Bosutinib STADA 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bosutinib Stada 100 mg film-coated tablets EFG

Bosutinib Stada 400 mg film-coated tablets EFG

Bosutinib Stada 500 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains the active substance bosutinib. It is used to treat adult patients with a type of leukaemia called Philadelphia chromosome-positive (Ph-positive) chronic myeloid leukaemia (CML), either newly diagnosed or in cases where previous treatments for CML have not been effective or are not suitable. Ph-positive CML is a blood cancer that causes the body to produce too many of a specific type of white blood cells called granulocytes.

If you have any questions about how bosutinib works or why you have been prescribed this medicine, please consult your doctor.

2. What you need to know before starting to take Bosutinib Stada

Do not take Bosutinib Stada

• if you are allergic to bosutinib or to any of the other ingredients of this medicine (listed in section 6).
• if your doctor has told you that you have impaired liver function.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with bosutinib:

• if you currently have or have previously had liver problems. Inform your doctor if you have a history of liver problems, including any type of hepatitis (liver infection or inflammation), or if you have experienced any of the following signs and symptoms of liver problems: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to check your liver function before starting treatment with bosutinib and during the first 3 months of treatment, or as clinically indicated.

• if you have diarrhea and vomiting. Inform your doctor if you experience any of the following signs and symptoms: an increase in the number of bowel movements per day, an increase in the number of vomiting episodes, blood in vomit, stool, or urine, or the appearance of black, tarry stools. Consult your doctor if antiemetic treatment may increase the risk of cardiac arrhythmias. In particular, consult your doctor if you wish to use any medicine containing domperidone to treat nausea and/or vomiting. Treating nausea or vomiting with such medicines while taking bosutinib may increase the risk of dangerous cardiac arrhythmias.

• if you have bleeding problems. Inform your doctor if you experience any of the following signs and symptoms, such as abnormal bleeding or bruising without injury.

• if you have an infection. Inform your doctor if you experience any of the following signs and symptoms, such as fever, urinary problems including a burning sensation when urinating, new cough, or new sore throat.

• if you have fluid retention. Inform your doctor if you experience any of the following signs and symptoms of fluid retention during treatment with bosutinib, such as swelling of the ankles, feet, or legs; difficulty breathing, chest pain, or cough (all of which may be signs of fluid retention in the lungs or chest).

• if you have heart problems. Inform your doctor if you have any heart conditions, such as arrhythmias or an abnormal electrical signal called "QT interval prolongation." These conditions are always important, but even more so if you experience frequent or prolonged diarrhea as mentioned above. If you faint (lose consciousness) or experience irregular heartbeats during treatment with bosutinib, inform your doctor immediately, as these may be signs of serious heart disease.

• if you have been told you have kidney problems. Inform your doctor if you urinate more frequently and produce larger amounts of light-colored urine, or if you urinate less frequently and produce smaller amounts of dark-colored urine. Also inform your doctor if you lose weight or experience swelling of the feet, ankles, legs, hands, or face.

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

• if you have or have previously had pancreas problems. Inform your doctor if you experience abdominal pain or discomfort.

• if you notice any of the following symptoms: severe skin rashes. Inform your doctor if you develop any of the following signs and symptoms of a painful red or purple rash that spreads and if blisters and/or other lesions begin to appear on mucous membranes (e.g., mouth and lips).

• if you experience any of the following symptoms: flank pain, blood in the urine, or reduced urine output. If your condition is severe, your body may not be able to eliminate waste products from dying cancer cells. This is known as tumor lysis syndrome and may lead to kidney failure and heart problems within 48 hours of the first dose of bosutinib. Your doctor will ensure you are adequately hydrated and may give you other medications to help prevent this.

Sun/UV Protection

During treatment with bosutinib, you may become more sensitive to sunlight or UV rays. It is important to cover exposed skin areas and use sunscreen with a high sun protection factor (SPF).

Children and adolescents

Bosutinib is not recommended for children and adolescents under 18 years of age. This medicine has not been studied in children or adolescents.

Other medicines and Bosutinib Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, vitamins, and herbal supplements. Some medicines may affect bosutinib levels in your body. You must inform your doctor if you are taking medicines containing any of the following active substances:

The following active substances may increase the risk of adverse effects with bosutinib:

• ketoconazole, itraconazole, voriconazole, posaconazole, and fluconazole, used to treat fungal infections.
• clarithromycin, telithromycin, erythromycin, and ciprofloxacin, used to treat bacterial infections.
• nefazodone, used to treat depression.
• mibefradil, diltiazem, and verapamil, used to lower blood pressure in people with high blood pressure.
• ritonavir, lopinavir/ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, amprenavir, fosamprenavir, and darunavir, used to treat human immunodeficiency virus (HIV)/AIDS infection.
• boceprevir and telaprevir, used to treat hepatitis C.
• aprepitant, used to prevent and control nausea and vomiting.
• imatinib, used to treat a type of leukemia.
• crizotinib, used to treat a type of lung cancer called non-small cell lung cancer.

The following active substances may reduce the effectiveness of bosutinib:

• rifampicin, used to treat tuberculosis.
• phenytoin and carbamazepine, used to treat epilepsy.
• bosentan, used to reduce high blood pressure in the lungs (pulmonary hypertension).
• nafcillin, an antibiotic used to treat bacterial infections.
• St. John’s wort (a herbal remedy available without prescription), used to treat depression.
• efavirenz and etravirine, used to treat HIV/AIDS infections.
• modafinil, used to treat certain types of sleep disorders.

You should avoid using these medicines during treatment with bosutinib. If you are taking any of them, inform your doctor. Your doctor may adjust the dose of these medicines, adjust your bosutinib dose, or switch you to a different medicine.

The following active substances may affect heart rate:

• amiodarone, disopyramide, procainamide, quinidine, and sotalol, used to treat heart disorders.
• chloroquine and halofantrine, used to treat malaria.
• clarithromycin and moxifloxacin, antibiotics used to treat bacterial infections.
• haloperidol, used to treat psychotic disorders such as schizophrenia.
• domperidone, used to treat nausea and vomiting, or to stimulate breast milk production.
• methadone, used to treat pain.

These medicines should be used with caution during treatment with bosutinib. If you are taking any of them, inform your doctor.

The medicines listed in this leaflet may not be the only ones that could interact with bosutinib.

Taking Bosutinib Stada with food and drinks

Do not take bosutinib with grapefruit or grapefruit juice, as this could increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

Bosutinib must not be used during pregnancy unless clearly necessary, as bosutinib could harm the unborn baby. If you are pregnant or think you may be pregnant, consult your doctor before starting bosutinib.

Women taking bosutinib should be advised to use effective contraception during treatment and for at least 1 month after the last dose. Vomiting and diarrhea may reduce the effectiveness of oral contraceptives.

Seek advice about sperm preservation before starting treatment if desired, due to the risk that bosutinib treatment may reduce fertility.

If you are breastfeeding, inform your doctor. Do not breastfeed during treatment with bosutinib, as it may harm the baby.

Driving and using machines

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

Bosutinib Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, “sodium-free.”

3. How to take Bosutinib Stada

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Bosutinib will only be prescribed by a doctor experienced in the use of medicines for treating leukemia.

Dosage and administration

The recommended dose is 400 mg once daily for patients with newly diagnosed CML. The recommended dose is 500 mg once daily for patients for whom previous treatments for CML have not been effective or are not suitable. In case of moderate or severe renal impairment, your doctor will reduce the dose by 100 mg once daily for moderate renal impairment and by an additional 100 mg once daily for severe renal impairment. Your doctor may adjust the dose using the 100 mg tablets, depending on your health status, response to treatment, and/or any adverse effects you may experience. Take the tablet(s) once daily with food. Swallow the tablet(s) whole with a little water.

If you take more Bosutinib Stada than you should

If you accidentally take too many bosutinib tablets or a higher dose than required, go immediately to a doctor. If possible, show the doctor the packaging or this leaflet. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bosutinib Stada

If less than 12 hours have passed, take the recommended dose. If more than 12 hours have passed, take your next dose at the usual time, the following day.

Do not take a double dose to make up for forgotten doses.

If you stop taking Bosutinib Stada

Do not stop taking bosutinib unless instructed by your doctor. If you are unable to take the medicine as directed by your doctor or think you no longer need it, consult your doctor immediately.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You should consult your doctor immediately if you experience any serious adverse effects (see also section 2, “What you need to know before taking Bosutinib Stada”):

Blood disorders. Inform your doctor immediately if you have any of the following symptoms: bleeding, fever, or frequent bruising (you may have a disorder of the blood or lymphatic system).

Liver disorders. Inform your doctor immediately if you have any of the following symptoms: itching, yellowing of the eyes or skin, dark urine, pain or discomfort in the upper right part of the stomach, or fever.

Stomach/intestinal disorders. Inform your doctor if you experience stomach pain, heartburn, diarrhea, constipation, nausea, or vomiting.

Heart problems. Inform your doctor if you have a heart condition such as an abnormal electrical signal known as “QT interval prolongation,” or if you faint (lose consciousness) or have an irregular heartbeat during treatment with bosutinib.

Reactivation of hepatitis B virus. Recurrence (reactivation) of hepatitis B virus infection if you have previously had hepatitis B (a liver infection).

Severe skin reactions. Inform your doctor immediately if you have any of the following symptoms: a painful red or purple rash that spreads and begins to blister and/or other lesions appear on mucous membranes (e.g., mouth and lips).

The adverse effects that may occur with bosutinib are:

Very common adverse effects (may affect more than 1 in 10 patients):

• reduction in the number of platelets, red blood cells, and/or neutrophils (a type of white blood cell).
• diarrhea, vomiting, stomach pain, nausea.
• fever, swelling of the hands, feet, or face, fatigue, weakness.
• respiratory tract infection.
• nasopharyngitis.
• abnormal blood test results indicating that bosutinib may be affecting the liver and/or pancreas, kidneys.
• decreased appetite.
• joint pain, back pain.
• headache.
• skin rash, with itching of the skin and/or generalized itching.
• cough.
• difficulty breathing.
• sensation of unsteadiness (dizziness).
• fluid in the lungs (pleural effusion).
• itching.

Common adverse effects (may affect up to 1 in 10 patients):

• decrease in white blood cell count (leukopenia).
• stomach irritation (gastritis), bleeding in the stomach or intestine.
• chest pain, pain.
• toxic liver injury, abnormal liver function, including liver disorder.
• lung infection (pneumonia), flu, bronchitis.
• decrease in heart rate leading to fainting, dizziness, and palpitations.
• increase in blood pressure.
• elevated potassium in the blood, decreased phosphorus in the blood, excessive loss of body fluids (dehydration).
• muscle pain.
• altered sense of taste (dysgeusia).
• acute kidney injury, kidney failure, renal impairment.
• fluid around the heart (pericardial effusion).
• ringing in the ears (tinnitus).
• urticaria (hives), acne.
• photosensitivity reaction (sensitivity to UV rays from sunlight and other light sources).
• allergic reaction.
• abnormally high blood pressure in the arteries of the lungs (pulmonary hypertension).
• acute inflammation of the pancreas (acute pancreatitis).
• respiratory failure.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• fever associated with low white blood cell count (febrile neutropenia).
• liver damage.
• life-threatening allergic reaction (anaphylactic shock).
• abnormal accumulation of fluid in the lungs (acute pulmonary edema).
• skin rash.
• inflammation of the lining of the heart or pericardium (pericarditis).
• significant decrease in the number of granulocytes (a type of white blood cell).
• serious skin disorder (erythema multiforme).
• nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue related to abnormal laboratory test results (elevated potassium, uric acid, and phosphorus in the blood, and decreased calcium in the blood) which may lead to changes in kidney function and acute kidney failure (tumor lysis syndrome [TLS]).
• inflammation of blood vessels in the skin, which may cause a skin rash or bruising (cutaneous vasculitis).

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

• serious skin disorder (Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative rash (scaly, peeling).
• interstitial lung disease (disorders causing scarring in the lungs): signs include cough, difficulty breathing, and painful breathing.

Reporting of adverse effects

If you experience any type of 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 Bosutinib Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the aluminium foil of the blister pack and on the outer packaging, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is bosutinib. Bosutinib Stada film-coated tablets EFG are available in various strengths.

Bosutinib Stada 100 mg: each film-coated tablet contains 100 mg of bosutinib.

Bosutinib Stada 400 mg: each film-coated tablet contains 400 mg of bosutinib.

Bosutinib Stada 500 mg: each film-coated tablet contains 500 mg of bosutinib.

• The other components are: microcrystalline cellulose (E460), sodium croscarmellose (E468), colloidal anhydrous silica, magnesium stearate. The tablet coating contains poly(vinyl alcohol) (E1203), macrogol, talc (E553b), titanium dioxide (E171) and yellow iron oxide (E172, in Bosutinib Stada 100 mg and 400 mg) or red iron oxide (E172, in Bosutinib Stada 400 mg and 500 mg).

Nature of the product and pack contents

Bosutinib Stada 100 mg film-coated tablets EFG are yellow, oval biconvex tablets, marked with the code “C18” on one side.

Bosutinib Stada 100 mg is available in blisters containing 28 or 112 film-coated tablets and in single-dose perforated blister packs of 28x1 or 112x1 film-coated tablets.

Bosutinib Stada 400 mg film-coated tablets EFG are orange, oval biconvex tablets, marked with the code “C19” on one side.

Bosutinib Stada 400 mg is available in blisters containing 28 or 112 film-coated tablets and in single-dose perforated blister packs of 28x1 or 112x1 film-coated tablets.

Bosutinib Stada 500 mg film-coated tablets EFG are pink, oval biconvex tablets, marked with the code “C20” on one side.

Bosutinib Stada 500 mg is available in blisters containing 28 or 112 film-coated tablets and in single-dose perforated blister packs of 28x1 or 112x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS -220 Hafnarfjordur

Iceland

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

Dortweil, Bad Vilbel

61118 Hesse

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Gurtnafleur, Clonmel,

E91 D768, Co. Tipperary

Ireland

This medicinal product is authorized in the European Economic Area member states 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

France BOSUTINIB EG 100 mg, comprimé pelliculé

BOSUTINIB EG 400 mg, comprimé pelliculé

BOSUTINIB EG 500 mg, comprimé pelliculé

Germany Bosutinib STADA 100 mg Filmtabletten

Bosutinib STADA 400 mg Filmtabletten

Bosutinib STADA 500 mg Filmtabletten

Iceland Bosutinib STADA

Ireland Bosutinib Clonmel 100 mg film coated tablets

Bosutinib Clonmel 400 mg film coated tablets

Bosutinib Clonmel 500 mg film coated tablets

Luxembourg Bosutinib EG 100 mg comprimés pelliculés

Bosutinib EG 400 mg comprimés pelliculés

Bosutinib EG 500 mg comprimés pelliculés

Netherlands Bosutinib CF 100 mg, filmomhulde tabletten

Bosutinib CF 400 mg, filmomhulde tabletten

Bosutinib CF 500 mg, filmomhulde tabletten

Norway Bosutinib STADA

Poland Bosutinib Stada

Spain Bosutinib Stada 100 mg comprimidos recubiertos con película EFG

Bosutinib Stada 400 mg comprimidos recubiertos con película EFG

Bosutinib Stada 500 mg comprimidos recubiertos con película EFG

Sweden Bosutinib STADA

Date of the most recent review of this leaflet: February 2026

Other sources of information. 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/)