Bosutinib Stada

Leaflet accompanying the packaging: information for the user

Bosutinib Stada, 100 mg, coated tablets

Bosutinib Stada, 400 mg, coated tablets

Bosutinib Stada, 500 mg, coated tablets

Bosutinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Bosutinib Stada and what is it used for
• 2. Important information before taking Bosutinib Stada
• 3. How to take Bosutinib Stada
• 4. Possible side effects
• 5. How to store Bosutinib Stada
• 6. Contents of the packaging and other information

1. What is Bosutinib Stada and what is it used for

Bosutinib Stada contains the active substance bosutinib. This medicine is used to treat adults with a type of leukemia called chronic myelogenous leukemia (CML) with positive Philadelphia chromosome (Ph-positive), who have been newly diagnosed or whose previous treatments for CML have not worked or were not suitable. Chronic myelogenous leukemia Ph-positive is a blood cancer that causes the body to produce too many specific white blood cells called granulocytes. If you have any questions about how Bosutinib Stada works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Bosutinib Stada

When not to take Bosutinib Stada

• if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6);
• if you have been informed by your doctor that you have liver damage and it is not working properly.

Warnings and precautions

Before starting treatment with Bosutinib Stada, discuss with your doctor, pharmacist, or nurse:

• if you have or have had liver disease.Tell your doctor about any previous liver disease, including hepatitis (infection or inflammation) of any type, as well as any previous signs and symptoms related to the liver, such as itching, yellowing of the whites of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. Before starting treatment with Bosutinib Stada and during the first 3 months of treatment, and in clinically indicated situations, your doctor should perform blood tests to check your liver function.

Bosutinib Stada and during the first 3 months of treatment, and in clinically indicated situations, your doctor should perform blood tests to check your liver function.

• if you have diarrhea and vomiting.Tell your doctor if you experience any of the following signs and symptoms: increased daily number of stools (bowel movements) exceeding the normal state, increased number of vomiting episodes, presence of blood in vomit, stools (bowel movements), or urine, presence of black stools (tar-like stools). Ask your doctor if the use of anti-emetic treatment may increase the risk of cardiac arrhythmia. Consult your doctor especially if a medicine containing domperidone is to be used to treat nausea and/or vomiting. Treating nausea or vomiting with such medicines along with Bosutinib Stada may increase the risk of serious cardiac arrhythmias.
• if you have bleeding.Tell your doctor if you experience any signs or symptoms, such as abnormal bleeding or bruising without injury.
• if you have an infection.Tell your doctor if you experience any signs or symptoms, such as fever, problems with urination (e.g., burning), new cough, or sore throat.
• if you have fluid retention.Tell your doctor if you experience any signs or symptoms of fluid retention, such as swelling of the ankles, feet, or face, difficulty breathing, chest pain, or cough (which may be signs of fluid retention in the lungs or chest).
• if you have heart disease.Tell your doctor if you have heart disease, such as arrhythmias or abnormal EKG signs called "QT interval prolongation". These conditions are always important, but are particularly significant in cases of frequent or prolonged diarrhea, as described above. If you experience fainting (loss of consciousness) or irregular heartbeat while taking Bosutinib Stada, consult your doctor immediately, as it may be a sign of a serious heart condition.
• if you have kidney disease.Tell your doctor if you experience more frequent urination and production of larger amounts of pale urine, or less frequent urination and production of smaller amounts of dark urine. Also, tell your doctor if you experience weight loss and swelling of the feet, ankles, legs, hands, or face.
• if you have had or may have hepatitis B virus infection. This is because Bosutinib Stada may cause the hepatitis B virus to become active again, which can be life-threatening in some cases; patients will be closely monitored by their doctor for signs of this infection before starting treatment.
• if you have or have had pancreatitis.Tell your doctor if you experience abdominal pain or discomfort in this area.
• if you experience any of the following symptoms: severe skin rash.Tell your doctor if you experience any of the following symptoms: painful, red, or purple spreading rash, blisters, and/or other lesions that begin to form on the mucous membranes (e.g., in the mouth and lips).
• if you experience any of the following symptoms: side pain, blood in urine

or decreased urine output.In the case of very severe disease, the body may not be able to remove all the components of dying cancer cells. This complication is called tumor lysis syndrome and may cause kidney failure and heart problems within 48 hours of taking the first dose of Bosutinib Stada. Your doctor is aware of the possibility of this complication and may recommend that you be properly hydrated, as well as administer other medicines to prevent its occurrence.

Sun protection/UV radiation

While taking bosutinib, you may be more sensitive to sunlight or UV radiation. It is essential to cover exposed skin areas and use sunscreens with a high sun protection factor (SPF).

Children and adolescents

Bosutinib Stada is not recommended for use in patients under 18 years of age. The use of this medicine has not been studied in children and adolescents.

Bosutinib Stada and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription, vitamins, and herbal medicines. Some medicines may affect the levels of Bosutinib Stada in your body. Inform your doctor about taking medicines containing the following active substances:

The following active substances may increase the risk of side effects of Bosutinib Stada:

Bosutinib Stada:

• ketokonazol, itrakonazol, worykonazol, posakonazol, and flukonazol used to treat fungal infections,
• klarytromycyna, telitromycyna, erytromycyna, and cyprofloksacyna used to treat bacterial infections,
• nefazodon used to treat depression,
• mibefradyl, diltiazem, and werapamil used to lower blood pressure in people with high blood pressure,
• rytonawir, lopinawir/rytonawir, indynawir, nelfinawir, sakwinawir, atazanawir, amprenawir, fosamprenawir, and darunawir used to treat human immunodeficiency virus (HIV)/AIDS,
• boceprewir and telaprewir used to treat hepatitis C,
• aprepitant used to prevent nausea (vomiting) and control it,
• imatynib used to treat a type of leukemia,
• kryzotynib used to treat a type of lung cancer called non-small cell lung cancer.

The following active substances may reduce the effectiveness of Bosutinib Stada:

• ryfampicyna used to treat tuberculosis,
• fenytoina and karbamazepina used to treat epilepsy,
• bozentan used to lower high blood pressure in the lungs (pulmonary arterial hypertension),
• nafcylina - an antibiotic used to treat bacterial infections,
• ziele dziurawca (a herbal medicine available without a prescription) used to treat depression,
• efawirenz and etrawiryna used to treat HIV/AIDS infections,
• modafinil used to treat certain types of sleep disorders.

Avoid taking these medicines while being treated with Bosutinib Stada. Inform your doctor if you are taking any of these medicines. Your doctor may change the doses of these medicines, the dose of Bosutinib Stada, or change the medicine to another one.

The following active substances may affect heart rhythm:

• amiodaron, dyzopiramid, prokainamid, chinidyna, and sotalol used to treat heart disorders,
• chlorochina, halofantryna used to treat malaria,
• antibiotics: klarytromycyna and moksyfloksacyna used to treat bacterial infections,
• haloperydol used to treat psychotic disorders, such as schizophrenia,
• domperydon used to treat nausea and vomiting or to stimulate milk production,
• metadon used to treat pain.

Be cautious when taking these medicines while being treated with Bosutinib Stada. Inform your doctor if you are taking any of these medicines. Other medicines not listed above may also interact with Bosutinib Stada.

Taking Bosutinib Stada with food and drink

Do not take Bosutinib Stada with grapefruit or grapefruit juice, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Bosutinib Stada may harm the unborn child, so it should not be taken during pregnancy unless it is necessary. If you are pregnant or think you may be pregnant, consult your doctor before taking Bosutinib Stada. Women taking Bosutinib Stada are advised to use effective contraception during treatment and for at least one month after the last dose of the medicine. Vomiting and diarrhea may reduce the effectiveness of oral contraceptives. Due to the risk of reduced fertility in men, consider sperm preservation before starting treatment with Bosutinib Stada. If you are breastfeeding, inform your doctor. Do not breastfeed while taking Bosutinib Stada, as it may harm the baby.

Driving and using machines

If you experience dizziness, blurred vision, or an unusual feeling of tiredness, do not drive or operate machinery until these side effects have resolved.

Bosutinib Stada contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Bosutinib Stada

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Bosutinib Stada will only be prescribed by a doctor who has experience in the use of medicines to treat leukemia.

Dose and method of administration

The recommended dose for patients with newly diagnosed chronic myelogenous leukemia is 400 mg once a day. The recommended dose for patients whose previous treatment for chronic myelogenous leukemia has not worked or was not suitable is 500 mg once a day. In patients with moderate or severe kidney disease, the doctor will reduce the dose by 100 mg per day in the case of moderate kidney disease and by an additional 100 mg per day in the case of severe kidney disease. The doctor may adjust the dose using 100 mg tablets, depending on the patient's condition, response to treatment, and/or possible side effects. Take the tablets once a day with a meal. Swallow the tablets whole with water.

Taking a higher dose of Bosutinib Stada than recommended

If you accidentally take too many tablets of Bosutinib Stada or a higher dose than needed, consult your doctor immediately. If possible, show your doctor the packaging of the medicine or this leaflet. You may need medical attention.

Missing a dose of Bosutinib Stada

If it has been less than 12 hours since the missed dose, take the recommended dose. If it has been more than 12 hours since the missed dose, take the next dose at the usual time the next day. Do not take a double dose to make up for a missed tablet.

Stopping treatment with Bosutinib Stada

Do not stop taking Bosutinib Stada unless your doctor tells you to. If you are unable to take the medicine as directed by your doctor or if you think you no longer need it, consult your doctor immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bosutinib Stada can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, consult your doctor immediately (see also section 2 "Important information before taking Bosutinib Stada"): Blood disorders.Tell your doctor immediately if you experience any of the following symptoms: bleeding, fever, or easy bruising (which may indicate a blood or lymphatic system disorder). Liver disorders.Tell your doctor immediately if you experience any of the following symptoms: itching, yellowing of the whites of the eyes or skin, dark urine, abdominal pain, or discomfort in the right upper abdomen or fever. Gastrointestinal disorders.Tell your doctor if you experience stomach pain, heartburn, diarrhea, constipation, nausea, and vomiting. Heart disorders.Tell your doctor if you experience heart disorders, such as abnormal heart rhythms called "QT interval prolongation", fainting (loss of consciousness), or irregular heartbeat while taking Bosutinib Stada. Reactivation of hepatitis B virus infection.Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who have had the disease in the past. Severe skin reactions.Tell your doctor immediately if you experience any of the following symptoms: painful, red, or purple spreading rash, blisters, and/or other lesions that begin to form on the mucous membranes (e.g., in the mouth and lips). Side effects associated with taking Bosutinib Stada may include:

Very common side effects (may occur in more than 1 in 10 people):

• decreased platelet count, red blood cells, and/or neutrophils (a type of white blood cell)
• diarrhea, vomiting, abdominal pain, nausea
• fever, swelling of hands, feet, or face, fatigue, weakness
• respiratory tract infection
• nasopharyngitis
• changes in blood test results to check if Bosutinib Stada affects the liver and/or pancreas, kidneys
• decreased appetite
• joint pain, back pain
• headache
• skin rash, which may be itchy and/or generalized
• cough
• shortness of breath
• feeling of imbalance (dizziness)
• fluid in the lungs (pleural effusion)
• itching.

Common side effects (may occur in up to 1 in 10 people):

• low white blood cell count (leukopenia)
• gastritis (stomach inflammation), gastrointestinal bleeding
• chest pain, pain
• toxic liver damage, abnormal liver function, including liver dysfunction
• pneumonia (lung infection), flu, bronchitis
• heart rhythm disorders that can lead to fainting, dizziness, and palpitations
• high blood pressure
• high potassium levels in the blood, low phosphorus levels in the blood, excessive fluid loss (dehydration)
• muscle pain
• change in taste
• acute kidney failure, kidney failure, kidney dysfunction
• fluid around the heart (pericardial effusion)
• ringing in the ears
• hives, acne
• photosensitivity reaction (sensitivity to UV radiation from the sun and other light sources)
• allergic reaction
• high blood pressure in the pulmonary arteries (pulmonary hypertension)
• acute pancreatitis
• respiratory failure.

Uncommon side effects (may occur in up to 1 in 100 people):

• fever associated with low white blood cell count (febrile neutropenia)
• liver damage
• life-threatening allergic reaction (anaphylactic shock)
• abnormal fluid accumulation in the lungs (acute pulmonary edema)
• skin lesions
• pericarditis (inflammation of the sac surrounding the heart)
• significant decrease in granulocyte count (a type of white blood cell)
• severe skin disorders (erythema multiforme)
• nausea, shortness of breath, irregular heartbeat, muscle spasms, seizures, clouding of urine, and fatigue associated with abnormal laboratory results (high potassium, uric acid, and phosphorus levels and low calcium levels in the blood), which can lead to kidney dysfunction and acute kidney failure - tumor lysis syndrome.

Frequency not known (frequency cannot be estimated from the available data):

• severe skin disorders (Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative rash
• interstitial lung disease (conditions that cause scarring in the lungs): symptoms include cough, difficulty breathing, painful breathing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bosutinib Stada

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated. There are no special storage instructions for this medicine. Do not use this medicine if you notice damage to the packaging or signs of tampering. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Bosutinib Stada contains

• The active substance is bosutinib. Bosutinib Stada coated tablets are available in different strengths. Bosutinib Stada 100 mg: each coated tablet contains 100 mg of bosutinib. Bosutinib Stada 400 mg: each coated tablet contains 400 mg of bosutinib. Bosutinib Stada 500 mg: each coated tablet contains 500 mg of bosutinib.
• Other ingredients are: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. The tablet coating contains: polyvinyl alcohol (E 1203), macrogol, talc, titanium dioxide (E 171), yellow iron oxide (E 172) - Bosutinib Stada 100 mg and 400 mg, and red iron oxide (E 172) - Bosutinib Stada 400 mg and 500 mg.

What Bosutinib Stada looks like and contents of the pack

Bosutinib Stada 100 mg coated tablets are yellow, oval, biconvex tablets with "C18" engraved on one side. Bosutinib Stada 100 mg is available in blisters containing 28 or 112 coated tablets, in a cardboard box. Bosutinib Stada 100 mg is available in perforated unit dose blisters containing 28x1 or 112x1 coated tablet, in a cardboard box. Bosutinib Stada 400 mg coated tablets are orange, oval, biconvex tablets with "C19" engraved on one side. Bosutinib Stada 400 mg is available in blisters containing 28 or 112 coated tablets, in a cardboard box. Bosutinib Stada 400 mg is available in perforated unit dose blisters containing 28x1 or 112x1 coated tablet, in a cardboard box. Bosutinib Stada 500 mg coated tablets are pink, oval, biconvex tablets with "C20" engraved on one side. Bosutinib Stada 500 mg is available in blisters containing 28 or 112 coated tablets, in a cardboard box. Bosutinib Stada 500 mg is available in perforated unit dose blisters containing 28x1 or 112x1 coated tablet, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer

Coripharma ehf., Reykjavíkurvegur 78, Hafnarfjörður 220, Iceland STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany Clonmel Healthcare Ltd., Waterford Road, Clonmel, E91 D768, Co. Tipperary, Ireland For further information about this medicine, contact the local representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warszawa, Tel. +48 22 737 79 20

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

Belgium Bosutinib EG 100 mg film-coated tablets Bosutinib EG 400 mg film-coated tablets Bosutinib EG 500 mg film-coated tablets Denmark Bosutinib STADA Finland Bosutinib STADA 100 mg film-coated tablets Bosutinib STADA 400 mg film-coated tablets Bosutinib STADA 500 mg film-coated tablets France BOSUTINIB EG 100 mg, film-coated tablet BOSUTINIB EG 400 mg, film-coated tablet BOSUTINIB EG 500 mg, film-coated tablet Spain Bosutinib Stada 100 mg film-coated tablets EFG Bosutinib Stada 400 mg film-coated tablets EFG Bosutinib Stada 500 mg film-coated tablets EFG Netherlands Bosutinib CF 100 mg, film-coated tablets Bosutinib CF 400 mg, film-coated tablets Bosutinib CF 500 mg, film-coated tablets Ireland Bosutinib Clonmel 100 mg film-coated tablets Bosutinib Clonmel 400 mg film-coated tablets Bosutinib Clonmel 500 mg film-coated tablets Iceland Bosutinib STADA Luxembourg Bosutinib EG 100 mg film-coated tablets Bosutinib EG 400 mg film-coated tablets Bosutinib EG 500 mg film-coated tablets Germany Bosutinib STADA 100 mg film-coated tablets Bosutinib STADA 400 mg film-coated tablets Bosutinib STADA 500 mg film-coated tablets Norway Bosutinib STADA 100 film-coated tablets Bosutinib STADA 400 film-coated tablets Bosutinib STADA 500 film-coated tablets Sweden Bosutinib STADA 100 film-coated tablets Bosutinib STADA 400 film-coated tablets Bosutinib STADA 500 film-coated tablets

Date of last revision of the leaflet: