Dasatinib Zentiva

Leaflet accompanying the packaging: 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dasatinib Zentiva and what is it used for
• 2. Important information before taking 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 is Dasatinib Zentiva and what is it used for

Dasatinib Zentiva contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children aged 1 year and above. Leukemia is a cancer of white blood cells. White blood cells normally help the body fight infection. In people with CML, white blood cells called granulocytes grow out of control. Dasatinib Zentiva stops the growth of these leukemia cells.

Dasatinib Zentiva is also used to treat acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positive (Ph+) in adults, adolescents, and children aged 1 year and above, as well as lymphoblastic blast crisis of CML in adults who have not responded to previous treatment. In people with acute lymphoblastic leukemia, white blood cells called lymphocytes multiply too quickly and live too long.

Dasatinib Zentiva stops the growth of these leukemia cells.

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

2. Important information before taking Dasatinib Zentiva

When not to take Dasatinib Zentiva

Warnings and precautions

Before starting to take Dasatinib Zentiva, you should discuss this with your doctor or pharmacist.

blood-thinning medicinesor medicines that prevent blood clots (see "Dasatinib Zentiva and other medicines"),

Your doctor will perform regular checks on your condition during treatment to assess whether Dasatinib Zentiva is having the desired effect. While taking Dasatinib Zentiva, you will also have regular blood tests.

Children and adolescents

This medicine should not be used in children under 1 year of age. There is limited data on the use of dasatinib in this age group. In children taking Dasatinib Zentiva, growth and bone development should be closely monitored.

Dasatinib Zentiva and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Dasatinib is mainly broken down in the liver. Certain medicines may affect the action of Dasatinib Zentiva if taken at the same time.

You should 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 block stomach acid production
• St. John's Wort - a herbal medicine available without prescription, used to treat depression and other conditions (also known as Hypericum perforatum)

You should not take medicines that neutralize stomach acid (such as aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Zentiva.

You should tell your doctor if you are taking medicines that thin the blood or prevent blood clots.

Taking Dasatinib Zentiva with food and drink

You should not take Dasatinib Zentiva with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

Women who are pregnant or think they may be pregnant should tell their doctor. Dasatinib Zentiva should not be given to pregnant women unless it is absolutely necessary. Your doctor will discuss the risks that may occur during treatment with Dasatinib Zentiva during pregnancy.

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

You should tell your doctor if you are breastfeeding. You should not breastfeed while taking Dasatinib Zentiva.

Driving and using machines

If you experience side effects such as dizziness and vision disturbances, you should be careful when driving or operating machinery.

Dasatinib Zentiva contains lactose and sodium

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

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

3. How to take Dasatinib Zentiva

Dasatinib Zentiva will only be prescribed by a doctor who is experienced in treating leukemia. You should always take this medicine exactly as your doctor has told you. If you are unsure, you should ask your doctor or pharmacist. Dasatinib Zentiva is for adults and children aged 1 year and above.

The recommended starting dose of Dasatinib Zentiva for adult patients in the chronic phase of CML is 100 mg taken orally once a day.

The recommended starting dose of Dasatinib Zentiva for adult patients in the accelerated phase or blast crisis of CML, or with Philadelphia chromosome-positive acute lymphoblastic leukemia, is 140 mg taken orally once a day.

The dose of Dasatinib Zentiva for children with CML in the chronic phase or Ph+ ALL is determined based on body weight.

Dasatinib is taken orally once a day in the form of tablets or powder for oral suspension. It is not recommended to use tablets in patients with a body weight of less than 10 kg.

In patients with a body weight of less than 10 kg and in patients who are unable to swallow tablets, the powder for oral suspension should be used. When switching from one form of the medicine to another (i.e., from tablets to powder for oral suspension), the dose may need to be adjusted; in such cases, you should not switch from one form of the medicine to another.

Based on the patient's body weight, side effects, and response to treatment, the doctor will determine the appropriate form and dose of the medicine. The starting dose of Dasatinib Zentiva in 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: It is not recommended to use tablets in patients with a body weight of less than 10 kg; in these patients, the powder for oral suspension should be used.

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

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

How to take Dasatinib Zentiva

Tablets should be taken at the same time every day. The tablets should be swallowed whole.

They should not be crushed, divided, or chewed. You should not take crushed tablets.

If the tablets are crushed, cut, chewed, or crushed, it is not certain that you will receive the correct dose.

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 this happens, people handling the medicine should wear protective gloves.

How long to take Dasatinib Zentiva

Dasatinib Zentiva should be taken every day until your doctor decides that you should stop taking it.

You should make sure that you take Dasatinib Zentiva for as long as your doctor has told you to.

Taking more than the recommended dose of Dasatinib Zentiva

If you accidentally take more tablets than you were told to, you should immediately tell your doctor, as you may need medical attention.

Missing a dose of Dasatinib Zentiva

You should not take a double dose to make up for a missed tablet. You should take the next dose at the usual time.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following symptoms may indicate serious side effects:

• if you experience chest pain, difficulty breathing, coughing, 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 symptoms may indicate an infection:

• if you experience fever, chills
• if you experience fever, mouth pain, or throat pain, with blistering or peeling of the skin and mucous membranes.

You should immediately tell your doctor if you experience any of the above symptoms.

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

• Infections (including bacterial, viral, and fungal infections)
• Heart and lungs: shortness of breath
• Digestive system: diarrhea, nausea, or vomiting
• Skin, hair, eyes, general symptoms: rash, fever, swelling of the face, hands, and feet, headache, feeling tired or weak, bleeding
• Pain: muscle pain (during or after treatment), abdominal pain
• Lab tests may show: low platelet count, low white blood cell count (neutropenia), anemia, 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 blood or tissue infections (including rare cases that were fatal)
• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakening of the heart muscle, high blood pressure, increased blood pressure in the lungs, coughing
• Digestive system: loss of appetite, changes in taste, bloating, inflammation of the large intestine, constipation, heartburn, mouth sores, weight gain, weight loss, stomach inflammation
• Skin, hair, eyes, general symptoms: tingling, itching, dry skin, acne, skin inflammation, ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred or disturbed vision), dry eye, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized 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 levels of uric acid in the blood.

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

• Heart and lungs: enlarged right heart chamber, heart muscle inflammation, blockage of blood flow to the heart (acute coronary syndrome), cardiac arrest (stop of heart function), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
• Digestive system: malabsorption (reduced absorption of nutrients from the gut), intestinal obstruction, anal fistula (abnormal passage between the anus and the skin around the anus), kidney problems, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic nerve inflammation (which can cause total or partial loss of vision), purple spots on the skin, overactive thyroid gland, thyroid gland inflammation, lack of coordination, difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• Brain: stroke, temporary neurological disturbances due to lack of blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reaction
• Musculoskeletal and connective tissue disorders: delayed bone growth (delayed closure of the growth plates); slowed or delayed growth.

Rareside effects (may affect up to 1 in 1000 people):

• Heart and lungs: enlarged right heart chamber, heart muscle inflammation, blockage of blood flow to the heart (acute coronary syndrome), cardiac arrest (stop of heart function), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
• Digestive system: malabsorption (reduced absorption of nutrients from the gut), intestinal obstruction, anal fistula (abnormal passage between the anus and the skin around the anus), kidney problems, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic nerve inflammation (which can cause total or partial loss of vision), purple spots on the skin, overactive thyroid gland, thyroid gland inflammation, lack of coordination, difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• Brain: stroke, temporary neurological disturbances due to lack of blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reaction
• Musculoskeletal and connective tissue disorders: delayed bone growth (delayed closure of the growth plates); slowed or delayed growth.

Other observed side effects with unknown frequency(frequency cannot be estimated from the available data):

• Pneumonia
• Gastrointestinal bleeding, which can be fatal
• Reactivation (recurrence) of hepatitis B virus infection (liver infection) in patients who have had the disease in the past
• Reaction with fever, blistering of the skin, and mucous membrane ulcers
• Kidney disease with symptoms such as swelling and abnormal laboratory test results, such as protein in the urine and low protein levels in the blood
• Damaged blood vessels known as thrombotic microangiopathy (TMA), including low red blood cell count, low platelet count, and blood clots. During treatment, your doctor will check for these side effects.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder or its representative.

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

5. How to store Dasatinib Zentiva

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label, blister, or carton after "EXP". The expiry date refers to the last day of the month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dasatinib Zentiva contains

• The active substance of the medicine 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, 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 authorization 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 authorized 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