Leaflet: information for the user

Imatinib Tarbis 100 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Imatinib Tarbis

4. Possible side effects

5. Storage of Imatinib Tarbis

6. Contents of the pack and additional information

Imatinib Tarbis is 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 Tarbis 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 Tarbisinhibits the growth of these cells.

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Imatinib Tarbis is also a treatment for adults for:

-Myeloproliferative/Myelodysplastic Syndromes (MPD/ MDS).These are a group of blood disorders in which some blood cells start to grow uncontrollably. Imatinib Tarbis inhibits the growth of these cells in a certain subtype of these diseases.

-Hyperosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL).These are blood disorders in which some blood cells (called eosinophils) start to grow uncontrollably. Imatinib Tarbis 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 Tarbis 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 Tarbis works or why this medication has been prescribed to you, ask your doctor.

Only a doctor with experience in prescribing medications to treat blood cell cancers or solid tumors will prescribe Imatinib Tarbis.

Followcarefullyall the instructions of your doctor, evenifthey are differentfrom the general information contained in this prospectus.

Do not take Imatinib Tarbis:

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

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

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 Tarbis:

-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 ever had or may have hepatitis B infection at this time. This is because Imatinib Tarbis may cause hepatitis B to become active again, which can be fatal. Your doctor will carefully check for signs of this infection before starting treatment.

• ifwhile takingImatinibyou experience bruising, bleeding,fever, fatigue, and confusion,please contactyour doctor. This could be a sign of a blood vessel damage called microangiopathic hemolytic anemia (MAHA).

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

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

During treatment with Imatinib Tarbis, inform your doctor immediatelyif you gain weightvery rapidly.ImatinibTarbismay cause severe fluid retention in the body.

Whileyou are takingImatinibTarbis, your doctor will regularly checkif the medication is working. Blood tests and regular weighing will also be performed.

Children and adolescents

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

Some children and adolescents taking ImatinibTarbismay experience slower than normal growth. Your doctor will monitor growth at regular visits.

Other medications and Imatinib TarbisTarbis

Inform your doctor or pharmacist if you areusing, have taken recently or may need to take any other medication, including those purchased over the counter (such as paracetamol) and even herbal medicines (such as St. John's Wort). Some medications may interfere with the effect of ImatinibTarbiswhen taken together.Thesemay increase or decrease the effect of ImatinibTarbis,leadingto an increase in side effects ormaking ImatinibTarbisless effective.ImatinibTarbismay produce the same effect on other medications.

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

Pregnancy, breastfeeding, and fertility

-If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

• It is not recommended to use Imatinib Tarbis during pregnancy exceptif it is clearlynecessary, as it may cause harm to your baby. Your doctorwill discuss with youthe possible risks of taking ImatinibTarbisduring pregnancy.
• 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 breastfeedyour baby during treatment with ImatinibTarbisor for the following 15 days after treatment has ended, as it may harm your baby.
• Patientsconcernedabout their fertilitywhile takingImatinibTarbisshould consult their doctor.

Driving and operating machines

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

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

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

Do not stop taking Imatinib Tarbis 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 time, contact your doctor immediately.

How much Imatinib Tarbis to take

Use in adults

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

• If you are being treated for LMC:

The usual initial dose is 400 mg or 600 mg once a day, depending on your situation:

• If you are being treated for GIST:

The initial dose is 400 mg once a 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, you should take 400 mg in the morning and 400 mg at night.

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

The initial dose is 600 mg once a day.

-If you are being treated for SMD/SMP:

The initial dose is 400 mg once a day.

-If you are being treated for SHE/LEC:

The initial dose is 100 mg once a day. Your doctor may decide to increase the dose to 400 mg once a day, depending on how you respond to treatment.

-If you are being treated for DFSP:

The dose is 800 mg per day, i.e., 400 mg in the morning and 400 mg at night.

The dose of 400 mg can be taken with 1 tablet of 400 mg or with 4 tablets of 100 mg.

The dose of 600 mg must be taken with 1 tablet of 400 mg and 2 tablets of 100 mg.

Use in children and adolescents

Your doctor will tell you how many Imatinib Tarbis tablets to administer to the child. The amount of Imatinib Tarbis administered will depend on the child's situation, weight, and height.The total daily dose in children should not exceed 800 mg for LMC and 600 mg for 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 at night).

When and how to take Imatinib Tarbis

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

-Swallow the tablets with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of water without gas or apple juice:

-Use approximately 50 ml for each 100 mg tablet or 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 dissolved tablet residue at the bottom of the glass.

For how long to take Imatinib Tarbis

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

If you take more Imatinib Tarbis than you should

If you have accidentally taken too many tablets, talk to your doctor immediately.You may need medical attention. Bring the medication packaging.

If you forget to take Imatinib Tarbis

• If youforget to take a dose, take itas soon asyou remember. However, if it is almost time for the next dose, do not take the one you forgot,
• Thencontinue with thenormal 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 Tarbis may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib Tarbis 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 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 heartbeat (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, blistering 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 skull or brain).
• Pale skin, feeling tired, difficulty breathing, dark urine (signs of low red blood cell count).
• Eye pain or vision problems, bleeding in the eyes.
• Bone or joint pain (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or cold sensation in the feet and toes (signs of Raynaud's syndrome).
• Rapid skin swelling and redness (signs of skin infection called cellulitis).
• Difficulty hearing.
• Weakness, muscle spasms, abnormal heart rhythm (signs of changes in potassium levels in the blood).
• Bruises.
• Stomach pain with nausea.
• Muscle spasms with fever, reddish-brown urine, muscle pain or weakness (signs of muscle problems).
• Lower 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 potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
• Microangiopathic thrombosis (blood clots in small blood vessels).

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.
• Reactivation of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

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 people):

• Headache or feeling tired.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or joint, muscle, or bone pain during treatment with imatinib or when 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), or watery eyes or blurred vision.
• Nasal bleeding.
• Abdominal pain, bloating, heartburn, or constipation.
• Itching.
• Unusual hair loss or weakness.
• Numbness or cold sensation 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 100 patients):

• Red, painful, or swollen skin lumps, skin pain, skin redness (inflammation of subcutaneous fat under the skin).
• Cough, nasal secretion, nasal congestion, or nasal blockage, feeling of heaviness or pain when pressing the eye area or the sides of the nose, congestion, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing or pulsating pain, usually on one side of the head, 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 reddish-brown urine (signs of urinary tract infection).
• Joint pain (signs of arthralgia).
• Feeling sad and losing interest, which interferes with normal life (signs of depression).
• Feeling anxious and worried, with physical symptoms such as palpitations, sweating, tremors, dry mouth (signs of anxiety).
• Drowsiness, excessive sleepiness, or excessive sleep.
• Tremors or involuntary movements (tremor).
• Memory damage.
• Need to constantly move legs (restless legs syndrome).
• Heard sounds (e.g., bells, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Skin discoloration.
• Brittle nails.
• Red, inflamed, or painful hair follicles, possibly with pain, itching, or burning sensation (signs of folliculitis).
• Peeling skin rash or skin peeling (dermatitis exfoliativa).
• Breast growth (may occur in men or women).
• Dull or heavy sensation in the testicles or lower abdomen, pain when urinating, during sex, or when ejaculating, blood in the urine (signs of testicular edema).
• Inability to achieve or maintain an erection (erectile dysfunction).
• Irregular or heavy menstrual periods.
• Difficulty achieving or maintaining sexual excitement.
• Decreased sex drive.
• Nipple pain.
• General feeling of discomfort (general malaise).
• Herpes labialis (cold sores).
• Lower back pain due to kidney problems.
• Increased frequency of urination.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling full, bloating, black stool (signs of stomach ulcer).
• Joint or muscle stiffness.
• Abnormal laboratory test results.
• If any of these affect you significantly, consult your doctor.

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

• Confusion.
• Discolored nails.

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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System 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 blister pack, the bottle label, or the box after CAD. The expiration date is the last day of the month indicated.

Do not use any container if you observe that it is damaged or shows signs of improper handling.

Do not use this medication after three months have passed since the initial opening of the HDPE container.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.In case of doubt,ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment

Composition of Imatinib Tarbis

- The active ingredient is imatinib mesylate. Each film-coated tablet contains 100 mg of imatinib (as mesylate).

- The other component of the tablet core is magnesium stearate.

- The other components of the tablet coating are macrogol, (E1521), talc (E553b), hypromellose (E464), and titanium dioxide (E171).

Appearance of the product and contents of the packaging

Imatinib Tarbis 100 mg film-coated tablets EFG are round, bisected, and scored tablets, white to off-white in color, engraved with a H on one face and a 19 on the other, with the 1 and 9 separated by the score.

Film-coated tablets are packaged in blisters of 20, 60, 90, 120, or 180 tablets, or in HDPE bottles of 90 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Tarbis Farma S.L.

Gran Vía Carlos III 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000;

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicinal product is authorized in the following Member States of the EEA under the following names:

Germany Imatinib Amarox 100 mg Filmtabletten

Denmark Imatinib Amarox 100 mg filmovertrukne tabletter

Spain Imatinib Tarbis 100 mg comprimidos recubiertos con película EFG

Netherlands Imatinib Amarox 100 mg filmomhulde tabletten

Sweden Imatinib Amarox 100 mg Filmdragerade tabletter

Last review date of this leaflet: July 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es )