Imatinib Sandoz

Leaflet attached to the packaging: patient information

Imatinib Sandoz, 400 mg, film-coated tablets

Imatinib

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. Contents of the pack 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 tumor of the stomach and intestines. It arises from the 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 you have any questions about how Imatinib Sandoz works and why it has been prescribed for you, you should ask your doctor.

2. Important information before taking Imatinib Sandoz

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

When not to take Imatinib Sandoz

If this information applies to you, you should tell your doctor before taking Imatinib Sandoz.
Your doctor.
If you suspect that you may be allergic but are not sure, you should consult your doctor.

Warnings and precautions

Before taking Imatinib Sandoz, you should discuss it with your doctor if:
you have or have ever had liver, kidney, or heart problems;
you are taking a medicine containing levothyroxine after thyroid removal;
you have or may have had 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;
if you experience bruising, bleeding, fever, fatigue, and disorientation while taking Imatinib Sandoz, you should contact your doctor. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
If any of these points apply to you, you should tell your doctor before taking Imatinib Sandoz.
During treatment with Imatinib Sandoz, your skin may become more sensitive to sunlight.
It is essential to protect areas of skin exposed to sunlight by wearing suitable clothing and using sunscreens with a high sun protection factor (SPF). These recommendations also apply to children.
If you experience very rapid weight gain during treatment with Imatinib Sandoz, you should tell your doctor immediately. Imatinib Sandoz may cause water retention in the body (severe fluid retention).
During treatment with Imatinib Sandoz, your doctor will regularly check the effectiveness of the treatment. Blood tests and body weight measurements 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 the medicine in children with CML under the age of 2. Experience with the use of the medicine 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. Your doctor will monitor your growth during regular visits.

Imatinib Sandoz and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines taken at the same time may interfere with the action of Imatinib Sandoz. They may increase or decrease the action of Imatinib Sandoz, causing increased side effects or reduced treatment efficacy. In the same way, Imatinib Sandoz may affect the action of other medicines.
You should tell your doctor about taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
• If it is not absolutely necessary, it is not recommended to take Imatinib Sandoz during pregnancy, as it may harm the baby. Your doctor will discuss with you the possible risks associated with taking Imatinib Sandoz during pregnancy.
• 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, you should not breastfeed, as it may harm the baby.
• Patient concerns about the impact of Imatinib Sandoz on fertility should consult their doctor.

Driving and using machines

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

3. How to take Imatinib Sandoz

Your doctor has prescribed Imatinib Sandoz for you because you have a serious illness. Imatinib Sandoz may help you fight the illness.
However, you should always take the medicine according to your doctor's or pharmacist's instructions. It is essential to take the medicine for as long as your doctor or pharmacist has prescribed. If you have any doubts, you should ask your doctor or pharmacist.
You should not stop taking Imatinib Sandoz unless your doctor tells you to. If you cannot take the medicine as prescribed by your doctor or think you no longer need it, you should contact your doctor immediately.

How much Imatinib Sandoz to take

Adult administration

Your doctor will determine the exact number of Imatinib Sandoz tablets you should take.

• CML treatment

Depending on your condition, the usual starting dose is 400 mg or 600 mg:

• 400 mg should be taken as one tablet oncea day,
• 600 mg should be taken as one 400 mg tablet plus ½ of a 400 mg tablet (or 2 100 mg tablets) oncea day.
• GIST treatmentThe starting dose is 400 mg, taken as 1 tablet oncea day.

Your doctor may prescribe a higher or lower dose in CML and GIST, depending on your body's response to treatment. If the daily dose is 800 mg (2 tablets), you should take 1 tablet in the morning and 1 tablet in the evening.

Ph-positive ALL treatment

The starting dose is 600 mg, which should be taken as one 400 mg tablet plus ½ of a 400 mg tablet (or 2 100 mg tablets) oncea day.

• MDS/MPD treatmentThe starting dose is 400 mg, which should be taken as one tablet oncea day.
• HES/CEL treatmentThe starting dose is 100 mg, which should be taken as one 100 mg tablet oncea day. Depending on your response to treatment, your doctor may decide to increase the dose to 400 mg, which should be taken as one 400 mg tablet oncea day.
• DFSP treatmentThe dose is 800 mg per day (2 tablets), which should be taken as 1 tablet in the morning and 1 tablet in the evening.

Administration in children and adolescents

Your doctor will determine the amount of Imatinib Sandoz tablets to give to your child. The dose of the medicine will depend on your 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 your child once a day or divided into two doses (half the dose in the morning and half the dose in the evening).
The film-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 upset during treatment with this medicine.
• The tablets should be swallowed whole, with a large glass of water.

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

• You should use about 200 ml of liquid for each 400 mg tablet or about 100 ml for ½ of a 400 mg tablet.
• Mix with a spoon until the tablets are completely dissolved.
• Immediately after dissolving the tablets, you should drink the entire contents of the glass. Residues of the dissolved tablets may remain on the glass.

How long to take Imatinib Sandoz

You should take the medicine every day for as long as your doctor has prescribed.

Taking more than the prescribed dose of Imatinib Sandoz

If you accidentally take too many tablets, you should immediatelytell your doctor, as medical attention may be necessary. You should bring the packaging of the medicine with you.

Missing a dose of Imatinib Sandoz

• If you miss a dose, you should take it as soon as you remember. However, if it is almost time for your next dose, you should not take the missed dose.
• You should then return to your previous dosing schedule.
• You should not take a double dose to make up for the missed dose.

If you have any further doubts about taking this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 serious. You should 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. 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-related disorders).
Cough, difficulty breathing, or chest pain (symptoms of lung-related disorders).
Feeling dizzy, dizzy spells, 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 blistering on the lips, eyes, skin, or mouth, peeling of the skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin-related 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-related disorders).
Significantly reduced urine output, feeling thirsty (symptoms of kidney-related disorders).
Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestine-related 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 tired and short of breath, and dark urine (symptoms of low red blood cell count).
Eye pain or vision changes, bleeding in the eyes.
Bone or joint pain (symptoms of bone death).
Blisters on the skin or mucous membranes (symptoms of blistering).
Numbness or feeling cold in the fingers and toes (symptoms of Raynaud's syndrome).
Sudden swelling and redness of the skin (symptoms of skin infection, called cellulitis).
Hearing disorders.
Muscle weakness and muscle cramps with heart rhythm disturbances (symptoms of potassium level changes in the blood).
Bruising.
Abdominal pain with nausea.
Muscle cramps with fever, dark urine, pain, or muscle 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 pain, 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).
Uncommon(may affect no more 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 or muscle pain (symptoms of joint pain).
• Constant feeling of sadness and loss of interest, preventing you from performing daily activities (symptoms of depression).
• Feeling anxious or worried, along with physical symptoms such as a strong heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness or excessive drowsiness.
• Trembling or muscle shaking.
• Memory disorders.
• Irrepressible urge to move your legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in your ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Stomatitis.
• Difficulty swallowing.
• Excessive sweating.
• Discoloration of the skin.
• Brittle nails.
• Red bumps or white pimples that form around hair roots, which can be painful, itchy, or burning (symptoms of folliculitis).
• 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).
• Impotence (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 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, and bloating, black stools (symptoms of stomach ulcers).
• Stiffness of joints and muscles.
• Abnormal laboratory test results.

Rare(may affect no more than 1 in 1000 people):

• Confusion.
• Nail discoloration.

Frequency not known(cannot be estimated from the available data):
A combination of widespread, severe rash, nausea, fever, high white blood cell count, or yellowing of the skin or eyes (symptoms of jaundice) with shortness of breath, chest pain/discomfort, significantly reduced urine output, and thirst, etc.
(symptoms of an allergic reaction related to treatment).
Chronic kidney failure.
Reactivation (relapse) of hepatitis B virus infection (liver infection) in patients who have had the disease in the past.
If you experience any of the above side effects, you should tell your doctor immediately.
Your doctor.

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 muscle or joint 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, you should tell your 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, bloating with gas, heartburn, or constipation.
Itching.
Excessive hair loss.
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, you should tell your doctor.
Frequency not known(cannot be estimated from the available data):
Redness and (or) swelling of the palms and soles, which may occur with tingling and burning pain.
Skin changes with pain and (or) blistering.
Slowed growth in children and adolescents.
If any of these symptoms are severe, you should tell your doctor.
Your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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 this medicine.

5. How to store Imatinib Sandoz

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Imatinib Sandoz contains

The active substance of the medicine is imatinib mesylate. Each film-coated tablet contains 400 mg of imatinib (in the form of 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 film-coated tablets are dark yellow to brown-orange, oval, biconvex, with beveled edges, approximately 19.2 mm in length and 7.7 mm in width, with the inscription "400" on one side and a score line between the letters "SA" on the other side.
The film-coated tablets are packaged in PVC/PE/PVDC/Aluminum blisters and placed in a carton containing 10, 30, 50, 60, 80, or 90 film-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

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, you should 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:10/2022
Sandoz logo