Imatinib Normon 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Imatinib Normon 100 mg film-coated tablets EFG

Read the entire 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 adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Imatinib Normon is a medicine containing 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 Normon 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 fight infections. Chronic myeloid leukaemia is a form of leukaemia in which abnormal white blood 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 blood cells normally help the body fight infections. Acute lymphoblastic leukaemia is a form of leukaemia in which abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib inhibits the growth of these cells.

Imatinib Normon is also a treatment for adults for:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood disorders 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 disorders 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 this medicine works or why this medicine has been prescribed for you, ask your doctor.

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

This medicine will only be prescribed by a doctor experienced in the use of medicines for treating 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 Normon:

• 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 this medicine.

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

Warnings and precautions

Talk to your doctor before starting to take this medicine:

• if you have or have had any liver, kidney, or heart problems,
• if you are taking a medicine containing levothyroxine because your thyroid gland has been removed,
• if you have ever had or may currently have an infection with hepatitis B virus. This is because imatinib could cause hepatitis B to become active again, which may be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment.
• if you develop bruising, bleeding, fever, fatigue, or confusion while taking this medicine, 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 Normon.

You may become more sensitive to sunlight while taking Imatinib Normon. 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 this medicine, inform your doctor immediately if you gain weight very rapidly. Imatinib may cause fluid retention in the body (serious fluid retention).

While taking this medicine, your doctor will regularly monitor whether 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. Experience in children with Ph-positive 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. Your doctor will monitor growth during periodic visits.

Other medicines and Imatinib Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 side effects or making this medicine less effective. This medicine may also affect the action of other medicines.

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

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.
• Use of imatinib during pregnancy is not recommended 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 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 fertility while taking Imatinib Normon 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 Normon

Your doctor has prescribed Imatinib Normon because you suffer from a serious illness. Imatinib Normon can help you fight this disease.

However, follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. It is important that you do so for the length of time specified by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not stop taking this medicine unless instructed by your doctor. If you are unable to take the medicine as prescribed by your doctor or think you no longer need to take it, 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 CML:

Depending on your condition, the normal starting dose is 400 mg or 600 mg:

• 400 mg, i.e. 4 tablets once daily.

• 600 mg, i.e. 6 tablets once daily.

• If you are being treated for GIST:

The initial dose is 400 mg, i.e. 4 tablets once daily.

For both 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 (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

• If you are being treated for Ph+ ALL:

The initial dose is 600 mg, i.e. 6 tablets once daily.

• If you are being treated for MDS/MPD:

The initial dose is 400 mg, i.e. 4 tablets once daily.

• If you are being treated for HES/CEL:

The initial dose is 100 mg, i.e. 1 tablet once daily. Your doctor may decide to increase the dose to 400 mg, taken as 4 tablets once daily, depending on your response to treatment.

• If you are being treated for DFSP:

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

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

The 600 mg dose should 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 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 to the child once daily or, alternatively, the dose may 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 may be divided into equal doses.

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

• Use approximately 50 mL for each 100 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink the entire contents of the glass immediately. There may be residue from the dissolved tablet at the bottom of the glass.

How long to take Imatinib Normon

Continue taking this medicine every day for as long as your doctor tells you.

If you take more Imatinib Normon 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine 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 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 missed doses.

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. These are usually mild to moderate.

Some adverse effects may 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 may 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 the 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, loss of appetite, dark-colored urine, yellowing of the skin or eyes (signs of liver problems).
• Rash, redness of the skin, with 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).
• Severe abdominal pain, blood in vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Markedly reduced urine output, feeling thirsty (signs of kidney problems).
• Nausea, with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness or paralysis in 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 levels in the blood).
• Eye pain or vision disturbances, bleeding in the eyes.
• Hip pain or difficulty walking.
• Numbness or cold sensation in 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 abnormal 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, feeling dizzy 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).
• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue beneath the skin).

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

• Combination of widespread rash, feeling unwell, fever, elevated levels of certain white blood cells or yellowing of the skin or eyes (jaundice) with difficulty breathing, chest pain/discomfort, severely reduced urine output, and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
  • Chronic kidney failure.
  • 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, inform 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, inform your doctor.

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

• Loss of appetite, weight loss, or altered taste sensation.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Watery, itchy, red, and swollen eyes (conjunctivitis), watery eyes, or blurred vision.
• 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, inform your doctor.

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 or burning pain.
• Painful and/or blistering skin lesions.
• Growth delay in children and adolescents.

If any of these affect you significantly, inform 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton after EXP. The expiry 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 from moisture.

Aluminum/PVDC-PE: Store below 30°C.

Store in the original packaging to protect from moisture.

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

Store in the original packaging to protect from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Imatinib Normon

• The active substance is imatinib. Each Imatinib Normon tablet contains 100 mg of imatinib (as mesilate).
• The other components are crospovidone, hypromellose, magnesium stearate and colloidal silicon dioxide.
• The tablet coating consists of iron oxide red (E172), iron oxide yellow (E172), macrogol 6000, talc and hypromellose.

Appearance of the product and contents of the pack

Imatinib Normon 100 mg film-coated tablets are orange-brown, round, biconvex and scored tablets.

They are available in packs containing 20, 60, 120 or 180 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Imatinib Normon 100 mg film-coated tablets EFG

Portugal: Imatinib Normon 100 mg film-coated tablets

Date of the most recent revision of this leaflet: May 2022

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