Package Leaflet: Information for the User

Imatinib Teva 400 mg Film-Coated Tablets

imatinib

Read this leaflet carefully before you start 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Imatinib Teva is a medication that contains an active ingredient called imatinib. This medication works by inhibiting the growth of abnormal cells in the following diseases, which include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• Chronic Myeloid Leukemia (CML). Leukemia is a cancer of the white blood cells of the blood. These white blood cells normally help the body fight infections. Chronic Myeloid Leukemia is a form of leukemia in which abnormal white blood cells (called myeloid cells) start to grow uncontrollably.

• Ph-Positive Acute Lymphoblastic Leukemia (ALL). Leukemia is a cancer of the white blood cells of the blood. These white blood cells normally help the body fight infections. Acute Lymphoblastic Leukemia is a form of leukemia in which abnormal white blood cells (called lymphoblasts) start to grow uncontrollably. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• Myeloproliferative/Myelodysplastic Syndromes (MPN/ MDS). These are a group of blood diseases in which some blood cells start to grow uncontrollably. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
• Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL). These are blood diseases in which some blood cells (called eosinophils) start to grow uncontrollably. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal Stromal Tumors (GIST). GIST is a cancer of the stomach and intestine. It originates from uncontrolled cellular growth of the supporting tissues of these organs.
• Dermatofibrosarcoma Protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which some cells start to grow uncontrollably. Imatinib Teva inhibits the growth of these cells.

In the rest of this prospectus, these abbreviations are used when referring to these diseases.

If you have any questions about how Imatinib Teva works or why this medication has been prescribed to you, ask your doctor.

Only a doctor with experience in cancer medications for blood cell cancers or solid tumors will prescribe Imatinib Teva.

Follow your doctor's instructions carefully, even if they differ from the general information contained in this prospectus.

Do not take Imatinib Teva

• if you are allergic to imatinib or any of the other components of this medication (listed in section6).

If this applies to you,inform your doctor and do not take Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Consult your doctor before starting to take Imatinib Teva:

• if you have or have had any liver, kidney, or heart problems.
• if you are taking a medication containing levotiroxine because your thyroid gland has been removed.
• if you have ever had or may have a hepatitis B virus infection at the present time. This is because Imatinib Teva may reactivate hepatitis B, which can be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment.
• if while takingImatinib Tevayou experience bruising, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of blood vessel damage called microangiopathic thrombosis (MAT).

If any of these cases apply to you,inform your doctor before taking Imatinib Teva.

It is possible that you may become more sensitive to the sun while taking Imatinib Teva. It is essential to cover exposed skin areas and use high-protection sunscreen. These precautions also apply to children.

Inform your doctor immediately during Imatinib Teva treatment if you experience a rapid weight gain. Imatinib Teva may cause severe fluid retention in the body.

While taking Imatinib Teva, your doctor will regularly monitor the medication's effectiveness. Blood tests and regular weighing will also be performed.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with LMC. There is no experience with children under 2 years of age with LMC. Experience with Ph-positive LLA is limited, and experience with SMD/SMP, DFSP, GIST, and SHE/LEC is very limited.

Some children and adolescents taking Imatinib Teva may experience slower-than-normal growth. Your doctor will monitor growth during regular visits.

Other medications and Imatinib Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications (such as paracetamol) and herbal medications (such as St. John's Wort). Some medications may interfere with the effect of Imatinib Teva when taken together. These may increase or decrease the effect of Imatinib Teva, leading to an increase in adverse effects or making Imatinib Teva less effective. Imatinib Teva may also produce the same effect on other medications.

Inform your doctor if you are using medications that prevent blood clotting.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.
• It is not recommended to use Imatinib Teva during pregnancy except when clearly necessary, as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Teva during pregnancy with you.
• Women who may become pregnant are advised to use an effective contraceptive method during treatment and for 15days after completing treatment.
• Do not breastfeed your baby during treatment with Imatinib Teva or for 15days after completing treatment, as it may harm your baby.
• Patients concerned about their fertility while taking Imatinib Teva should consult their doctor.

Driving and operating machinery

You may experience dizziness, drowsiness, or blurred vision while taking this medication. If you experience these symptoms, do not drive or operate tools or machinery until you feel better again.

Your doctor has prescribed Imatinib Teva because you have a serious disease. Imatinib Teva may help you fight this disease.

However, follow exactly the administration instructions for this medication indicated by your doctor, pharmacist or nurse. It is essential that you do this for the time your doctor, pharmacist or nurse tells you. In case of doubt, consult your doctor, pharmacist or nurse.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you cannot take the medication as prescribed by your doctor or think you do not need to take it for a longer time, contact your doctor immediately.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many Imatinib Teva tablets you should take.

• If you are being treated for LMC:

Depending on your situation, the initial normal dose is 400 mg or 600 mg:

• 400 mg, that is, 1 tablet once a day,
• 600 mg, that is, 1 tablet of 400 mg plus 2 tablets of 100 mg or 1 and a half tablets of 400 mg once a day.

• If you are being treated for GIST:

The initial dose is 400 mg, that is, 1 tablet once a day.

For LMC and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg (2 tablets), you should take 1 tablet in the morning and a second tablet at night.

• If you are being treated for LLA Ph-positive:

The initial dose is 600 mg, that is, a tablet of 400 mg plus 2 tablets of 100 mg or 1 and a half tablets of 400 mg once a day.

• If you are being treated for SMD/SMP:

The initial dose is 400 mg, that is, 1 tablet once a day.

• If you are being treated for SHE/LEC:

The initial dose is 100 mg, that is, 1 tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, that is, 1 tablet of 400 mg once a day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg per day (2 tablets), that is, 1 tablet in the morning and a second tablet at night.

Use in children and adolescents

Your doctor will tell you how many Imatinib Teva tablets to administer to the child. The amount of Imatinib Teva administered will depend on the child's situation, weight and height. The total daily dose in children and adolescents should not exceed 800 mg in LMC and 600 mg in LLA Ph+. Treatment may be given to the child once a day or, alternatively, the dose may be divided into two doses (half in the morning and half at night).

When and how to take Imatinib Teva

• Take Imatinib Teva with food.This will help protect you from stomach problems when taking Imatinib Teva.
• Swallow the tablets with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of water without gas or apple juice:

• Use approximately 200 ml for each 400 mg tablet
• Stir until the tablets have dissolved completely
• Once the tablet has dissolved, drink the contents of the glass immediately. There may be remaining dissolved tablet residue at the bottom of the glass.

The tablet can be divided into equal doses.

For how long to take Imatinib Teva

Continue taking Imatinib Teva every day for the time your doctor tells you.

If you take more Imatinib Teva than you should

If you accidentally take too many tablets, talk to your doctor immediately. You may need medical attention. Bring the medication packaging.

If you forget to take Imatinib Teva

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the one you forgot,
• Then continue with the normal schedule.
• Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These are usually mild to moderate.

Some side effects can be serious. Inform your doctor immediately if you experience any of the following:

Very common(may affect more than 1 in 10patients)or common(may affect up to 1 in 10patients):

• Rapid weight gain. Imatinib Teva can cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib Teva can reduce the number of white blood cells in your blood, making you more susceptible to infections.
• Bleeding or unexpected bruising (when you have not had any injury).

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

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, difficulty breathing, or painful breathing (signs of lung problems).
• Dizziness, lightheadedness, or fainting (signs of low blood pressure).
• Nausea, loss of appetite, dark urine, yellow skin or eyes (signs of liver problems).
• Rash, skin redness, blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple spots, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stool, or urine, black stool (signs of gastrointestinal problems).
• Significant decrease in urine output, feeling thirsty (signs of kidney problems).
• Nausea, diarrhea, and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in your arms or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the brain).
• Pale skin, feeling tired, and difficulty breathing, dark urine (signs of low red blood cell count).
• Eye pain or vision problems,bleeding in the eyes.
• Bone or joint pain (signs of osteonecrosis).
• Blisterson the skin or mucous membranes (signs of pemphigus).
• Numbness or coldness in your feet and toes (signs of Raynaud's syndrome).
• Rapid swelling and redness of the skin (sign of skin infection called cellulitis).
• Difficulty hearing.
• Weakness and muscle spasms, abnormal heart rhythm (signs of changes in potassium levels in the blood).
• Bruises.
• Abdominal pain with nausea.
• Muscle spasms with fever, reddish-brown urine, muscle pain or weakness (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, unexpected vaginal bleeding, dizziness or fainting due to low blood pressure (signs of ovarian or uterine problems).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal laboratory test results (e.g., elevated potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
• Microangiopathic thrombosis.

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

• Combination of widespread generalized rash, feeling unwell, fever, elevated levels of certain blood cells, or yellow skin or eyes (signs of jaundice) with difficulty breathing, chest pain, decreased urine output, and feeling thirsty, etc. (signs of an allergic reaction related to treatment)

• Chronic kidney disease.
• Recurrence (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

If you experience any of the above symptoms,inform your doctor immediately.

Other side effects may include:

Very common(may affect more than 1 in 10people):

• Headache or feeling tired
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the muscles, joints, or bones,during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Inflammations such as swollen ankles or eyes.
• Weight gain.

If any of these affect you significantly,inform your doctor.

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

• Loss of appetite, weight loss, or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Excessive tearing of the eyes with itching, redness, and swelling (conjunctivitis), watery eyes, or blurred vision.
• Nasal bleeding.
• Abdominal pain, bloating, heartburn, or constipation.
• Itching.
• Unusual hair loss or weakness.
• Numbness or coldness in your hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

If any of these affect you significantly,consult your doctor.

Uncommon(may affect up to 1 in 100patients):

• Cough, nasal discharge, nasal congestion, sore throat, or headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing or pulsating pain, usually on one side of the head, often accompanied by nausea, vomiting, and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms.
• Pain or burning sensation while urinating, fever, pelvic pain, cloudy or reddish-brown urine (signs of urinary tract infection).
• Joint pain (signs of arthralgia).
• Feeling sad and losing interest in activities that you normally enjoy, which interferes with your ability to live a normal life (signs of depression).
• Feeling anxious and worried, accompanied by physical symptoms such as palpitations, sweating, tremors, dry mouth (signs of anxiety).
• Drowsiness, excessive sleepiness, or excessive sleep.
• Tremors or involuntary movements (tremor).
• Memory problems.
• Restless legs syndrome.
• Hearing ringing or other sounds in your ears that are not external (tinnitus).
• High blood pressure.
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Skin discoloration.
• Brittle nails.
• Red, painful bumps on the skin, skin pain, skin redness (inflammation of the subcutaneous tissue).

If any of these affect you significantly,consult your doctor.

Rare(may affect up to 1 in 1,000patients):

• Confusion.
• Yellowing of the nails.

If any of these affect you significantly,consult your doctor.

Frequency not known(cannot be estimated from 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 sensation.
• Painful skin lesions.
• Delayed growth in children and adolescents.

If any of these affect you significantly,consult your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack afterEXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use any packaging if you observe that it is damaged or shows signs of manipulation

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Imatinib Teva

• The active ingredient is imatinib (as mesylate).
• Each film-coated tablet of Imatinib Teva contains 400mg of imatinib (as mesylate).

• The other components are calcium hydrogen phosphate, crospovidone, and magnesium stearate.
• The tablet coating is formed bypartially hydrolyzed polyvinyl alcohol, macrogol, yellow iron oxide (E172), talc, titanium dioxide (E171), and red iron oxide (E172).

Appearance of the product and contents of the pack

Imatinib Teva 400mg film-coated tablets are oblong, film-coated tablets of dark yellow to brownish-orange color with a notch on one side. The tablet is engraved with “IT” and “4” on either side of the notch. The tablets are approximately 20mm in length and approximately 10mm in width.

Imatinib Teva 400mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blister.

Imatinib Teva 400mg film-coated tablets are available in pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blister.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible Person

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770

Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str.3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80 31-546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet {Month/year}.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.