Package Leaflet: Information for the Patient

Imatinib Sandoz 100 mg Film-Coated Tablets

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, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking 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+ 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 skin cancer in which certain 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 any of the other components of 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 levotiroxine because your thyroid has been removed,
• if you have ever had or may have a hepatitis B infection at this time. This is because imatinib could make hepatitis B 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 blood vessel damage called microangiopathic thrombosis (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 exposed skin areas 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. Blood tests and regular weighing will also be performed.

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 medicines (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 experience these symptoms, 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 essential that you do it for the time 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 tell you 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 4 tabletsoncea day,
• 600 mg, that is 6 tabletsoncea day.

• If you are being treated for GIST:

The initial dose is 400 mg, that is 4 tabletsoncea 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 (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

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

The initial dose is 600 mg, that is 6 tabletsoncea day.

• If you are being treated for SMD/SMP:

The initial dose is 400 mg, that is 4 tabletsoncea day.

• If you are being treated for SHE/LEC:

The initial dose is 100 mg, that is 1 tabletoncea day. Your doctor may decide to increase the dose to 400 mg, that is 4 tabletsoncea day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg a day (8 tablets), that is 4 tablets in the morning and 4 tablets in the evening.

Use in children and adolescents

• Your doctor will tell you how many imatinib tablets to administer 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 in LMC and 600 mg in LLA Ph+. The 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:

• Useapproximately50 ml for each 100 mg tablet.
• Stir until the tablets have completely dissolved.
• Once the tablet has dissolved, drink the contents of the glass immediately. There may be remaining dissolved tablet at the bottom of the glass.

For how long should you take Imatinib Sandoz

Continue taking imatinib every day for the time 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 medication packaging.

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)

• Weight gain. Imatinib can cause your body to retain water (severe fluid retention).
• Symptoms of infection such as fever, chills, sore throat, or mouth ulcers. Imatinib 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 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).
• Red, painful skin bumps, 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, 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 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, dark urine, pain or weakness in the muscles (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).
• Small blood clots in small blood vessels (microangiopathic thrombosis).

Frequency not known(cannot be estimated from available data)

• Combinationof widespread 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 virus 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 pain in the muscles, joints, or bonesduring treatment with imatinib 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, bloating, heartburn, or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness in the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased sensitivity of the skin.
• 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, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing or pulsating pain, usually on one side of the head, and 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, with 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 leg syndrome.
• Heard sounds (e.g., bells, buzzing) in the ears that do not come from the outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Decoloration of the skin.
• Brittle nails.
• Red, painful spots or pimples 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, aching pain or feeling of heaviness in the testicles or scrotum, pain while urinating, during sex, or during ejaculation, blood in the urine (signs of testicular edema).
• Difficulty achieving or maintaining an erection (erectile dysfunction).
• Irregular or heavy 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 frequency of urination.
• 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 patients)

• Confusion.
• Discoloration of the nails.

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 with blisters.
• 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 prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 100 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 100 mg film-coated tablets are tablets with an approximate diameter of 9.2 mm, very dark yellow to orange-brown in color, round, biconvex with beveled edges, marked with “NVR” on one face and a groove on the other face and with “SA” on each side of the groove.

The tablets are packaged in PVC/Aluminum or PVC/PE/PVDC/Aluminum blisters inside a cardboard container that contains 20, 30, 50, 60, 80, 90, or 120 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

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/