Imatenil

Package Leaflet: Information for the User

Imatenil, 400 mg, film-coated tablets

Imatinib

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Imatenil is and what it is used for
• 2. Before you take 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 that contains the active substance imatinib. It works by blocking the growth of abnormal cells in certain diseases listed below.

Imatenil is used to treat adults and children with:

• Chronic myeloid leukaemia (CML) -a type of cancer that affects the white blood cells. Normally, white blood cells help the body fight infection. In CML, certain abnormal white blood cells (called myeloid cells) start to grow out of control.
• Acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL). Leukaemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infection. Acute lymphoblastic leukaemia is a type of leukaemia where certain abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatenil blocks the growth of these cells.

Imatenil is also used to treat children with:

• Newly diagnosed CMLwho are not eligible for bone marrow transplantation as first-line treatment;
• CML in the chronic phasewhen alpha-interferon treatment is not effective or in the accelerated phase of the disease.

Imatenil is also used to treat adults with:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD) -a group of blood disorders where certain white blood cells start to grow out of control. Imatenil blocks the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and (or) chronic eosinophilic leukaemia (CEL) -blood disorders where certain cells (called eosinophils) start to grow out of control. Imatenil blocks the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP) -a type of skin cancer where certain cells start to grow out of control. Imatenil blocks the growth of these cells.

In the rest of this leaflet, the abbreviations for the names of the diseases listed above will be used.

2. Before you take Imatenil

Imatenil is prescribed by doctors who are experienced in the use of medicines to treat cancer or blood disorders.

When not to take Imatenil

• if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6). If this applies to you, tell your doctor before taking the medicine

Warnings and precautions

Before taking Imatenil, tell your doctor:

• if you have or have had liver, kidney, or heart disease.
• if you are taking levothyroxine after thyroid removal.
• if you have or have had hepatitis B infection; this is because Imatenil may cause the hepatitis B virus to become active again, which can be fatal in some cases; you will be closely monitored by your doctor for signs of this infection before starting treatment.
• if you experience bruising, bleeding, fever, tiredness, and confusion while taking Imatenil, contact your doctor. This could be a sign of a blood vessel problem called thrombotic microangiopathy (TMA). If any of the above apply to you, tell your doctor before taking the medicine.

Tell your doctor immediately if you experience a rapid increase in weight during treatment with Imatenil. Imatenil may cause fluid retention in the body (severe fluid retention). Your doctor will regularly check your health while you are taking Imatenil to see if the treatment is working. Blood tests and weight checks will be done regularly while you are taking this medicine.

Children and adolescents

Imatenil is also used to treat children with CML. There is no experience 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.

Imatenil and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have 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 way Imatenil works, or Imatenil may affect the way other medicines work, which may lead to increased side effects or make Imatenil less effective.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Imatenil is not recommended during pregnancy unless clearly necessary. Your doctor will discuss the potential risks with you.
• Women who may become pregnant should use effective contraception during treatment with Imatenil.
• Do not breastfeed while taking Imatenil.
• Patients concerned about their fertility during treatment with Imatenil should consult their doctor.

Driving and using machines

While taking Imatenil, you may experience dizziness or drowsiness, or have problems with your vision. Do not drive or operate any tools or machines until you feel well enough.

Imatenil contains a colouring – orange yellow S (E 110).

This may cause allergic reactions.

3. How to take Imatenil

Your doctor has prescribed Imatenil for your condition. Imatenil may help improve your condition.

How much Imatenil to take

Adults

Your doctor will decide the exact number of Imatenil tablets you should take.

For CML treatment:

The usual starting dose is 600 mg, taken as one tablet plus half a tablet oncea day.

For Ph-positive ALL treatment:

The starting dose is 600 mg, taken as one tablet plus half a tablet oncea day.

For MDS/MPD treatment:

The starting dose is 400 mg, taken as one tablet oncea day.

For HES/CEL treatment:

The starting dose is 100 mg, taken as one 100 mg tablet oncea day.

For DFSP treatment:

The daily dose is 800 mg(2 tablets), taken as one tablet in the morning and one tablet in the evening.

Children and adolescents

Your doctor will decide the number of tablets to give to your child. The dose will depend on the child's condition, weight, and height. The total daily dose in children should not be higher than 800 mg. The dose can be taken 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 Imatenil

• Take Imatenil with foodto protect your stomach while taking Imatenil.

Swallow the tablets with a large glass of water.

The tablet can be divided into two equal doses.

If you cannot swallow the tablets, you may crush them or dissolve them in a glass of non-fizzy water or apple juice:

• Use about 200 ml for each 400 mg tablet.
• Mix with a spoon until the tablet dissolves completely.
• Drink the liquid immediately. There may be some residue at the bottom of the glass.

How long to take Imatenil

Take Imatenil every day for as long as your doctor tells you to.

What to do if you take too much Imatenil

If you accidentally take too many tablets, tell your doctor immediatelyas you may need medical attention. Take the medicine pack with you.

What to do if you forget to take Imatenil

• 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 normal dose schedule.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Imatenil can cause side effects, although not everybody gets them.

Some side effects may be serious. Tell your doctor immediately if you 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. Imatenil may cause fluid retention in the body (severe fluid retention).
• Infection symptoms, such as fever, chills, sore throat, and mouth ulcers. Imatenil may reduce the number of white blood cells in your blood, which can increase your risk of infection.
• Unusual bleeding or bruising (without 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 (heart problems).
• Cough, difficulty breathing, or chest pain (lung problems).
• Dizziness, fainting, or confusion (low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (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, or pustular rash (skin problems).
• Severe abdominal pain, blood in vomit, stools, or urine, black stools (stomach and intestine problems).
• Reduced urine output, thirst (kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (intestine problems).
• Severe headache, weakness, or paralysis of the arms and legs or face, difficulty speaking, sudden loss of consciousness (nervous system problems, such as bleeding or swelling in the brain).
• Pale skin, feeling tired and short of breath, and dark urine (low red blood cell count).
• Blood clots in small blood vessels (thrombotic microangiopathy).
• Eye pain or vision problems, bleeding in the eyes.
• Hip or walking difficulties.
• Numbness or feeling cold in fingers and toes (Raynaud's syndrome).
• Sudden swelling and redness of the skin (skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and cramps with irregular heartbeat (changes in potassium levels in the blood).
• Easy bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine, pain, and weakness (muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (ovarian or uterine problems).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness, and (or) joint problems with abnormal laboratory test results (e.g., high potassium, uric acid, and phosphorus levels and low calcium levels in the blood).
• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin)

If you experience any of the above side effects, tell your doctor immediately.

Other side effects may include: Very common (may affect more than 1 in 10 people):

• Headache or tiredness.
• 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.

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.
• Increased sensitivity to sunlight (abnormal skin reactions to sunlight).
• Hot flushes, chills, or night sweats.

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

• Redness and (or) swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and burning pain.
• Slowed growth in children and adolescents.
• Reactivation of hepatitis B infection (liver infection) in patients who have had the infection in the past.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatenil

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
• There are no special storage conditions for this medicine.
• Do not use this medicine if the packaging is damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatenil contains

• The active substance is imatinib mesylate. Each Imatenil tablet contains 400 mg of imatinib (as mesylate).
• The other ingredients are crospovidone (type A) and magnesium stearate.
• The tablet coating contains hypromellose, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and orange yellow S (E 110).

What Imatenil looks like and contents of the pack

Imatenil 400 mg film-coated tablets are brown, oval (17.8 mm x 7.7 mm), biconvex tablets, without defects and with a score line on one side.

They are packaged in aluminium-aluminium blisters, together with a patient information leaflet, in a cardboard box.

They are available in packs of 10, 30, or 90 tablets, but not all pack sizes may be available 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 Member States of the European Economic Area under the following names:

Poland:

Imatenil

Date of last revision of the leaflet: 22.06.2022