Imatinib Sandoz

Leaflet attached to the packaging: patient information

Imatinib Sandoz, 100 mg, coated tablets

Imatinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Imatinib Sandoz and what is it used for
• 2. Important information before taking Imatinib Sandoz
• 3. How to take Imatinib Sandoz
• 4. Possible side effects
• 5. How to store Imatinib Sandoz
• 6. Package contents and other information

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

Imatinib Sandoz is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the following diseases. These include certain types of cancer.

Imatinib Sandoz is indicated for the treatment of adults and children with:

• Chronic myeloid leukemia (CML) -English: chronic myeloid leukemia. Leukemia is a cancer that originates from white blood cells. White blood cells usually help the body fight infection. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Acute lymphoblastic leukemia with Philadelphia chromosome(English: Ph-positive ALL). Leukemia is a cancer that originates from white blood cells. White blood cells usually help the body fight infection. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to multiply uncontrollably. Imatinib Sandoz inhibits the growth of these cells.

Imatinib Sandoz is also indicated for the treatment of adult patients with:

• Myelodysplastic/myeloproliferative diseases MDS/MPD -English: myelodysplastic/myeloproliferative diseases. This is a group of blood diseases in which certain white blood cells begin to multiply uncontrollably. Imatinib Sandoz inhibits their growth in certain subtypes of these diseases.
• Hypereosinophilic syndrome HES -English: hypereosinophilic syndrome) and (or) chronic eosinophilic leukemia CEL -English: chronic eosinophilic leukemia). These are blood diseases in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Imatinib Sandoz inhibits their growth in certain subtypes of these diseases.
• Gastrointestinal stromal tumors GIST- English: Gastrointestinal Stromal Tumors). GIST is a stomach and intestine tumor. It occurs as a result of uncontrolled growth of connective tissue cells in these organs.
• Dermatofibrosarcoma protuberans DFSP -English: dermatofibrosarcoma protuberans). DFSP is a tumor of the subcutaneous tissue, in which certain cells begin to multiply uncontrollably. Imatinib Sandoz inhibits the growth of these cells.

In the rest of this leaflet, abbreviations of the names of the diseases mentioned above will be used.
If the patient has any questions about how Imatinib Sandoz works and the justification for its administration, they should ask their doctor.

2. Important information before taking Imatinib Sandoz

Imatinib Sandoz is prescribed by a doctor with experience in using medicines for the treatment of blood cancers or solid tumors.
Follow the doctor's instructions carefully, even if they differ from the general information contained in this leaflet.

When not to take Imatinib Sandoz

If this information applies to the patient, they should tell their doctor before taking Imatinib Sandoz.
The doctor will decidewhether the patient can take Imatinib Sandoz.
If the patient suspects that they may be allergic but is not sure, they should consult their doctor.

Warnings and precautions

Before taking Imatinib Sandoz, the patient should discuss it with their doctor if:
they have or have ever had liver, kidney, or heart function disorders;
they are taking a medicine containing levothyroxine after thyroid removal;
they have or may have a hepatitis B virus infection;
this is because Imatinib Sandoz may cause reactivation of hepatitis B virus infection, which can be fatal in some cases; patients will be closely monitored by their doctor for signs of this infection before starting treatment;
while taking Imatinib Sandoz, the patient experiences bruising, bleeding, fever, fatigue, and disorientation, they should contact their doctor. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
If any of these points apply to the patient, they should tell their doctor before taking Imatinib Sandoz.
During treatment with Imatinib Sandoz, the patient's skin may become more sensitive to sunlight.
It is essential to protect the skin areas exposed to sunlight by wearing suitable clothing and using sunscreens with a high sun protection factor (SPF). These recommendations also apply to children.
If the patient experiences very rapid weight gain during treatment with Imatinib Sandoz, they should tell their doctor immediately. Imatinib Sandoz may cause water retention in the body (severe fluid retention).
During treatment with Imatinib Sandoz, the doctor will regularly monitor the effectiveness of the treatment. Blood tests and measurements of the patient's weight will also be performed.

Children and adolescents

Imatinib Sandoz is also used to treat children with CML. There is no experience with the use of Imatinib Sandoz in children with CML under the age of 2. Experience with the use of Imatinib Sandoz in children with Ph-positive ALL is limited, and experience with the use in children with MDS/MPD, DFSP, GIST, and HES/CEL is very limited.
In some children and adolescents taking Imatinib Sandoz, growth may be slower than normal. The doctor will monitor the patient's growth during regular visits.

Imatinib Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines used at the same time may interfere with the action of Imatinib Sandoz. They may enhance or reduce the effect of Imatinib Sandoz, causing increased side effects or reduced treatment effectiveness. Similarly, Imatinib Sandoz may affect the action of other medicines.
The patient should tell their doctor about taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
• If it is not absolutely necessary, Imatinib Sandoz should not be used during pregnancy, as it may harm the baby. The doctor will discuss the possible risks associated with taking Imatinib Sandoz during pregnancy with the patient.
• Women who may become pregnant are advised to use effective contraception during treatment and for 15 days after its completion.
• During treatment with Imatinib Sandoz and for 15 days after its completion, the patient should not breastfeed, as Imatinib Sandoz may harm the baby.
• Patient concerned about the effect of Imatinib Sandoz on fertility should consult their doctor.

Driving and using machines

While taking this medicine, the patient may experience dizziness, drowsiness, or blurred vision. In this case, they should not drive vehicles, operate any tools, or machines until these symptoms have resolved.

3. How to take Imatinib Sandoz

The doctor has prescribed Imatinib Sandoz to the patient because of a serious illness. Imatinib Sandoz may help fight the illness.
However, the medicine should always be taken according to the doctor's or pharmacist's instructions. It is essential to take the medicine for as long as the doctor or pharmacist has prescribed. If the patient has any doubts, they should ask their doctor or pharmacist.
The patient should not stop taking Imatinib Sandoz unless their doctor tells them to. If the patient cannot take the medicine as prescribed by their doctor or thinks they no longer need it, they should contact their doctor immediately.

How much Imatinib Sandoz to take

Adult administration

The doctor will determine the exact number of Imatinib Sandoz tablets the patient should take.

• CML treatmentDepending on the patient's condition, the usual initial dose is 400 mg or 600 mg:
• 400 mg should be taken as 4 tablets oncea day,
• 600 mg should be taken as 6 tablets oncea day.
• GIST treatmentThe initial dose is 400 mg, taken as 4 tablets oncea day.

The doctor may prescribe a higher or lower dose in CML and GIST, depending on the patient's response to treatment. If the daily dose is 800 mg (8 tablets), the patient should take 4 tablets in the morning and 4 tablets in the evening.

• Ph-positive ALL treatmentThe initial dose is 600 mg, taken as 6 tablets oncea day.
• MDS/MPD treatmentThe initial dose is 400 mg, taken as 4 tablets oncea day.
• HES/CEL treatmentThe initial dose is 100 mg, taken as one tablet oncea day. Depending on the patient's response to treatment, the doctor may decide to increase the dose to 400 mg, taken as 4 tablets oncea day.
• DFSP treatmentThe dose is 800 mg per day (8 tablets), taken as 4 tablets in the morning and 4 tablets in the evening.

Administration in children and adolescents

The doctor will determine the number of Imatinib Sandoz tablets to be given to the child. The dose of the medicine will depend on the child's condition, weight, and growth. The total daily dose in children should not exceed 800 mg in CML treatment and 600 mg in Ph+ ALL treatment. The dose can be given to the child once a day or divided into two doses (half a dose in the morning and half a dose in the evening).
The coated tablets can be divided into equal doses.

When and how to take Imatinib Sandoz

• Imatinib Sandoz should be taken during a meal, which will help prevent stomach disorders during treatment with this medicine.
• The tablets should be swallowed whole, with a large glass of water.

If the patient is unable to swallow the tablets, they can dissolve them in a glass of non-carbonated water or apple juice:

• About 50 ml of liquid should be used for each 100 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• Drink the entire contents of the glass immediately after dissolving the tablets. Residues of the dissolved tablets may remain on the glass.

How long to take Imatinib Sandoz

The medicine should be taken every day for as long as the doctor has prescribed.

Taking more Imatinib Sandoz than prescribed

If the patient accidentally takes too many tablets, they should immediatelytell their doctor, as medical attention may be necessary. The patient should take the packaging of the medicine with them.

Missing a dose of Imatinib Sandoz

• If a dose is missed, the patient should take it as soon as they remember. However, if it is almost time for the next dose, they should not take the missed dose.
• The patient should then return to their previous dosing schedule.
• The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should ask their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Imatinib Sandoz can cause side effects, although not everybody gets them.
The severity of these side effects is usually mild or moderate.

Some side effects can be severe. The patient should tell their doctor immediately if they 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. Imatinib Sandoz may cause water retention in the body (severe fluid retention).
Infection symptoms, such as fever, chills, sore throat, or mouth ulcers.
Imatinib Sandoz may cause a decrease in the number of white blood cells, increasing the risk of infection.
Unexpected bleeding or bruising (even without injury).
Uncommon(may affect less than 1 in 100 people) or rare(may affect less than 1 in 1000 people)
Chest pain, irregular heartbeat (symptoms of heart disorders).
Cough, difficulty breathing, or chest pain (symptoms of lung disorders).
Dizziness, dizziness, or fainting (symptoms of low blood pressure).
Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms of liver function disorders).
Rash, redness of the skin with blisters on the lips, eyes, skin, or mouth, peeling skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin disorders).
Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin).
Severe abdominal pain, blood in vomit, stool, or urine, black stools (symptoms of stomach and intestine disorders).
Significantly reduced urine output, feeling of thirst (symptoms of kidney disorders).
Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestine disorders).
Severe headache, weakness, or paralysis of limbs or facial muscles, difficulty speaking, sudden loss of consciousness (symptoms of nervous system disorders, such as bleeding or swelling in the skull/brain).
Pale skin, feeling of tiredness and shortness of breath, and dark urine (symptoms of low red blood cell count).
Eye pain or vision problems, bleeding in the eyes.
Bone or joint pain (symptoms of bone necrosis). Blisters on the skin or mucous membranes (symptoms of pemphigus).
Numbness or cold sensation in the fingers and toes (symptoms of Raynaud's syndrome).
Sudden swelling and redness of the skin (symptoms of skin infection, so-called cellulitis).
Hearing disorders.
Muscle weakness and cramps with heart rhythm disorders (symptoms of changes in potassium levels in the blood).
Bruising.
Abdominal pain with nausea.
Muscle cramps with fever, brown urine, pain, or weakness (symptoms of muscle disorders).
Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (symptoms of ovarian or uterine disorders).
Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and (or) joint problems, as well as abnormal laboratory test results (e.g., high potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
Blood clots in small blood vessels (thrombotic microangiopathy).
Frequency not known(frequency cannot be estimated from the available data):
A combination of widespread, severe rash, nausea, fever, high levels of certain white blood cells, or yellowing of the skin or eyes (symptoms of allergic reaction to treatment) with shortness of breath, chest pain/discomfort, significantly reduced urine output, and feeling of thirst, etc. (symptoms of anaphylaxis).
Chronic kidney failure.
Reactivation of hepatitis B virus infection (liver infection) in patients who have had this disease in the past.
If the patient experiences any of the above side effects, they should tell their doctor immediately.

Other side effects:

Very common(may affect more than 1 in 10 people)
Headache or fatigue.
Nausea, vomiting, diarrhea, or indigestion.
Rash.
Muscle cramps or joint pain, muscle pain, or bone pain during or after taking this medicine.
Swelling, such as swelling around the ankles or eyes.
Weight gain.
If any of these symptoms are severe, the patient should tell their doctor.
Common(may affect less than 1 in 10 people)
Lack of appetite, weight loss, or taste disorders.
Dizziness or weakness.
Difficulty sleeping (insomnia).
Eye discharge with itching, redness, and swelling (conjunctivitis), tearing, or blurred vision.
Nosebleeds.
Abdominal pain or swelling, 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.
Hot flashes, chills, or night sweats.
If any of these symptoms are severe, the patient should tell their doctor.
Uncommon(may affect less than 1 in 100 people):

• Cough, runny nose, or stuffy nose, feeling of pressure or pain when pressing on the area above the eyes or on both sides of the nose, nasal congestion, sneezing, sore throat, which may be accompanied by headache or not (symptoms of upper respiratory tract infection).
• Severe headache felt as a pulsating pain or a feeling of pulsation, usually on one side of the head, which is often accompanied by nausea, vomiting, and sensitivity to light or sounds (symptoms of migraine).
• Flu-like symptoms (flu).
• Pain or burning sensation when urinating, elevated body temperature, pain in the groin or pelvic area, red or brown urine, or cloudy urine (symptoms of urinary tract infection).
• Joint pain or swelling (symptoms of joint pain).
• Feeling of sadness and loss of interest, preventing the patient from performing daily activities (symptoms of depression).
• Feeling of anxiety or apprehension with physical symptoms, such as a strong heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness/excessive drowsiness.
• Trembling or muscle twitching.
• Memory disorders.
• Irrepressible urge to move the legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Stomatitis.
• Difficulty swallowing.
• Excessive sweating.
• Skin discoloration.
• Brittle nails.
• Red bumps or white pimples that form around the hair roots, which can cause pain, itching, or burning sensation (symptoms of folliculitis).
• Blistering skin rash with peeling skin (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and (or) feeling of heaviness in the testicles or in the lower abdomen, pain when urinating, during sexual intercourse, or during ejaculation, blood in the urine (symptoms of testicular swelling).
• Difficulty achieving or maintaining an erection (erectile dysfunction).
• Heavy or irregular menstrual bleeding.
• Difficulty achieving or maintaining sexual arousal.
• Decreased sex drive.
• Nipple pain.
• General malaise.
• Viral infection, such as a cold.
• Back pain in the lower back due to kidney disorders.
• Increased frequency of urination.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and (or) chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness, and bloating, black stools (symptoms of stomach ulcers).
• Stiffness of joints and muscles.
• Abnormal laboratory test results.

Rare(may affect less than 1 in 1000 people):

• Confusion. Nail discoloration. Frequency not known(frequency cannot be estimated from the available data):

Skin changes with pain and (or) blistering.
Slowed growth in children and adolescents.
If any of these symptoms are severe, the patient should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Imatinib Sandoz

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Imatinib Sandoz contains

The active substance of the medicine is imatinib mesylate. Each coated tablet contains 100 mg of imatinib (as imatinib mesylate).
The other ingredients are: microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate, colloidal anhydrous silica
Coating: red iron oxide (E 172), yellow iron oxide (E 172), macrogol 4000, talc, hypromellose.

What Imatinib Sandoz looks like and contents of the pack

The coated tablets are dark yellow to brown-orange, round, biconvex, with beveled edges, approximately 9.2 mm in diameter, with the inscription "NVR" on one side and a score line between the letters "SL" on the other side.
The coated tablets are packaged in PVC/Aluminum or PVC/PE/PVDC/Aluminum blisters and placed in a carton containing 20, 30, 50, 60, 80, 90, or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg, Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the leaflet:08/2022
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