Imatinib Sandoz

Package leaflet: Information for the patient

Imatinib Sandoz 100 mg film-coated tablets, 400 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this 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 containing an active substance called imatinib. In the conditions listed below, this medicine works by inhibiting the growth of abnormal cells, including certain types of cancer.

Imatinib Sandoz is indicated in adult and pediatric patients for the treatment of:

• Chronic myeloid leukemia (CML). Leukemia is a cancer of white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.

• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Leukemia is a cancer of white blood cells. White blood cells normally help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib Sandoz inhibits the growth of these cells.

Imatinib Sandoz is also indicated in adults for the treatment of:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of hematological disorders in which certain blood cells begin to grow uncontrollably. Imatinib Sandoz inhibits the growth of these cells in certain subtypes of these diseases.

• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Sandoz inhibits the growth of these cells in a specific subtype of these diseases.

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• Malignant gastrointestinal stromal tumors (GIST). GIST is a tumor of the stomach and intestine. It arises from uncontrolled cell growth in the cells supporting the tissues of these organs.

• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumor of the subcutaneous tissue in which certain cells begin to grow uncontrollably. Imatinib Sandoz inhibits the growth of these cells.

In the remainder of this patient information leaflet, abbreviations will be used when referring to these conditions.
If you have any questions about how Imatinib Sandoz works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before taking Imatinib Sandoz

Imatinib Sandoz will only be prescribed by a doctor experienced in medicines for the treatment of blood cancers or solid tumors.
Carefully follow all your doctor’s instructions, even if they differ from the general information contained in this leaflet.
Do not take Imatinib Sandoz

• if you are allergic to imatinib or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, consult your doctor before taking Imatinib Sandoz.

If you think you might be allergic but are unsure, ask your doctor for advice.
Warnings and precautions
Talk to your doctor before taking Imatinib Sandoz

• if you have or have ever had a problem with your liver, kidneys, or heart.
• if you are taking the medicine levothyroxine because your thyroid gland has been removed.
• if you have ever had or may currently have hepatitis B infection. This is because Imatinib Sandoz could cause reactivation of hepatitis B, which in some cases can be fatal. Your doctor will carefully monitor you for signs of this infection before starting treatment.
• if you develop bruising, bleeding, fever, tiredness, or confusion while taking Imatinib Sandoz, contact your doctor immediately. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

If you are in any of these situations, consult your doctor before taking Imatinib Sandoz.
During treatment with Imatinib Sandoz, you may become more sensitive to sunlight. It is important to cover skin areas exposed to the sun and to use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.
During treatment with Imatinib Sandoz, inform your doctor immediately if you experience rapid weight gain. Imatinib Sandoz may cause your body to retain fluid (severe fluid retention).
While taking Imatinib Sandoz, your doctor will need to regularly check whether the medicine is working. You will also have regular blood tests and be weighed regularly.
Children and adolescents
Imatinib Sandoz is also a treatment for children with CML. There is no experience in children under 2 years of age with CML. Experience is limited in children with Ph+ ALL and very limited in children with MDS/MPD, DFSP, GIST, and HES/LEC.
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Some children and adolescents taking Imatinib Sandoz may have slower than normal growth. Your doctor will monitor growth at regular intervals.
Other medicines and Imatinib Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available without a prescription (such as paracetamol), and including herbal medicines (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Sandoz when taken together. They may increase or decrease the effect of Imatinib Sandoz, leading to an increase in side effects or making Imatinib Sandoz less effective. Imatinib Sandoz may have similar effects on other medicines.
Inform your doctor if you are taking medicines that prevent blood clots from forming.
Pregnancy, breastfeeding, and fertility

• If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
• Imatinib Sandoz is not recommended during pregnancy unless strictly necessary, as it may harm the unborn baby. Your doctor will discuss with you the possible risks of taking Imatinib Sandoz during pregnancy.
• Women who could become pregnant are advised to use an effective method of contraception during treatment and for 15 days after treatment has ended.
• Do not breastfeed during treatment with Imatinib Sandoz and for 15 days after treatment has ended, as it may harm the baby.
• Patients concerned about fertility during treatment with Imatinib Sandoz are advised to consult their doctor.

Driving and using machines
You may experience dizziness, drowsiness, or blurred vision while taking this medicine. If this occurs, do not drive or operate tools or machinery until you feel well again.

3. How to take Imatinib Sandoz

Your doctor has prescribed Imatinib Sandoz because you suffer from a serious condition. Imatinib Sandoz can help you
fight this condition.
However, you must take this medicine exactly as instructed by your doctor or pharmacist. It is important that you do so for as long as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not stop taking Imatinib Sandoz unless your doctor tells you to. If you are unable to take the medicine as prescribed or feel you no longer need it, contact your doctor immediately.
How much Imatinib Sandoz to take
Use in adults
Your doctor will tell you exactly how many Imatinib Sandoz tablets you should take.

• If you are being treated for CML: Depending on your condition, the usual starting dose is either 400 mg or 600 mg:
• 400 mg to be taken as 4 tablets once daily
• 600 mg to be taken as 6 tablets once daily.

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• 400 mg to be taken as 1 tablet once daily
• 600 mg to be taken as 1 tablet of 400 mg plus half a tablet of 400 mg (or 2 tablets of 100 mg) once daily.
• If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once daily. The starting dose is 400 mg, to be taken as one tablet once daily.

For both CML and GIST, your doctor may prescribe a higher or lower dose depending on your response to
treatment. If the daily dose is 800 mg (8 tablets), you must take 4 tablets in the morning and 4 tablets
in the evening. If the daily dose is 800 mg (2 tablets), you must take 1 tablet in the morning and 1 tablet
in the evening.

• If you are being treated for Ph+ ALL: The initial dose is 600 mg to be taken as 6 tablets once daily.

• If you are being treated for MF/MPN: The starting dose is 400 mg, taken as 4 tablets once daily. The starting dose is 400 mg, taken as 1 tablet once daily.
• If you are being treated for HES/CEL: The starting dose is 100 mg, taken as 1 tablet once daily. Your doctor may decide to increase the dose to 400 mg, taken as 4 tablets once daily, based on your response to treatment.

• If you are being treated for DFSP: The dose is 800 mg daily (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.

Use in children and adolescents
Your doctor will tell you how many Imatinib Sandoz tablets to give your child. The amount of Imatinib Sandoz administered will depend on the child's condition, weight, and height. The total daily dose must not exceed 800 mg in children with CML and 600 mg in children with Ph+ ALL. Treatment may be given to the child as a single daily dose or, alternatively, the daily dose may be divided into two administrations (half in the morning and half in the evening).
The film-coated tablet may be divided into two equal doses.

When and how to take Imatinib Sandoz

• Take Imatinib Sandoz with a meal. This will help you avoid stomach problems when taking Imatinib Sandoz.
• Swallow the tablets whole with a large glass of water.

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

• Use approximately 50 mL for each 100 mg tablet. Use approximately 200 mL for each 400 mg tablet or approximately 100 mL for each half of a 400 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink the entire contents of the glass immediately. Any residue from the dissolved tablets may be left in the glass.

How long to take Imatinib Sandoz
Continue taking Imatinib Sandoz every day for as long as your doctor tells you to.

If you take more Imatinib Sandoz than you should
If you have taken too many tablets by accident, contact your doctor immediately. You may need medical attention. Take the medicine pack with you.

If you forget to take Imatinib Sandoz

• If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Then continue with your regular dosing schedule.
• Do not take a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Usually side effects are mild to moderate.
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):

• Rapid weight gain. Imatinib Sandoz may cause your body to retain water (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 and therefore you may get infections more easily.
• Unexpected bleeding or bruising (when you have not injured yourself).

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).
• Feeling of dizziness, lightheadedness or fainting (signs of low blood pressure).
• Feeling unwell (nausea), with loss of appetite, dark-coloured urine, yellowing of the skin or eyes (signs of liver problems).
• Skin rash, redness of the skin with blisters on lips, eyes, skin or mouth, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Painful red lumps on the skin, skin pain, skin redness (inflammation of the subcutaneous fatty tissue).
• Severe abdominal pain, presence of blood in vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Marked decrease in urine output, feeling of thirst (signs of kidney problems).
• Feeling unwell (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of intestinal problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Paleness, feeling of tiredness and shortness of breath and dark-coloured urine (signs of low red blood cell levels).
• Eye pain or deterioration of vision, 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 fingers or toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Hearing problems.
• Muscle weakness and muscle spasms with an abnormal heart rhythm (signs of changes in blood potassium levels).
• Bruising.
• Stomach pain with feeling unwell (nausea).
• Muscle cramps with fever, red-brown urine, muscle pain or weakness (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with ovaries and uterus).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness and/or joint problems associated with abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium and low levels of phosphorus in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe skin reaction, feeling unwell, fever, increase in number of certain types of white blood cells or yellowing of the skin or eyes (jaundice) with shortness of breath, chest pain/discomfort, marked decrease in urine production and feeling of thirst, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure.
• Reactivation (recurrence) of hepatitis B infection if you have previously had hepatitis B (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.
• Feeling unwell (nausea), vomiting, diarrhoea or indigestion.
• Skin rash.
• Muscle cramps or joint, muscle or bone pain during treatment with Imatinib Sandoz or after stopping Imatinib Sandoz.
• Swelling, for example around the ankles or puffy eyes.
• Weight gain. If any of these effects become severe, inform your doctor immediately.

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Common (may affect up to 1 in 10 people):

• Loss of appetite, weight loss or altered sense of taste.
• Feeling dizzy or weak.
• Sleep disturbances (insomnia).
• Itchy eye discharge, redness and swelling (conjunctivitis), increased tearing or blurred vision.
• Nosebleeds.
• Abdominal pain or bloating, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eyes.
• Reduced or increased skin sensitivity.
• Hot flushes, chills or night sweats. If any of these effects become severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people):

• Cough, runny or blocked nose, feeling of heaviness or pain when pressing the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache felt as a pulsating pain or throbbing sensation, usually on one side of the head and often accompanied by nausea, vomiting and sensitivity to light or sound (signs of migraine).
• Influenza-like symptoms (flu).
• Pain or burning sensation during urination, increased body temperature, groin or pelvic pain, red, brown or cloudy urine (signs of urinary tract infection).
• Joint pain and swelling (signs of arthralgia).
• Persistent feeling of sadness and loss of interest, preventing you from carrying out your normal activities (signs of depression).
• Feeling of apprehension and worry together with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Drowsiness/lethargy/excessive sleepiness.
• Trembling or shaky movements (tremor).
• Memory disturbances.
• Uncontrollable urge to move the legs (restless legs syndrome).
• Hearing noises in the ears (e.g. ringing, buzzing) that have no external source (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Change in skin colour.
• Fragility of nails.
• Red bumps or boils with white tips around hair roots, possibly with pain, itching or burning sensation (signs of inflammation of hair follicles also called folliculitis).
• Skin rash with peeling or shedding (exfoliative dermatitis).
• Breast enlargement (can occur in men or women).

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• Dull and/or heavy sensation in the testicles or lower abdomen, pain during urination, sexual intercourse or ejaculation, blood in the urine (signs of testicular oedema).
• Inability to achieve or maintain an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving/maintaining sexual arousal.
• Decreased sexual desire.
• Nipple pain.
• General feeling of being unwell (malaise).
• Viral infection such as cold sores.
• Lower back pain due to kidney disease.
• Increased frequency of urination (micturition).
• Increased appetite.
• Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, dark-coloured stools (signs of stomach ulcer).
• Stiffness of joints and muscles.
• Abnormal laboratory test results.

Rare (may affect up to 1 in 1,000 people):

• Confusion.
• Change in nail colour.

Not known (frequency cannot be estimated from the available data):

• Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and painful burning.
• Painful skin lesions and/or blistering.
• Slowed growth in children and adolescents. If any of these effects become severe, inform your doctor.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the blister or carton after "Exp.". The expiry
date refers to the last day of that month.
Do not store above 30°C.
PVC/PE/PVDC/Aluminium blisters
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
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Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imatinib Sandoz contains

• The active substance is imatinib mesilate. Each film-coated tablet contains 100 mg of imatinib (as mesilate). Each film-coated tablet contains 400 mg of imatinib (as mesilate).
• The other components of the tablet core are microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate and anhydrous colloidal silica.
• The other components of the tablet coating are iron oxide red (E172), iron oxide yellow (E172), macrogol 4000, talc and hypromellose.

Description of the appearance of Imatinib Sandoz and contents of the pack
Each film-coated tablet of Imatinib Sandoz, with an approximate diameter of 9.2 millimetres, is dark yellow to brownish-orange in colour, round, biconvex with bevelled edges, marked with "NVR" on one side and "SA" and a breakline between the letters on the opposite side.
Each film-coated tablet of Imatinib Sandoz, with an approximate length of 19.2 millimetres and a thickness of 7.7 mm, is dark yellow to brownish-orange in colour, ovaloid, biconvex with bevelled edges, marked with "400" on one side and a breakline on the opposite side, with “SL” on each side of the breakline.
The tablets are packed in blisters made of PVC/Aluminum or PVC/PE/PVDC/Aluminum and placed in cardboard cartons containing 20, 30, 50, 60, 80, 90 or 120 film-coated tablets.
The tablets are packed in blisters made of PVC/PE/PVDC/Aluminum and placed in cardboard cartons containing 10, 30, 50, 60, 80 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57, 1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D, 9220 Lendava
Slovenia
Novartis Pharma GmbH
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Roonstrasse 25, 90429 Nürnberg
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben
Germany
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57, 1000 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria Imatinib Sandoz 100 mg – Filmtabletten
Imatinib Sandoz 400 mg – Filmtabletten
Belgium Imatinib Sandoz, 100 mg filmomhulde tabletten
Imatinib Sandoz, 400 mg filmomhulde tabletten
Bulgaria Imatinib Sandoz
Croatia Imatinib Sandoz 100 mg filmom obložene tablete
Imatinib Sandoz 400 mg filmom obložene tablete
Cyprus Imatinib Sandoz 100 mg
Imatinib Sandoz 400 mg
Czech Republic Imatinib Sandoz 100 mg
Imatinib Sandoz 400 mg
Denmark Imatinib Sandoz
Estonia Imatinib Sandoz
Finland Imatinib Sandoz
France Imatinib Sandoz 100 mg, comprimé pelliculé sécable
Imatinib Sandoz 400 mg, comprimé pelliculé sécable
Germany Imatinib HEXAL 100 mg Filmtabletten
Imatinib HEXAL 400 mg Filmtabletten
Greece IMATINIB/SANDOZ
Hungary Imatinib Sandoz 100 mg filmtabletta
Imatinib Sandoz 400 mg filmtabletta
Ireland Imatinib Rowex 100 mg Film-coated tablets
Imatinib Rowex 400 mg Film-coated tablets
Italy Imatinib Sandoz
Latvia Imatinib Sandoz 100 mg apvalkotās tabletes
Imatinib Sandoz 400 mg apvalkotās tabletes
Lithuania Imatinib Sandoz 100 mg plėvele dengtos tabletės
Imatinib Sandoz 400 mg plėvele dengtos tabletės
Luxembourg Imatinib Sandoz 100 mg comprimés pelliculés
Imatinib Sandoz 400 mg comprimés pelliculés
Netherlands Imatinib Sandoz 100 mg, filmomhulde tabletten
Imatinib Sandoz 400 mg, filmomhulde tabletten
Norway Imatinib Sandoz
Poland Imatinib Sandoz
Portugal Imatinib Sandoz
Romania Imatinib Sandoz 100 mg comprimate filmate
Imatinib Sandoz 400 mg comprimate filmate
Slovakia Imatinib Sandoz 100 mg
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Imatinib Sandoz 400 mg
Slovenia Imatinib Lek 100 mg filmsko obložene tablete
Imatinib Lek 400 mg filmsko obložene tablete
Spain Imatinib Sandoz 100 mg comprimidos recubiertos con película EFG
Imatinib Sandoz 400 mg comprimidos recubiertos con película EFG
Sweden Imatinib Sandoz
United Kingdom (Northern Ireland) Imatinib 100 mg film-coated tablets
Imatinib 400 mg film-coated tablets
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