Package Insert: Information for the Patient

Imatinib Cipla 100 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Imatinib Cipla

4. Possible adverse effects

5. Storage of Imatinib Cipla

6. Contents of the package and additional information

Imatinib Cipla is a medication that contains an active ingredient called imatinib. This medication acts by inhibiting the growth of abnormal cells in the following diseases, which include some types of cancer.

Imatinib is a treatment for adults 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 form of leukemia in which abnormal white blood cells (called myeloid cells) start to grow uncontrollably.

-Acute Lymphoblastic Leukemia with Philadelphia chromosome positive (ALL Ph-positive). Leukemia is a cancer of the white blood cells. These white blood cells normally help the body fight infections. Acute lymphoblastic leukemia 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 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 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 an uncontrolled growth of the supporting tissue 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 imatinib works, or why this medication has been prescribed to you, ask your doctor.

Only a doctor with experience in cancer medications for blood cell cancers or solid tumors will prescribe imatinib.

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

Do not take Imatinib Cipla:

- 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 Imatinib Cipla.

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 Cipla:

- if you have or have had any liver, kidney, or heart problems.

- if you are taking a medication that contains levotiroxine because your thyroid gland has been removed.

- If you have or have had hepatitis B infection at any time. This is because imatinib can cause hepatitis B to reappear, and this can be fatal in some cases. Patients should be carefully examined by their doctor to detect signs of infection before starting treatment.

- If while taking Imatinib Cipla you experience bruising, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of blood vessel damage called microangiopathic thrombosis (MAT).

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

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

Inform your doctor immediately during imatinib treatmentif you gain weight very quickly. Imatinib can cause severe fluid retention in the body.

While taking imatinib, your doctor will regularly check if the medication is working. Blood tests and regular weighing will also be performed.

Children and adolescents

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

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

Other medications and Imatinib Cipla

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including over-the-counter medications (such as paracetamol) and herbal medications (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 imatinib less effective. Imatinib may also produce the same effect on other medications.

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

Pregnancy, breastfeeding, and fertility

-If you are pregnant or breastfeeding, or 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 imatinib 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 imatinib treatment or for 15 days after treatment has ended, as it may harm your baby.

- Patients concerned about their fertility while taking imatinib 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 again.

Imatinib Cipla contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free."

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

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

Do not stop taking imatinib 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.

What amount to take of Imatinib Cipla

The recommended doses are:

Use in adults

Your doctor will tell you exactly how many capsules of imatinib you should take.

-If you are being treated for LMC:

Depending on your situation, the initial normal dose is 400 or 600 mg:

-400 mg, that is 4 capsulesonce a day.

-600 mg, that is 6 capsulesonce a day.

-If you are being treated for GIST:

The initial dose is 400 mg, that is 4 capsulesonce a day.

Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

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

The initial dose is 600 mg, that is 6 capsulesoncea day.

-If you are being treated for SMD/SMP:

The initial dose is 400 mg, that is 4 capsulesoncea day.

-If you are being treated for SHE/LEC:The initial dose is 100 mg, that is 1 capsule of 100 mgoncea day. Your doctor may decide to increase the dose to 400 mg, that is 4 capsulesoncea day, depending on how you respond to treatment.

-If you are being treated for DFSP:

The dose is 800 mg per day (8 capsules), that is 4 capsules in the morning and 4 capsules in the evening.

Use in children and adolescents

Your doctor will tell you how many capsules of imatinib to administer to the child. The amount of imatinib 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+. 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 Cipla

-Take imatinib with food.This will help protect you from stomach problems when taking imatinib capsules.

-Swallow the capsules with a large glass of water.Do not open or crush the capsules unless you have difficulty swallowing them (for example, in children).

- If you are unable to swallow the capsules, you can open them and pour the powder into a glass of water or apple juice.

- If you are a pregnant woman or may become pregnant and try to open the capsules, you should handle the contents with caution to avoid contact with the skin and eyes or inhalation. You should wash your hands immediately after opening the capsules.

For how long to take Imatinib Cipla

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

If you take more Imatinib Cipla than you should

If you have accidentally taken too many capsules, talk to your doctorimmediately. 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: 915620420, indicating the medication and the amount ingested.

If you forgot to take Imatinib Cipla

- 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 one you forgot.

- Then continue with the normal schedule.

- Do not take a double dose to compensate for the missed doses.

If you have any other doubts 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 can cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib can reduce the number of white blood cells in your blood, making you more susceptible to infections.
• Bleeding or unexpected bruising (when you have not had 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, dizziness, 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, pustular rash (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, 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, difficulty breathing, dark urine (signs of low red blood cell count).
• Eye pain or vision problems, bleeding in the eyes.
• Painin the bones or joints (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or feeling of coldness in the feet and toes (signs of Raynaud's syndrome).
• Swelling and redness of the skin (signs of cellulitis).
• Difficulty hearing.
• Weakness and muscle spasms, abnormal heart rhythm (signs of changes in potassium levels in the blood).
• Brusing.
• Abdominal pain with nausea.
• Muscle spasms with fever, urine that is reddish-brown, 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, or joint pain associated with abnormal laboratory test results (e.g., elevated or low potassium, high uric acid and calcium, and low phosphorus levels in the blood).
• Clots in small blood vessels (microangiopathic thrombosis).

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

• Combination of widespread rash, feeling unwell, fever, elevated levels of certain blood cells or yellow skin or eyes (signs of jaundice) with difficulty breathing, chest pain, decreased urine output, and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney disease
• Inflammation of the sac that surrounds the heart. It may manifest as chest pain that varies with each breath. The pain often increases when lying down and decreases when sitting up. It is often accompanied by fever, cough, and palpitations. It can be serious and require medical intervention (pericarditis).
• Cardiac tamponade caused by the accumulation of blood, fluid, pus, blood, or gas in the pericardial space, resulting in reduced ventricular filling and subsequent hemodynamic problems. Cardiac tamponade is a medical emergency,
• Widespread skin peeling (toxic epidermal necrolysis) or generalized redness with liver, blood, and other organ involvement (adverse reaction with eosinophilia and systemic symptoms).
• Reactivation of hepatitis B infection if you had hepatitis B in the past (a liver infection).
• Bleeding in the vitreous body (vitreous hemorrhage)
• Clot in a blood vessel, usually in a leg, causing pain, swelling, or redness (thrombosis)
• Acute respiratory failure that occurs when the respiratory system does not adequately oxygenate (acute respiratory failure).
• Pulmonary interstitial disease, which can cause shortness of breath and difficulty breathing (pulmonary interstitial disease).
• Gastrointestinal bleeding (antral gastric vascular ectasia (EGVA).

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

Other side effects may include:

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

• Headache or feeling tired
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the muscles, joints, or bones, during treatment with Imatinib capsules or after stopping Imatinib capsules.
• 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 patients):

• 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 in the hands or feet.
• Mouth ulcers.
• Joint pain 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.

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

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

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

If any of these affect you significantly,consult 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 and burning sensation.
• Painful or blistering skin lesions
• Delayed growth in children and adolescents.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse reactions, 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 box and blister after CAD. The expiration date is the last day of the month indicated.

?Do not store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

?Do not use this medication if you observe that it is damaged or shows signs of manipulation.

?Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at the Sigre Point of the pharmacy or in any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Imatinib Cipla

- The active ingredient is imatinib. Each capsule of Imatinib Cipla contains 100 mg of imatinib (as mesylate).

- The other components are anhydrous lactose, crospovidone (type B), anhydrous colloidal silica, and magnesium stearate.

- The capsule coating is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and sodium lauryl sulfate

Appearance of the product and contents of the package

The Imatinib Cipla 100 mg capsules contain yellow granules and are hard gelatin capsules of size “3” with a brown cap and a white body.

The capsule size is 15.8mm

It is packaged in a PVC/PE/PVDC-aluminum blister

It is supplied in sizes of 20, 60, 120, and 180 capsules

Only some package sizes may be commercially available

Holder of the marketing authorization and responsible manufacturer.

Holder of the marketing authorization:

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Responsible manufacturer:

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Local representative:

Cipla Europe NV subsidiary in Spain

C/Guzmán el Bueno, 133 Edif Britannia

28003 Madrid, Spain

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

Last review date of this leaflet:January 2025

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