IMATINIB NORMON 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Imatinib Normon 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 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 Normon and what is it used for
2. What you need to know before you take Imatinib Normon
3. How to take Imatinib Normon
4. Possible side effects
5. Storage of Imatinib Normon
6. Contents of the pack and other information

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

Imatinib Normon 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 Normon is a treatment foradults and children for:

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

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

Imatinib Normon is also a treatment for adults for:

• Mycloproliferative/myelodysplastic syndromes (MPS/MDS).These are a group of blood diseases in which some blood cells start to grow out of control. 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 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 tumors (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 are used when referring to these diseases.

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

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

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

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

Do not take Imatinib Normon:

• 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 takethis medicine.

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

Warnings and precautions

Talk to your doctor before starting Imatinib Normon:

• if you have or have had any liver, kidney, or heart problems,
• if you are taking a medicine that contains levotiroxine because you have had your thyroid gland removed,
• if you have ever had or may 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 should carefully check for signs of this infection before starting treatment,
• if while taking this medicine you experience bruising, bleeding, fever, fatigue, and 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 Normon.

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

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

While taking this medicine, 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 Normon is also a treatment for children with CML. There is no experience in children with CML under 2 years of age. The experience in children with Ph+ ALL is limited, and the experience in children with MPS/MDS, 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 Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought 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 this medicine less effective. This medicine may have the same effect on other medicines.

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

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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 this medicine during pregnancy.
• Women who could become pregnant are advised to use an effective method of contraception during treatment and for 15 days after finishing treatment.
• Do not breastfeed while taking imatinib and for 15 days after finishing treatment, as it may harm your baby.
• Patients who are concerned about their fertility while taking Imatinib Normon should consult their doctor.

Driving and using machines

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

3. How to take Imatinib Normon

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

However, follow your doctor's or pharmacist's instructions exactly. It is important that you do this for the time your doctor or pharmacist tells you. If you are unsure, ask your doctor or pharmacist again.

Do not stop taking this medicine 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 Normon

Adult use

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

• If you are being treated for CML:

Depending on your situation, the initial dose is usually 400 mgor 600 mg:

• 400 mg,which is one tablet oncea day.
• 600 mg, which is one 400 mg tablet plus two 100 mg tablets oncea day.

• If you are being treated for GIST:

The initial dose is 400 mg, which is one tablet 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 (2 tablets), take one tablet in the morning and one tablet in the evening.

• If you are being treated for Ph+ ALL:

The initial dose is 600 mg, which is one 400 mg tablet plus two 100 mg tablets oncea day.

• If you are being treated for MPS/MDS:

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

• If you are being treated for HES/CEL:

The initial 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 mga day (2 tablets), taken as one tablet in the morning and one tablet in the evening.

A dose of 400 mgcan be taken as either one 400 mg tablet or four 100 mg tablets.

A dose of 600 mgshould be taken as one 400 mg tablet and two 100 mg tablets.

Use in children and adolescents

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

The total daily dose in children should not exceed 800 mgin CML and 600 mgin 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).

When and how to take Imatinib Normon

• Take Imatinib Normon with food. This will help protect you from stomach problems when taking this medicine.
• Swallow the tablets with a large glass of water.

The tablet can be divided into equal doses.

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

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

How long to take Imatinib Normon

Continue taking this medicine 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. Take the medicine pack with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

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 your 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. 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 frequent(may affect more than 1 in 10 patients) or frequent(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).
• Dizziness, dizziness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, yellowish 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).
• 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 nervous system problems, 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).
• Eyepain or vision disorders, bleeding in the eyes.
• Hip pain 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, 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, tiredness, and/or joint pain 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).
• Painful red lumps on the skin, skin pain, skin redness (inflammation of the fatty tissue under the skin).

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

• Combination of widespread generalized rash, feeling of discomfort, fever, high levels of certain white blood cells, or yellowish skin and eyes (signs of jaundice) with difficulty breathing, chest pain, severely decreased urine production, and feeling of thirst, etc. (signs of a treatment-related allergic reaction).
• 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 frequent(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 during treatment with imatinib or when interrupting treatment.
• Inflammations such as swollen ankles or eyes.
• Weight gain.

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

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

• Anorexia, weight loss, or altered sense of taste.
• Feeling of tiredness or weakness.
• Difficulty sleeping (insomnia).
• 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.
• 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, inform your doctor.

Frequency not known(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 a tingling sensation and burning pain.
• Painful skin lesions and/or blisters.
• Delayed growth in children and adolescents.

If any of these affect you significantly, inform 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 prospectus. 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 Normon

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

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

Aluminum/Aluminum-polyamide-PVC: This medicine 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 medicine 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 tampering.

Medicines should not be thrown away through the sewers or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Normon

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

Appearance of the Product and Package Contents

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

They are available in packages containing 10, 30, or 90 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and 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 under the following names:

Spain: Imatinib Normon 400 mg film-coated tablets EFG

Portugal: Imatinib Normon 400 mg film-coated tablets

Date of the Last Revision of this Prospectus: 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/