IMATINIB KERN PHARMA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Imatinib Kern Pharma 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, 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 signs of illness are the same as yours.
• If you get 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 Kern Pharma and what is it used for
2. What you need to know before you take Imatinib Kern Pharma
3. How to take Imatinib Kern Pharma
4. Possible side effects

5 Storage of Imatinib Kern Pharma

1. Contents of the pack and other information

1. What is Imatinib Kern Pharma and what is it used for

Imatinib Kern Pharma 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.

In adult patients, Imatinib Kern Pharma is used to treat a late stage of chronic myeloid leukaemia called “blast crisis”. However, in children and adolescents, it can be used to treat all stages of the disease.

• 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 some 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:

• Mycloproliferative or myelodysplastic syndromes (MDS/MPD). These are a group of diseases of the blood 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 diseases of the blood 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.

• 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.

For 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 it has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Kern Pharma

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

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

Do not take this medicine:

• 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 this medicine.

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

Warnings and precautions

Consult your doctor before taking imatinib:

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

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

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

While taking imatinib, your doctor will regularly check if the medicine is working. 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+ ALL is limited, and experience in children with MDS/MPD, DFSP, and HES/CEL is very limited.

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

Using Imatinib Kern Pharma with other medicines

Tell your doctor or pharmacist that 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 this medicine, 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.

Pregnancy, breastfeeding, and fertility

• 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.
• Do not breastfeed while taking imatinib.
• Patient concerns about fertility while taking imatinib should be discussed with 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 any tools or machines until you feel better.

Imatinib Kern Pharma contains glucose

This medicine contains glucose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Imatinib Kern Pharma

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

However, follow your doctor’s or pharmacist’s instructions exactly. It is important to do this for as long as your doctor or pharmacist tells you. If you are in doubt, 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

Use in adults

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

• If you are being treated for CML:

The usual starting dose is 600 mg, which is 1 tablet of 400 mg plus 2 tablets of 100 mg oncea day.

Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg (2 tablets), take one tablet in the morning and a second tablet in the evening.

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg, which is one 400 mg tablet plus 2 tablets of 100 mg oncea day.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg, which is one tablet oncea day.

• If you are being treated for HES/CEL:

The starting dose is 100 mg, which is one 100 mg tablet oncea day. Your doctor may decide to increase the dose to 400 mg, which is one 400 mg tablet oncea day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg a day (2 tablets), which is one tablet in the morning and one tablet 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 condition, body weight, and height. The total daily dose in children should not exceed 800 mg in CML and 600 mg in Ph+ ALL. 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).

When and how to take imatinib

• Take imatinib with food. This will help protect you from stomach problems when taking imatinib.
• Swallow the tablets 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 200 ml for each 400 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Drink the whole contents of the glass immediately. There may be some residue left in the glass.

The tablet can be divided into equal doses.

How long to take Imatinib

Keep taking imatinib every day for as long as your doctor tells you.

If you take more Imatinib Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 915620420, stating the medicine and the amount taken.

If you forget to take Imatinib Kern Pharma

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

If you have any further questions on the use of this product, 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. These are usually mild to moderate.

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 patients) or Common(may affect up to 1 in 10 patients):

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

• 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 elimination, 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 problems in the nervous system, such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of tiredness, 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 hip or difficulty walking.
• 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).
• Hearing difficulties.
• Muscle weakness and muscle spasms, with an abnormal heartbeat (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, reddish-brown 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, tiredness, 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 widespread rash, feeling of discomfort, fever, high levels of certain blood cells, or yellow skin and eyes (signs of jaundice) with difficulty breathing, chest pain/discomfort, severely decreased urine production, 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 alterations, inform your doctor immediately.

Other Adverse Effects May Include:

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

• Headache or feeling of tiredness.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the joints, muscles, or bones.
• Swelling such as swollen ankles or eyes.
• Weight gain.

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

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

• Anorexia, weight loss, or altered sense of taste.
• Feeling of tiredness or weakness.
• Difficulty sleeping (insomnia).
• Watery eyes with itching, redness, and swelling (conjunctivitis), tearful eyes, or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Weakness 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.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

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

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 tingling sensation and burning pain.
• Delayed growth in children and adolescents.

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 or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Imatinib Kern Pharma

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

Do not store above 30°C.

Do not use this medicine after the expiry date that appears on the packaging after "CAD". The expiry date is the last day of the month indicated.

Do not use any packaging if you notice that it is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Kern Pharma

• The active ingredient is imatinib mesylate. Each tablet contains 400 mg of imatinib (as mesylate).
• The other ingredients (excipients) are: hydrated dextrates (containing glucose), crospovidone, magnesium stearate, partially hydrolyzed polyvinyl alcohol, macrogol 4000, talc (E-553b), titanium dioxide (E-171), yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Coated tablets, dark yellow to brown-orange in color, oblong, and scored on both sides. The tablet can be divided into two equal halves. Each package contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Leaflet: May 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/