IMATINIB TARBIS 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Imatinib Tarbis 400 mg film-coated tablets 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 Tarbis and what is it used for
2. What you need to know before you take Imatinib Tarbis
3. How to take Imatinib Tarbis
4. Possible side effects
5. Storage of Imatinib Tarbis
6. Contents of the pack and other information

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

Imatinib Tarbis 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 Tarbis 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 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.
  • Acute lymphoblastic leukaemia with positive Philadelphia chromosome (Ph+ ALL).Leukaemia is a cancer of the 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 Tarbis inhibits the growth of these cells.

.

Imatinib Tarbis 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 Tarbis 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 Tarbis inhibits the growth of these cells in a certain subtype of these diseases.
  • Gastrointestinal stromal tumours (GISTs).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 Tarbis 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 Tarbis works or why it has been prescribed for you, ask your doctor.

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

Imatinib Tarbis will only be prescribed by a doctor who has experience in medicines for treating blood cell cancer or solid tumours.

Follow carefully all instructions given by your doctor, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Tarbis:

• 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 Tarbis.

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

Warnings and precautions

Consult your doctor before taking Imatinib Tarbis:

• 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 ever had or may currently have a hepatitis B virus infection. This is because Imatinib Tarbis could cause the hepatitis B virus to become active again, which can be life-threatening in some cases. Your doctor should check carefully for signs of this infection before starting treatment.

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

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

During treatment with Imatinib Tarbis, tell your doctor immediatelyif you gain weight very quickly. Imatinib Tarbis can cause water retention in the body (severe fluid retention).

While taking Imatinib Tarbis, 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 Tarbis 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 who take Imatinib Tarbis may have slower than normal growth. The doctor will check growth during regular visits.

Other medicines and Imatinib Tarbis

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 Tarbis when taken together. They may increase or decrease the effect of Imatinib Tarbis, leading to an increased risk of side effects or making Imatinib Tarbis less effective. Imatinib Tarbis 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, consult your doctor before using this medicine.
  • Imatinib Tarbis is not recommended during pregnancy unless clearly necessary, as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Tarbis during pregnancy with you.
  • 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 Tarbis and for 15 days after finishing treatment, as it may harm your baby.
  • Patients who are concerned about their fertility while taking Imatinib Tarbis 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.

3. How to take Imatinib Tarbis

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

However, follow your doctor's or pharmacist's instructions exactly. It is important that you do this for the time period your doctor or pharmacist tells you. If you are in doubt, consult your doctor or pharmacist again.

Do not stop taking Imatinib Tarbis unless your doctor tells you to. If you cannot take the medicine as your doctor has prescribed or think you no longer need it, contact your doctor immediately.

How much to take of Imatinib Tarbis

Adult use

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

• If you are being treated for CML:

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

• If you are being treated for GIST:

The starting dose is 400 mg 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, you should take 400 mg in the morning and 400 mg in the evening.

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg once a day.

• If you are being treated for MPD:

The starting dose is 400 mg once a day.

• If you are being treated for HES/CEL:

The starting 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 a day, which is 400 mg in the morning and 400 mg in the evening.

A dose of 400 mg can be taken as either 1 tablet of 400 mg or 4 tablets of 100 mg.

A dose of 600 mg should be taken as 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 give to the child. The amount of Imatinib Tarbis 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 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 still water or apple juice:

• Use approximately 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• Drink the whole contents of the glass immediately. There may be some leftover tablet residue in the bottom of the glass.

How long to take Imatinib Tarbis

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

If you take more Imatinib Tarbis than you should

If you accidentally take too many tablets, talk to your doctor immediately.You may need medical attention. Take the medicine pack with you.

If you forget to take Imatinib Tarbis

• 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 Tarbis may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or ulcers in the mouth. Imatinib Tarbis 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, with difficulty breathing or painful breathing (signs of lung problems).
• Feeling of dizziness, dizziness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark urine, or yellow skin and eyes (signs of liver problems).
• Rash, skin redness, with blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin spots, itching, burning sensation, rash with pustules (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, with 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 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, reddish-brown urine, pain, or weakness in the muscles (signs of muscle problems).
• Pelvic pain, 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, fatigue, and/or joint discomfort associated with abnormal laboratory test results (e.g., high levels of potassium, uric acid, and calcium, and low levels of phosphorus in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

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

• Combination of a widespread rash, feeling of discomfort, fever, high levels of certain blood cells, or yellow skin and eyes (signs of jaundice) with difficulty breathing, chest pain, decreased urine production, and feeling of thirst, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection).

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

Other adverse effects may include:

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

• 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 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):

• 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.
• Ulcers in the mouth.
• 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 significantly, 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 nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing pain or a throbbing 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 reddish-brown 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 spots 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).
• Intense or irregular menstrual periods.
• Difficulty achieving/maintaining sexual arousal.
• Decreased sexual desire.
• Pain in the nipples.
• General feeling of discomfort (general discomfort)
• Viral infections such as cold sores.
• Lower back pain 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 significantly, consult your doctor.

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

• Confusion.
• Discoloration of the nails.

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 significantly, consult your doctor.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. 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 Tarbis 400 mg Film-Coated Tablets EFG

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

Do not use this medicine after the expiration date stated on the blister, label, or carton after EXP. The expiration date is the last day of the month indicated.

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

Do not use this medicine after three months from the initial opening of the HDPE container.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Tarbis

• The active ingredient is imatinib mesylate. Each film-coated tablet contains 400 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 Package Contents

Imatinib Tarbis 400 mg film-coated tablets EFG are capsule-shaped, bisected, and scored, film-coated, white to off-white, engraved with an H on one side and a 20 on the other, with the 2 and 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 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000;

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicine is authorized in the following EEA Member States under the following names:

Germany Imatinib Amarox 400 mg Filmtabletten

Denmark Imatinib Amarox 400 mg filmovertrukne tabletter

Spain Imatinib Tarbis 400 mg comprimidos recubiertos con película EFG

Netherlands Imatinib Amarox 400 mg filmomhulde tabletten

Sweden Imatinib Amarox 400 mg Filmdragerade tabletter

Date of the Last Revision of this Prospectus: July 2022

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)