Dasatinib Stada

Leaflet accompanying the packaging: information for the user

Dasatinib Stada, 20 mg, coated tablets

Dasatinib Stada, 50 mg, coated tablets

Dasatinib Stada, 70 mg, coated tablets

Dasatinib Stada, 80 mg, coated tablets

Dasatinib Stada, 100 mg, coated tablets

Dasatinib Stada, 140 mg, 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 another person, even if their symptoms are the same.
• 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 Stada and what is it used for
• 2. Important information before taking Dasatinib Stada
• 3. How to take Dasatinib Stada
• 4. Possible side effects
• 5. How to store Dasatinib Stada
• 6. Contents of the packaging and other information

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

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

Dasatinib Stada is also used to treat acute lymphoblastic leukemia (ALL) with Philadelphia chromosome-positive (Ph+) in adults, adolescents, and children aged 1 year and older, as well as lymphoblastic blast crisis 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 Stada inhibits the growth of these cancer cells.

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

2. Important information before taking Dasatinib Stada

When not to take Dasatinib Stada

• if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).

You should consult a doctor if you suspect an allergy.

Warnings and precautions

Before starting to take Dasatinib Stada, you should discuss it with your doctor or pharmacist.

• if you are taking blood thinners or medications that prevent blood clots (see "Dasatinib Stada and other medicines");
• if you have had liver or heart problems in the past or currently;
• if you experience difficulty breathing, chest pain, or cough while taking dasatinib: this may be a sign of fluid buildup in the lungs or chest (which may occur more frequently in patients aged 65 and older) or changes in the blood vessels that supply blood to the lungs;
• if you have ever had hepatitis B virus infection or are suspected to have it, as dasatinib may cause the hepatitis B virus to become active again, which can be life-threatening. Before starting treatment, your doctor will check if you have this infection.
• if you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Stada, you should contact your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will monitor your health status during treatment to assess whether dasatinib is having the desired effect. You will also have regular blood tests while taking Dasatinib Stada.

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 Stada, bone growth and development should be closely monitored.

Dasatinib Stada and other medicines

You should tell your doctorabout 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 if taken at the same time.

The following medicines should not be taken with dasatinib:

• 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 in epilepsy;
• rifampicin - this is a medicine used in tuberculosis;
• famotidine, omeprazole - these are medicines that block stomach acid production;
• St. John's Wort - herbal medicines available without a prescription, used to treat depression and other conditions (also known as Hypericum perforatum).

You should not takemedicines that neutralize stomach acid (such as aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking dasatinib.

You should tell your doctorif you are taking blood thinners or medications that prevent blood clots.

Taking Dasatinib Stada with food and drink

You should not take dasatinib with grapefruit or grapefruit juice.

Pregnancy and breastfeeding Women who are pregnant or think they may be pregnant should immediately

tell their doctor. Dasatinib should not be taken during pregnancy, unless it is absolutely necessary. Your doctor will discuss the possible risks of taking dasatinib during pregnancy with you.

Both men and women taking dasatinib are advised to use effective contraception.

You should inform your doctor if you are breastfeeding.You should not breastfeed while taking dasatinib.

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 Stada contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Dasatinib Stada contains sodium

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

3. How to take Dasatinib Stada

Dasatinib Stada can only be prescribed by a doctor 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 Stada is prescribed for adults, adolescents, and children aged 1 year and older.

The recommended initial dose of Dasatinib Stada for adult patients in the chronic phase of CML is

100 mg once daily.

The recommended initial dose of Dasatinib Stada for adult patients in the accelerated phase or blast crisis phase of CML or with Ph+ ALL is 140 mg once daily.

Dosing in children with CML in the chronic phase or Ph+ ALL is based on body weight.

Dasatinib is given orally once daily in the form of tablets or powder for oral suspension. It is not recommended to use Dasatinib Stada 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 changing the formulation (i.e., tablets and powder for oral suspension), a dose change may be necessary, so you should not change one formulation to another.

Based on the patient's body weight, side effects, and response to treatment, the doctor will determine the appropriate formulation and dose. The initial dose of Dasatinib Stada in children is calculated based on body weight, as shown below:

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
Dasatinib Stada tablets should not be used 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 Stada in children under 1 year of age.

Depending on the response to treatment, the doctor may decide to increase or decrease the dose, or even temporarily stop treatment. To give large or small doses, it may be necessary to use multiple tablets of different strengths.

How to take Dasatinib Stada

Tablets should be taken every day at the same time. Tablets should be swallowed whole. You should notcrush, cut, or chew them.You should not take crushed, cut, chewed, or broken tablets. If tablets are crushed, cut, chewed, or broken, it is not certain that you will receive the correct dose. Dasatinib Stada can be taken with or without food.

Special precautions for handling Dasatinib Stada

It is unlikely that Dasatinib Stada tablets will be damaged. However, if this happens, people other than the patient who come into contact with the medicine should wear protective gloves.

How long to take Dasatinib Stada

Dasatinib Stada should be taken every day, until your doctor decides that you should stop taking the medicine. You should make sure that you take Dasatinib Stada for as long as your doctor has told you to.

Taking more Dasatinib Stada than prescribed

If you accidentally take more tablets than prescribed, you should immediatelytell your doctor, as you may need medical attention.

Missing a dose of Dasatinib Stada

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

If you have any further doubts 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.

All the following symptoms may indicate 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 have blood in your vomit, stool, or urine, or if your stool is black;
• if you experience symptoms of infection such as fever, severe chills;
• if you experience fever, mouth pain, or throat pain, blistering, or peeling of the skin and (or) mucous membranes. You should immediately tell your doctorif you experience any of the above symptoms.

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

• Infections(including bacterial, viral, and fungal infections)
• Heart and lung disorders:shortness of breath
• Digestive disorders:diarrhea, nausea, or vomiting
• Skin, hair, eyes, general symptoms:skin rash, fever, swelling of the face, hands, and feet, headache, feeling tired or weak, bleeding
• Pain:muscle pain (during or after treatment), abdominal pain
• Additional tests may show:low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs

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

• Infections: pneumonia, herpes virus infection (including cytomegalovirus infection), upper respiratory tract infections, severe blood or tissue infections (including some cases that were fatal)
• Heart and lung disorders:rapid heartbeat, irregular heartbeat, heart failure, weakened heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Digestive disorders:loss of appetite, taste disturbances, bloating, colitis, constipation, heartburn, mouth ulcers, weight gain, weight loss, gastritis
• Skin, hair, eyes, general symptoms:tingling, itching, dry skin, acne, skin inflammation, ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred 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 arms and legs, chills, muscle stiffness and joint stiffness, muscle cramps
• Additional tests may show:fluid around the heart, fluid in the lungs, heart rhythm disturbances, low white blood cell count (neutropenia) with fever, gastrointestinal bleeding, high uric acid levels in the blood

Uncommon side effects (may affect up to 1 in 100 people)

• Heart and lung disorders:heart attack (including some cases that were fatal), inflammation of the sac around the heart, irregular heartbeat, chest pain due to lack of blood flow to the heart (angina pectoris), low blood pressure, narrowing of the airways, which can cause difficulty breathing, asthma, increased blood pressure in the pulmonary arteries
• Digestive disorders:pancreatitis, stomach ulcers, esophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux disease (a condition in which stomach acid and other stomach contents flow back into the throat)
• Skin, hair, eyes, general symptoms:allergic reactions, including sensitivity to pressure, red bumps on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased sex drive, fainting, tremors, eye inflammation, which can cause redness or pain, skin disease characterized by sensitivity to pressure, redness, and the appearance of distinct red patches on the skin with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, vision disturbances (including blurred vision), dry eye, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling, 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 disease that reduces blood flow to the bone, which can cause bone tissue loss and death), joint inflammation, skin swelling anywhere on the body
• Pain:inflammation of the veins, which can cause redness, pain, and swelling, tendon inflammation
• Brain:memory loss
• Additional tests may show:tumor lysis syndrome (a condition that occurs when a large number of cancer cells die within a short period), 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 creatine phosphokinase activity (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin activity (an enzyme found mainly in the heart and skeletal muscles), increased gamma-glutamyltransferase activity (an enzyme found mainly in the liver), milky fluid around the lungs (chylous effusion)

Rare side effects (may affect up to 1 in 1,000 people)

• Heart and lung disorders:enlargement of the right heart chamber, heart muscle inflammation, a condition that occurs when the blood flow to the heart is blocked (acute coronary syndrome), cardiac arrest (when the heart stops pumping blood), coronary artery disease (heart disease), inflammation of the tissue surrounding the heart and lungs, blood clots, blood clots in the lungs
• Digestive disorders:malabsorption of nutrients from the digestive tract, intestinal obstruction, anal fistula, kidney disease with symptoms including swelling and abnormal laboratory test results, such as protein in the urine and low albumin levels in the blood, 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 inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• Brain:stroke, transient neurological disturbances caused by lack of blood flow, facial nerve paralysis, dementia
• Immune system:severe allergic reaction
• Musculoskeletal and connective tissue disorders:delayed bone growth, growth retardation

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

• Pneumonia
• Bleeding in the stomach or intestines, which can be fatal
• Reactivation of hepatitis B virus infection (liver infection) in patients who have had the disease in the past
• A reaction with fever, blisters, and ulcers of the mucous membranes
• Kidney disease with symptoms including swelling and abnormal laboratory test results, such as protein in the urine and low albumin levels in the blood
• Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelet count, and blood clot formation

During treatment, your doctor will check if you have experienced any of the above 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.

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

5. How to store Dasatinib Stada

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

You should not take 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 stated.

The abbreviation "Lot" on the label, blister, or carton means "Batch number".

There are no special precautions for storing the 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 packaging and other information

What Dasatinib Stada contains

• The active substance of the medicine is dasatinib. Each coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, or 140 mg of dasatinib.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate (see section 2 "Important information before taking Dasatinib Stada"); croscarmellose sodium, hydroxypropylcellulose, magnesium stearate. Coating:polyvinyl alcohol, titanium dioxide (E 171), talc, glycerol monostearate, sodium lauryl sulfate.

What Dasatinib Stada looks like and contents of the pack

Dasatinib Stada 20 mg: the coated tablet is white or almost white, biconvex, round, with the inscription "20" on one side and smooth on the other, with a diameter of 6.1 mm.

Dasatinib Stada 50 mg: the coated tablet is white or almost white, biconvex, oval, with the inscription "50" on one side and smooth on the other, with dimensions 10.9 mm x 5.8 mm.

Dasatinib Stada 70 mg: the coated tablet is white or almost white, biconvex, round, with the inscription "70" on one side and smooth on the other, with a diameter of 8.9 mm.

Dasatinib Stada 80 mg: the coated tablet is white or almost white, biconvex, triangular, with the inscription "80" on one side and smooth on the other, with dimensions 10.3 mm x 10.0 mm.

Dasatinib Stada 100 mg: the coated tablet is white or almost white, biconvex, oval, with the inscription "100" on one side and smooth on the other, with dimensions 14.8 mm x 7.2 mm.

Dasatinib Stada 140 mg: the coated tablet is white or almost white, biconvex, round, with the inscription "140" on one side and smooth on the other, with a diameter of 11.8 mm.

Dasatinib Stada, 20 mg, 50 mg, 70 mg, coated tablets

Aluminum/OPA/Aluminum/PVC (perforated blisters divisible into single doses).

Aluminum/OPA/Aluminum/PVC blisters.

High-density polyethylene (HDPE) bottles with child-resistant polypropylene closures and plastic containers (HDPE) containing a desiccant (silica gel).

Cartons containing 60 x 1 or 100 x 1 coated tablets in perforated blisters divisible into single doses.

Cartons containing 60 or 100 coated tablets in blisters.

Cartons containing bottles with 60 coated tablets.

Dasatinib Stada, 80 mg, 100 mg, 140 mg, coated tablets

Aluminum/OPA/Aluminum/PVC (perforated blisters divisible into single doses).

Aluminum/OPA/Aluminum/PVC blisters.

High-density polyethylene (HDPE) bottles with child-resistant polypropylene closures and plastic containers (HDPE) containing a desiccant (silica gel).

Cartons containing 30 x 1, 60 x 1, or 100 x 1 coated tablets in perforated blisters divisible into single doses.

Cartons containing 30, 60, or 100 coated tablets in blisters.

Cartons containing bottles with 30 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Tel. +48 22 737 79 20

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium

Dasatinib EG 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Germany

Dasatinib AL 20mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Denmark

Dasatinib STADA

Finland

Dasatinib STADA 20, 50, 70, 80, 100, 140 mg film-coated tablets

Italy

Dasatinib EG

Luxembourg

Dasatinib EG 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Netherlands

Dasatinib CF 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Poland

Dasatinib Stada

Sweden

Dasatinib STADA 20, 50, 70, 80, 100, 140 mg film-coated tablets

Date of last revision of the leaflet: 02/2025