Leaflet: information for the user

Bosutinib Stada 100 mg film-coated tablets

Bosutinib Stada 400 mg film-coated tablets

Bosutinib Stada 500 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 or pharmacist.
• 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, even if they are not listed in this leaflet. See section 4.

This medication contains the active ingredient bosutinib. It is used to treat adult patients who suffer from a type of leukemia called chronic myeloid leukemia (CML) with a Philadelphia chromosome positive (Ph-positive) diagnosis, either newly diagnosed or for whom previous medications to treat CML have not been effective or are not suitable. CML Ph-positive is a blood cancer that causes the body to produce an excessive amount of a specific type of white blood cells called granulocytes.

If you have any doubts about how bosutinib works or why you have been prescribed this medication, consult your doctor.

Do not take Bosutinib Stada

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take bosutinib:

Sol/UV protection

During treatment with bosutinib, you may be more sensitive to the sun or UV rays. It is essential to cover exposed areas of the body and use high-factor sunscreen (SPF).

Children and adolescents

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

Other medications and Bosutinib Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications, vitamins, and herbal supplements. Some medications may affect the concentrations of bosutinib in your body. You should inform your doctor if you are using medications that contain active ingredients such as the following:

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

The following active ingredients may reduce the effectiveness of bosutinib:

You should avoid using these medications during treatment with bosutinib. If you are using any of them, inform your doctor. Your doctor may change the doses of these medications, change the dose of bosutinib, or have you use a different medication.

The following active ingredients may affect heart rate:

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

It is possible that the medications listed in this prospectus 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 it may increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

Bosutinib should not be used during pregnancy unless it is clearly necessary, as bosutinib may harm the fetus. If you are pregnant or think you may be pregnant, consult your doctor before starting to take bosutinib.

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

Request information on sperm preservation before starting treatment, if desired, given the risk of reduced fertility during treatment with bosutinib.

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

Driving and operating machines

If you experience dizziness, blurred vision, or unusual fatigue, do not drive or operate machines until these adverse effects have disappeared.

Bosutinib Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Bosutinib will only be prescribed by a doctor experienced in using medications to treat leukemia.

Dose and Administration Form

The recommended dose is 400 mg once a day for patients with newly diagnosed LMC. The recommended dose is 500 mg once a day for patients whose previous medications to treat LMC have not been effective or are not suitable. In case of moderate or severe kidney problems, your doctor will reduce the dose by 100 mg once a day for moderate kidney problems and an additional 100 mg once a day for severe kidney problems. Your doctor may adjust the dose using 100 mg tablets, based on your health status, in response to treatment and/or adverse effects you may experience. Take the tablet(s) once a day, 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 you need, go immediately to a doctor. If possible, show the doctor the packaging or this leaflet. You may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 next day.

Do not take a double dose to compensate for missed doses.

If You Interrupt Treatment with Bosutinib Stada

Do not stop taking bosutinib unless your doctor tells you to. If you cannot take the medication as indicated by your doctor or think you no longer need it, consult your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

You should consult your doctor immediately if you experience any severe side effects (see also section 2 “What you need to know before starting to take Bosutinib Stada”):

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

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

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

Cardiac problems.Inform your doctor if you experience any of the following: abnormal heart rhythm called “prolongation of the QT interval,” or if you faint (lose consciousness) or experience irregular heartbeats during treatment with bosutinib.

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

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

The side effects that may occur with bosutinib are:

Very common side 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.
• Loss of appetite.
• Joint pain, back pain.
• Headache.
• Rash, itching on the skin, and/or generalized.
• Cough.
• Difficulty breathing.
• Dizziness (lightheadedness).
• Liquid in the lungs (pleural effusion).
• Itching.

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

• Decrease in the white blood cell count (leucopenia).
• Stomach irritation (gastritis), bleeding in the stomach or intestines.
• Chest pain, pain.
• Toxic liver damage, abnormal liver function, including liver disorder.
• Pulmonary infection (pneumonia), flu, bronchitis.
• Decrease in heart rate that predisposes to fainting, dizziness, and palpitations.
• Increased blood pressure.
• Elevated potassium in the blood, decreased phosphorus in the blood, excessive loss of body fluids (dehydration).
• Muscle pain.
• Alteration of taste (dysgeusia).
• Acute kidney failure, renal failure, renal deterioration.
• Liquid around the heart (pericardial effusion).
• Tinnitus (ringing in the ears).
• Hives, acne.
• Photosensitivity reaction (sensitivity to UV rays from the sun and other light sources).
• Allergic reaction.
• Abnormally high blood pressure in the pulmonary arteries (pulmonary hypertension).
• Acute pancreatitis (inflammation of the pancreas).
• Respiratory insufficiency.

Rare side effects (may affect up to 1 in 100 patients):

• Fever associated with low white blood cell count (neutropenic fever).
• Liver damage.
• Life-threatening allergic reaction (anaphylactic shock).
• Abnormal accumulation of fluid in the lungs (acute pulmonary edema).
• Rash.
• Pericarditis (inflammation of the heart sac or pericardium).
• Significant decrease in granulocyte count (a type of white blood cell).
• Severe skin disorder (erythema multiforme).
• Nausea, difficulty breathing, irregular heartbeats, 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) that may cause renal dysfunction and acute kidney failure (tumor lysis syndrome [TLS]).

Unknown frequency (cannot be estimated from available data):

• Severe skin disorder (Stevens-Johnson syndrome, toxic epidermal necrolysis) caused by an allergic reaction, exfoliative dermatitis (scaly, peeling).
• Pulmonary interstitial disease (diseases that cause scarring in the lungs): symptoms include cough, difficulty breathing, and painful breathing.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. 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 aluminum foil of the blister pack and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been altered.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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.

Appearance of the product and contents of the package

Bosutinib Stada 100 mg film-coated tablets are yellow in color and oval-shaped, biconvex, marked with the legend “C18” on one side.

Bosutinib Stada 100 mg is marketed in blisters containing 28 or 112 film-coated tablets and in pre-cut single-dose blisters of 28x1 or 112x1 film-coated tablets.

Bosutinib Stada 400 mg film-coated tablets are orange in color and oval-shaped, biconvex, marked with the legend “C19” on one side.

Bosutinib Stada 400 mg is marketed in blisters containing 28 or 112 film-coated tablets and in pre-cut single-dose blisters of 28x1 or 112x1 film-coated tablets.

Bosutinib Stada 500 mg film-coated tablets are pink in color and oval-shaped, biconvex, marked with the legend “C20” on one side.

Bosutinib Stada 500 mg is marketed in blisters containing 28 or 112 film-coated tablets and in pre-cut single-dose blisters of 28x1 or 112x1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Coripharma ehf.

Reykjavikurvegur 78

IS -220 Hafnarfjordur

Islandia

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

Dortweil, Bad Vilbel

61118 Hassia

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Gurtnafleur, Clonmel,

E91 D768, Co. Tipperary

Ireland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Bélgica Bosutinib EG 100 mg filmomhulde tabletten

Bosutinib EG 400 mg filmomhulde tabletten

Bosutinib EG 500 mg filmomhulde tabletten

Dinamarca Bosutinib STADA

Finlandia Bosutinib STADA

Francia BOSUTINIB EG 100 mg, comprimé pelliculé

BOSUTINIB EG 400 mg, comprimé pelliculé

BOSUTINIB EG 500 mg, comprimé pelliculé

Alemania Bosutinib STADA 100 mg Filmtabletten

Bosutinib STADA 400 mg Filmtabletten

Bosutinib STADA 500 mg Filmtabletten

Islandia Bosutinib STADA

Irlanda Bosutinib Clonmel 100 mg film coated tablets

Bosutinib Clonmel 400 mg film coated tablets

Bosutinib Clonmel 500 mg film coated tablets

Luxemburgo Bosutinib EG 100 mg comprimés pelliculés

Bosutinib EG 400 mg comprimés pelliculés

Bosutinib EG 500 mg comprimés pelliculés

Países Bajos Bosutinib CF 100 mg, filmomhulde tabletten

Bosutinib CF 400 mg, filmomhulde tabletten

Bosutinib CF 500 mg, filmomhulde tabletten

Noruega Bosutinib STADA

Polonia Bosutinib Stada

España 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

Suecia Bosutinib STADA

Last revision date of this leaflet: January 2024

Other sources of information. The 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/ )