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Package Leaflet: Information for the Patient

Imatinib Normon 400 mg Film-Coated Tablets

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Imatinib Normon is and what it is used for

2. What you need to know before you start taking Imatinib Normon

3. How to take Imatinib Normon

4. Possible side effects

5. Storage of Imatinib Normon

6. Contents of the pack and additional information

Imatinib Normonis a medication that contains an active ingredient called imatinib. This medication acts by inhibiting the growth of abnormal cells in the diseases described below. These include some types of cancer.

Imatinib Normon is a treatment foradults and children for:

• Chronic Myeloid Leukemia (CML).CML is a cancer of the white blood cells. These white blood cells normally help the body fight infections. CML is a form of leukemia in which abnormal white blood cells (called myeloid cells) start to grow uncontrollably.

• Ph-positive Acute Lymphoblastic Leukemia (ALL Ph-positive). ALL is a cancer of the white blood cells. These white blood cells normally help the body fight infections. ALL is a form of leukemia in which abnormal white blood cells (called lymphoblasts) start to grow uncontrollably. Imatinib inhibits the growth of these cells.

Imatinib Normon is also a treatment for adults for:

• Myeloproliferative/Myelodysplastic Syndromes (MPN/ MDS).These are a group of blood disorders in which some blood cells start to grow uncontrollably. Imatinib Normon inhibits the growth of these cells in a certain subtype of these diseases.
• Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL). These are blood disorders in which some blood cells (called eosinophils) start to grow uncontrollably. Imatinib inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal Stromal Tumors (GIST). GIST is a cancer of the stomach and intestine. It originates from uncontrolled cellular 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 uncontrollably. Imatinib inhibits the growth of these cells.

In the rest of this prospectus, these abbreviations are used when referring to these diseases.

If you have any questions about how this medication works or why this medication has been prescribed to you, ask your doctor.

Only a doctor with experience in prescribing medications for treating blood cell cancers or solid tumors will prescribe this medication.

Follow your doctor's instructions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Normon:

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

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

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

Warnings and precautions

Consult your doctor before starting to take Imatinib Normon:

• if you have or have had any liver, kidney, or heart problems,
• if you are taking a medication containing levotiroxine because your thyroid gland has been removed,
• if you have ever had or may currently have a hepatitis B infection. This is because imatinib could make hepatitis B become active again, which can be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment,
• if while taking this medication you experience bruising, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of a condition called microangiopathic thrombosis (MAT).

If any of these cases apply to you, inform your doctor before taking Imatinib Normon.

You may become more sensitive to the sun while taking Imatinib Normon. It is essential to cover areas of skin exposed to the sun and use high-protection sunscreen. These precautions also apply to children.

Inform your doctor immediately if you experience rapid weight gain during treatment with this medication. Imatinib can cause severe fluid retention in the body.

While taking this medication, your doctor will regularly check if the medication is working.

You will also have regular blood tests and be weighed.

Children and adolescents

Imatinib Normon is also a treatment for children with LMC. There is no experience with children with LMC under 2 years of age. Experience with children with Ph-positive LLA is limited, and experience with SMD/SMP, DFSP, GIST, and SHE/LEC is very limited.

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

Other medications and Imatinib Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications (such as paracetamol) and herbal remedies (such as St. John's Wort). Some medications may interfere with the effect of imatinib when taken together. These may increase or decrease the effect of imatinib, leading to an increase in side effects or making this medication less effective. This medication may also affect other medications.

Inform your doctor if you are using medications that prevent blood clotting.

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 medication.
• It is not recommended to use imatinib during pregnancy except when clearly necessary, as it may harm your baby. Your doctor will discuss the possible risks of taking this medication during pregnancy with you.
• Women who may become pregnant are advised to use an effective contraceptive method during treatment and for 15 days after treatment has ended.
• Do not breastfeed your baby during treatment with imatinib or for 15 days after treatment has ended, as it may harm your baby.
• Patients concerned about their fertility while taking Imatinib Normon should consult their doctor.

Driving and operating machinery

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

Your doctor has prescribed Imatinib Normon because you have a serious disease. Imatinib Normon may help you fight this disease.

However, follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. It is essential that you do so for the time your doctor or pharmacist tells you. In case of doubt, consult your doctor or pharmacist again.

Do not stop taking this medication unless your doctor tells you to. If you cannot take the medication as prescribed by your doctor or think you no longer need to take it for a longer period, contact your doctor immediately.

How much Imatinib Normon to take

Use in adults

Your doctor will tell you exactly how many Imatinib Normon tablets you should take.

-If you are being treated for LMC:

Depending on your situation, the usual initial dose is400 mgor600 mg:

• 400 mg,that is, one tabletonceper day.
• 600 mg, that is, one tablet of 400 mg plus two tablets of 100 mgonceper day.

• If you are being treated for GIST:

The initial dose is400 mg, that is, one tabletonceper day.

For LMC 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 (2 tablets), take one tablet in the morning and one tablet in the evening.

-If you are being treated for LLA Ph-positive:

The initial dose is 600 mg, that is, one tablet of 400 mg plus two tablets of 100 mgonceper day.

-If you are being treated for SMD/SMP:

The initial dose is 400 mg, that is, one tabletonceper day.

-If you are being treated for SHE/LEC:

The initial dose is 100 mg, that is, one tablet of 100 mgonceper day. Your doctor may decide to increase the dose to 400 mg, which is taken in one tablet of 400 mgonceper day, depending on how you respond to treatment.

-If you are being treated for DFSP:

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

The dose of 400 mg can be taken either with one tablet of 400 mg or with four tablets of 100 mg.

The dose of 600 mg must be taken with one tablet of 400 mg and two tablets of 100 mg.

Use in children and adolescents

Your doctor will tell you how many Imatinib Normon tablets to administer to the child. The amount of Imatinib Normon administered will depend on the child's situation, weight, and height.

The total daily dose in children should not exceed 800 mg in LMC and 600 mg in LLA Ph+.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).

When and how to take Imatinib Normon

-Take Imatinib Normon with food.This will help protect you from stomach problems when taking this medication.

-Swallow the tablets with a large glass of water.

The tablet can be split into equal doses.

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

•Use approximately 200 ml for each 400 mg tablet

•Stir until the tablets have completely dissolved

•Once the tablet has dissolved, drink the contents of the glass immediately. There may be remaining tablet residue at the bottom of the glass.

For how long to take Imatinib Normon

Continue taking this medication every day for the time your doctor tells you.

If you take more Imatinib Normon than you should

If you accidentally take too many tablets, talk to your doctor immediately.

You may need medical attention. Bring the medication packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Imatinib Normon

-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 compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These are usually 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 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 mouth ulcers. Imatinib may reduce the number of white blood cells in your blood, making you more susceptible to infections.
• Bleeding or unexpected bruising (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 heart rhythm (signs of heart problems).
• Cough, difficulty breathing, or painful breathing (signs of lung problems).
• Dizziness, lightheadedness, or fainting (signs of low blood pressure).
• Nausea, loss of appetite, dark urine, yellow skin or eyes (signs of liver problems).
• Rash, skin redness, blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin patches, itching, burning sensation, rash with pustules (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stool, or urine, black stool (signs of gastrointestinal problems).
• Significant decrease in urine output, feeling thirsty (signs of kidney problems).
• Nausea, 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 brain or skull).
• Pale skin, feeling tired, and difficulty breathing, dark urine (signs of low red blood cell count).
• Eye pain or vision problems, bleeding in the eyes.
• Hip pain or difficulty walking.
• Numbness or feeling of coldness in the feet and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and muscle spasms, abnormal heart rhythm (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, urine of a reddish-brown color, 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 ovarian or uterine problems).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal laboratory test results (e.g., elevated potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
• Clots in small blood vessels (microangiopathic thrombosis).
• Painful red bumps on the skin, skin pain, skin redness (inflammation of the fatty tissue under the skin).

Unknown frequency(cannot be estimated from available data):

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

If you experience any of the above changes,inform your doctor immediately.

Other side 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 the muscles, joints, or bones during treatment with imatinib or after stopping treatment.
• Inflammations 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):

• Loss of appetite, weight loss, or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Excessive tearing of the eyes with itching, redness, and swelling (conjunctivitis), watery eyes, or blurred vision.
• Nasal bleeding.
• Abdominal pain, bloating, heartburn, or constipation.
• Itching.
• Unusual hair loss or weakness.
• Numbness of the hands or feet.
• Mouth ulcers.
• Pain or swelling in the joints.
• 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,inform your doctor.

Unknown frequency(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 sensation.
• Painful skin lesions or blisters.
• Delayed growth in children and adolescents.

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

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the boxafter CAD. The expiration date is the last day of the month indicated.

Aluminum/Aluminum-polyamide-PVC: This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Aluminum/PVDC-PE: Store at a temperature below 30°C.

Store in the original packaging to protect it from moisture.

Aluminum/PVC-PVDC: This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

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

Medications should not be disposed of through drains or trash. Deposit the packaging and medications that you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Imatinib Normon

• The active ingredient is imatinib. Each Imatinib Normon tablet contains 400 mg of imatinib (as mesylate).
• The other components are crospovidone, hydroxypropylmethylcellulose, magnesium stearate, and colloidal silica.
• The tablet coating is formed by red iron oxide (E172), yellow iron oxide (E172), macrogol 6000, talc, and hydroxypropylmethylcellulose.

Appearance of the product and content of the packaging

Imatinib Normon 400 mg film-coated tablets are orange-brown, elongated, biconvex, and scored tablets.

They are presented in packaging containing 10, 30, or 90 film-coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Imatinib Normon 400 mg film-coated tablets EFG

Portugal: Imatinib Normon 400 mg film-coated tablets

Last review date of this leaflet: May 2022

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