Dasatinib Sun

Leaflet accompanying the packaging: information for the user

Dasatinib SUN, 20 mg, film-coated tablets

Dasatinib SUN, 50 mg, film-coated tablets

Dasatinib SUN, 70 mg, film-coated tablets

Dasatinib SUN, 80 mg, film-coated tablets

Dasatinib SUN, 100 mg, film-coated tablets

Dasatinib SUN, 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 you can read it again if you need to. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Dasatinib SUN and what is it used for
• 2. Important information before taking Dasatinib SUN
• 3. How to take Dasatinib SUN
• 4. Possible side effects
• 5. How to store Dasatinib SUN
• 6. Contents of the packaging and other information

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

Dasatinib SUN 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 SUN stops the growth of these leukemia cells. Dasatinib SUN is also used to treat acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positive (Ph+) in adults, adolescents, and children aged 1 year and above, and 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 SUN stops the growth of these leukemia cells. If you have any questions about how Dasatinib SUN works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Dasatinib SUN

When not to take Dasatinib SUN

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

You should consult your doctor if you think you may have an allergic reaction.

Warnings and precautions

Before starting to take Dasatinib SUN, you should discuss it with your doctor or pharmacist. if you are taking blood thinning medicines or medicines to prevent blood clots (see section "Dasatinib SUN and other medicines") if you have had or currently have liver or heart problems if you experience difficulty breathing, chest pain, or cough while taking Dasatinib SUN: this may be a sign of fluid build-up in the lungs or chest (which may occur more frequently in patients aged 65 and older) or may be caused by changes in the blood vessels that supply blood to the lungs if you have ever had or may currently have a hepatitis B virus infection; this is because Dasatinib SUN may cause the hepatitis B virus to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment. if you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib SUN, you should contact your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA). Your doctor will periodically check your health during treatment to assess whether Dasatinib SUN is having the desired effect. During treatment with Dasatinib SUN, regular blood tests will also be performed.

Children and adolescents

This medicine should not be used in children under 1 year of age. Data on the use of Dasatinib SUN in this age group are limited. In children taking Dasatinib SUN, bone growth and development should be closely monitored.

Dasatinib SUN and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Dasatinib SUN is mainly broken down in the liver. Certain medicines may affect the action of Dasatinib SUN if taken at the same time.

The following medicines should not be taken with Dasatinib SUN:

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 a prescription, used to treat depression and other conditions (also known as Hypericum perforatum) Do not take medicines that neutralize stomach acid (such as aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib SUN. Tell your doctor if you are taking medicines that thin the blood or prevent blood clots.

Taking Dasatinib SUN with food and drink

Do not take Dasatinib SUN with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

Pregnant or potentially pregnant women should inform their doctor. Dasatinib SUN 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 SUN during pregnancy. It is recommended that both men and women use effective methods of contraception during treatment with Dasatinib SUN. If you are breastfeeding, inform your doctor. During treatment with Dasatinib SUN, do not breastfeed.

Driving and using machines

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

Dasatinib SUN contains lactose

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

3. How to take Dasatinib SUN

Dasatinib SUN should only be prescribed by a doctor experienced in treating leukemia. This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist. Dasatinib SUN is intended for adults and children aged 1 year and above. The recommended initial dose of Dasatinib SUN for adult patients in the chronic phase of CML is 100 mg taken orally once a day. The recommended initial dose of Dasatinib SUN for adult patients in the accelerated phase or blast crisis phase of CML, or with Philadelphia chromosome-positive acute lymphoblastic leukemia, is 140 mg taken orally once a day. The dosage of Dasatinib SUN for children with CML in the chronic phase and Ph+ ALL is determined based on body weight. It is not recommended to use Dasatinib SUN 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, a different medicine containing dasatinib in the form of a 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 changed; in such cases, do 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 initial dose of Dasatinib SUN in children is calculated based on body weight, as shown below: Body weight (kg)a

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 a Do not use tablets in patients with a body weight of less than 10 kg; in these patients, use the powder for oral suspension. There are no recommendations for the dose of Dasatinib SUN 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 take higher or lower doses, it may be necessary to use a combination of tablets of different strengths.

How to take Dasatinib SUN

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

Special precautions for handling Dasatinib SUN

It is unlikely that Dasatinib SUN tablets will be damaged. However, if this happens, people handling the medicine should wear protective gloves.

How long to take Dasatinib SUN

Dasatinib SUN should be taken every day until your doctor decides to stop treatment. Make sure to take Dasatinib SUN for as long as your doctor has prescribed.

Taking a higher dose of Dasatinib SUN than recommended

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

Missing a dose of Dasatinib SUN

Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time. If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

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

All of the following symptoms may indicate 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 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 or throat pain, blistering, or peeling of the skin and (or) mucous membranes You should immediately inform your doctorif you experience any of the above symptoms.

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

Infections (including bacterial, viral, and fungal infections) Heart and lungs: shortness of breath Digestive disorders: 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 Laboratory tests may show: low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs

Common side effects (may occur in less than 1 in 10 people)

Infections: pneumonia, herpes virus infection (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, congestive heart failure, weakened heart muscle, high blood pressure, increased blood pressure in the lungs, cough Digestive disorders: loss of appetite, taste disorders, bloating or gas, 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 or disturbed vision), dry eyes, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling Blood and lymphatic system disorders: anemia, low platelet count, low white blood cell count (neutropenia) Immune system disorders: low white blood cell count (neutropenia)

Uncommon side effects (may occur in less than 1 in 100 people)

Heart and lungs: heart attack (including fatal cases), inflammation of the sac surrounding 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 (blood vessels) 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 the development of painful, red lumps on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremors, eye inflammation, which can cause redness or pain, skin disease characterized by painful, red, distinct spots on the skin with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, vision disturbances, increased tearing, 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 disease in which there is decreased blood flow to the bone, leading to loss of bone mass and bone death), arthritis, swelling of the skin at any site on the body Pain: inflammation of the veins, which can cause redness, pain, and swelling, tendon inflammation Nervous system disorders: memory loss Laboratory tests may show: abnormal blood test results and possible kidney function disorders caused by tumor breakdown products (tumor lysis syndrome), low albumin levels in the blood, low lymphocyte count in the blood, high cholesterol levels in the blood, lymph node swelling, bleeding in the brain, irregular heart rhythm, enlarged heart muscle, liver inflammation, protein in the urine, increased activity of creatine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin levels (an enzyme found mainly in the heart and skeletal muscles), increased activity of gamma-glutamyltransferase (an enzyme found mainly in the liver), milky fluid around the lungs (chylous effusion).

Rare side effects (may occur in less than 1 in 1000 people)

Heart and lungs: enlargement of the right heart chamber, heart muscle inflammation, a condition characterized by blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (stoppage of blood flow from the heart), coronary artery disease (heart), inflammation of the tissue surrounding the heart and lungs, blood clots, blood clots in the lungs Digestive disorders: loss of essential nutrients from the digestive tract, such as proteins, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and the surrounding skin), kidney function disorders, diabetes Skin, hair, eyes, general symptoms: seizures, optic nerve inflammation, which can cause total or partial loss of vision, blue-purple spots on the skin, hyperthyroidism, thyroid gland inflammation, lack of coordination (a condition related to lack of muscle coordination), difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring Nervous system disorders: stroke, transient neurological disturbances caused by lack of blood flow, facial nerve paralysis, dementia Immune system disorders: severe allergic reaction Musculoskeletal and connective tissue disorders: delayed closure of the growth plates (the ends of bones that form joints); slowed or delayed growth

Other observed side effects with unknown frequency (frequency cannot be estimated from 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 A reaction characterized by fever, blistering of the skin, and mucous membrane ulcers

• Kidney disease with symptoms including swelling and abnormal laboratory test results, such as protein in the urine and low protein 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 for these side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 SUN

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister or carton after: EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. 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 SUN contains

The active substance of the medicine is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, or 140 mg of dasatinib. The other ingredients are: Tablet core: lactose monohydrate (see section 2 "Dasatinib SUN contains lactose"), croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, calcium phosphate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), triacetin (E 1518).

What Dasatinib SUN looks like and contents of the pack

Dasatinib SUN 20 mg is a white or almost white, biconvex, round film-coated tablet with a diameter of 5.5 mm, with the imprint "851" on one side and smooth on the other. Dasatinib SUN 50 mg is a white or almost white, biconvex, oval film-coated tablet with dimensions of 10.8 x 5.7 mm, with the imprint "852" on one side and smooth on the other. Dasatinib SUN 70 mg is a white or almost white, biconvex, round film-coated tablet with a diameter of 8.5 mm, with the imprint "853" on one side and smooth on the other. Dasatinib SUN 80 mg is a white or almost white, biconvex, triangular film-coated tablet with dimensions of 10.210 x 9.916 mm, with the imprint "854" on one side and smooth on the other. Dasatinib SUN 100 mg is a white or almost white, biconvex, oval film-coated tablet with dimensions of 14.7 x 7.0 mm, with the imprint "855" on one side and smooth on the other. Dasatinib SUN 140 mg is a white or almost white, biconvex, round film-coated tablet with a diameter of 11.0 mm, with the imprint "856" on one side and smooth on the other. Dasatinib SUN 20 mg, 50 mg, or 70 mg film-coated tablets are available in cartons containing 60 x 1 film-coated tablet in single-dose blisters. Dasatinib SUN 80 mg, 100 mg, or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablet in single-dose blisters. Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp Netherlands

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp Netherlands Terapia S.A. 124 Fabricii Street 400632, Cluj-Napoca Cluj County Romania

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

Romania: Dasatinib SUN Date of last revision of the leaflet:05.12.2022