IMATINIB CIPLA 100 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Imatinib Cipla 100 mg hard capsules 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 Cipla and what is it used for
2. What you need to know before you take Imatinib Cipla
3. How to take Imatinib Cipla
4. Possible side effects
5. Storage of Imatinib Cipla
6. Contents of the pack and other information

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

Imatinib Cipla 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 is a treatment for adults and children for:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of 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.

• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of 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 disorders (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.

• Gastrointestinal stromal tumours (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 will be used when referring to these diseases.

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

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

Imatinib will only be prescribed by a doctor with experience in medicines to treat 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 Imatinib Cipla:

• 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 Imatinib Cipla.

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

Warnings and precautions

Tell your doctor before you take Imatinib Cipla:

• 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 or have had hepatitis B infection. This is because imatinib may cause hepatitis B to come back again, and this can be fatal in some cases. Patients must be carefully checked by their doctor for signs of infection before starting treatment.

If while taking Imatinib Cipla you get bruises, 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.

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

Tell your doctor immediatelyif you gain weight very quickly while taking imatinib. 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 MPD, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents taking imatinib may grow more slowly than normal. The doctor will check growth at regular visits.

Other medicines and Imatinib Cipla

Tell your doctor or pharmacist if 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.

These may increase or decrease the effect of imatinib, 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 from forming.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.
• 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 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 concerned about their fertility while taking imatinib should consult 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 tools or machines until you feel better.

Imatinib Cipla contains lactose and sodium

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

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

3. How to take Imatinib Cipla

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

However, follow your doctor's or pharmacist's instructions exactly as they tell you. It is important that you do this for the time they tell 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 do not need it anymore, contact your doctor immediately.

How much to take of Imatinib Cipla

Recommended doses are:

Adult use

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

• If you are being treated for CML:

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

• 400 mg, i.e., 4 capsules once a day.
• 600 mg, i.e., 6 capsules once a day.

• If you are being treated for GIST:

The initial dose is 400 mg, i.e., 4 capsules once a 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 (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

• If you are being treated for Ph+ ALL:

The initial dose is 600 mg, i.e., 6 capsules oncea day.

• If you are being treated for MPD:

The initial dose is 400 mg, i.e., 4 capsules oncea day.

• If you are being treated for HES/CEL: The initial dose is 100 mg, i.e., 1 capsule of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, i.e., 4 capsules once a day, depending on how you respond to treatment.

• If you are being treated for DFSP:

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

Use in children and adolescents

Your doctor will tell you how many imatinib capsules to give to the child. The amount of imatinib given will depend on the child's situation, body weight, and height. The total daily dose in children should not exceed 800 mg in CML and 600 mg in 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 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 a woman who could become pregnant and are trying to open the capsules, you should handle the contents with care to avoid contact with the skin and eyes or inhalation. You should wash your hands immediately after opening the capsules.

How long to take Imatinib Cipla

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

If you take more Imatinib Cipla than you should

If you accidentally take too many capsules, 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: 915620420, indicating the medicine and the amount taken.

If you forget 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 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 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, 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, difficulty breathing, or painful breathing (signs of lung problems).
• Feeling of 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, skin redness, blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in urine output, feeling of thirst (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 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 bones or joints (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• 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).
• Pain in the pelvis, 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/low potassium levels, high uric acid and calcium, and low phosphorus levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Frequency Not Known(cannot be estimated from the available data):

• Combination of a generalized rash, feeling of discomfort, fever, elevated levels of certain blood cells, or yellowing of the skin or eyes with difficulty breathing, chest pain, decreased urine production, and feeling of thirst, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure.
• Inflammation of the sac surrounding the heart. It can manifest as chest pain that varies with each inspiration. The pain often increases when lying down and decreases when sitting up. It is also often accompanied by fever, cough, and palpitations. It can be severe 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 (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection).
• Bleeding in the eyeball (vitreous hemorrhage).
• Blood clot, usually in a leg, that causes pain, swelling, or redness (thrombosis).
• Respiratory failure that occurs when the respiratory system does not oxygenate well (acute respiratory failure).
• Inflammation of the lungs, which can cause shortness of breath and difficulty breathing (interstitial lung disease).
• Gastrointestinal bleeding (gastric antral vascular ectasia (GAVE)).

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

Other Adverse Effects May Include:

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

• 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 capsules or after stopping Imatinib capsules.
• Swelling such as swollen ankles or eyes.
• Weight gain.

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

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

• 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.
• Mouth ulcers.
• 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 importantly, consult your doctor.

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

• Painful red lumps on the skin, skin pain, skin redness (inflammation of the fatty tissue under the skin).
• Cough, secretion, or blockage in the nose, feeling of heaviness or pain when pressing the area around the eyes or to the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing pain or a pulsating sensation, usually on one side of the head, and often accompanied by nausea, vomiting, and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation when urinating, fever, pain in the groin or pelvis, cloudy or dark-colored urine (signs of urinary tract infection).
• Pain and swelling of the joints (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which disrupts daily life (signs of depression).
• A feeling of apprehension and concern along with physical symptoms such as palpitations, sweating, tremors, dry mouth (signs of anxiety).
• Drowsiness/somnolence/excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory impairment.
• Need to constantly move the legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Discoloration of the skin.
• Brittle nails.
• Reddish bumps or pimples around the hair root, possibly with pain, itching, or burning sensation (signs of folliculitis).
• Skin rash with peeling or skin shedding (exfoliative dermatitis).
• Breast growth (can occur in men or women).
• Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain when urinating, having sex, or ejaculating, blood in the urine (signs of testicular edema).
• Difficulty having or maintaining an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving/maintaining sexual excitement.
• Decreased sexual desire.
• Pain in the nipples.
• General feeling of discomfort (general discomfort).
• Viral infections such as cold sores.
• Back pain in the lower part of the back due to a kidney disorder.
• Increased frequency of urination.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, black stools (signs of stomach ulcer).
• Stiffness in the joints or muscles.
• Abnormal laboratory test results.

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

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

• Confusion.
• An episode of spasms and reduced consciousness (seizures).
• Discoloration of the nails.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed 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 Cipla

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

? Do not use this medicine after the expiration date shown on the box and blister after CAD. The expiration date is the last day of the month indicated.

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

? Do not use this medicine if you notice that it is damaged or shows signs of tampering.

? Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the Sigre Point of the pharmacy or in any other system for collecting medicinal waste. In case of doubt, 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 Cipla

• The active ingredient is imatinib. Each Imatinib Cipla capsule contains 100 mg of imatinib (as mesilate).
• The other ingredients are anhydrous lactose, crospovidone (type B), anhydrous colloidal silica, and magnesium stearate.
• The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and sodium lauryl sulfate.

Appearance of the Product and Package Contents

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 pack.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer.

Marketing Authorization Holder:

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Manufacturer:

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Local Representative:

Cipla Europe NV, branch in Spain

C/Guzmán el Bueno, 133 Edif Britannia

28003 Madrid, Spain

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

Date of the Last Revision of this Leaflet:January 2025

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