IMATINIB SANDOZ 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Imatinib Sandoz 100 mg film-coated tablets EFG

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 further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Imatinib Sandoz and what is it used for
2. What you need to know before you take Imatinib Sandoz
3. How to take Imatinib Sandoz
4. Possible side effects
5. Storage of Imatinib Sandoz
6. Contents of the pack and further 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 diseases described below. These include some types of cancer.

Imatinib is a treatment for adults and children for:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body to fight infections. Chronic myeloid leukaemia is a type of leukaemia in which some abnormal white blood cells (called myeloid cells) start to grow out of control.

• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body to fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which certain abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatinib inhibits the growth of these cells.

Imatinib is also a treatment for adults for:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start to grow out of control. Imatinib inhibits the growth of these cells in a certain subtype of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (called eosinophils) start to grow out of control. Imatinib inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and intestine. It originates from uncontrolled cell growth of the supporting tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which some cells start to grow out of control. Imatinib inhibits the growth of these cells.

In the rest of this leaflet, these abbreviations will be used when referring to these diseases.

If you have any questions about how imatinib works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Sandoz

Imatinib will only be prescribed by a doctor who has experience in medicines for treating blood cell cancer or solid tumours.

Follow carefully all instructions given by your doctor, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Sandoz:

• if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor and do not take imatinib.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Sandoz:

• if you have or have had liver, kidney, or heart problems,
• if you are taking the medicine levothyroxine because you have had your thyroid removed,
• if you have ever had or might currently have a hepatitis B virus infection. This is because imatinib could cause the hepatitis B virus to become active again, which can be fatal in some cases. Your doctor should check carefully for signs of this infection before starting treatment,
• if, while taking imatinib, you get bruises, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of damage to the blood vessels called thrombotic microangiopathy (TMA).

If any of these apply to you, tell your doctor before taking imatinib.

You may be more sensitive to the sun while taking imatinib. It is important that you cover the areas of your skin that are exposed to the sun and use high-protection sunscreen. These precautions also apply to children.

During treatment with imatinib, tell your doctor immediatelyif you gain weight very quickly. Imatinib can cause water retention in the body (severe fluid retention).

While taking imatinib, your doctor will regularly check if the medicine is working properly. You will also have regular blood tests and will be weighed regularly.

Children and adolescents

Imatinib is also a treatment for children with CML. There is no experience in children with CML under 2 years of age. Experience in children with Ph+ ALL is limited, and experience in children with MDS/MPD, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents taking imatinib may have slower than normal growth. The doctor will check growth during regular visits.

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 obtained without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may interfere with the effect of imatinib when taken together. They may increase or decrease the effect of imatinib, leading to an increased risk of side effects or making imatinib less effective. Imatinib may have the same effect on other medicines.

Tell your doctor if you are taking medicines that prevent blood clots from forming.

Pregnancy, breast-feeding, and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.
• The use of imatinib is not recommended during pregnancy unless clearly necessary, as it may harm your baby. Your doctor will discuss with you the potential risks of taking imatinib during pregnancy.
• Women who could become pregnant are advised to use an effective method of contraception during treatment and for 15 days after stopping treatment.
• Do not breast-feed while taking imatinib and for 15 days after stopping treatment, as it may harm your baby.
• Patients who are concerned about their fertility while taking imatinib should consult their doctor.

Driving and using machines

You may feel dizzy or drowsy or have blurred vision while taking this medicine. If this happens, do not drive or use tools or machines until you feel better.

3. How to take Imatinib Sandoz

Your doctor has prescribed imatinib for you because you have a serious disease. Imatinib can help you fight this disease.

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. It is important to do this for the entire time your doctor or pharmacist tells you. If you are unsure, ask your doctor or pharmacist again.

Do not stop taking imatinib unless your doctor tells you to. If you cannot take the medicine as your doctor has prescribed or think you no longer need it, contact your doctor immediately.

How much to take of Imatinib Sandoz

Use in adults

Your doctor will tell you exactly how many imatinib tablets to take.

• If you are being treated for CML:

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

• 400 mg, i.e., 4 tablets oncea day,
• 600 mg, i.e., 6 tablets oncea day.

• If you are being treated for GIST:

The starting dose is 400 mg, i.e., 4 tablets oncea day.

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

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg, i.e., 6 tablets oncea day.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg, i.e., 4 tablets oncea day.

• If you are being treated for HES/CEL:

The starting dose is 100 mg, i.e., 1 tablet oncea day. Your doctor may decide to increase the dose to 400 mg, i.e., 4 tablets oncea day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg a day (8 tablets), i.e., 4 tablets in the morning and 4 tablets in the evening.

Use in children and adolescents

• Your doctor will tell you how many imatinib tablets to give to the child. The amount of imatinib given will depend on the child's situation, body weight, and height. The total daily dose in children should not exceed 800 mg in CML and 600 mg in Ph+ ALL. The treatment can be given to the child once a day or, alternatively, the dose can be divided into two doses (half in the morning and half in the evening).

The film-coated tablet can be divided into equal doses.

When and how to take Imatinib Sandoz

• Take imatinib with food. This will help protect you from stomach problems when taking imatinib.
• Swallow the tablets whole with a large glass of water.

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

• Use approximately 50 ml for each 100 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Drink the entire contents of the glass immediately. There may be leftover tablet residue at the bottom of the glass.

How long to take Imatinib Sandoz

Continue taking imatinib every day for the entire time your doctor has told you.

If you take more Imatinib Sandoz than you should

If you accidentally take too many tablets, talk to your doctor immediately. You may need medical attention. Bring the medicine pack with you.

If you have taken more Imatinib Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Imatinib Sandoz

• if you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose,
• then continue with the normal schedule,
• do not take a double dose to make up for missed doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious. Inform your doctor immediately if you suffer from 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 may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or ulcers in the mouth. Imatinib may reduce the number of white blood cells in your blood, so you may suffer from infections more easily.
• Bleeding or bruising unexpectedly (when you have not suffered any injury).

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, with difficulty breathing or painful breathing (signs of lung problems).
• Feeling of dizziness, dizziness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, yellow skin or eyes (signs of liver problems).
• Rash, skin redness, with blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin spots, itching, burning sensation, rash with pustules (signs of skin problems).
• Painful red lumps on the skin, skin pain, skin redness (inflammation of the fatty tissue under the skin).
• Severe abdominal pain, blood in your vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in urine output, feeling of thirst (signs of kidney problems).
• Feeling of dizziness (nausea) with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of fatigue, and difficulty breathing, dark-colored urine (signs of low red blood cell count in the blood).
• Pain in the eyes or vision disorders, bleeding in the eyes.
• Pain in the bones or joints (signs of osteonecrosis),
• Blisters on the skin or mucous membranes (signs of pemphigus),
• Numbness or feeling of cold in the feet and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Muscle weakness and muscle spasms, with an altered heart rate (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, dark-colored urine, pain, or weakness in the muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling of dizziness or fainting due to low blood pressure (signs of problems in the ovaries or uterus).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint discomfort 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).

Frequency Not Known(cannot be estimated from the available data)

• Combination of a widespread rash, feeling of discomfort, fever, high levels of certain blood cells, or yellow skin or eyes (signs of jaundice) with difficulty breathing, chest pain, severely decreased urine output, and feeling of thirst, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection).

If you suffer from any of the above effects, inform your doctor immediately.

Other Adverse Effects May Include:

Very Common(may affect more than 1 in 10 people)

• Headache or feeling of fatigue.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the joints, muscles, or bones during treatment with imatinib or when stopping treatment.
• Inflammations such as swollen ankles or eyes.
• Weight gain.

If any of these affect you significantly, consult your doctor.

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

• Anorexia, weight loss, or altered sense of taste.
• Feeling of fatigue or weakness.
• Tearing of the eyes with itching, redness, and swelling (conjunctivitis), watery eyes, or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Hair loss or unusual hair loss.
• Numbness of the hands or feet.
• Ulcers in the mouth.
• Pain in the joints with swelling.
• Dry mouth, dry skin, or dry eyes.
• Hot flashes, chills, or night sweats.

If any of these affect you significantly, consult your doctor.

Uncommon(may affect up to 1 in 100 people)

• Cough, secretion, or blockage in the nose, feeling of heaviness or pain when pressing the area around the eyes or to the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing pain or a throbbing sensation, usually on one side of the head, and often accompanied by nausea, vomiting, and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (flu).
• Pain or burning sensation when urinating, fever, pain in the groin or pelvis, cloudy or reddish-brown urine (signs of urinary tract infection).
• Pain and swelling of the joints (signs of arthralgia).
• A constant feeling of thirst and loss of interest, which disrupts daily life (signs of depression).
• A feeling of apprehension and concern along with physical symptoms such as palpitations, sweating, tremors, dry mouth (signs of anxiety).
• Numbness/somnolence/excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory damage.
• Need to constantly 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 or gas.
• Lip inflammation.
• Increased sweating.
• Discoloration of the skin.
• Brittle nails.
• Reddish or pimple-like spots around the hair root, possibly with pain, itching, or burning sensation (signs of folliculitis, also called inflammation of the hair follicles).
• Skin rash with peeling or skin shedding (exfoliative dermatitis).
• Breast growth (can occur in men or women).
• Dull pain and/or feeling of heaviness in the testicles or under the groin, pain when urinating, having sex, or ejaculating, blood in the urine (signs of testicular edema).
• Inability to have or maintain an erection (erectile dysfunction).
• Intense or irregular menstrual periods.
• Pain in the nipples.
• General feeling of discomfort (general discomfort).
• Viral infections such as cold sores.
• Pain in the lower back due to a kidney disorder.
• 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 (signs of stomach ulcer).
• Stiffness in the joints or muscles.
• Abnormal laboratory test results.

Rare(may affect up to 1 in 1,000 patients)

• Confusion.
• Discoloration of the nails.

Frequency Not Known(cannot be estimated from the available data):

• Redness and/or swelling of the palms of the hands and the soles of the feet, which may be accompanied by a feeling of tingling and burning pain.
• Painful skin lesions and/or blisters.

If any of these affect you significantly, consult your doctor.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Imatinib Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the blister pack and carton after CAD/EXP. The expiration date is the last day of the month indicated.

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. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Sandoz

• The active ingredient is imatinib mesylate. Each tablet contains 100 mg of imatinib (as mesylate).
• The other excipients in the tablet core are microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate, and anhydrous colloidal silica.
• The other excipients in the tablet coating are red iron oxide (E172), yellow iron oxide (E172), macrogol 4000, talc, and hypromellose.

Appearance of the Product and Package Contents

Imatinib Sandoz 100 mg film-coated tablets are tablets with an approximate diameter of 9.2 mm, dark yellow to orange-brown in color, round, biconvex with beveled edges, marked with "NVR" on one face and a score line on the other face, and with "SA" on each side of the score line.

The tablets are packaged in PVC/Aluminum or PVC/PE/PVDC/Aluminum blisters within a cardboard box containing 20, 30, 50, 60, 80, 90, or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ul. 57

1526 Ljubljana

Slovenia

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg, Bayern

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Novartis Pharmaceutical

Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana,

Slovenia

Date of Last Revision of this Leaflet:August 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/