Imatinib Tarbis 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Imatinib Tarbis 100 mg Film-coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Imatinib Tarbis is and what it is used for
2. What you need to know before taking Imatinib Tarbis
3. How to take Imatinib Tarbis
4. Possible side effects
5. How to store Imatinib Tarbis
6. Contents of the pack and other information

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

Imatinib Tarbis is a medicine that contains an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases described below. These include certain 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 cells normally help the body fight infections. Chronic myeloid leukaemia is a type of leukaemia in which abnormal white cells (called myeloid cells) begin to grow uncontrollably.
  • Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. These white cells normally help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which abnormal white cells (called lymphoblasts) begin to grow uncontrollably. Imatinib Tarbis inhibits the growth of these cells.

Imatinib Tarbis is also a treatment for adults for:

• Myelodysplastic/myeloproliferative syndromes (MDS/MPS). These are a group of blood disorders in which certain blood cells begin to grow uncontrollably. Imatinib Tarbis inhibits the growth of these cells in a specific subtype of these disorders.

• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Tarbis inhibits the growth of these cells in a specific subtype of these disorders.

  • Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and intestine. It arises from uncontrolled cell growth in the supportive tissues of these organs.

• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which certain cells begin to grow uncontrollably. Imatinib Tarbis inhibits the growth of these cells.

In the remainder of this leaflet, these abbreviations are used when referring to these diseases.

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

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

Imatinib Tarbis will only be prescribed by a doctor experienced in using medicines to treat blood cell cancers or solid tumours.

Carefully follow all instructions from 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 to any of the other ingredients of this medicine (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, consult your doctor.

Warnings and precautions

Talk to 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 medicine containing levothyroxine because your thyroid gland has been removed.
• if you have ever had or might currently have an infection with hepatitis B virus. This is because Imatinib Tarbis could cause hepatitis B to become active again, which may be fatal. Your doctor must carefully check for signs of this infection before starting treatment.
  • if you develop bruising, bleeding, fever, fatigue, or confusion while taking Imatinib, please contact your doctor immediately. These could be signs of blood vessel damage called thrombotic microangiopathy (TMA).

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

You may become more sensitive to sunlight while taking Imatinib Tarbis. It is important to cover skin areas exposed to sunlight and use high-protection sunscreen. These precautions also apply to children.

During treatment with Imatinib Tarbis, inform your doctor immediately if you experience rapid weight gain. Imatinib Tarbis may cause fluid retention in the body (severe fluid retention).

While you are taking Imatinib Tarbis, your doctor will regularly monitor whether 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-positive ALL is limited, and experience in children with MDS/MPN, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents taking Imatinib Tarbis may have slower than normal growth. Your doctor will monitor growth during periodic visits.

Other medicines and Imatinib Tarbis

Inform your doctor or pharmacist if you are using, have recently taken, or might need to take any other medicines, including those obtained without a prescription (such as paracetamol), and even herbal medicines (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Tarbis when taken together. These may increase or decrease the effect of Imatinib Tarbis, leading to an increase in side effects or making Imatinib Tarbis less effective. Imatinib Tarbis may also affect the action of other medicines.

Inform 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 are planning to become pregnant, consult your doctor before using this medicine.
  • The use of Imatinib Tarbis during pregnancy is not recommended unless clearly necessary, as it may harm your baby. Your doctor will discuss with you the potential risks of taking Imatinib Tarbis during pregnancy.
  • Women who could become pregnant are advised to use an effective method of contraception during treatment and for 15 days after stopping treatment.
  • Do not breastfeed during treatment with Imatinib Tarbis or for the following 15 days after stopping treatment, as it may harm your baby.
  • Patients concerned about fertility while taking Imatinib Tarbis should discuss this with their doctor.

Driving and use of machines

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

3. How to take Imatinib Tarbis

Your doctor has prescribed Imatinib Tarbis because you suffer from a serious illness. Imatinib Tarbis can help you fight this disease.

However, always follow exactly the administration instructions for this medicine given by your doctor or pharmacist. It is important that you do so for the length of time specified by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

How much to take of Imatinib Tarbis

Use in adults

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

• If you are being treated for CML:

Depending on your condition, the usual initial dose is 400 mg or 600 mg once daily.

• If you are being treated for GIST:

The initial dose is 400 mg once daily.

For both 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 initial dose is 600 mg once daily.

• If you are being treated for MDS/MPD:

The initial dose is 400 mg once daily.

• If you are being treated for HES/CEL:

The initial dose is 100 mg once daily. Your doctor may decide to increase the dose to 400 mg once daily, 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 in the evening.

The 400 mg dose can be taken either as one 400 mg tablet or as four 100 mg tablets.

The 600 mg dose should be taken as one 400 mg tablet and two 100 mg tablets.

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 condition, body weight, and height. The total daily dose in children must not exceed 800 mg in CML and 600 mg in Ph+ ALL. The treatment may be given to the child once daily or, alternatively, the dose may 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 may 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 have completely dissolved.
• Once the tablet has dissolved, drink the entire contents of the glass immediately. There may be some residue of the dissolved tablet remaining at the bottom of the glass.

How long to take Imatinib Tarbis

Continue taking Imatinib Tarbis every day for as long as your doctor tells you.

If you take more Imatinib Tarbis than you should

If you have accidentally taken too many tablets, speak to your doctor immediately. You may require medical attention. Bring the medicine packaging 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 your next dose, do not take the missed dose.
• Then continue with your regular dosing schedule.
• Do not take a double dose to make up for missed doses.

If you have any further 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 everyone will experience them. These are usually mild to moderate.

Some adverse effects may 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, so you may be more prone to infections.
• Bleeding or bruising unexpectedly (when you have not sustained an 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).
• Dizziness, lightheadedness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, or yellowing of the skin or eyes (signs of liver problems).
• Rash, redness of the skin, 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 disturbances).
• Markedly reduced urine output, feeling thirsty (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 tired and short of breath, dark-colored urine (signs of low red blood cell count).
• Eye pain or vision disturbances, 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 fingers (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 blood potassium levels).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, red-brown urine, 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 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. elevated 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 available data):

• Combination of widespread rash, feeling unwell, fever, elevated levels of certain blood cells or yellowing of the skin or eyes (jaundice), together with difficulty breathing, chest pain/discomfort, severely reduced urine output, and intense thirst, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure.
• Reactivation of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection).

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

Other adverse 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.
• Swelling; 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).
• Watery, itchy, red, and swollen eyes, watery eyes, or blurred vision (conjunctivitis).
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Unusual hair thinning or hair loss.
• 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 flushes, 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, redness of the skin (inflammation of the fatty tissue under the skin).
• Cough, nasal discharge or congestion, feeling of heaviness or pain when pressing the area around the eyes or 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 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 reddish-brown urine (signs of urinary tract infection).
• Pain and swelling in the joints (signs of arthralgia).
• Persistent feeling of sadness and loss of interest, interfering with the ability to lead a normal life (signs of depression).
• A feeling of apprehension and worry accompanied by physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Numbness/sleepiness/excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory impairment.
• An uncontrollable need to keep moving the legs (restless legs syndrome).
• Hearing noises (e.g. ringing, buzzing) in the ears not originating from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Discoloration of the skin.
• Brittle nails.
• Red pimples or acne-like spots around the hair roots, possibly with pain, itching, or burning sensation (signs of inflammation of the hair follicles, also called folliculitis).
• Skin rash with peeling or shedding of the skin (exfoliative dermatitis).
• Breast enlargement (can occur in men or women).
• Dull pain and/or heaviness in the testicles or lower abdomen, pain when urinating, during sexual intercourse, or ejaculation, blood in the urine (signs of testicular edema).
• Inability to achieve or maintain an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving/maintaining sexual arousal.
• Decreased sexual desire.
• Pain in the nipples.
• General feeling of being unwell (malaise).
• 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 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 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imatinib Tarbis

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

Do not use this medicine after the expiry date stated on the blister, the label of the bottle, or the outer carton following EXP. The expiry date refers to the last day of the month indicated.

Do not use any container if it appears damaged or shows signs of tampering.

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Imatinib Tarbis

• The active substance is imatinib mesilate. Each film-coated tablet contains 100 mg of imatinib (as mesilate).
• 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 pack

Imatinib Tarbis 100 mg film-coated tablets EFG are round, biconvex, and scored tablets, white to off-white in colour, engraved with an "H" on one side and "19" on the other, with the "1" and "9" separated by the score line.

The film-coated tablets are packed in blisters of 20, 60, 90, 120 or 180 tablets, or in HDPE bottles containing 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

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

The Netherlands

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

Germany Imatinib Amarox 100 mg Filmtabletten

Denmark Imatinib Amarox 100 mg filmovertrukne tabletter

Spain Imatinib Tarbis 100 mg film-coated tablets EFG

The Netherlands Imatinib Amarox 100 mg filmomhulde tabletten

Sweden Imatinib Amarox 100 mg Filmdragerade tabletter

Date of the most recent revision of this leaflet: July 2022

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