Imatinib lek-am

Package leaflet: Information for the user

Imatinib LEK-AM, 100 mg, hard capsules
Imatinibum

Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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. 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 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 diseases.

• 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 how this medicine works or why it has been prescribed, 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 doctor'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, they should inform their 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 your 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 their doctor for signs of this infection before starting treatment.
• if, while taking Imatinib LEK-AM, the patient develops bruising, bleeding, fever, fatigue, or confusion, they should contact their 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, they should inform their 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 their doctor if there is a very rapid increase in body weight 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 evaluated by the doctor to monitor the effectiveness of treatment with Imatinib LEK-AM.
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 under 2 years of age with CML. Experience with use in children with Ph+ ALL is limited, and experience 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 inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those obtained without a prescription (such as paracetamol), as well as 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, which could lead to increased side effects or make Imatinib LEK-AM less effective. In the same way, Imatinib LEK-AM may affect the action of certain other medicines.
The patient should inform their doctor if they are taking medicines to prevent blood clots.
Pregnancy, breastfeeding, and effects on 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 an effective method of contraception during treatment with Imatinib LEK-AM and for 15 days after stopping treatment.
• Breastfeeding is not recommended 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 they feel well again.

3. How to take 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 your doctor or pharmacist has told you. It is important to take the medicine for as long as your doctor or pharmacist has advised. 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 medicine prescribed by your doctor 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 the treatment of CML:

Depending on the patient's condition, the usual starting dose is 400 mg or 600 mg:

• 400 mg taken as 4 capsules once daily,
• 600 mg taken as 6 capsules once daily.

During 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), you should take 4 capsules in the morning and 4 capsules in the evening.

• For the treatment of Ph-positive ALL: The starting dose is 600 mg, taken as 6 capsules once daily.
• For the treatment of MDS/MPD: The starting dose is 400 mg, taken as 4 capsules once daily.
• For the treatment of HES/CEL: The starting dose is 100 mg, taken as 1 capsule once daily. Your doctor may decide to increase the dose to 400 mg taken as 4 capsules once daily, depending on your response to treatment.
• For the treatment of DFSP: The daily dose is 800 mg (8 capsules), taken as 4 capsules in the morning and 4 capsules 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 CML treatment and 600 mg in Ph-positive ALL treatment. 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.
• 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 may open them and mix the powder with a glass of still mineral water or apple juice.
• Women who are pregnant or who may become pregnant and who open capsules should handle the contents with care: avoid contact of the powder with skin or eyes and do not inhale it. Wash hands 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 Imatinib LEK-AM than prescribed
Patients who have accidentally taken too many capsules should immediately inform their doctor, as medical attention may be required. Take 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
They are usually mild to moderate.
Some adverse reactions may be serious. You must immediately tell your doctor
if any of the following adverse reactions occur:
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 increase 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 1000 people):

• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, difficulty breathing, or pain when breathing (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, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Painful red nodules on the skin, skin pain, redness of the skin (inflammation of the fatty tissue beneath the skin).
• Severe abdominal pain, presence of blood in vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Significantly reduced urine output, feeling thirsty (signs of kidney problems).
• Nausea with diarrhoea and vomiting, abdominal pain, or fever (signs of intestinal 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 within the skull/brain).
• Pale skin, feeling tired and short of breath, and dark urine (signs of low red blood cell count).
• Eye pain or blurred vision, bleeding in the eye.
• Hip pain or difficulty walking.
• 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 cramps with irregular heartbeat (signs of changes in potassium levels in the patient's blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, red-brown discoloration of urine, muscle pain and weakness (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, sudden vaginal bleeding, dizziness or fainting due to low blood pressure (signs 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 unknown (cannot be estimated from available data):

• Co-occurrence of extensive, 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 previously had this disease.

If any of the above adverse reactions occur, you must immediately inform your doctor.
Other adverse reactions 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 discontinuation of 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 inform your doctor.

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

• Loss of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep difficulties (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 in 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 inform your doctor.
  Frequency unknown (cannot be estimated from 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 inform your doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Imatinib LEK-AM

• Keep this medicine out of 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 must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Imatinib LEK-AM contains

• The active substance is imatinib. One 100 mg hard capsule of Imatinib LEK-AM contains 100 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). The printing ink on the capsule contains shellac, potassium hydroxide, and red iron oxide (E 172).

What Imatinib LEK-AM looks like and contents of the pack
Imatinib LEK-AM 100 mg hard gelatin capsules: size "1" capsules containing white to cream-coloured granules, with a caramel-coloured body and cap. A red band is printed on both the cap and body of the capsule.
Blisters made of OPA/Aluminum/PVC/Aluminum, each containing 10 capsules, are placed in a cardboard box.
The pack contains 10, 20, 30, 60, 90, 100, 120 or 180 capsules.

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