Leaflet: information for the user

Imatinib Tarbis 400 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.

Follow carefully all the instructions of your doctor, even if they are different from 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 could have hepatitis B infection at this time. This is because Imatinib Tarbis could make hepatitis B 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 Imatinib Tarbis you develop 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 Tarbis.

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

During treatment with Imatinib Tarbis, inform your doctor immediately if you gain weight very quickly.Imatinib Tarbis can cause severe fluid retention in the body.

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

Children and adolescents

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

Some children and adolescents taking Imatinib Tarbis may experience slower-than-normal growth. Your doctor will monitor growth during regular visits.

Other medications and Imatinib Tarbis

Inform your doctor or pharmacist if you are using, have taken recently, or may need to take any other medication, including those acquired without a prescription (such as paracetamol) and even herbal medicines (such as St. John's Wort). Some medications may interfere with the effect of Imatinib Tarbis when taken together.They may increase or decrease the effect of Imatinib Tarbis, leading to an increase in adverse effects or making Imatinib Tarbis less effective.Imatinib Tarbis may produce the same effect on other medications.

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

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 except when clearly necessary, as it may cause harm to your baby. Your doctor will discuss with you the possible risks of taking Imatinib Tarbis during 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 breastfeed your baby during treatment with Imatinib Tarbis or for the 15 days after treatment has ended, as it may harm your baby.
• Patients concerned about their fertility while taking Imatinib Tarbis 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.

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:

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

• 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 injuries).

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 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 abdominal 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 pain in the muscles, joints, or bones 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 or swelling, flatulence, 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, sore throat, or headache (signs of upper respiratory tract infection).
• Severe headache, often on one side of the head, often accompanied by nausea, vomiting, and sensitivity to light or sound (signs of migraine).
• Influenza-like symptoms.
• Abdominal pain, urinary frequency, or painful urination, 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.
• Restless leg syndrome.
• Heard sounds (e.g., bells, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure.
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Skin discoloration.
• Brittle nails.
• Red, itchy, or painful bumps around the hair follicles, possibly with pain, itching, or burning sensation (signs of folliculitis).
• Dermatitis exfoliativa (skin rash with peeling or shedding).
• Breast growth (may occur in men or women).
• Testicular pain or swelling, pain during urination, sex, or ejaculation, blood in the urine (signs of testicular edema).
• Difficulty achieving or maintaining an erection (erectile dysfunction).
• Irregular or intense menstrual periods.
• Difficulty achieving or maintaining sexual excitement.
• Decreased sex drive.
• Breast pain.
• General feeling of discomfort.
• Herpes labialis (cold sores).
• Lower back pain due to kidney problems.
• Increased urination frequency.
• Increased appetite.
• Abdominal pain or heartburn, nausea, vomiting, acid reflux, feeling full, bloated, or dark stool (signs of stomach ulcers).
• 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.
• Nail discoloration.

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 and/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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 packaging 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 packaging.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. In case of doubt,ask your pharmacist how to dispose of the packaging and medications that 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 400 mg of imatinib (as mesylate).

-The other core component of the tablet 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 package

Imatinib Tarbis 400 mg film-coated tablets EFG are capsule-shaped, bisected and scored, film-coated, white to off-white in color, engraved with an H on one face and with a 20 on the other, with the 2 and the 0 separated by the score.

The film-coated tablets are packaged in blisters of 10, 30 or 90 tablets, or in HDPE bottles of 30 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization 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:

GermanyImatinib Amarox 400 mg Filmtabletten

DenmarkImatinib Amarox 400 mg filmovertrukne tabletter

SpainImatinib Tarbis 400 mg film-coated tablets EFG

NetherlandsImatinib Amarox 400 mg filmomhulde tabletten

SwedenImatinib Amarox 400 mg Filmdragerade tabletter

Last review date of this leaflet: July 2022

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)