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 this 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 you only. Do not pass it on to others. It may harm them, even if their symptoms 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:

• 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 pack 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 leukaemia (CML) in adults, adolescents and children aged 1 year and above. 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 SUN stops these leukaemic cells from growing. Dasatinib SUN is also used to treat acute lymphoblastic leukaemia (ALL) with Philadelphia chromosome positive (Ph+) in adults, adolescents and children aged 1 year and above, as well as lymphoid blast crisis CML in adults who have not responded to previous treatment. In patients with acute lymphoblastic leukaemia, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib SUN stops these leukaemic cells from growing. If you have any questions about how Dasatinib SUN works or why this medicine 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 taking Dasatinib SUN, tell your doctor or pharmacist: if you are taking blood thinning medicines or medicines that 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 years and older) or are 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 can be fatal in some cases. You will be closely monitored by your doctor for signs of this infection before starting treatment. if you experience bruising, bleeding, fever, tiredness and confusion while taking Dasatinib SUN, contact your doctor. This may indicate damage to the blood vessels known as thrombotic microangiopathy (TMA). Your doctor will monitor your health during treatment to see if Dasatinib SUN is having the desired effect. You will also have regular blood tests while taking Dasatinib SUN.

Children and adolescents

Dasatinib SUN should not be used in children under 1 year of age. There is limited experience with the use of Dasatinib SUN in this age group. In children taking Dasatinib SUN, 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 prescription, used to treat depression and other conditions (also known as Hypericum perforatum) Do not take medicines that neutralize stomach acid (such as aluminium 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 possibly pregnant patients should inform their doctor. Dasatinib SUN should not be taken during pregnancy unless clearly necessary. Your doctor will discuss the potential risks with you. Both men and women taking Dasatinib SUN should use effective contraceptive methods during treatment. If you are breastfeeding, tell your doctor. You should not breastfeed while taking Dasatinib SUN.

Driving and using machines

Be careful when driving or using machines if you experience side effects such as dizziness or blurred vision.

Dasatinib SUN contains lactose

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

3. How to take Dasatinib SUN

Dasatinib SUN should only be prescribed by a doctor with experience in the treatment of leukaemia. You should always take Dasatinib SUN exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Dasatinib SUN is for adults and children aged 1 year and above. The recommended starting dose for adults with chronic phase CML is 100 mg taken orally once a day. The recommended starting dose for adults with accelerated phase or blast crisis CML, or with Philadelphia chromosome positive ALL is 140 mg taken orally once a day. The dose for children with CML in the chronic phase and Ph+ ALL is based on body weight. Dasatinib SUN tablets should not be used in patients with a body weight below 10 kg. For patients with a body weight below 10 kg and for patients who cannot swallow tablets, another dasatinib-containing medicine in the form of a powder for oral suspension should be used. When switching from one formulation to another (i.e. tablets and powder for oral suspension), the dose may need to be adjusted; do not switch from one formulation to another. Based on body weight, side effects, and response to treatment, your doctor will determine the appropriate formulation and dose. The starting dose of Dasatinib SUN for children is calculated based on body weight, as follows:

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: Dasatinib SUN tablets should not be used in patients with a body weight below 10 kg; for these patients, the powder for oral suspension should be used. There are no recommendations for the dose of Dasatinib SUN in children under 1 year of age. Based on the response to treatment, your doctor may decide to increase or decrease the dose, or even interrupt treatment for a short time. To take higher or lower doses, it may be necessary to use a combination of tablets of different strengths.

How to take Dasatinib SUN

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 divided tablets. If the tablets are crushed or divided, it is not certain that you 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 tablets should wear protective gloves.

How long to take Dasatinib SUN

Take Dasatinib SUN every day, unless your doctor tells you to stop. Make sure you take Dasatinib SUN for as long as your doctor has told you.

Taking more Dasatinib SUN than prescribed

If you accidentally take more tablets than you should, tell 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 forgotten tablet. Take the 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 SUN 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 or black stools if you experience signs of infection such as fever, chills if you experience fever, mouth or throat ulcers, or skin rash Tell your doctor immediatelyif 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 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, 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), anaemia, fluid around the lungs

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

Infections: pneumonia, cytomegalovirus (CMV) infection, 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 Gastrointestinal disorders: loss of appetite, taste disturbance, bloating or swelling of the 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, hair loss, excessive sweating, vision disturbances (including blurred vision), dry eyes, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalised swelling Kidney and urinary disorders: kidney failure (including rare cases that were fatal) 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 heart rhythm, neutropenic fever, gastrointestinal bleeding, high uric acid levels in the blood

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

Heart and lungs: heart attack (including fatal cases), pericarditis, irregular heartbeat, chest pain due to reduced 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) Gastrointestinal disorders: pancreatitis, stomach ulcers, oesophagitis, abdominal swelling, anal fissure, difficulty swallowing, cholecystitis, bile duct obstruction, gastro-oesophageal reflux (a condition in which acid and other stomach contents flow back up into the throat) Skin, hair, eyes, general disorders: 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 causes 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 (including blurred vision), 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 reduced blood flow to the bone, leading to bone loss and bone death), arthritis, swelling of the skin at any site in the body Pain: inflammation of the veins which can cause redness, pain and swelling, tendon inflammation Brain and nervous system: 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, irregular heart rhythm, enlarged heart muscle, liver inflammation, protein in the urine, increased creatine phosphokinase activity (an enzyme found mainly in the heart, brain and skeletal muscle), increased troponin levels (an enzyme found mainly in the heart and skeletal muscle), 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 1000 people)

Heart and lungs: enlarged right heart chamber, heart muscle inflammation, a condition characterized by blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of heart function), coronary artery disease (heart disease), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs Gastrointestinal disorders: malabsorption of nutrients from the gut, such as proteins, intestinal obstruction, anal fistula, kidney damage, diabetes Skin, hair, eyes, general disorders: seizures, optic neuritis which can cause total or partial loss of vision, purple spots on the skin, hyperthyroidism, thyroid inflammation, lack of coordination (a condition related to poor muscle coordination), difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring Brain and nervous system: stroke, transient 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; growth retardation

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

Pneumonia Gastrointestinal bleeding which can be fatal Reactivation (flare-up) 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 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 the 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 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 SUN

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 or carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions 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 SUN contains

The active substance 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, 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 a smooth surface 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 a smooth surface 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 a smooth surface 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 a smooth surface 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 a smooth surface 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 a smooth surface on the other. Dasatinib SUN 20 mg, 50 mg or 70 mg film-coated tablets are available in cardboard boxes 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 cardboard boxes containing 30 x 1 film-coated tablet in single-dose blisters. Not all pack sizes may be marketed.

Marketing authorisation holder

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

Manufacturer

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 authorised 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