Patient Information Leaflet

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
Dasatinibum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm
someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or
pharmacist. See section 4.
Contents of the leaflet:

What Dasatinib SUN is and what it is used for
What you need to know before taking Dasatinib SUN
How to take Dasatinib SUN
Possible side effects
How to store Dasatinib SUN
Contents of the pack and other information

1. What Dasatinib SUN is and what it is 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 at least 1 year.
Leukaemia is a cancer of the white blood cells. Normally, white blood cells help the body fight
infection. In people with CML, white blood cells called granulocytes grow uncontrollably.
Dasatinib SUN inhibits the growth of these leukaemic cells.
Dasatinib SUN is also used to treat Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukaemia (ALL) in adults, adolescents and children aged at least 1 year, as well
as for the lymphoid blast phase of CML in adults who have not responded to prior therapy. In
people with acute lymphoblastic leukaemia, white blood cells called lymphocytes multiply too
quickly and live too long. Dasatinib SUN inhibits the growth of these leukaemic cells.
If you have any questions about how Dasatinib SUN works or why it has been prescribed for
you, please consult your doctor.

2. Important information before taking Dasatinib SUN

When not to take Dasatinib SUN
if the patient is allergic to dasatinib or any of the other ingredients
of this medicine (listed in section 6).
Patients should consult their doctor if they suspect an allergic reaction may occur.
Warnings and precautions
Before starting treatment with Dasatinib SUN, patients should discuss this with their doctor or
pharmacist.
if they are taking blood-thinning medicines or medicines that prevent blood clots (see section “Dasatinib SUN and other medicines”)
if the patient has previously or currently has liver or heart function disorders
if the patient experiences difficulty breathing, chest pain, or cough during treatment with Dasatinib SUN: this may be a sign of fluid accumulation in the lungs or
chest cavity (which may occur more frequently in patients aged 65 years and
older) or may be caused by changes in blood vessels supplying blood to the lungs
if the patient has ever had or may currently have hepatitis B virus infection; this is because Dasatinib SUN may reactivate hepatitis B virus infection, which in
some cases may lead to death. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.
if the patient experiences bruising, bleeding, fever, fatigue, or confusion during treatment with Dasatinib SUN, they should contact their doctor immediately. These symptoms may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).
The doctor will periodically monitor the patient's health status during treatment to assess whether Dasatinib SUN is producing the intended effect. Regular blood tests will also be performed during treatment with Dasatinib SUN.
Children and adolescents
Dasatinib SUN should not be used in children under one year of age. Data on the use of Dasatinib SUN in this age group are limited. Growth and development should be closely monitored in children receiving Dasatinib SUN.
Dasatinib SUN and other medicines
Patients should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Dasatinib SUN is mainly metabolized in the liver. Certain medicines may affect the action of Dasatinib SUN when taken concomitantly.
The following medicines should not be used with Dasatinib SUN:
ketoconazole, itraconazole – antifungal medicines
erythromycin, clarithromycin, telithromycin – antibiotics
ritonavir – an antiviral medicine
phenytoin, carbamazepine, phenobarbital – medicines used in epilepsy
rifampicin – a medicine used to treat tuberculosis
famotidine, omeprazole – medicines that reduce stomach acid secretion
St. John’s wort – a herbal medicine available without prescription, used in the treatment of depression and other conditions (also known as Hypericum perforatum)
Patients should avoid taking medicines that neutralize stomach acid (such as aluminium hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib SUN.
Patients should inform their doctor if they are taking medicines that thin the blood or prevent blood clots.
Taking Dasatinib SUN with food and drink
Patients should not take Dasatinib SUN with grapefruit or grapefruit juice.
Pregnancy and breastfeeding
Female patients who are pregnant or suspect they may be pregnant should inform their doctor. Dasatinib SUN should not be given to pregnant women unless absolutely necessary. The doctor will explain the potential risks associated with taking Dasatinib SUN during pregnancy.
It is recommended that both men and women use effective contraception during treatment with Dasatinib SUN.
Patients should inform their doctor if they are breastfeeding. Breastfeeding is not recommended during treatment with Dasatinib SUN.
Driving and operating machinery
If adverse effects such as dizziness or visual disturbances occur, patients should exercise particular caution when driving or operating machinery.
Dasatinib SUN contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should inform their doctor before taking this medicine.

3. How to take Dasatinib SUN

Dasatinib SUN should only be prescribed by a physician experienced in the treatment of
leukemia. This medicine must always be taken exactly as directed by the physician. If in
doubt, consult the physician or pharmacist. Dasatinib SUN is intended for use in adults and children aged at least 1 year.
The recommended initial dose for adult patients with chronic phase CML is 100 mg taken orally once daily.
The recommended initial dose for adult patients with accelerated phase or blast phase CML, or with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is 140 mg taken orally once daily.
Dosing in children with chronic phase CML or Ph+ ALL is based on body weight. The use of Dasatinib SUN tablets is not recommended in patients weighing less than 10 kg. In patients weighing less than 10 kg and in patients unable to swallow tablets, an alternative dasatinib formulation as an oral suspension powder should be used. When switching between formulations (i.e. tablets and oral suspension powder), the dose may change; therefore, patients should not switch from one formulation to another without medical advice.
Based on the patient's body weight, adverse reactions, and response to treatment, the physician will determine the appropriate formulation and dose. The initial dose of Dasatinib SUN in children, calculated according to body weight, is as follows:
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 and above 100 mg
a The use of tablets is not recommended in patients weighing less than 10 kg; in such patients, an oral suspension powder formulation should be used.
There are no dosage recommendations for Dasatinib SUN in children under 1 year of age.
Depending on the response to treatment, the physician may decide to increase or reduce the dose, or temporarily interrupt treatment. To achieve 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 each day. Tablets must be swallowed whole. Do not crush, split, or chew them. Do not take crushed tablets. If tablets are crushed, cut, chewed, or otherwise damaged, it cannot be ensured that the patient receives the correct dose. Dasatinib SUN tablets may be taken with or without food.
Special handling instructions for Dasatinib SUN
It is unlikely that Dasatinib SUN tablets will be damaged. However, in such a case, individuals handling Dasatinib SUN should wear protective gloves.
How long to take Dasatinib SUN
Dasatinib SUN should be taken daily until the physician decides to discontinue treatment. Ensure that Dasatinib SUN is taken for as long as recommended by the physician.
If you take more Dasatinib SUN than recommended
If a patient accidentally takes more tablets than recommended, contact the physician immediately, as medical attention may be required.
If you miss 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 the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
All of the symptoms listed below may indicate serious adverse reactions.
if chest pain, difficulty breathing, cough and fainting occur
if unexpected bleeding or bruising occurs without prior injury
if blood is present in vomit, stool or urine, or if the stool is black
in colour
if signs of infection such as fever, severe chills occur
if fever, mouth or throat pain, formation of blisters or peeling of the
skin and (or) mucous membranes occur
You should contact your doctor immediately if any of the symptoms
listed above occur.
Very common adverse reactions (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 symptoms: skin rash, fever, swelling of the face, hands and feet, headache, feeling tired or weak, bleeding
Pain: muscle pain (during treatment or after discontinuation), abdominal pain
Laboratory tests may show: too low platelet count, too low white blood cell count (neutropenia), anaemia, fluid around the lungs
Common adverse reactions (may affect less than 1 in 10 people)
Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infections, severe blood or tissue infection (including uncommon cases resulting in death)
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weakening of the heart muscle, high blood pressure, increased blood pressure in the lungs, cough
Gastrointestinal disorders: loss of appetite, taste disturbances, bloating or abdominal distension, inflammation of the large intestine, constipation, heartburn, mouth ulcers, weight gain, weight loss, stomach inflammation
Skin, hair, eyes, general symptoms: tingling, itchy skin, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred and impaired vision), dry eyes, bruising, depression, insomnia, sudden flushing of the skin, dizziness, injuries (bruises), loss of appetite, drowsiness, generalised swelling
Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, stiffness of muscles and joints, muscle cramps
Laboratory tests may show: fluid around the heart, fluid in the lungs, heart rhythm disturbances, neutropenic fever, gastrointestinal bleeding, high levels of uric acid in the blood
Uncommon adverse reactions (may affect less than 1 in 100 people)
Heart and lungs: heart attack (including fatal cases), inflammation of the lining (fibrous sac) around the heart, irregular heartbeat, chest pain due to lack of blood supply to the heart (angina pectoris), low blood pressure, narrowing of the airways which may cause breathing difficulties, asthma, increased blood pressure in the pulmonary arteries (blood vessels)
Gastrointestinal disorders: pancreatitis, peptic ulcer disease, oesophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, biliary tract obstruction, gastro-oesophageal reflux (a condition in which acid and other stomach contents flow back into the throat)
Skin, hair, eyes, general symptoms: allergic reactions, including formation of tender, red nodules on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremor, eye inflammation causing redness or pain, skin disease characterised by tender, red, well-defined skin lesions with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, visual disturbances, excessive tearing, skin pigmentation disorders, inflammation of subcutaneous fat tissue, skin ulceration, blistering of the skin, nail disorders, hair disorders, disorders of hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, reduced thyroid function, loss of balance while walking, bone necrosis (a condition in which reduced blood flow to the bone causes loss of bone mass and bone death), joint inflammation, skin swelling at any site on the body
Pain: vein inflammation which may cause redness, pain and swelling, tendon inflammation
Brain: memory loss
Laboratory tests may show: abnormal blood test results and possible kidney function disorders caused by tumour breakdown products (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 within the brain, irregular electrical activity of the heart, enlargement of the heart muscle, liver inflammation, presence of protein in the urine, increased creatine phosphokinase activity (an enzyme mainly present in the heart, brain and skeletal muscles), increased troponin levels (an enzyme mainly present in the heart and skeletal muscles), increased gamma-glutamyl transferase activity (an enzyme mainly present in the liver), milky fluid around the lungs (chylothorax).
Rare adverse reactions (may affect less than 1 in 1000 people)
Heart and lungs: enlargement of the right ventricle of the heart, myocarditis (inflammation of the heart muscle), acute coronary syndrome (a set of symptoms resulting from blocked blood flow to the heart muscle), cardiac arrest (cessation of blood ejection from the heart), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
Gastrointestinal disorders: loss of essential nutrients from the gastrointestinal tract such as proteins, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and surrounding skin), kidney function disorders, diabetes
Skin, hair, eyes, general symptoms: seizures, optic neuritis (inflammation of the optic nerve) which may cause complete or partial vision loss, blue-purple spots on the skin, hyperthyroidism, thyroid gland inflammation, ataxia (a condition associated with lack of muscle coordination), difficulty walking, miscarriage, cutaneous vasculitis (inflammation of blood vessels in the skin), skin fibrosis
Brain: stroke, transient neurological deficits caused by lack of blood flow, facial nerve paralysis, dementia
Immune system: severe allergic reaction
Musculoskeletal and connective tissue: delayed healing of rounded ends of bones (epiphyses) forming joints; delayed or slowed growth
Other observed adverse reactions with unknown frequency (frequency cannot be estimated from the available data)
Pneumonitis
Bleeding from the stomach or intestines, which may lead to death
Reactivation of hepatitis B virus infection (liver infection) in patients who have previously had this disease
Reaction with fever, blistering of the skin and mucosal ulceration

Kidney disease with symptoms including swelling and abnormal laboratory test results such as protein in the urine and low blood protein levels
Damage to blood vessels known as thrombotic microangiopathy (TMA), including reduced number of red blood cells, reduced platelet count and formation of blood clots
During treatment, your doctor will check whether any of the listed adverse reactions have occurred.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Dasatinib SUN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton following:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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 coated tablet contains 20 mg, 50 mg,
70 mg, 80 mg, 100 mg or 140 mg of dasatinib.
The other ingredients are:
Tablet core: monohydrate lactose (see section 2 “Dasatinib SUN contains
lactose”), sodium croscarmellose, hydroxypropylcellulose, magnesium stearate,
anhydrous colloidal silicon dioxide, calcium hydrogen 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, round, biconvex coated tablet with a diameter of 5.5 mm, embossed with the code “851” on one side and plain on the other side.
Dasatinib SUN 50 mg is a white or almost white, oval, biconvex coated tablet measuring 10.8 x 5.7 mm, embossed with the code “852” on one side and plain on the other side.
Dasatinib SUN 70 mg is a white or almost white, round, biconvex coated tablet with a diameter of 8.5 mm, embossed with the code “853” on one side and plain on the other side.
Dasatinib SUN 80 mg is a white or almost white, biconvex, triangular coated tablet measuring 10.210 x 9.916 mm, embossed with the code “854” on one side and plain on the other side.
Dasatinib SUN 100 mg is a white or almost white, oval, biconvex coated tablet measuring 14.7 x 7.0 mm, embossed with the code “855” on one side and plain on the other side.
Dasatinib SUN 140 mg is a white or almost white, round, biconvex coated tablet with a diameter of 11.0 mm, embossed with the code “856” on one side and plain on the other side.
Dasatinib SUN 20 mg, 50 mg or 70 mg coated tablets are available in cardboard boxes containing 60 x 1 coated tablet in single-dose blisters.
Dasatinib SUN 80 mg or 140 mg coated tablets are available in cardboard boxes containing 30 x 1 coated tablet in single-dose blisters.
Dasatinib SUN 100 mg coated tablets are available in cardboard boxes containing 30 x 1 or 60 x 1 coated tablets 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
The Netherlands
Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicinal product is authorised in the European Economic Area countries under the following names:
Romania: Dasatinib SUN