Bosutinib Dr. Reddy's 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bosutinib Dr. Reddys 100 mg film-coated tablets EFG

Bosutinib Dr. Reddys 400 mg film-coated tablets EFG

Bosutinib Dr. Reddys 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 you should not give it 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 the effects are not listed in this leaflet. See section 4.

Package leaflet

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

1. What Bosutinib Dr. Reddy's 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 an excessive number of a specific type of white blood cells called granulocytes.

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

2. What you need to know before starting to take Bosutinib Dr. Reddys

Do not take bosutinib

• 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 and that your liver does not work properly.

Warnings and precautions

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

• if you 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 a history of 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 area 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 with bosutinib, or as clinically indicated.

• if you have diarrhoea and vomiting. Inform your doctor if you experience any of the following signs and symptoms: an increase in the number of daily bowel movements, an increase in the number of vomiting episodes, blood in vomit, stools or urine, or the appearance of black, tarry stools. Consult your doctor if treatment for vomiting may lead to an increased risk of cardiac arrhythmias. In particular, consult your doctor if you intend to use any medicine containing domperidone to treat nausea and/or vomiting. Treating nausea or vomiting with such medicines, when used together with Bosutinib Dr. Reddys, 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 such as 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 condition, such as arrhythmias or an abnormal electrical signal known as "prolongation of the QT interval". These conditions are always important, but even more so if you have frequent or prolonged diarrhoea 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 a serious heart condition.

• if you have been told you have kidney problems. Inform your doctor if you urinate more frequently and produce larger amounts of clear-coloured urine, or if you urinate less frequently and produce smaller amounts of dark-coloured 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 might currently have an infection with the hepatitis B virus. 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 experience 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 notice any of the following symptoms: flank pain, blood in the urine, or decreased urine output. If your condition is very severe, your body may not be able to eliminate all waste products from dying cancer cells. This is known as tumour lysis syndrome and may lead to kidney failure and heart problems within 48 hours after the first dose of Bosutinib Dr. Reddys. Your doctor will ensure you are adequately hydrated and will give you other medications to help prevent this.

Sun/UV Protection

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

Children and adolescents

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

Other medicines and bosutinib

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription, vitamins, and herbal supplements. Some medicines can affect the levels of bosutinib in your body. You should inform your doctor if you are using medicines containing active substances such as those listed below:

The following active substances may increase the risk of experiencing 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 reduce 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 efficacy 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 must avoid using these medications during bosutinib treatment. If you are taking any of them, inform your doctor. Your doctor may adjust the doses of these medications, adjust your bosutinib dose, or switch you to a different medication.

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, which are 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 taken with caution during treatment with Bosutinib Dr. Reddy's. If you are taking any of them, inform your doctor.

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

Taking bosutinib 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 must not be used during pregnancy unless clearly necessary, as bosutinib may harm the fetus. If you are pregnant or think you might be pregnant, consult your doctor before starting bosutinib treatment.

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.

Seek information on 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 bosutinib treatment, as it may harm the baby.

Driving and operating machinery

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

Bosutinib Dr. Reddy's contains sodium

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

3. How to take Bosutinib Dr. Reddys

Follow exactly the dosage instructions for this medicine as indicated 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 method of 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 medications to treat 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 adverse effects you may experience. Take the tablet(s) once daily with food. Swallow the tablet(s) whole with some water.

If you take more bosutinib than you should

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

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

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 a missed dose.

If treatment with bosutinib is interrupted

Do not stop taking bosutinib unless instructed by your doctor. If you are unable to take the medication as directed by your doctor or 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 adverse effects

Like all medicines, this medicine may 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 starting to take Bosutinib Dr. Reddys"):

Blood disorders. Immediately inform your doctor 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. Immediately inform your doctor if you have any of the following symptoms: itching, yellowing of the eyes or skin, dark urine, pain or discomfort in the upper right side 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 called "QT interval prolongation," or if you faint (lose consciousness) or have an irregular heartbeat during treatment with Bosutinib Dr. Reddys.

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 form blisters and/or other lesions on the 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 cells).
• 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.
• feeling of instability (dizziness).
• fluid in the lungs (pleural effusion).
• itching.

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

• decrease in white blood cell count (leucopenia).
• 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.
• decreased heart rate leading to fainting, dizziness, and palpitations.
• increased blood pressure.
• elevated potassium in the blood, decreased phosphate in the blood, excessive loss of body fluids (dehydration).
• muscle pain.
• disturbance of taste sensation (dysgeusia).
• acute kidney failure, renal failure, kidney impairment.
• fluid around the heart (pericardial effusion).
• ringing in the ears (tinnitus).
• hives (urticaria), 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).
• marked decrease in the number of granulocytes (a type of white blood cells).
• severe 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 levels in the blood and decreased calcium levels in the blood), which may lead to changes in kidney function and acute kidney injury (tumor lysis syndrome [TLS]).
• inflammation of the blood vessels in the skin, which may cause a skin rash or bruising (cutaneous vasculitis).

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bosutinib Dr. Reddy's

• Keep this medicine out of the 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. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Bosutinib Dr. Reddy's

• The active substance is bosutinib. Bosutinib Dr. Reddy's film-coated tablets are available in various strengths.

Bosutinib Dr. Reddy's 100 mg: each film-coated tablet contains 100 mg of bosutinib.

Bosutinib Dr. Reddy's 400 mg: each film-coated tablet contains 400 mg of bosutinib.

Bosutinib Dr. Reddy's 500 mg: each film-coated tablet contains 500 mg of bosutinib.

• The other ingredients 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), yellow iron oxide (E172, in Bosutinib Dr. Reddy's 100 mg and 400 mg), red iron oxide (E172, in Bosutinib Dr. Reddy's 400 mg and 500 mg).

Appearance of the product and contents of the pack

Bosutinib Dr. Reddy's 100 mg film-coated tablets are yellow, oval-shaped, biconvex tablets, marked with the code "C18" on one side.

Bosutinib Dr. Reddy's 100 mg is available in blisters containing 28 or 112 tablets.

Bosutinib Dr. Reddy's 100 mg is also available in single-dose perforated blister packs containing 28x1 or 112x1 tablets.

Bosutinib Dr. Reddy's 400 mg film-coated tablets are orange, oval-shaped, biconvex tablets, marked with the code "C19" on one side.

Bosutinib Dr. Reddy's 400 mg is available in blisters containing 28 tablets.

Bosutinib Dr. Reddy's 400 mg is also available in single-dose perforated blister packs containing 28x1 tablets.

Bosutinib Dr. Reddy's 500 mg film-coated tablets are pink, oval-shaped, biconvex tablets, marked with the code "C20" on one side.

Bosutinib Dr. Reddy's 500 mg is available in blisters containing 28 tablets.

Bosutinib Dr. Reddy's 500 mg is also available in single-dose perforated blister packs containing 28x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS -220 Hafnarfjordur

Iceland

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

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

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.