Imatenil

Package leaflet: Information for the user

Imatenil, 400 mg, film-coated tablets
Imatynib
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 ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine 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 Imatenil is and what it is used for
2. What you need to know before taking Imatenil
3. How to take Imatenil
4. Possible side effects
5. How to store Imatenil
6. Contents of the pack and other information

1. What Imatenil is and what it is used for

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

• Chronic myeloid leukaemia (CML – Chronic Myeloid Leukaemia) in blast crisis. 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. Imatenil inhibits the growth of these cells. Imatenil is also indicated for the treatment of children with:
• Newly diagnosed CML who are not candidates for bone marrow transplantation as first-line therapy;
• Chronic phase CML, when treatment with interferon alfa has failed, or in the accelerated phase of the disease.

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

• Myelodysplastic/myeloproliferative syndromes (MDS/MPD – myelodysplastic/myeloproliferative syndromes). These are blood disorders in which certain white blood cells begin to multiply uncontrollably. Imatenil inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES – Hypereosinophilic Syndrome) and/or chronic eosinophilic leukaemia (CEL – Chronic Eosinophilic Leukaemia). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Imatenil inhibits the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP – dermatofibrosarcoma protuberans). DFSP is a tumour of the skin and subcutaneous tissues in which certain cells begin to multiply uncontrollably. Imatenil 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 Imatenil

Imatenil is prescribed to patients only by physicians experienced in the use of drugs used in the treatment of haematological malignancies or solid tumours.
You must strictly follow your doctor's instructions, even if they differ from the general information contained in this leaflet.
When not to use Imatenil

• 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, he or she should inform the doctor before taking Imatenil.

If an allergy is suspected but not certain, medical advice should be sought.
Warnings and precautions
Before starting treatment with Imatenil, 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 removal of the thyroid gland.
• if the patient has ever had, or may currently have, hepatitis B virus infection; this is because Imatenil may cause reactivation of hepatitis B virus infection, which in some cases may 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 Imatenil, contact the doctor immediately. These may be symptoms of damage to blood vessels known as thrombotic microangiopathy (TMA). If any of the above points apply to the patient, the patient should inform the doctor before taking Imatenil.

Tell your doctor immediately if, during treatment with Imatenil, there is a rapid increase in body weight.
Imatenil may cause fluid retention (severe fluid retention).
While taking Imatenil, the patient's health status will be regularly monitored by the doctor to assess whether treatment with Imatenil is effective. Blood tests and body weight measurements will be performed regularly during treatment with this medicine.
Children and adolescents
Imatenil 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 with use in children with Ph-positive ALL is limited, and experience with use in children with MDS/MPD, DFSP and HES/CEL is very limited.
Some children and adolescents taking Imatenil may experience slower than normal growth. The doctor will monitor growth during regular visits.
Imatenil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 Imatenil when taken at the same time. They may increase or decrease the effect of Imatenil, which could lead to increased adverse reactions or make Imatenil less effective. Imatenil may also affect the action of some other medicines in a similar way.
Tell your doctor if the patient is 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.
• Imatenil is not recommended for use during pregnancy unless absolutely necessary, as it may harm the unborn child. The doctor will explain the possible risks associated with taking Imatenil during pregnancy.
• Women of childbearing potential are advised to use an effective method of contraception during treatment with Imatenil.
• Breastfeeding must not be used during treatment with Imatenil.
• Patients concerned about fertility during treatment with Imatenil should consult their doctor.

Driving and operating machinery
While taking Imatenil, dizziness, somnolence or visual disturbances may occur. In such cases, patients should not drive or operate tools or machinery until they feel well again.
Imatenil contains a colouring agent – sunset yellow (E 110).
This medicine may cause allergic reactions.

3. How to take Imatenil

Your doctor has prescribed Imatenil because of your serious medical condition. Imatenil may help improve this condition.
However, this medicine should always be taken exactly as prescribed by your doctor or pharmacist. It is important to take the medicine for as long as your doctor or pharmacist has recommended. If you have any doubts, consult your doctor or pharmacist.
Do not stop taking Imatenil 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 Imatenil should be taken

Use in adult patients
Your doctor will determine the exact number of Imatenil tablets to take.

• For the treatment of CML: The usual starting dose is 600 mg, taken as one tablet plus half a tablet 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 (2 tablets), you should take one tablet in the morning and one tablet in the evening.

• For the treatment of Ph-positive ALL: The starting dose is 600 mg, taken as one tablet plus half a tablet once daily.
• For the treatment of MDS/MPD: The starting dose is 400 mg, taken as one tablet once daily.
• For the treatment of HES/CEL: The starting dose is 100 mg, taken as one 100 mg tablet once daily. Your doctor may decide to increase the dose to 400 mg, taken as one tablet once daily, depending on your response to treatment.
• For the treatment of DFSP: The daily dose is 800 mg (2 tablets), taken as one tablet in the morning and one tablet in the evening.

Use in children and adolescents
Your doctor will determine the number of tablets 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. 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 Imatenil

• Imatenil should be taken with food to protect the stomach during treatment.
• Swallow the tablets with a large glass of water.
• The tablet may be divided into two equal doses.

If you are unable to swallow the tablets, you may break or dissolve them in a glass of non-carbonated water or apple juice:

• Use approximately 200 mL of liquid for each 400 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• After dissolving, drink the entire contents of the glass immediately. Traces of dissolved tablets may remain in the glass.

How long to take Imatenil
Take Imatenil every day for as long as your doctor has instructed.

Taking more Imatenil than prescribed
Patients who have accidentally taken too many tablets should tell their doctor immediately, as medical attention may be required. Take the medicine packaging with you.

If you forget to take Imatenil

• If you forget 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, ask your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
They are usually mild to moderate.
Some adverse reactions may be serious. You must immediately inform your doctor
if any of the following adverse symptoms occur.
Very common (may affect more than 1 in 10 people) or common (may affect less than 1
in 10 people):

• Rapid weight gain. Imatenil may cause fluid retention (severe fluid retention).
• Signs of infection, such as fever, severe chills, sore throat, and mouth ulcers. Imatenil 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, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).
• Severe abdominal pain, presence of blood in vomit, stool, or urine, black stools (symptoms of stomach and intestinal 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 within the skull/brain).
• Pale skin, feeling of fatigue and shortness of breath, and dark urine (symptoms of red blood cell deficiency).
• Blood clots in small blood vessels (thrombotic microangiopathy).
• Eye pain or blurred vision, bleeding in the eyes.
• 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 a 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 pulse, cloudy urine, fatigue, and (or) joint complaints accompanied by abnormal laboratory test results (e.g., high levels of potassium, uric acid, and phosphorus, and low calcium levels in the blood).
• Painful red nodules on the skin, skin pain, redness of the skin (inflammation of the fatty tissue beneath the skin).

If any of the above adverse symptoms 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, diarrhea, indigestion.
• Rash.
• Muscle or joint cramps, muscle or bone pain.
• 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 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 gas release, 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.
• Photosensitivity (abnormal skin reactions to sunlight).
• Hot flushes, chills, or night sweats. If any of the above symptoms worsen, you should inform your doctor.

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

• Redness and (or) swelling of the palms and soles of the feet, which may be accompanied by tingling and burning pain.
• Slowed growth in children and adolescents.
• Reactivation of hepatitis B virus infection (liver infection) in patients who have previously had this disease. If any of the above symptoms worsen, you should inform your doctor.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above Department}
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Imatenil

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
• There are no special storage instructions for this medicine.
• Do not use the medicine if the packaging is damaged or shows signs of having been opened.
• 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 Imatenil contains

• The active substance is imatinib mesilate. Each Imatenil tablet contains 400 mg of imatinib (as mesilate).
• The other ingredients are: crospovidone (type A) and magnesium stearate.
• The tablet coating consists of polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and sunset yellow (E 110).

What Imatenil looks like and contents of the pack
Imatenil 400 mg film-coated tablets are brown, elongated (17.8 mm x 7.7 mm), biconvex tablets, free from spots and chipping, with a score line on one side.
The tablets are packed in aluminium-aluminium foil blisters, placed together with the patient leaflet in a cardboard box.
They are available in pack sizes containing 10, 30 or 90 tablets, although not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel.: +48 61 66 51 500
Fax: +48 61 66 51 505

Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Imatenil
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