Product Information for the Patient

Imatinib Sandoz 400 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine, because it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1.What Imatinib Sandoz is and for what it is used

2.What you need to know before starting to take Imatinib Sandoz

3.How to take Imatinib Sandoz

4.Possible side effects

5.Storage of Imatinib Sandoz

6.Contents of the pack and additional information

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

Imatinib is a treatment for adults and children for:

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

Imatinib is also a treatment for adults for:

• Myeloproliferative/Myelodysplastic Syndromes (MPN/ MDS).These are a group of blood disorders in which some blood cells start to grow uncontrollably. Imatinib inhibits the growth of these cells in a certain subtype of these diseases.
• Systemic Mastocytosis (SM) and/or Chronic Eosinophilic Leukemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) start to grow uncontrollably. Imatinib 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 an uncontrolled 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 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 works or why this medication has been prescribed to you, ask your doctor.

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

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

Do not take Imatinib Sandoz:

• if you are allergic to imatinib or to any of the other ingredients in this medication (listed in section 6).

If this is the case, inform your doctor and do not take imatinib.

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 Sandoz:

• if you have or have had any liver, kidney, or heart problems,
• if you are taking the medication levotiroxina because your thyroid has been removed,
• if you have ever had or may currently have a hepatitis B infection. This is because imatinib could make hepatitis B become active again, which can be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment,
• if while taking imatinib you develop bruises, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of a condition called microangiopathic thrombocytopenic purpura (MAT).

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

You may become more sensitive to the sun while taking imatinib. It is essential to cover areas of the skin exposed to the sun and use high-protection sunscreen. These precautions also apply to children.

Inform your doctor immediately during imatinib treatmentif you gain weight very quickly.Imatinib can cause severe fluid retention in the body.

While taking imatinib, your doctor will regularly check if the medication is working properly. You will also have regular blood tests and be weighed regularly.

Children and adolescents

Imatinib is also a treatment for children with LMC. There is no experience with children with LMC under 2 years of age. Experience with children 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 may experience slower-than-normal growth. Your doctor will monitor growth during regular visits.

Other medications and Imatinib Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 when taken together. These may increase or decrease the effect of imatinib, leading to an increase in side effects or making imatinib less effective. Imatinib may also affect other medications.

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

Pregnancy,breastfeeding, and fertility

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

Driving and operating machines

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. It is important that you do it for the time that your doctor or pharmacist indicates. In case of doubt, consult your doctor or pharmacist again.

Do not stop taking imatinib 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 Sandoz to take

Use in adults

Your doctor will indicate exactly how many imatinib 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 one tabletonceper day,
• 600 mg, that is one 400 mg tablet plus half a 400 mg tablet (or two 100 mg tablets)onceper day.

• If you are being treated for GIST:

The initial dose is 400 mg, that is one tabletonceper 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 (two tablets), you should take one tablet in the morning and one tablet in the evening.

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

The initial dose is 600 mg, that is one 400 mg tablet plus half a 400 mg tablet (or two 100 mg tablets)onceper day.

• If you are being treated for SMD/SMP:

The initial dose is 400 mg, that is one tabletonceper day.

• If you are being treated for SHE/LEC:

The initial dose is 100 mg, that is one 100 mg tabletonceper day. Your doctor may decide to increase the dose to 400 mg, that is one 400 mg tabletonceper day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg per day (two tablets), that is, one tablet in the morning and one tablet in the evening.

Use in children and adolescents

Your doctor will indicate how many imatinib tablets you should give to the child. The amount of imatinib administered will depend on the child's situation, weight, and height. The total daily dose in children should not exceed 800 mg for LMC and 600 mg for LLA Ph+. Treatment can be given to the child once a day or, alternatively, the dose can be divided into two doses (half in the morning and half in the evening).

The film-coated tablet can be divided into equal doses.

When and how to take Imatinib Sandoz

• Take imatinib with food. This will help protect you from stomach problems when taking imatinib.
• Swallow the tablets whole 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:

• Useapproximately200 ml for each 400 mg tablet or approximately 100 ml for each half 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 tablet residue at the bottom of the glass.

For how long should you take Imatinib Sandoz

Continue taking imatinib every day for the time that your doctor has indicated.

If you take more Imatinib Sandoz than you should

If you have accidentally taken too many tablets, talk to your doctorimmediately. You may need medical attention. Bring the packaging of the medication.

If you have taken more Imatinib Sandoz than you should, consult your doctor immediately, your pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Imatinib Sandoz

• 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.

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 10 people)or common(may affect up to 1 in 10 people):

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

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

• Chest pain, irregular heartbeat (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 skin patches, itching, burning sensation, rash with pustules (signs of skin problems).
• Painful red lumps on the skin, skin pain, skin redness (inflammation of the subcutaneous tissue).
• 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).
• Dizziness (nausea) with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/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).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or feeling of coldness in the feet and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and muscle spasms, with an irregular heartbeat (signs of changes in potassium levels in the blood).
• Bruises.
• Stomach pain with nausea.
• Muscle spasms with fever, reddish-brown urine, muscle pain or weakness (signs of muscle problems).
• Abdominal pain, 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).
• Small blood clots in small blood vessels (microangiopathic thrombosis).

Unknown frequency(cannot be estimated from available data):

• Combinationof 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 failure.
• Reactivation (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

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

Other side effects may include:

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

• Headache or feeling tired.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or joint, muscle, or bone painduring imatinib treatment or when stopping treatment.
• Inflammations such as swollen ankles or eyes.
• Weight gain.

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

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

• 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, flatulence, heartburn, or constipation.
• Itching.
• Unusual hair loss or weakness.
• Numbness of the 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 100 people)

• Cough, nasal secretion, 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 (influenza).
• Pain or burning sensation while urinating, fever, pain in the groin or pelvis, cloudy or reddish-brown urine (signs of urinary tract infection).
• Joint pain (arthritis).
• Constant feeling of thirst and loss of interest, which interrupts the ability to lead 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 damage.
• Restless legs syndrome.
• Heard sounds (e.g., bells, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Decoloration of the skin.
• Brittle nails.
• Red, itchy, or painful bumps around the hair follicles, possibly with pain, itching, or burning sensation (signs of folliculitis).
• Dermatitis exfoliativa (skin rash with peeling or shedding).
• Breast growth (may occur in men or women).
• Dull or heavy sensation in the testicles or scrotum, pain while urinating, during sex, or ejaculation, blood in the urine (signs of testicular edema).
• Inability to achieve or maintain an erection (erectile dysfunction).
• Irregular or intense menstrual periods.
• Difficulty achieving or maintaining sexual excitement.
• Decreased libido.
• Breast pain.
• General feeling of discomfort (general malaise).
• Herpes labialis (cold sores).
• Lower back pain due to kidney problems.
• Increased urination frequency.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling full, bloating, black stool (signs of stomach ulcers).
• Joint or muscle stiffness.
• Abnormal laboratory test results.

Rare(may affect up to 1 in 1,000 people)

• Confusion.
• Discoloration of the nails.

Unknown frequency(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 or blistering 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 not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Imatinib Sandoz

• The active ingredient is imatinib mesylate. Each tablet contains 400 mg of imatinib (as mesylate).
• The other core excipients of the tablet are microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate, and anhydrous colloidal silica.
• The other coating excipients of the tablet are iron oxide red (E172), iron oxide yellow (E172), macrogol 4000, talc, and hypromellose.

Appearance of the product and contents of the package

Imatinib Sandoz 400 mg film-coated tablets are tablets with an approximate length of 19.2 mm and 7.7 mm in width, very dark yellow to orange-brown in color, ovaloid, biconvex, with beveled edges, marked with “400” on one face and a groove on the other face and with SL on each side of the groove.

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters that are contained in a cardboard package containing 10, 30, 50, 60, 80, or 90 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Verovškova ul. 57

1526 Ljubljana

Slovenia

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg, Bayern

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Novartis Pharmaceutical

Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana,

Slovenia

Last review date of this leaflet:August 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/