Bosutinib dr. reddys 100 mg comprimidos recubiertos con pelicula efg
Introduction
Prospect: information for the user
Bosutinib Dr. Reddys 100 mg film-coated tablets
Bosutinib Dr. Reddys 400 mg film-coated tablets
Bosutinib Dr. Reddys 500 mg film-coated tablets
Read this prospect carefully before starting to take this medicine, as it contains important information for you.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed to you alone, 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 adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.
Content of the prospect
- What Bosutinib Dr. Reddys is and for what it is used
- What you need to know before starting to take Bosutinib Dr. Reddys
- How to take Bosutinib Dr. Reddys
- Possible adverse effects
- Storage of Bosutinib Dr. Reddys
- Contents of the package and additional information
1. What is Bosutinib Dr. Reddys and how is it used
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 positive Philadelphia chromosome (Ph-positive) that has recently been diagnosedor 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 the reason why you have been prescribed this medication, consult your doctor.
2. What you need to know before starting Bosutinib Dr. Reddys
Do not take bosutinib
- if you are allergic to bosutinib or any of the other ingredients in this medicine (listed in section 6).
- if your doctor has told you that you have a damaged liver and it does not work normally.
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to take bosutinib:
- if you have, or have had in the past, liver problems.Inform your doctor if you have a history of liver problems, including any type of hepatitis (infection or inflammation of the liver), or a history of any of the following signs and symptoms of liver problems: itching, yellow eyes or skin, dark urine, and pain or discomfort in the upper right side 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 diarrhea and vomiting.Inform your doctor if you experience any of the following signs and symptoms: increased frequency of bowel movements, increased frequency of vomiting episodes, blood in the vomit, stools or urine, or the appearance of black stools (“tarry stools”). Consult your doctor if the treatment for vomiting may increase the risk of cardiac arrhythmias. In particular, consult your doctor if you wish to use a medication containing domperidone for the treatment of nausea and/or vomiting. The treatment of nausea or vomiting with medications of this type, if used in combination with Bosutinib Dr. Reddys, may increase the risk of life-threatening 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 petechiae without any 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 burning sensation while urinating, new cough or 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 cardiac alteration, such as arrhythmias or an abnormal electrical signal called "prolongation of the QT interval". These problems are always important, but even more so if you have frequent or prolonged diarrhea as indicated above. If you faint (lose consciousness) or experience irregular heartbeats during treatment with bosutinib, inform your doctor immediately, as they may be signs of a serious heart disease.
- if you have been told that you have kidney problems.Inform your doctor if you urinate more frequently and produce larger amounts of clear urine, or if you urinate less frequently and produce smaller amounts of dark 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 have a hepatitis B virus infection.This is because bosutinib may reactivate hepatitis B, which can be fatal in some cases. The doctor should carefully check for signs of this infection before starting treatment.
- if you have or have had in the past pancreas problems.Inform your doctor if you experience any abdominal pain or discomfort.
- if you experience any of the following symptoms: severe skin eruptions.Inform your doctor if you experience any of the following signs and symptoms of 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).
- if you experience any of the following symptoms: side pain, blood in the urine or decreased urine output.If your disease is very serious, your body may not be able to eliminate all the waste products of dying cancer cells. This is called tumor lysis syndrome and can cause kidney failure and heart problems within 48 hours of the first dose of Bosutinib Dr. Reddys. Your doctor will ensure that you are well-hydrated and will give you other medications to help prevent it.
Sun/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 a high-factor sunscreen (SPF).
Children and adolescents
Bosutinib is not recommended for children under 18 years of age. This medicine has not been studied in children or adolescents.
Other medicines and bosutinib
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including over-the-counter medicines, vitamins and herbal remedies. Some medicines may affect the concentrations of bosutinib in your body. You should inform your doctor if you are using medicines that contain active ingredients such as the following:
The following active ingredients 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 reduce blood pressure in people with high blood pressure.
- ritonavir, lopinavir/ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, amprenavir, fosamprenavir and darunavir, used to treat HIV/AIDS.
- 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-microcytic lung cancer.
The following active ingredients 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 medicinal herb that can be obtained without a prescription), used to treat depression.
- efavirenz and etravirine, used to treat HIV/AIDS.
- modafinil, used to treat certain types of sleep disorders.
You should avoid using these medicines during treatment with bosutinib. If you are using any of them, inform your doctor. Your doctor may change the doses of these medicines, change the dose of bosutinib or have you use a different medicine.
The following active ingredients may affect heart rate:
- amiodarone, disopyramide, procainamide, quinidine and sotalol, used to treat cardiac 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 milk production.
- methadone, used to treat pain.
These medicines should be taken with caution during treatment with Bosutinib Dr. Reddys. If you are taking any of them, inform your doctor.
It is possible that the medicines listed in this prospectus 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 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 Dr. Reddys contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.
3. How to Take Bosutinib Dr. Reddys
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 who has experience with medications used 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 for treating 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 than you should
If you accidentally take too many bosutinib tablets or a higher dose than you need, go to a doctor immediately. 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
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
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.
4. Possible Adverse Effects
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 serious side effects (see also section 2 “What you need to know before starting to take Bosutinib Dr. Reddys”):
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 stomach pain, heartburn, diarrhea, constipation, nausea, or vomiting.
Cardiac problems.Inform your doctor if you experience any cardiac alteration, such as an abnormal electrical signal called “prolongation of the QT interval,” or if you faint (lose consciousness) or experience irregular heartbeats during treatment with Bosutinib Dr. Reddys.
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 appear 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.
- Alteration of blood tests indicating that bosutinib may be affecting the liver and/or pancreas, kidneys.
- Decreased appetite.
- Joint pain, back pain.
- Headache.
- Skin rash, itching on the skin and/or generalized.
- Cough.
- Difficulty breathing.
- Dizziness (dizziness).
- Liquid in the lungs (pleural effusion).
- Itching.
Common side effects (may affect up to 1 in 10 patients):
- Decrease in the count of white blood cells (leucopenia).
- Stomach irritation (gastritis), bleeding in the stomach or intestine.
- 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 renal failure, renal failure, renal deterioration.
- Liquid around the heart (pericardial effusion).
- Tinnitus (ringing in the ears).
- Urticaria (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.
- Severe allergic reaction with risk of death (anaphylactic shock).
- Abnormal accumulation of fluid in the lungs (acute pulmonary edema).
- Skin rash.
- Pericarditis (inflammation of the heart or pericardium).
- Significant decrease in the number of granulocytes (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 renal failure (tumor lysis syndrome [TLS]).
Unknown frequency (cannot be estimated from available data):
- Severe skin disorder (Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative dermatitis.
- Pulmonary interstitial disease (diseases that cause scarring in the lungs): symptoms are cough, difficulty breathing, and painful breathing).
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.
By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Bosutinib Dr. Reddys
- 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 conditions for conservation.
- Do not use this medication if you observe that the packaging is deteriorated or presents signs of having been altered.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
Bosutinib Composition by Dr. Reddys
- The active ingredient is bosutinib. Bosutinib Dr. Reddys film-coated tablets are available in various doses.
Bosutinib Dr. Reddys 100 mg: Each film-coated tablet contains 100 mg of bosutinib.
Bosutinib Dr. Reddys 400 mg: Each film-coated tablet contains 400 mg of bosutinib.
Bosutinib Dr. Reddys 500 mg: Each film-coated tablet contains 500 mg of bosutinib.
- The other components are: microcrystalline cellulose (E460), sodium croscarmellose (E468), anhydrous colloidal silica, magnesium stearate. The tablet coating contains poly(vinyl alcohol) (E1203), macrogol, talc (E553b) titanium dioxide (E171), yellow iron oxide (E172, in Bosutinib Dr. Reddys 100 mg and 400 mg), red iron oxide (E172, in Bosutinib Dr. Reddys 400 mg and 500 mg).
Product Appearance and Packaging Contents
Bosutinib Dr. Reddys 100 mg film-coated tablets are yellow in color and oval-shaped biconvex, marked with the legend “C18” on one face.
Bosutinib Dr. Reddys 100 mg is marketed in blisters containing 28 or 112 tablets.
Bosutinib Dr. Reddys 100 mg is marketed in perforated single-dose blisters containing 28x1 or 112x1 tablets.
Bosutinib Dr. Reddys 400 mg film-coated tablets are orange in color and oval-shaped biconvex, marked with the legend “C19” on one face.
Bosutinib Dr. Reddys 400 mg is marketed in blisters containing 28 tablets.
Bosutinib Dr. Reddys 400 mg is marketed in perforated single-dose blisters containing 28x1 tablets.
Bosutinib Dr. Reddys 500 mg film-coated tablets are pink in color and oval-shaped biconvex, marked with the legend “C20” on one face.
Bosutinib Dr. Reddys 500 mg is marketed in blisters containing 28 tablets.
Bosutinib Dr. Reddys 500 mg is marketed in perforated single-dose blisters containing 28x1 tablets.
Only some packaging sizes may be marketed.
Marketing Authorization Holder
Reddy Pharma Iberia, S.A.
Avda. Josep Tarradellas nº 38
08029 Barcelona
Spain
Responsible Person for Manufacturing
Coripharma ehf.
Reykjavikurvegur 78
IS -220 Hafnarfjordur
Iceland
This medicinal product is authorized in the member states of the European Economic Area with the following names:
Member State Name | Medicinal Product Name |
Germany | Bosutinib beta 100 mg Filmtabletten Bosutinib beta 400 mg Filmtabletten Bosutinib beta 500 mg Filmtabletten |
Spain | 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 |
Iceland | Bosutinib beta |
Italy | Bosutinib Dr. Reddy’s |
Last review date of this leaflet:January 2024
Further 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/.
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