Package leaflet: Information for the patient

Imatinib Sandoz, 100 mg, film-coated tablets
Imatinibum
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Imatinib Sandoz is and what it is used for
Important information before taking Imatinib Sandoz
How to take Imatinib Sandoz
Possible side effects
How to store Imatinib Sandoz
Contents of the pack and other information

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

Imatinib Sandoz is a medicine containing the active substance called imatinib. This medicine works by
inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.
Imatinib Sandoz is indicated for the treatment of adults and children with:

Chronic myeloid leukaemia (CML). Leukaemia is a cancer arising from white blood cells. White blood cells normally help the body fight infection. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer arising from white blood cells. White blood cells normally help the body fight infection. Acute lymphoblastic leukaemia is a type of leukaemia 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). This is a group of blood disorders in which certain white blood cells begin to multiply uncontrollably. Imatinib Sandoz inhibits their growth in certain subtypes of these diseases.
Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Imatinib Sandoz inhibits their growth in certain subtypes of these diseases.
Gastrointestinal stromal tumours (GIST). GIST is a tumour of the stomach and intestines. It arises due to uncontrolled growth of connective tissue cells in these organs.
Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the subcutaneous tissue in which certain cells begin to multiply uncontrollably. Imatinib Sandoz inhibits the growth of these cells.

In the remainder of this leaflet, the abbreviated names of the above-mentioned diseases will be used.
If you have any questions regarding how Imatinib Sandoz works or why it has been prescribed, please ask your doctor.

2. Important information before using Imatinib Sandoz

Imatinib Sandoz is prescribed by a physician experienced in the use of drugs used to treat
blood cancers or solid tumours.
It is essential to strictly follow the doctor's instructions, even if they differ from the general information
provided in this leaflet.
When not to use Imatinib Sandoz

if the patient is allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to the patient, the patient must tell the doctor before using Imatinib Sandoz.
If the patient suspects they may be allergic but are not certain, they should consult their
doctor.
Warnings and precautions
Before using Imatinib Sandoz, discuss with the doctor if:
the patient has or has ever had liver, kidney or heart function disorders;
the patient is taking a medicine containing levothyroxine following thyroid removal;
the patient has ever had, or may currently have, hepatitis B virus infection;
this is because Imatinib Sandoz may cause reactivation of hepatitis B virus infection, which may be fatal in some cases; patients will be closely monitored by the doctor for signs of this infection before starting treatment;
if the patient develops bruising, bleeding, fever, fatigue or confusion during treatment with Imatinib Sandoz, the patient should contact the doctor immediately. These may be symptoms of a blood vessel disorder called thrombotic microangiopathy (TMA).
If any of these points apply to the patient, the patient must tell the doctor before using Imatinib Sandoz.
During treatment with Imatinib Sandoz, skin sensitivity to sunlight may increase.
Protection of skin areas exposed to sunlight is important by wearing appropriate clothing and using sunscreens with a high sun protection factor (SPF). These recommendations also apply to children.
If during treatment with Imatinib Sandoz there is a very rapid increase in the patient's body weight, the patient must tell the doctor immediately. Imatinib Sandoz may cause fluid retention in the body (severe fluid retention).
While the patient is taking Imatinib Sandoz, the doctor will regularly monitor treatment effectiveness. 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 2 years of age. Experience with use in children with Ph-positive ALL is limited, and experience with 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 with other medicines
The patient must tell the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines (such as paracetamol) and herbal medicines (such as St John's wort). Some medicines taken concomitantly may interfere with the action of Imatinib Sandoz. They may increase or decrease the effect of Imatinib Sandoz, leading to increased adverse effects or reduced treatment efficacy. In the same way, Imatinib Sandoz may affect the action of other medicines.
The patient must tell the doctor if they are taking medicines to prevent blood clots.
Pregnancy, breastfeeding and effects on fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the doctor before using this medicine.
Unless absolutely necessary, use of Imatinib Sandoz during pregnancy is not recommended, as it may harm the unborn child. The doctor will discuss with the patient the possible risks associated with taking Imatinib Sandoz during pregnancy.
Women who could become pregnant are advised to use effective contraception during treatment and for 15 days after its completion.
Breastfeeding must not be used during treatment with Imatinib Sandoz and for 15 days after its completion, as it may harm the child.
Patients 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 such cases, the patient must not drive, operate tools or machinery until these symptoms subside.
3. How to use Imatinib Sandoz
The doctor has prescribed Imatinib Sandoz for a serious condition. Imatinib Sandoz may
help fight the disease.
However, the medicine must always be used exactly as directed by the doctor or pharmacist. It is important to take the medicine for as long as the doctor or pharmacist has advised. If in doubt, the patient should consult the doctor or pharmacist.
The patient must not stop using Imatinib Sandoz unless instructed to do so by the doctor. If the patient is unable to take the medicine as prescribed by the doctor or thinks they no longer need it, they should contact the doctor immediately.
How much Imatinib Sandoz to use
Use in adults
The doctor will determine the exact number of Imatinib Sandoz tablets to be taken.

Treatment of CML Depending on the patient's condition, the usual starting dose is 400 mg or 600 mg:
- 400 mg should be taken as 4 tablets once daily,
- 600 mg should be taken as 6 tablets once daily.
Treatment of GIST The starting dose is 400 mg, taken as 4 tablets once daily.

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.

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

Use in children and adolescents
The doctor will determine the number of Imatinib Sandoz tablets to be given to the child. The dose will depend on the child's condition, body weight and height. The total daily dose in children must not exceed 800 mg in CML treatment and 600 mg in Ph+ ALL treatment. The dose may be given once daily or divided into two doses (half in the morning and half in the evening).
Film-coated tablets may be divided into equal doses.
When and how to take Imatinib Sandoz

Imatinib Sandoz should be taken with food, which will help prevent gastrointestinal disturbances during treatment with this medicine.
Tablets should be swallowed whole with a large glass of water.

If the patient is unable to swallow the tablets, they may dissolve them in a glass of still water or apple juice:

Use approximately 50 ml of liquid per 100 mg tablet.
Stir with a spoon until the tablets are completely dissolved.
Immediately after dissolving, drink the entire contents of the glass. Traces of dissolved tablets may remain in the glass.

How long to take Imatinib Sandoz
The medicine should be taken daily for as long as directed by the doctor.
Taking more than the recommended dose of Imatinib Sandoz
If the patient accidentally takes too many tablets, they must tell the doctor immediately, as medical help may be needed. The patient should bring the medicine packaging with them.
Missing a dose of Imatinib Sandoz

If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should not be taken.
The patient should then return to the previous dosing schedule.
The patient must not take a double dose to make up for a missed dose.

If the patient has any further questions about the use of this medicine, they should consult their
doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The severity of these reactions is usually mild or moderate.
Some adverse reactions may be severe. You must immediately tell the doctor if the patient experiences any of the following adverse reactions:
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 fluid retention in the body (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat, or mouth ulcers.
Imatinib Sandoz may reduce the number of white blood cells, increasing susceptibility to infections.
Unexpected bleeding or bruising (despite no 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 pain when breathing (symptoms of lung-related disorders).
Dizziness, vertigo, 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, around the eyes, on the skin, or in the mouth, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin-related disorders).
Painful red nodules on the skin, skin pain, redness of the skin (inflammation of subcutaneous fat tissue).
Severe abdominal pain, presence of blood in vomit, stool, or urine, black stools (symptoms of stomach and intestinal disorders).
Markedly reduced urine output, feeling of thirst (symptoms of kidney-related disorders).
Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestinal 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 within the skull/brain).
Pale skin, feeling of fatigue and shortness of breath, and dark urine (symptoms of low red blood cell count).
Eye pain or worsening vision, 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 fingers and toes (symptoms of Raynaud's syndrome).
Sudden swelling and redness of the skin (symptoms of skin infection, so-called connective tissue inflammation).
Hearing disturbances.
Muscle weakness and muscle cramps with irregular heartbeat (symptoms of changes in blood potassium levels).
Bruising.
Stomach pain with nausea.
Muscle cramps with fever, reddish-brown discoloration of urine, muscle pain or weakness (symptoms of muscle disorders).
Pelvic pain, sometimes with nausea and vomiting, sudden vaginal bleeding, dizziness or fainting due to low blood pressure (symptoms of disorders related to ovaries or uterus).
Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and (or) joint complaints, and abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium, and low levels of phosphorus in blood).
Blood clots in small blood vessels (thrombotic microangiopathy).
Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):
Combination of widespread, severe rash, nausea, fever, high number of certain white blood cells or yellowing of the skin or eyes (jaundice) with shortness of breath, chest pain/discomfort, markedly reduced urine output, and feeling of thirst, etc. (symptoms of an allergic reaction related to treatment).
Chronic kidney failure.
Reactivation (recurrence) of hepatitis B virus infection in patients who previously had this disease.
If any of the above adverse reactions occur, you must immediately inform the doctor.
Other adverse reactions:
Very common (may affect more than 1 in 10 people)
Headache or fatigue.
Nausea, vomiting, diarrhea, or indigestion.
Rash.
Muscle or joint cramps, muscle or bone pain during or after treatment with this medicine.
Swelling, such as swelling around the ankles or around the eyes.
Weight gain.
If any of the listed symptoms are severe, you should inform the doctor.
Common (may affect less than 1 in 10 people)
Loss of appetite, weight loss, or taste disturbances.
Dizziness or weakness.
Difficulty falling asleep (insomnia).
Eye discharge with itching, redness, and swelling (conjunctivitis), tearing, or blurred vision.
Nosebleeds.
Abdominal pain or bloating, flatulence, 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 flushes, chills, or night sweats.
If any of the listed symptoms are severe, you should inform the doctor.
Uncommon (may affect up to 1 in 100 people):

Cough, watery nasal discharge, or nasal congestion, feeling of pressure or pain upon pressing the area above the eyes or on both sides of the nose, nasal mucosa congestion, sneezing, sore throat, with or without headache (symptoms of upper respiratory tract infection).
Severe headache felt as pulsating pain or sensation of pulsation, usually on one side of the head, often accompanied by nausea, vomiting, and sensitivity to light or sound (symptoms of migraine).
Flu-like symptoms (influenza).
Pain or burning sensation during urination, elevated body temperature, pain in the groin or pelvic area, red or brown discoloration of urine, or cloudy urine (symptoms of urinary tract infection).
Joint pain and swelling (symptoms of joint pain).
Persistent feeling of sadness and loss of interest, preventing the patient from performing daily activities (symptoms of depression).
Feeling of nervousness or anxiety with somatic symptoms such as rapid heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
Drowsiness / excessive sleepiness.
Tremor or muscle shaking.
Memory disturbances.
Irresistible urge to move the legs (restless legs syndrome).
Perception of noises (e.g. ringing, buzzing) in the ears not originating from outside (tinnitus).
High blood pressure (hypertension).
Belching.
Inflammation of the lips.
Difficulty swallowing.
Excessive sweating.
Skin discoloration.
Brittle nails.
Red nodules or whiteheads forming around hair roots, which may cause pain, itching, or burning sensation (symptoms of folliculitis).
Skin rash with skin peeling (exfoliative dermatitis).
Breast enlargement (may occur in men or women).
Dull pain and (or) feeling of heaviness in the testicles or lower abdomen, pain during urination, during sexual intercourse, or during ejaculation, blood in urine (symptoms of testicular swelling).
Inability to achieve or maintain erection (erectile dysfunction).
Heavy or irregular menstrual bleeding.
Difficulty achieving/maintaining sexual arousal.
Decreased libido.
Nipple pain.
General malaise.
Viral infection, such as common cold.
Lower back pain due to kidney disorders.
Increased frequency of urination.
Increased appetite.
Pain or burning sensation in the upper abdomen and (or) in the chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, black stools (symptoms of stomach ulcer).
Stiffness of joints and muscles.
Abnormal laboratory test results.

Rare (may affect up to 1 in 1000 people):

Confusion. Nail discoloration. Frequency unknown (cannot be estimated from available data): Redness and (or) swelling of the palms and soles, which may occur together with tingling and burning pain.

Skin changes with pain and (or) blister formation.
Growth retardation in children and adolescents.
If any of the listed symptoms are severe, you should inform the doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Imatinib Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

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

What Imatinib Sandoz looks like and contents of the pack
The coated tablets are dark yellow to brownish-orange, round, biconvex, with bevelled edges, approximately 9.2 mm in diameter, engraved with the code "NVR" on one side and a breakline between the letters "SL" on the other side.
The coated tablets are packed in blisters made of PVC/Aluminum or PVC/PE/PVDC/Aluminum and placed in a cardboard box containing 20, 30, 50, 60, 80, 90 or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg, Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For further information about the medicinal product 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
tel. 22 209 70 00