Imatilek

Package leaflet: Information for the user

Imatilek, 100 mg, hard capsules
Imatinibum

Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult 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.

Leaflet contents

1. What Imatilek is and what it is 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 Imatilek is and what it is used for

Imatilek 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.

Imatilek 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. Imatilek inhibits the growth of these cells.

Imatilek 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. Imatilek 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. Imatilek inhibits the growth of these cells in certain subtypes of these
  disorders.

• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the skin and subcutaneous tissues in which certain cells begin to multiply uncontrollably. Imatilek inhibits the growth of these cells.

In the remainder of this leaflet, the abbreviated names of the diseases listed above will be used.
For any questions regarding how this medicine works and why it has been prescribed, please consult your doctor.

2. Important information before using Imatilek

Imatilek is prescribed to patients only by doctors experienced in the use of drugs used to treat haematological malignancies or solid tumours.
It is essential to strictly follow the doctor's instructions, even if they differ from the general information provided in this leaflet.
When not to use Imatilek:

• if the patient is allergic to imatinib or 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 Imatilek.

If an allergy is suspected but not certain, medical advice should be sought.
Warnings and precautions
Before starting treatment with Imatilek, 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 Imatilek may cause reactivation of hepatitis B virus, which in some cases can be fatal; patients will be closely monitored by their doctor for signs of this infection before starting treatment.
• if the patient develops bruising, bleeding, fever, fatigue, or confusion while taking Imatilek, they should contact their doctor immediately. These symptoms may indicate damage to blood vessels known as thrombotic microangiopathy (TMA). If any of the above points apply to the patient, they should inform their doctor before taking Imatilek.

While taking Imatilek, 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 Imatilek. Imatilek may cause fluid retention (severe fluid retention).
While taking Imatilek, the patient's health status will be regularly assessed by the doctor to monitor the effectiveness of treatment. Blood tests and body weight measurements will be performed regularly during treatment.
Children and adolescents
Imatilek is also used to treat children with CML. There is no experience with use in children with CML below 2 years of age. Experience with use 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 experience slower than normal growth. The doctor will monitor growth during regular visits.
Imatilek and other medicines
The patient should inform 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 over-the-counter medicines (such as paracetamol) and herbal medicines (such as St. John's wort). Some medicines may interact with Imatilek when taken at the same time. They may increase or reduce the effect of Imatilek, potentially leading to increased side effects or reduced effectiveness. Imatilek may also 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 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.
• Imatilek is not recommended during pregnancy unless absolutely necessary, as it may harm the unborn child. The doctor will discuss the potential risks associated with taking Imatilek during pregnancy.
• Women of childbearing potential are advised to use effective contraception during treatment with Imatilek and for 15 days after stopping treatment.
• Breastfeeding must be avoided during treatment with Imatilek and for 15 days after treatment ends, as it may harm the breastfed infant.
• Patients concerned about fertility during treatment with Imatilek 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 any tools or machinery until they feel well again.

3. How to take Imatilek

Your doctor has prescribed Imatilek because of your serious medical condition. Imatilek may help improve
this condition.
However, this medicine should always be taken exactly as directed by your doctor or pharmacist. 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 Imatilek unless your doctor tells you to do so. 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 Imatilek should be taken?
Use in adult patients
Your doctor will determine the exact number of Imatilek capsules to take.

• For the treatment of CML:
  Depending on your condition, the usual starting dose is either 400 mg or 600 mg:

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

In the treatment of CML, 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 Imatilek 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 the dose in the morning and half in the evening).

When and how to take Imatilek

• Imatilek 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 be opened and the powder poured into 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 and eyes and do not inhale it. Hands should be washed immediately after opening the capsules.

How long should Imatilek be taken?
You should take Imatilek every day for as long as your doctor has instructed.

Taking more Imatilek than prescribed
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 Imatilek

• 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 tell your doctor immediately
if you experience any of the following adverse symptoms:
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).
• Signs of infection such as fever, severe chills, sore throat, and mouth ulcers. Imatilek 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 less than 1 in 100 people) or rare (may affect less than 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 of emptiness in the head, 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, blister-like rash (symptoms 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, stool, or urine, black stools (symptoms of stomach and intestinal disorders).
• Markedly reduced urine output, feeling of thirst (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 of fatigue and shortness of breath, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or worsening of vision, bleeding within the eye.
• Hip pain or difficulty walking.
• Numbness or cold sensation 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 discoloration of 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 unknown (cannot be estimated from available data):

• Co-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, markedly reduced urine output, and feeling of thirst, etc. (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who have previously had this disease.

If any of the above adverse symptoms occur, you must tell your doctor immediately.
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 Imatilek.
• 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 less than 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.
• Abdominal pain or swelling, 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 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 tell your doctor.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should tell 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 authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Imatilek

• 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 tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Imatilek contains

• The active substance is imatinib. One 100 mg hard capsule of Imatilek contains 100 mg of imatinib (as imatinib mesilate).
• The other ingredients are: crospovidone, magnesium stearate and colloidal hydrated 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 Imatilek looks like and contents of the pack
Imatilek 100 mg hard gelatin capsules: size "1" capsules containing white to off-white granules, composed of a caramel-coloured body and cap. A red band is printed on both the cap and body of the capsule.
Blisters made of OPA/Aluminium/PVC/Aluminium, each containing 10 capsules, are placed in a cardboard box.
Pack sizes: 10, 20, 30, 60, 90, 100, 120 or 180 capsules.

Marketing Authorisation Holder and Manufacturer
LEK-AM Pharmaceutical Company 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