Imatinib Sandoz 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Imatinib Sandoz 400 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. 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 an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases described below. These include certain 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 cells normally help the body fight infections. Chronic myeloid leukaemia is a form of leukaemia in which abnormal white cells (called myeloid cells) begin to grow uncontrollably.

• Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. These white cells normally help the body fight infections. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (called lymphoblasts) begin to grow uncontrollably. 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 certain blood cells begin to grow uncontrollably. Imatinib inhibits the growth of these cells in a specific subtype of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib inhibits the growth of these cells in a specific subtype of these diseases.
• Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and intestine. It arises from uncontrolled cell growth in the supportive tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which certain cells begin to grow uncontrollably. Imatinib inhibits the growth of these cells.

In the remainder of this leaflet, these abbreviations are used when referring to these diseases.

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

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

Imatinib will only be prescribed by a doctor experienced in using medicines to treat blood cell cancers or solid tumors.

Carefully follow all instructions from 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 to any of the other ingredients of this medicine (listed in section 6).

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

If you think you may be allergic but are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take Imatinib Sandoz:

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

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

You may become more sensitive to sunlight while taking imatinib. It is important to cover skin areas exposed to sunlight and to use high-protection sunscreen. These precautions also apply to children.

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

While you are taking imatinib, your doctor will regularly monitor whether the medicine is working properly. You will also have regular blood tests and 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-positive ALL is limited, and experience in children with MDS/MPN, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents taking imatinib may experience slower than normal growth. Your doctor will monitor growth during periodic visits.

Other medicines and Imatinib Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription (such as paracetamol) and even herbal medicines (such as St. John’s wort). Some medicines may interfere with the effect of imatinib when taken together. These may increase or decrease the effect of imatinib, leading to an increase in adverse effects or making imatinib less effective. Imatinib may also affect other medicines in the same way.

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

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• 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 breastfeed during treatment with imatinib and for 15 days after stopping treatment, as it may harm your baby.
• Patients concerned about their fertility while taking imatinib should discuss this with their doctor.

Driving and using machines

You may experience dizziness, drowsiness, or blurred vision while taking this medicine. If you experience these symptoms, do not drive or operate tools or machinery until you feel well again.

3. How to take Imatinib Sandoz

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

Follow exactly the instructions given by your doctor or pharmacist on how to take this medicine. It is important that you continue taking it for the length of time prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not stop taking imatinib unless your doctor tells you to. If you are unable to take the medicine as prescribed or think you no longer need to continue taking 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 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, i.e. one tablet once daily,

• 600 mg, i.e. one 400 mg tablet plus half a 400 mg tablet (or 2 tablets of 100 mg) once daily.

• If you are being treated for GIST:

The starting dose is 400 mg, i.e. one tablet once daily.

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

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg, i.e. one 400 mg tablet plus half a 400 mg tablet (or 2 tablets of 100 mg) once daily.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg, i.e. one tablet once daily.

• If you are being treated for HES/CEL:

The starting dose is 100 mg, i.e. one 100 mg tablet once daily. Your doctor may decide to increase the dose to 400 mg, i.e. one 400 mg tablet once daily, depending on your response to treatment.

• If you are being treated for DFSP:

The dose is 800 mg per day (2 tablets), i.e. one tablet in the morning and one tablet in the evening.

Use in children and adolescents

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

The film-coated tablet may 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 may dissolve them in a glass of still water or apple juice:

• Use approximately 200 ml for each 400 mg tablet or approximately 100 ml for each half 400 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• Once the tablet has dissolved, drink the entire contents of the glass immediately. There may be residue of the dissolved tablet at the bottom of the glass.

How long to take Imatinib Sandoz

Continue taking imatinib every day for as long as your doctor has instructed.

If you take more Imatinib Sandoz than you should

If you have accidentally taken too many tablets, speak to your doctor immediately. You may require medical attention. Bring the medicine packaging with you.

If you have taken more Imatinib Sandoz than prescribed, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 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 your next dose, do not take the missed dose,
• Then continue with your regular dosing schedule,
• Do not take a double dose to make up for a missed dose.

If you have any further 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 everyone will experience them.

Some adverse effects can be serious. Immediately inform your doctor 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 can cause your body to retain fluid (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib may reduce the number of white blood cells in your blood, so you may be more prone to infections.
• Unexpected bleeding or bruising (when you have not sustained an 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).
• Dizziness, lightheadedness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, yellowing of the skin or eyes (signs of liver problems).
• Rash, redness of the skin, blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin spots, itching, burning sensation, pustular rash (signs of skin problems).
• 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 your vomit, stools, or urine, black stools (signs of gastrointestinal disturbances).
• Markedly reduced urine output, feeling of thirst (signs of kidney problems).
• 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 tired, and difficulty breathing, dark-colored urine (signs of low red blood cell count).
• Eye pain or vision disturbances, bleeding in the eyes.
• Bone or joint pain (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or cold sensation in the feet and fingers (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and muscle spasms, with an irregular heartbeat (signs of changes in blood potassium levels).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, red-brown urine, muscle pain or weakness (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, unexpected vaginal bleeding, 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., elevated 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 available data):

• Combination of widespread rash, feeling unwell, fever, elevated levels of certain blood cells or yellowing of the skin or eyes (jaundice), difficulty breathing, chest pain/discomfort, severely reduced urine output, and feeling thirsty, 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 experience any of the above, contact your doctor immediately.

Other adverse effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in joints, muscles, or bones during treatment with imatinib or when stopping treatment.
• Swelling 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):

• Loss of appetite, weight loss or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Watery, itchy, red, and swollen eyes, watery eyes, or blurred vision (conjunctivitis).
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Unusual hair thinning or hair loss.
• Numbness in 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 these affect you significantly, consult your doctor.

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

• Cough, runny or stuffy nose, feeling of heaviness or pain when pressing the area around the eyes or sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, such as a stabbing pain or pulsating 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 in the joints (signs of arthralgia).
• Persistent feeling of sadness and loss of interest, interfering with normal daily life (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Numbness/drowsiness/excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory impairment.
• An irresistible urge to keep moving the legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in the ears not originating from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Swelling of the lips.
• Difficulty swallowing.
• Increased sweating.
• Skin discoloration.
• Brittle nails.
• Red bumps or pimples around the hair roots, possibly with pain, itching, or burning sensation (signs of inflammation of hair follicles, also called folliculitis).
• Skin rash with skin peeling or shedding (exfoliative dermatitis).
• Breast enlargement (can occur in men or women).
• Dull and/or heavy sensation in the testicles or lower abdomen, pain when urinating, during sexual intercourse, or ejaculation, blood in the urine (signs of testicular edema).
• 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 infections such as cold sores.
• Lower back pain 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 joints or muscles.
• Abnormal laboratory test results.

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

• Confusion.
• Discoloration of the nails.

Frequency not known (cannot be estimated from available data):

• Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and burning pain.
• Painful and/or blistering skin lesions.
• Growth delay in children and adolescents.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister and outer carton following CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Any unused medicines and their containers should be handed over to your local pharmacy’s SIGRE Point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Imatinib Sandoz

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

Appearance of the product and contents of the pack

Imatinib Sandoz 400 mg film-coated tablets are approximately 19.2 mm long and 7.7 mm wide, very dark yellow to brownish-orange in colour, oval-shaped, biconvex tablets with bevelled edges, marked with “400” on one side and a score line on the other side, with “SL” on each side of the score line.

The tablets are packed in PVC/PE/PVDC/Aluminium blisters, contained in a cardboard box with 10, 30, 50, 60, 80 or 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 Nuremberg, Bavaria

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 the most recent revision of this leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/