Imatinib sandoz

Package leaflet: Information for the patient

Imatinib Sandoz, 400 mg, film-coated tablets
Imatinibum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Imatinib Sandoz is and what it is used for
2. What you need to know 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 Imatinib Sandoz is and what it is used for

Imatinib Sandoz is a medicine that contains 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 of 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 of 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 disorders.
• 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 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 diseases listed above will be used.
If you have any questions about 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 doctor experienced in the use of medications for the treatment of
blood cancers or solid tumors.
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 to any of the other ingredients of this medicine (listed in section 6).

If this applies to the patient, the patient must inform 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 taking 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 after removal of the thyroid gland;
• 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;
• during treatment with Imatinib Sandoz, the patient develops bruising, bleeding, fever, fatigue, or confusion, 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 inform 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, including 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 inform the doctor immediately. Imatinib Sandoz may cause fluid retention in the body (severe fluid retention).

While taking Imatinib Sandoz, the doctor will regularly monitor the treatment's effectiveness. Blood tests and body weight measurements will also be performed.

Children and adolescents
Imatinib Sandoz is also used in the treatment of 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 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 must inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take, including over-the-counter medicines (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 its effect, leading to increased side effects or reduced treatment effectiveness. In the same way, Imatinib Sandoz may affect the action of other medicines.

The patient must inform the doctor if they are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and 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 operating machinery
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 resolve.

3. How to use Imatinib Sandoz
The doctor has prescribed Imatinib Sandoz due to a serious illness. Imatinib Sandoz may help fight the disease.
However, the medicine must always be taken exactly as directed by the doctor or pharmacist. It is important to take the medicine for as long as the doctor or pharmacist has instructed. If in doubt, contact the doctor or pharmacist.

Do not stop taking Imatinib Sandoz unless instructed by the doctor. If the patient cannot 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 take

Use in adults
The doctor will determine the exact number of Imatinib Sandoz tablets to take.

• 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 one tablet once daily,
  • 600 mg should be taken as one 400 mg tablet plus ½ of a 400 mg tablet (or 2 tablets of 100 mg) once daily.

• Treatment of GIST
  The starting dose is 400 mg, taken as one tablet 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 (2 tablets), one tablet should be taken in the morning and one in the evening.

• Treatment of Ph-positive ALL
  The starting dose is 600 mg, taken as one 400 mg tablet plus ½ of a 400 mg tablet (or 2 tablets of 100 mg) once daily.

• Treatment of MDS/MPD
  The starting dose is 400 mg, taken as one tablet once daily.

• Treatment of HES/CEL
  The starting dose is 100 mg, taken as one 100 mg tablet once daily. Depending on the patient's response to treatment, the doctor may decide to increase the dose to 400 mg, taken as one 400 mg tablet once daily.

• Treatment of DFSP
  The dose is 800 mg per day (2 tablets), taken as one tablet in the morning and one in the evening.

Use in children and adolescents
The doctor will determine the number of Imatinib Sandoz tablets to give 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 the dose 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 helps prevent gastrointestinal disturbances during treatment.
• 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 200 ml of liquid per 400 mg tablet or about 100 ml per ½ of a 400 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 the doctor has instructed.

Accidentally taking more than the recommended dose of Imatinib Sandoz
If the patient has accidentally taken too many tablets, the patient must inform the doctor immediately, as medical help may be needed. The patient should bring the medicine packaging with them.

Missed dose of Imatinib Sandoz

• If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, do not take the missed dose.
• Then return to the previous dosing schedule.
• Do not take a double dose to make up for a missed dose.

If there are any further questions about the use of this medicine, consult the 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 effects is usually mild or moderate.
Some side effects may be serious. You must immediately tell the doctor if the patient experiences
any of the following side effects:
Very common (may affect more than 1 in 10 people) or common (may affect up to 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 up to 1 in 100 people) or rare (may affect up to 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 dysfunction).
Rash, redness of the skin with blister formation on the lips, around the eyes, on the skin or in the mouth, skin peeling, fever, red or purple raised 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 the fatty tissue beneath the skin).
Severe abdominal pain, 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 diarrhoea 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, dark urine (symptoms of low red blood cell count).
Eye pain or blurred 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 cellulitis).
Hearing disturbances.
Muscle weakness and cramps with heart rhythm disturbances (symptoms of changes in blood potassium levels).
Bruising.
Stomach pain with nausea.
Muscle cramps with fever, red-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 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).
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 a 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).
• Influenza-like symptoms (flu-like illness).
• 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 accompanied by 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 white pustules forming around hair roots, which may cause pain, itching or burning sensation (symptoms of folliculitis).
• Skin rash with skin peeling (desquamative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and (or) heaviness in the testicles or lower abdomen, pain during urination, during sexual intercourse or 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.
• Reduced sexual drive.
• 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) chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, black stools (symptoms of stomach ulcer).
• Joint and muscle stiffness.
• Abnormal laboratory test results.

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

• Confusion.
• Nail discoloration.

Frequency not known (frequency cannot be estimated from the 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 of hepatitis B virus infection in patients who previously had this disease.
If any of the above side effects occur, you must immediately tell the doctor.
Other side effects:
Very common (may affect more than 1 in 10 people)
Headache or fatigue.
Nausea, vomiting, diarrhoea or indigestion.
Rash.
Muscle cramps or joint, 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 these symptoms are severe, you must tell the doctor.
Common (may affect up to 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.
Dryness of the mouth, dry skin or dry eyes.
Decreased or increased skin sensitivity.
Hot flushes, chills or night sweats.
If any of these symptoms are severe, you must tell the doctor.
Frequency not known (frequency cannot be estimated from the 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.
Slowed growth in children and adolescents.
If any of these symptoms are severe, you must tell the doctor.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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
Side effects can also be reported to the responsible entity.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Imatinib Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton after "EXP". The expiry date refers to the last day of the stated month.
Store below 25°C.
Store in the original packaging to protect from moisture.
Medicines should 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 packaging and other information

What Imatinib Sandoz contains
The active substance is imatinib mesilate. Each coated tablet contains 400 mg of imatinib (as imatinib mesilate).
The other components are: microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate, colloidal anhydrous silica.
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, oval, biconvex, with bevelled edges, approximately 19.2 mm in length and 7.7 mm in width, with the imprint “400” on one side and a break line between the letters “SA” on the other side.
The coated tablets are packed in blisters made of PVC/PE/PVDC/Aluminium and placed in cardboard boxes containing 10, 30, 50, 60, 80 or 90 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 more detailed 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