubts, consult your
doctor or pharmacist.
Do not stop taking Imatinib LEK-AM unless your doctor tells you to. If you are unable to take the prescribed medicine or think you no longer need it, you should contact your doctor immediately.

What dose of Imatinib LEK-AM should be taken?
Use in adult patients
Your doctor will determine the exact number of Imatinib LEK-AM capsules to take.

• For treatment of CML:
  Depending on the patient's condition, the usual starting dose is 400 mg or 600 mg:

  • 400 mg taken as 1 capsule once daily,
  • 600 mg taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once daily.

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

• For treatment of Ph-positive ALL: The starting dose is 600 mg, taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once daily.
• For treatment of MDS/MPD: The starting dose is 400 mg, taken as 1 capsule of 400 mg once daily.
• For treatment of HES/CEL: The starting dose is 100 mg, taken as 1 capsule of 100 mg once daily. Your doctor may decide to increase the dose to 400 mg, taken as 1 capsule of 400 mg once daily, depending on the patient's response to treatment.
• For treatment of DFSP: 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
Your doctor will determine the number of Imatinib LEK-AM capsules to give to the child. The dose will depend on the child's condition, body weight, and height. The total daily dose in children must not exceed 800 mg in the treatment of CML and 600 mg in the treatment of Ph-positive ALL. The dose may be given once daily or divided into two doses (half in the morning and half in the evening).

When and how to take Imatinib LEK-AM

• Imatinib LEK-AM should be taken with food to protect the stomach during treatment.
• Capsules should be swallowed whole, with a large glass of water. Do not open or crush the capsules unless the patient has difficulty swallowing (e.g., in children).
• If a patient is unable to swallow the capsules, they may open them and mix the powder with a glass of still mineral water or apple juice.
• Women who are pregnant or may become pregnant and who open capsules should handle the contents with care: avoid contact of the powder with skin and eyes, and do not inhale it. Hands should be washed immediately after opening the capsules.

How long to take Imatinib LEK-AM
You should take Imatinib LEK-AM every day for as long as your doctor has instructed.

Taking more than the recommended dose of Imatinib LEK-AM
Patients who have accidentally taken too many capsules should immediately inform their doctor, as they may require medical attention. Bring the medicine packaging with you.

Missing a dose of Imatinib LEK-AM

• If you forget to take 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 a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
They are usually mild to moderate.
Some side effects may be serious. You must tell your doctor immediately
if you get any of the following side effects:
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):

• Rapid weight gain. Imatinib LEK-AM may cause fluid retention (severe fluid retention).
• Signs of infection 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 may lead to increased susceptibility to infection.
• Unexpected bleeding or bruising (despite no injury).

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

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing or pain when breathing (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, skin peeling, 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 beneath the skin).
• Severe abdominal pain, blood in vomit, stools or urine, black stools (symptoms of stomach and intestinal disorders).
• Significantly reduced urine output, feeling thirsty (symptoms of kidney problems).
• Nausea with diarrhoea 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 within the skull/brain).
• Pale skin, feeling tired and short of breath, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or blurred vision, bleeding in the eye.
• Hip pain or difficulty walking.
• 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 cramps with irregular heartbeat (symptoms of changes in potassium levels in the patient's blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, red-brown urine, muscle pain and weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, 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 complaints accompanied by 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).

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

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

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

• Headache or fatigue.
• Nausea, vomiting, diarrhoea, indigestion.
• Rash.
• Muscle or joint cramps, muscle or bone pain during or after stopping treatment with Imatinib LEK-AM.
• Swelling, such as swelling of the ankles or around the eyes.
• Weight gain. If any of the above symptoms worsen, you should tell your doctor.

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

• Loss of appetite, weight loss or taste disturbances.
• Dizziness or weakness.
• Sleep problems (insomnia).
• Eye discharge with itching, redness and swelling (conjunctivitis), excessive tearing or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, bloating with passing wind, 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 flushes, chills or night sweats. If any of the above symptoms worsen, you should 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) blister formation.
• Slowed growth in children and adolescents.

If any of the above symptoms worsen, you should tell your doctor.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Imatinib LEK-AM

• Keep the 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 stated month.
• Do not store above 30°C.
• Do not use the medicine if the packaging is damaged or shows signs of having been opened.
• Medicines should not be disposed of via the sewage system 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 Imatinib LEK-AM contains

• The active substance is imatinib. One 400 mg hard capsule of Imatinib LEK-AM contains 400 mg of imatinib (as imatinib mesilate).
• 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).

What Imatinib LEK-AM looks like and contents of the pack
Imatinib LEK-AM 400 mg hard gelatin capsules: size "00" capsules containing granules ranging from off-white to cream-coloured, with a body and cap in caramel colour.
Blisters made of OPA/Aluminium/PVC/Aluminium, each containing 10 capsules, placed in a cardboard carton.
Pack sizes contain 10, 20, 30, 60, 90, 100, 120 or 180 capsules.

Marketing Authorisation Holder and Manufacturer
LEK-AM Pharmaceutical Company Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
14.07.2022