Dasatinib Zentiva

Package Leaflet: Information for the User

Dasatinib Zentiva, 20 mg, film-coated tablets

Dasatinib Zentiva, 50 mg, film-coated tablets

Dasatinib Zentiva, 80 mg, film-coated tablets

Dasatinib Zentiva, 100 mg, film-coated tablets

Dasatinib Zentiva, 140 mg, film-coated tablets

Dasatinib

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Dasatinib Zentiva is and what it is used for
• 2. Before you take Dasatinib Zentiva
• 3. How to take Dasatinib Zentiva
• 4. Possible side effects
• 5. How to store Dasatinib Zentiva
• 6. Contents of the pack and other information

1. What Dasatinib Zentiva is and what it is used for

Dasatinib Zentiva contains the active substance dasatinib. It is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children aged 1 year and older. Leukaemia is a cancer of white blood cells. White blood cells are important for fighting infections. In people with CML, white blood cells called granulocytes grow out of control. Dasatinib Zentiva blocks a protein made by the BCR-ABL gene that is present in CML cells, which helps to stop the disease from progressing.

Dasatinib Zentiva is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) in adults, adolescents and children aged 1 year and older, as well as lymphoid blast crisis CML in adults who have not responded to previous treatment. In people with Ph+ ALL, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Zentiva blocks the BCR-ABL protein, which helps to stop the disease from progressing.

If you have any questions about how Dasatinib Zentiva works or why it has been prescribed for you, ask your doctor.

2. Before you take Dasatinib Zentiva

Do not take Dasatinib Zentiva

• if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, tell your doctor.

Warnings and precautions

Before taking Dasatinib Zentiva, tell your doctor or pharmacist:

• if you are taking medicines that prevent blood clotting or medicines that prevent the formation of blood clots (see section “Dasatinib Zentiva and other medicines”)
• if you have had liver or heart problems in the past
• if you experience difficulty breathing, chest pain or cough while taking Dasatinib Zentiva: this may be a sign of fluid build-up in the lungs or chest, or changes in the blood vessels that supply the lungs (these may occur more frequently in patients aged 65 and over)
• if you have ever had hepatitis B infection: dasatinib may cause the hepatitis B virus to become active again, which can be fatal in some cases. You will be closely monitored by your doctor for signs of hepatitis B infection before starting treatment
• if you experience bruising, bleeding, fever, tiredness and confusion while taking Dasatinib Zentiva: this may indicate a condition called thrombotic microangiopathy (TMA), a condition that affects the blood vessels and can cause blood clots to form in small blood vessels

Your doctor will monitor you closely while you are taking Dasatinib Zentiva to check that the medicine is working and to check for any side effects.

Children and adolescents

Dasatinib Zentiva should not be used in children under 1 year of age. There is limited experience with dasatinib in this age group. Children taking Dasatinib Zentiva should be closely monitored for growth and development problems.

Dasatinib Zentiva and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Dasatinib is broken down in the liver. Certain medicines may affect the levels of dasatinib in your blood. Do not take the following medicines with Dasatinib Zentiva:

• ketokonazole, itraconazole - these are antifungal medicines
• erythromycin, clarithromycin, telithromycin - these are antibiotics
• ritonavir - this is an antiviral medicine
• phenytoin, carbamazepine, phenobarbital - these are medicines used to treat epilepsy
• rifampicin - this is a medicine used to treat tuberculosis
• famotidine, omeprazole - these are medicines that reduce stomach acid
• St John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression and other conditions

Do not take medicines that reduce stomach acid (such as aluminium or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Zentiva.

Tell your doctor if you are taking medicines that thin the blood or prevent blood clots.

Taking Dasatinib Zentiva with food and drink

Do not take Dasatinib Zentiva with grapefruit or grapefruit juice.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, tell your doctor. Dasatinib Zentiva should not be used during pregnancy unless clearly necessary. Your doctor will discuss the potential risks with you.

It is recommended that both men and women use effective contraception during treatment with Dasatinib Zentiva.

Do not breast-feed while taking Dasatinib Zentiva.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, be careful when driving or using machines.

Dasatinib Zentiva contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

3. How to take Dasatinib Zentiva

Dasatinib Zentiva will only be prescribed by a doctor with experience in the treatment of leukaemia. Always take Dasatinib Zentiva exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Dasatinib Zentiva is for adults and children aged 1 year and older.

The recommended starting dose for adults with chronic phase CML is 100 mg taken once daily.

The recommended starting dose for adults with accelerated phase CML, blast crisis CML or Ph+ ALL is 140 mg taken once daily.

The dose for children with CML or Ph+ ALL is based on body weight.

Dasatinib is taken once daily, either as tablets or as a powder for oral suspension. Tablets should not be used in patients who weigh less than 10 kg. For patients who weigh less than 10 kg or who cannot swallow tablets, the powder for oral suspension should be used.

When switching from one formulation to another (e.g. from tablets to powder for oral suspension), the dose may need to be adjusted. Do not switch from one formulation to another.

Based on the patient's weight, side effects and response to treatment, your doctor will decide on the appropriate formulation and dose of Dasatinib Zentiva.

The starting dose of Dasatinib Zentiva for children is calculated based on body weight, as follows:

Body weight (kg)

Daily dose (mg)

10 to less than 20 kg

40 mg

20 to less than 30 kg

60 mg

30 to less than 45 kg

70 mg

45 kg or more

100 mg

Note: Tablets should not be used in patients who weigh less than 10 kg; for these patients, the powder for oral suspension should be used.

There are no recommendations for the use of Dasatinib Zentiva in children under 1 year of age.

Based on the response to treatment, your doctor may decide to increase or decrease the dose, or to temporarily stop treatment. To take higher or lower doses, a combination of tablets of different strengths may be needed.

How to take Dasatinib Zentiva

Take the tablets at the same time each day. Swallow the tablets whole. Do not crush, cut or chew them. Do not take crushed or broken tablets.

Dasatinib Zentiva tablets can be taken with or without food.

Special precautions for handling Dasatinib Zentiva

It is unlikely that Dasatinib Zentiva tablets will be damaged. However, if they are, anyone handling the tablets should wear protective gloves.

How long to take Dasatinib Zentiva

Take Dasatinib Zentiva every day until your doctor tells you to stop.

If you take more Dasatinib Zentiva than you should

If you accidentally take more tablets than you should, tell your doctor immediately. You may need medical attention.

If you forget to take Dasatinib Zentiva

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dasatinib Zentiva can cause side effects, although not everybody gets them.

The following may be signs of serious side effects:

• if you experience chest pain, difficulty breathing, cough or fainting
• if you experience unexpected bleeding or bruising without previous injury
• if you vomit blood or black stools

if you experience signs of infection, such as fever, chills

• if you experience fever, mouth or throat ulcers, or skin rash and (or) mucosal lesions

Tell your doctor immediately if you experience any of the above side effects.

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

• Infections (including bacterial, viral and fungal infections)
• Heart and lungs: shortness of breath
• Gastrointestinal disorders: diarrhoea, nausea or vomiting
• Skin, hair, eyes, general disorders: rash, fever, swelling of the face, hands and feet, headache, tiredness or weakness, bleeding
• Pain: muscle pain (during or after treatment), abdominal pain
• Lab tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, fluid around the lungs

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

• Infections: pneumonia, cytomegalovirus (CMV) infection, upper respiratory tract infections, severe blood or tissue infections (which can be life-threatening)
• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakened heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Gastrointestinal disorders: loss of appetite, taste disturbance, bloated or enlarged abdomen, colitis, constipation, heartburn, mouth ulcers, weight gain, weight loss, gastritis
• Skin, hair, eyes, general disorders: tingling, itching, dry skin, acne, skin rash, ringing in the ears, continuous ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred or disturbed vision), dry eye, bruising, depression, insomnia, flushing, dizziness, injury (bruising), loss of appetite, drowsiness, general swelling
• Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness
• Lab tests may show: fluid around the heart, fluid in the lungs, irregular heartbeat, low white blood cell count (neutropenia) with fever, gastrointestinal bleeding, high uric acid levels in the blood

Uncommonside effects (may affect up to 1 in 100 people):

• Heart and lungs: heart attack (which can be life-threatening), inflammation of the sac around the heart, irregular heartbeat, chest pain due to reduced blood flow to the heart (angina), low blood pressure, narrowing of the airways which can cause difficulty breathing, asthma, increased blood pressure in the pulmonary arteries
• Gastrointestinal disorders: pancreatitis, stomach ulcers, oesophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastro-oesophageal reflux disease (a condition in which acid and other stomach contents flow back up into the throat)
• Skin, hair, eyes, general disorders: allergic reactions, including hives, itching, swelling, redness, and blistering of the skin and mucous membranes, anxiety, confusion, mood changes, decreased sex drive, fainting, tremors, eye inflammation, which can cause redness or pain, a skin condition characterized by painful red lumps on the skin with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, vision disturbances, excessive tear production, skin discoloration, inflammation of the fatty tissue under the skin, skin ulcers, blistering of the skin, nail disorders, hair disorders, disorders of the hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, decreased thyroid function, loss of balance while walking, bone death (a condition characterized by reduced blood flow to the bones, leading to bone loss and bone death), joint inflammation, skin swelling at any site on the body
• Pain: blood clots in the veins, which can cause redness, pain and swelling, tendon inflammation
• Brain: memory loss
• Lab tests may show: abnormal blood test results and possible kidney damage due to the breakdown of cancer cells (tumour lysis syndrome), low albumin levels in the blood, low lymphocyte count in the blood, high cholesterol levels in the blood, swollen lymph nodes, bleeding in the brain, abnormal heart rhythm, enlarged heart, liver inflammation, protein in the urine, increased levels of an enzyme called creatine phosphokinase (found mainly in the heart, brain and skeletal muscles), increased levels of an enzyme called troponin (found mainly in the heart and skeletal muscles), increased levels of an enzyme called gamma-glutamyltransferase (found mainly in the liver), milky fluid around the lungs (chylous effusion)

Rareside effects (may affect up to 1 in 1,000 people):

• Heart and lungs: enlarged right chamber of the heart, heart muscle inflammation, a condition characterized by blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (when the heart stops beating), coronary artery disease (a condition in which the blood vessels that supply the heart become narrowed), inflammation of the tissue surrounding the heart and lungs, blood clots, blood clots in the lungs
• Gastrointestinal disorders: malabsorption (when the body does not absorb nutrients from food), intestinal obstruction, anal fistula (an abnormal connection between the anus and the skin), kidney damage, diabetes
• Skin, hair, eyes, general disorders: seizures, optic neuritis (inflammation of the nerve that carries vision), which can cause complete or partial loss of vision, purple spots on the skin, overactive thyroid gland, thyroid inflammation, lack of coordination, difficulty walking, miscarriage, skin inflammation, skin thickening
• Brain: stroke, temporary disturbance of brain function due to lack of blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reaction
• Musculoskeletal and connective tissue disorders: delayed bone growth (in children); growth delay or slowing

Other side effects with frequency not known(cannot be estimated from the available data):

• Pneumonia
• Bleeding in the stomach or intestines, which can be life-threatening
• Reactivation of hepatitis B infection (liver infection) in patients who have had the infection in the past
• A reaction characterized by fever, rash and ulcers on the skin and mucous membranes
• Kidney disease with symptoms such as swelling and abnormal laboratory test results, such as protein in the urine and low albumin levels in the blood
• A condition that affects the blood vessels and can cause blood clots to form in small blood vessels, called thrombotic microangiopathy (TMA), including low red blood cell count, low platelet count and blood clots. Your doctor will monitor you closely for signs of TMA while you are taking Dasatinib Zentiva.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite.

Side effects can also be reported to the Marketing Authorisation Holder or its local representative.

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

5. How to store Dasatinib Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dasatinib Zentiva contains

• The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 80 mg, 100 mg or 140 mg of dasatinib.
• The other ingredients are:
• Tablet core:lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate
• Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin (see section 2 “Dasatinib Zentiva contains lactose and sodium”)

What Dasatinib Zentiva looks like and contents of the pack

Dasatinib Zentiva20 mg: the film-coated tablet is white or almost white, biconvex, round, approximately 5.6 mm in diameter, with “D7SB” engraved on one side and “20” on the other side.

Dasatinib Zentiva50 mg: the film-coated tablet is white or almost white, biconvex, oval, approximately 6.0 mm in diameter, with “D7SB” engraved on one side and “50” on the other side.

Dasatinib Zentiva80 mg: the film-coated tablet is white or almost white, biconvex, triangular, approximately 10.4 mm in length, with “D7SB” engraved on one side and “80” on the other side.

Dasatinib Zentiva100 mg: the film-coated tablet is white or almost white, biconvex, oval, approximately 15.1 mm in length and 7.1 mm in width, with “D7SB” engraved on one side and “100” on the other side.

Dasatinib Zentiva140 mg: the film-coated tablet is white or almost white, biconvex, round, approximately 11.7 mm in diameter, with “D7SB” engraved on one side and “140” on the other side.

Dasatinib Zentiva20 mg or 50 mg is available in cardboard boxes containing 60 film-coated tablets in blisters or 60 x 1 film-coated tablet in single-dose blisters. They are also available in cardboard boxes containing bottles of 60 film-coated tablets.

Dasatinib Zentiva80 mg, 100 mg or 140 mg is available in cardboard boxes containing 30 film-coated tablets in blisters or 30 x 1 film-coated tablet in single-dose blisters. They are also available in cardboard boxes containing bottles of 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer

Synthon Hispania, S.L., Calle Castello 1, Poligono Las Salinas, Sant Boi De Llobregat, 08830 Barcelona, Spain

Synthon B.V., Microweg 22, 6545 CM Nijmegen, Netherlands

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria, Estonia, Croatia, Denmark, France, Netherlands, Lithuania, Latvia, Poland, Portugal, Czech Republic, Slovakia, Romania, Sweden, Hungary, United Kingdom (Northern Ireland), Italy: Dasatinib Zentiva

Date of last revision of the leaflet: May 2022