BOSUTINIB 100 mg Tabletki Powlekane

Treść ulotki

1. Bosutinib Teva 100 mg film-coated tablets, 400 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Bosutinib Teva and what is it used for
   2. What you need to know before taking Bosutinib Teva
   3. How to take Bosutinib Teva
   4. Possible side effects
   5. How to store Bosutinib Teva
   6. Package contents and other information

Bosutinib Teva 100 mg film-coated tablets, 400 mg film-coated tablets, 500 mg film-coated tablets

bosutinib

Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Bosutinib Teva contains the active substance bosutinib. It is used to treat adult patients suffering
from a type of leukemia called chronic myeloid leukemia with positive Philadelphia chromosome
(Ph+) and who are newly diagnosed or for whom previous treatments for chronic myeloid
leukemia have not worked or were not adequate. Ph+ chronic myeloid leukemia is a form of
blood cancer that causes the production of an excessive number of a specific type of white
blood cells called granulocytes.
If you have any questions about the action of Bosutinib Teva or the reason why this medicine has been
prescribed to you, please consult your doctor.

2. What you need to know before taking Bosutinib Teva

Do not take Bosutinib Teva

• 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 it is not working normally.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bosutinib Teva:

• if you have or have had liver problems in the past.Tell your doctor if you have had liver problems in the past, including hepatitis (infection or inflammation of the liver) of any kind, or if you have experienced any of the following signs and symptoms of liver problems: itching, yellowing of the skin or eyes, dark urine, and pain or discomfort in the upper right side of your abdomen. Your doctor needs to perform blood tests to check your liver function before starting treatment with Bosutinib Teva, during the first 3 months of treatment with Bosutinib Teva, and when clinically indicated.

with Bosutinib Teva, during the first 3 months of treatment with Bosutinib Teva and when clinically indicated.

• if you have diarrhoea and vomiting.Tell your doctor if you develop any of the following signs and symptoms: an increase in the number of bowel movements (stools) per day beyond the normal, an increase in the number of vomiting episodes, blood in your vomit, stools (bowel movements) or urine, or black stools (tarry stools). You should ask your doctor if treating your vomiting may involve a greater risk of developing heart rhythm problems. In particular, you should seek your doctor's advice if you want to take a medicine containing domperidone to treat nausea and/or vomiting. Treating nausea or vomiting with this type of medicine in combination with Bosutinib Teva may increase the risk of dangerous heart rhythm abnormalities.
• if you have bleeding problems.Tell your doctor if you develop any of the following signs and symptoms, such as abnormal bleeding or bruising, without any injury.
• if you have an infection.Tell your doctor if you develop any of the following signs and symptoms, such as fever, problems with urination, such as a burning sensation when urinating, new onset of cough, or new onset of sore throat.
• if you have fluid retention.Tell your doctor if you develop any of the following signs and symptoms of fluid retention during treatment with Bosutinib Teva, such as swelling of the ankles, feet or legs, difficulty breathing, chest pain or cough (these may be signs of fluid retention in the lungs or chest).
• if you have heart problems.Tell your doctor if you suffer from a heart condition, such as arrhythmias or an abnormal electrical signal called “prolonged QT interval”. This is always important, but especially if you experience frequent or prolonged diarrhoea, as described above. If you faint (lose consciousness) or have an irregular heartbeat while taking Bosutinib Teva, tell your doctor immediately as it may be a sign of a serious heart condition.
• if you have been told you have kidney problems.Tell your doctor if you urinate more frequently and produce larger amounts of light-coloured urine, or if you urinate less frequently and produce smaller amounts of dark-coloured urine. Also, tell your doctor if you are losing weight or if you have had swelling in your feet, ankles, legs, hands or face.
• if you have had or may currently have a hepatitis B infection.This is because Bosutinib Teva may cause reactivation of hepatitis B, which can be fatal in some cases. Patients will be carefully examined by their doctor for signs of this infection before starting treatment.
• if you have or have had problems with your pancreas.Tell your doctor if you develop abdominal pain or discomfort.
• if you have any of these symptoms: severe skin rash.Tell your doctor if you develop any of the following signs or symptoms of painful, red or purplish skin rash that is progressively spreading, and blisters and/or other lesions that begin to appear on the mucous membranes (e.g. mouth and lips).
• if you experience any of these symptoms: flank pain, blood in the urine, or reducedurine output.If your condition is very severe, your body may not be able to eliminate all waste products from the dying cancer cells. This condition is called tumor lysis syndrome and can cause kidney failure and heart problems within 48 hours of the first dose of Bosutinib Teva. Your doctor is aware of this situation and can

ensure that you receive adequate hydration and may provide you with other medicines to
prevent this condition.

Sun protection/UV
While taking bosutinib you may become more sensitive to the sun or UV rays. It is important to
cover areas of skin exposed to sunlight and use sunscreens with a high sun protection factor (SPF).

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

Other medicines and Bosutinib Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any medicines, including those available without a prescription, vitamins and herbal medicines.
Some medicines can affect the levels of Bosutinib Teva in the body. You should tell your
doctor if you are taking medicines containing the active substances listed below:

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

• 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 HIV/AIDS infections.
• 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 Teva:

• rifampicin, used to treat tuberculosis.
• phenytoin and carbamazepine, used to treat epilepsy.
• bosentan, used to lower high blood pressure in the lungs (pulmonary hypertension).
• nafcillin, an antibiotic used to treat bacterial infections.
• St John's Wort (Hypericum perforatum, a herbal remedy sold without a prescription), used to treat depression.
• efavirenz and etravirine, used to treat human immunodeficiency virus (HIV)/AIDS infections.
• modafinil, used to treat certain types of sleep disorders.

These medicines should be avoided while taking Bosutinib Teva. If you are taking any of
these medicines, tell your doctor. Your doctor may adjust the dose of these medicines or of
Bosutinib Teva, or switch you to a different medicine.

The following active substances may alter the heart rhythm:

• amiodarone, disopyramide, procainamide, quinidine and sotalol, used to treat heart diseases.
• chloroquine, halofantrine, used to treat malaria.
• clarithromycin and moxifloxacin, antibiotics used to treat bacterial infections.
• haloperidol, used to treat psychotic illnesses, 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 while taking Bosutinib Teva. If
you are taking any of these medicines, tell your doctor.
The medicines listed here may not be the only ones to interact with Bosutinib Teva.

Bosutinib Teva with food and drink
Do not take Bosutinib Teva with grapefruit or grapefruit juice as the risk of side
effects may increase.

Pregnancy, breastfeeding and fertility
Bosutinib Teva should not be used during pregnancy unless considered necessary
because it may cause harm to the fetus. Ask your doctor for advice before taking Bosutinib Teva if you are
pregnant or might become pregnant.
Women taking Bosutinib Teva will be advised to use an effective method of contraception
during treatment and for at least 1 month after the last dose. Vomiting or diarrhoea may
reduce the effectiveness of oral contraceptives.
There is a possibility that treatment with Bosutinib Teva may lead to a decrease in
male fertility, so it may be possible to seek advice on sperm preservation before starting
therapy.
If you are breastfeeding, tell your doctor. Do not breastfeed during
treatment with Bosutinib Teva as it may cause harm to the baby.

Driving and using machines
If you experience dizziness, blurred vision or feel unusually tired, do not drive or use machines
until these side effects have worn off.

3. How to take Bosutinib Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Bosutinib Teva will be prescribed to you exclusively by a doctor experienced in medicines for the treatment
of leukemia.

Dosage and method of administration
The recommended dose is 400 mg once daily for patients with newly diagnosed chronic myeloid leukemia.
The recommended dose is 500 mg once daily for patients for whom previous medicines for the treatment
of chronic myeloid leukemia have not worked or are not suitable. If you have moderate or severe
kidney problems, your doctor will reduce the dose by 100 mg once daily for moderate kidney problems and
by another 100 mg once daily for severe kidney problems. Based on your medical condition, your
response to treatment and/or the side effects you may experience, your doctor may adjust the dose using
the 100 mg tablets. Take the tablet(s) once daily with food. Swallow the tablet(s) whole with a little
water.

If you take more Bosutinib Teva than you should
If you accidentally take too many Bosutinib Teva tablets or a higher dose than necessary, contact a doctor
immediately for advice. If possible, show the doctor the

If you forget to take Bosutinib Teva
If less than 12 hours have passed since the scheduled time of administration, take the recommended dose.
If more than 12 hours have passed, take the next dose at the usual time the next day.
Do not take a double dose to make up for forgotten tablets.

If you stop taking Bosutinib Teva
Do not stop taking Bosutinib Teva unless your doctor tells you to do so. If you are unable to
take the medicine as prescribed by your doctor or if you feel you no longer need it, contact your
doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You should immediately contact your doctor if you experience any of the serious side effects
(see also section 2 “What you need to know before taking Bosutinib Teva”):

Blood disorders.Immediately inform your doctor if you have any of these symptoms:
bleeding, fever or easy bruising (you may have a blood or lymphatic system disease).

Liver disorders.Immediately inform your doctor if you have any of these symptoms: itching,
yellowing of the skin or eyes, dark urine and pain or discomfort in the upper right area of the stomach or
fever.

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

Heart problems.Inform your doctor if you suffer from a heart condition, such as an abnormal electrical
signal called “QT prolongation” or if you faint (loss of consciousness) or have
an irregular heartbeat while taking Bosutinib Teva.

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

Severe skin reactions. Seek immediate medical attention if you have any of these symptoms: painful, red or
purple rash that spreads progressively, and blisters and/or other
lesions that begin to appear on the mucous membranes (e.g. mouth and lips).
The side effects of Bosutinib Teva may include:

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

• 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
• changes in blood tests indicating that Bosutinib Teva is affecting the liver and/or pancreas, kidneys
• decreased appetite
• joint pain, back pain
• headache
• skin rash, which may be itchy and/or widespread
• cough
• shortness of breath
• feeling unstable (dizziness)
• fluid in the lungs (pleural effusion)
• itching.

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

• low number of white blood cells (leukopenia)
• stomach irritation (gastritis), bleeding from the stomach or intestine
• chest pain, pain
• toxic damage to the liver, abnormal liver function, including liver disorders
• lung infection (pneumonia), influenza, bronchitis
• heart rhythm defect that predisposes to fainting, dizziness and palpitations
• increased blood pressure
• high potassium levels in the blood, low phosphorus levels in the blood, excessive loss of body fluids (dehydration)
• muscle pain
• altered sense of taste (dysgeusia)
• acute kidney failure, kidney failure, kidney impairment
• fluid around the heart (pericardial effusion)
• ringing in the ears (tinnitus)
• hives, acne
• photosensitivity reaction (sensitivity to UV rays from the sun 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 side effects (may affect up to 1 in 100 people):

• fever associated with a low red blood cell count (febrile neutropenia)
• liver damage
• potentially life-threatening allergic reaction (anaphylactic shock)
• abnormal accumulation of fluid in the lungs (acute pulmonary edema)
• skin rash
• inflammation of the membrane lining the heart (pericarditis)
• marked reduction in the number of granulocytes (a type of white blood cells)
• serious skin disorder (erythema multiforme)
• nausea, shortness of breath, irregular heartbeat, muscle cramps, convulsions, cloudy urine and fatigue associated with abnormal laboratory results (high levels of potassium, uric acid and phosphorus and low levels of calcium in the blood) which may cause changes in kidney function and acute kidney failure - (tumor lysis syndrome (TLS)).

Not known (frequency cannot be estimated based on available data):

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

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Bosutinib Teva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the blister and the package after “Scad.”. The expiry date refers to the last day of that month.
• This medicine does not require special storage conditions.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bosutinib Teva contains

• The active ingredient is bosutinib. Bosutinib Teva film-coated tablets are available in various strengths. Bosutinib Teva 100 mg: each film-coated tablet contains 100 mg of bosutinib (as dihydrate). Bosutinib Teva 400 mg: each film-coated tablet contains 400 mg of bosutinib (as dihydrate). Bosutinib Teva 500 mg: each film-coated tablet contains 500 mg of bosutinib (as dihydrate).
• The other ingredients are: Tablet core: microcrystalline cellulose, crospovidone, poloxamer 188, povidone, magnesium stearate. The film coating of the 100 mg tablet contains: hypromellose, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172). The film coating of the 400 mg tablet contains: hypromellose, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), red iron oxide (E 172). The film coating of the 500 mg tablet contains: hypromellose, titanium dioxide (E 171), macrogol 400, talc, red iron oxide (E 172).

Description of the appearance of Bosutinib Teva and package contents
Bosutinib Teva 100 mg film-coated tablets are film-coated
biconvex, yellow, oval tablets, approximately 11 mm x 5 mm in size, with the inscription “100” on one
side and the inscription “B” on the opposite side.
Bosutinib Teva 100 mg is available in PVC/Aclar-aluminum blisters containing 28, 30 or 112
film-coated tablets or in unit-dose divisible PVC/Aclar-aluminum blisters containing
28x1, 30x1 or 112x1 film-coated tablets.
Bosutinib Teva 400 mg film-coated tablets are film-coated
biconvex, orange, oval tablets, approximately 16 mm x 9 mm in size, with the inscription “400” on
one side and the inscription “B” on the opposite side.
Bosutinib Teva 400 mg is available in PVC/Aclar-aluminum blisters containing 28 or 30 film-coated
tablets or in unit-dose divisible PVC/Aclar-aluminum blisters containing 28x1 or
30x1 film-coated tablets.
Bosutinib Teva 500 mg film-coated tablets are film-coated
biconvex, red, oval tablets, approximately 18 mm x 9 mm in size, with the inscription “500” on one
side and the inscription “B” on the opposite side.
Bosutinib Teva 500 mg is available in PVC/Aclar-aluminum blisters containing 28 or 30 film-coated
tablets or in unit-dose divisible PVC/Aclar-aluminum blisters containing 28x1 or
30x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA3000 Paola, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Bosutinib Teva 100 mg Filmtabletten, Bosutinib Teva 400 mg Filmtabletten,
Bosutinib Teva 500 mg Filmtabletten
Belgium Bosutinib Teva 100 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten,
Bosutinib Teva 400 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten,
Bosutinib Teva 500 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Bulgaria Босутиниб Тева 100 mg филмирани таблетки, Bosutinib Teva 100 mg film-
coated tablets, Босутиниб Тева 500 mg филмирани таблетки, Bosutinib Teva
500 mg film-coated tablets
Czech Republic Bosutinib Teva
Germany Bosutinib-ratiopharm 100 mg Filmtabletten, Bosutinib-ratiopharm 400 mg
Filmtabletten, Bosutinib-ratiopharm 500 mg Filmtabletten
Denmark Bosutinib Teva
France BOSUTINIB TEVA 100 mg, comprimé pelliculé, BOSUTINIB TEVA 400 mg,
comprimé pelliculé, BOSUTINIB TEVA 500 mg, comprimé pelliculé
Croatia Bosutinib Teva 100 mg, 400 mg, 500 mg filmom obložene tablete
Iceland Bosutinib Teva
Italy Bosutinib Teva
Luxembourg Bosutinib Teva 100 mg comprimés pelliculés, Bosutinib Teva 400 mg comprimés
pelliculés, Bosutinib Teva 500 mg comprimés pelliculés
Netherlands Bosutinib Teva 100 mg, filmomhulde tabletten, Bosutinib Teva 400 mg,
filmomhulde tabletten, Bosutinib Teva 500 mg, filmomhulde tabletten
Norway Bosutinib Teva
Portugal Bosutinib Teva
Romania Bosutinib Teva 100 mg, 400 mg, 500 mg comprimate filmate
Sweden Bosutinib Teva