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. What you need to know 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 normally help the body to fight infection. In patients with CML, white blood cells called granulocytes grow out of control. Dasatinib Zentiva blocks a protein made by certain cancer cells, called BCR-ABL, which signals cancer cells to multiply. 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 are no longer benefiting from previous therapy. In patients with Ph+ ALL, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Zentiva blocks the BCR-ABL protein, which signals cancer cells to multiply. If you have any questions about how Dasatinib Zentiva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know 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, ask your doctor for advice.

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 ever had liver or heart problems,
• if you experience shortness of breath, chest pain or cough while taking Dasatinib Zentiva: this may be a sign of fluid in the lungs or around the heart (which may occur more frequently in patients aged 65 and over) or changes in the blood vessels that supply blood to the lungs,
• 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 carefully 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 be a sign of a condition called thrombotic microangiopathy (TMA), which is 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. Regular blood tests will also be performed while you are taking Dasatinib Zentiva.

Children and adolescents

Dasatinib Zentiva must not be used in children under 1 year of age. There is limited experience in children under 18 years old. If your child is taking Dasatinib Zentiva, their growth and development will be closely monitored.

Dasatinib Zentiva and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those you have bought without a prescription. Dasatinib is mainly broken down in the liver. Certain medicines may affect the levels of dasatinib in your blood and so should not be taken 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 remedy used to treat depression and other conditions

Do not take medicines that reduce stomach acid (such as aluminium or magnesium hydroxide) in the 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

Women who are pregnant or think they may be pregnant should tell their doctor. Dasatinib Zentiva should not be taken during pregnancy unless clearly necessary. Your doctor will discuss the potential risks with you. Both men and women taking Dasatinib Zentiva should use effective contraception during treatment. If you are breast-feeding, tell your doctor. You should not breast-feed while taking Dasatinib Zentiva.

Driving and using machines

Dasatinib Zentiva may cause side effects such as dizziness and blurred vision that may affect your ability to drive or use machines. If this happens, do not drive or use 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 treating leukaemia. Always take Dasatinib Zentiva exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Dasatinib Zentiva is for adults and children aged 1 year and older. The recommended starting dose for adults with CML in the chronic phase is 100 mg taken once daily. The recommended starting dose for adults with CML in the accelerated phase or blast crisis, or with Ph+ ALL is 140 mg taken once daily. For children with CML in the chronic phase or Ph+ ALL, the dose will be based on their body weight. Dasatinib is taken once daily by mouth, either as tablets or as a powder for oral suspension. Tablets should not be used in patients weighing less than 10 kg. For patients weighing less than 10 kg and for patients who cannot swallow tablets, the powder for oral suspension should be used. If you switch from one formulation to the other, your doctor may need to adjust your dose. Your doctor will decide on the appropriate formulation and dose based on your weight, any side effects and how you respond to the treatment. The starting dose of Dasatinib Zentiva for children is calculated based on their 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 weighing 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. Your doctor may adjust the dose based on your response to the treatment, and may temporarily stop treatment if you experience side effects. To take a higher or lower dose, your doctor may prescribe more than one tablet of different strengths.

How to take Dasatinib Zentiva

Take the tablets at the same time each day. Swallow the tablets whole with a glass of water. Do not crush, cut or chew the tablets. Do not take broken or crushed tablets. If the tablets are crushed or cut, you may not get the correct dose. You can take Dasatinib Zentiva with or without food.

Special precautions for handling Dasatinib Zentiva

It is unlikely that Dasatinib Zentiva tablets will be damaged. However, if you come into contact with a damaged tablet, wear protective gloves.

How long to take Dasatinib Zentiva

Take Dasatinib Zentiva every day until your doctor tells you to stop. Make sure you take Dasatinib Zentiva for as long as your doctor recommends.

If you take more Dasatinib Zentiva than you should

If you accidentally take more tablets than you should, contact 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 your next dose at the usual time. If you have any further questions on the use of this product, 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 and fainting
• if you experience unexpected bleeding or bruising without previous injury
• if you vomit blood, have black stools or blood in your urine

The following may be signs of serious side effects:

• if you experience signs of infection, such as fever, chills
• if you experience fever, mouth sores or throat sores, blistering and peeling of skin and mucous membranes.

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
• Laboratory 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, viral infections (including cytomegalovirus (CMV)), upper respiratory tract infections, severe infections of the blood or tissues (which can be life-threatening)
• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakening of the heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Gastrointestinal disorders: loss of appetite, changes in taste, bloating or swelling of the abdomen, inflammation of the large intestine, constipation, heartburn, mouth sores, weight gain, weight loss, inflammation of the stomach
• Skin, hair, eyes, general disorders: tingling, itching, dry skin, acne, skin inflammation, ringing in the ears, continuous ringing in the ears, hair loss, excessive sweating, changes in vision (including blurred vision and double vision), dry eye, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, sleepiness, general swelling
• Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness
• Laboratory tests may show: fluid around the heart, fluid in the lungs, irregular heartbeat, low white blood cell count (neutropenia) with fever, gastrointestinal bleeding, high levels of uric acid 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 surrounding 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: inflammation of the pancreas, stomach ulcers, inflammation of the oesophagus, abdominal swelling, anal fistula, kidney problems, diabetes
• Skin, hair, eyes, general disorders: seizures, inflammation of the optic nerve which can cause blindness, purple spots on the skin, overactive thyroid gland, inflammation of the thyroid gland, lack of coordination, difficulty walking, miscarriage, inflammation of blood vessels in the skin, skin thickening
• Brain: memory loss
• Laboratory 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 (a type of white blood cell) 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 creatine phosphokinase (an enzyme found mainly in the heart, brain and skeletal muscle), increased levels of troponin (an enzyme found mainly in the heart and skeletal muscle), increased levels of gamma-glutamyltransferase (an enzyme 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: enlargement of the right chamber of the heart, inflammation of the heart muscle, blockage of blood flow to the heart (acute coronary syndrome), cardiac arrest (heart stops beating), coronary artery disease (heart disease), 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, kidney damage, diabetes
• Skin, hair, eyes, general disorders: convulsions, inflammation of the optic nerve which can cause blindness, purple spots on the skin, overactive thyroid gland, inflammation of the thyroid gland, lack of coordination, difficulty walking, miscarriage, inflammation of blood vessels in the skin, 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; growth retardation.

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

• Pneumonitis
• 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 before
• A reaction that includes fever, blistering of the skin and mouth sores
• Kidney disease with symptoms such as swelling and abnormal laboratory tests, such as protein in the urine and low levels of protein in the blood
• Disease of the blood vessels, known as 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 during treatment.

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. You can also report side effects directly via the national reporting system listed in the “Contact details for reporting side effects” section below. 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 blister, carton or bottle after “EXP”. The expiry date refers to the last day of that month. There are no special storage requirements for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, sodium croscarmellose, hydroxypropylcellulose, 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 medicinal product 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