Prospect: information for theuser

Dasatinib Stada 50 mg film-coated tablets

Dasatinib Stada 70 mg film-coated tablets

Read this prospect carefully before starting to take this medicinebecauseit contains important information foryou.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor orpharmacist.
• This medicine has been prescribed only to you, and you must not give it to otherpeoplealthough they may have the same symptoms as you, as it mayharm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

Content ofthe prospect

1.What is Dasatinib Stada and for what it isused

2.What you need to know before starting to take Dasatinib Stada

3.How to take Dasatinib Stada

4.Possible adverseeffects

5.Storage of Dasatinib Stada

6.Contents of the package and additionalinformation

Dasatinib Stada contains the active ingredient dasatinib. This medicine is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children at least 1 year of age. Leukemia is a type of cancer of the white blood cells. These white blood cells usually help the body fight infections. In patients with CML, a type of white blood cell called granulocytes begin to multiply uncontrollably. Dasatinib inhibits the growth of these leukemia cells.

Dasatinib is also used to treat acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positive (Ph+) in adults, adolescents, and children at least 1 year of age and CML lymphoblastic lymphoma in adults who do not benefit from previous treatments. In patients with ALL, a type of white blood cell called lymphocytes multiply too quickly and live too long. Dasatinib inhibits the growth of these leukemia cells.

If you have any doubts about how dasatinib works or why you have been prescribed this medicine, consult your doctor.

Do not take Dasatinib Stada

??if you areallergicto dasatinib or any of the other ingredients in this medicine(listed in section6).

If you think you may be allergic, consult yourdoctor.

Warnings andprecautions

Consult your doctor or pharmacist before starting to take dasatinib.

??if you are takingblood thinnersor medications to prevent blood clots(seeDasatinib and othermedicines)

??if you have or have had any liver or heart problems

??if you start to have difficulty breathing, chest pain or cough while taking dasatinib: this may be a sign of fluid retention in the lungs or chest(which may be more common in patients aged 65 years or older) or due to changes in the blood vessels that supply blood to thelungs

?if you have ever had or could have hepatitis B infection. This is because dasatinib could make hepatitis B active again,whichcan be fatal in some cases. Your doctor shouldcarefully check for signs of this infection before starting treatment.

??if you experience bruising, bleeding, fever, fatigue and confusion while taking dasatinib,contact your doctor. This may be a sign of damage to the blood vessels known as microangiopathic haemolytic anaemia(MAHA).

Your doctor will monitor your condition regularly to check if dasatinib is having the desired effect.Regular blood tests will also be done while you are taking dasatinib.

Children andadolescents

Do not administer this medicine to children under one year of age. The experience with the use of dasatinib in this age group is limited. In children taking dasatinib, their growth and bone development should be closelymonitored.

Other medicines and Dasatinib Stada

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any othermedicine.

Dasatinib is mainly broken down by the liver. Some medicines may interfere with the effect of dasatinib when takentogether.

The following medicines should not be used during treatment with Dasatinib Stada::

??ketoconazole, itraconazole – antifungal medicines

??erythromycin, clarithromycin, telithromycin –antibiotics

??ritonavir – an antiviral medicine

??phenytoin, carbamazepine, phenobarbital – epilepsy treatments

??rifampicin – a treatment for tuberculosis

??famotidine, omeprazole – medicines that block stomach acid secretion

??St. John's Wort – a plant-based medicine that can be bought over the counter for the treatment of depression and other conditions(also known asHypericum perforatum)

Do not take medicines that neutralize stomach acid (antacids such as aluminium hydroxide/magnesium hydroxide) in the 2 hours before or 2 hours after taking dasatinib.

Inform your doctor if you are taking medicines to thin the blood or prevent blood clots.

Taking Dasatinib Stada with food anddrinks

Do not take dasatinib with grapefruit or grapefruit juice.

Pregnancy andbreastfeeding

If you are pregnant or think you may be pregnant, inform your doctor immediately. Dasatinib should not be used during pregnancy unless it is clearly necessary. Your doctor will inform you of the potential risk of taking dasatinib during pregnancy.

Both men and women should use effective contraceptive methods during treatment with dasatinib.

If you are breastfeeding, inform your doctor. You should stop breastfeeding while taking dasatinib.

Driving and operatingmachines

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

Dasatinib Stada containslactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Dasatinib will only be prescribed by an experienced doctor in the treatment ofleukemia.Follow exactly the administration instructions for this medication indicated by yourdoctor.In case of doubt, consult your doctor or pharmacist again. Dasatinib is prescribed for adultsandchildren of at least 1 year ofage.

The recommended initial dose for adult patients with CML in the chronic phase is 100 mg once a day.

The recommended initial dose for adult patients with CML in the accelerated phase or in blast crisis orPh+ ALL is 140 mg once aday.

Dosing schedule in children with CML in the chronic phase or Ph+ ALL based on body weightdasatinib is administered orally once a day in both tablets and oral powder forsuspension. Dasatinib tablets are not recommended in patients weighing less than 10 kg.Theoral powder for suspension should be used in patients weighing less than 10 kg and in patients whocannotswallow tablets. A change in dose can be made when switching betweenformulations (i.e., tablets and oral powder for suspension), so do not change from one formulation totheother.

Your doctor will decide on the correct formulation and dose based on your weight, side effects, andresponse to treatment. In children, the starting dose of dasatinib is calculated based on body weight asshownbelow:

No tablets are recommended in patients weighing less than 10 kg, the oral powder for suspension should be used in these patients.

No dose recommendation is available for dasatinib in children under 1 year ofage.

Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose, or eveninterruptthe treatment briefly. To take higher or lower doses, you may need to take combinations of tablets of differentconcentrations.

How to take Dasatinib Stada

Take the tablets at the same time every day.Swallow the tablets whole. Do not crush, cut, or chew. Do not take the tablets dissolved. It cannot be guaranteed that you will receive the correct dose if you crush, cut, chew, or disperse the tablets. Dasatinib tablets can be taken with or withoutfood.

Special instructions for handling Dasatinib Stada

It is unlikely that dasatinib tablets will break, but if they break, people who are not patients should use gloves when handlingdasatinib.

For how long to take Dasatinib Stada

Take dasatinib daily until your doctor tells you to stop treatment.Make sure to take dasatinib for the time prescribed.

If you take more Dasatinib Stada than youshould

If you accidentally take too many tablets, consult your doctorimmediately.You may need medicalattention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dasatinib Stada

Do not take a double dose to make up for the missed doses. Take the next scheduled dose at the usualtime.

If you have any other questions about the use of this medication, ask your doctor orpharmacist.

Like all medicines, this medicine can cause side effects, althoughnoteveryone will experience them.

The following may be signs of serious side effects:

??If you have chest pain, difficulty breathing, coughing, anddesmayos

??If you have an unexpected bleeding or bruising withoutinjury

??If you observe blood in vomit, stools, or urine, or have blackstools

??If you developsymptoms of infection, such as fever, chillsintensos

??If you have fever, pain in themouth or throat, itching, or peeling of the skin and/or mucousmembranes

Contact your doctor immediatelyif you notice any of theabove.

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

??Infections (caused by bacteria, viruses, andfungi)

??Heart and lungs: difficulty breathing

??Digestive problems: diarrhea, feeling unwell (nausea, vomiting)

??Skin, hair, eyes, general: skin rash, fever, swelling in the face, hands, andfeet, headache, fatigue or weakness, hematomas

??Pain: muscle pain (during or after stopping treatment), abdominalpain

??Laboratory tests: low platelet count, low white blood cell count (neutropenia), anemia, fluid around thelungs

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

??Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases with fataloutcomes)

??Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, high blood pressure in thelungs, cough

??Digestive problems: changes in appetite, changes in taste, abdominal distension or swelling, colon inflammation, constipation, gastroesophageal reflux, oral ulceration, weight gain, gastritis

??Skin, hair, eyes, general: skin pruritus, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, visual disturbances (including blurred vision and distorted vision), dry eyes, carotenemia, depression, insomnia, hot flashes, dizziness, bruises (hematomas), anorexia, somnolence, generalized edema

?Pain: joint pain, muscle weakness, chest pain, pain in the legs and hands, chills, muscle stiffness and joint stiffness, muscle spasms

??Laboratory tests: fluid around the heart, fluid in the lungs, arrhythmias, neutropenic fever, deficiency in all blood cells, gastrointestinal hemorrhage, high uric acid levels in the blood

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

??Heart and lungs: heart attack (including fatal outcome), pericarditis, irregular heartbeat, angina due to reduced blood supply to the heart, low blood pressure, respiratory tract narrowing that may cause breathing difficulties, asthma, high blood pressure in the arteries (vasosanguineous) that go to the lungs

??Digestive problems: pancreatitis, peptic ulcer, gastrointestinal tract inflammation, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux (acid and other stomach contents return to the throat)

??Skin, hair, eyes, general: allergic reactions including sensitivity, red bumps on the skin (erythema nodosum), anxiety, confusion, mood swings, low libido, fainting, tremors, eye inflammation that may cause redness or pain, skin disease characterized by sensitivity, redness, well-defined patches with the sudden appearance of fever and elevated white blood cell count (dermatitis neutrophilica), hearing loss, light sensitivity, visual disturbances, increased eye injuries, skin color changes, inflammation of subcutaneous fat, skin ulceration, blisters on the skin, nail changes, hair changes, hand and foot changes, kidney failure, urinary frequency, breast enlargement in men, menstrual changes, general weakness and discomfort, low thyroid function, loss of balance while walking, osteonecrosis (a disease where blood supply to bones is reduced, causing bone loss and death), arthritis, skin swelling in any part of the body.

??Pain: inflammation of veins that may cause redness, sensitivity, and swelling, inflammation of tendons

??Brain: memory loss

??Complementary examinations: abnormal results in blood tests and possibly renal insufficiency caused by tumor waste products in the healing process (tumor lysis syndrome), low albumin levels in blood, low lymphocyte levels in blood, high cholesterol levels in blood, lymph node swelling, cerebral hemorrhage, irregular heart activity, dilated heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme mainly found in the heart, brain, and skeletal muscle), increased troponin (an enzyme mainly found in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme mainly found in the liver), fluid with a milky appearance around the lungs (pleural effusion).

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

??Heart and lungs: right ventricular dilation, myocardial inflammation, acute coronary syndrome (a group of symptoms produced by the blockage of blood supply to the heart muscle), heart attack (interruption of blood supply to the heart), coronary artery disease (of the heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs

??Digestive problems: loss of vital nutrients such as protein from the digestive apparatus, intestinal obstruction, anal fistula (abnormal opening of the anus to the skin surrounding the anus), renal insufficiency, diabetes

??Skin, hair, eyes, general: convulsions, inflammation of the optic nerve that may cause complete or partial loss of vision, blue or purple spots on the skin, abnormal thyroid function, inflammation of the thyroid gland, ataxia (associated with muscle coordination loss), difficulty walking, spontaneous abortion, inflammation of the skin of blood vessels, cutaneous fibrosis

??Brain: cerebral hemorrhage, episode of neurological insufficiency caused by blood flow loss, facial nerve paralysis, dementia

??Immune system: severe allergic reactions

??Connective tissue and musculoskeletal: delayed fusion of rounded ends that form joints (epiphysis); slow orretardedgrowth

Other side effects that have been reported with unknown frequency (cannot be estimated from available data)

??Pulmonary inflammation

??Bleeding in the stomach or intestine that may causedeath

??Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection)

??Reaction with fever, blisters on the skin, and mucous membrane ulceration

??Renal disorders with symptoms such as edema and abnormal laboratory test results such as protein in urine and low protein levels inblood

??Vascular damage known as microangiopathic thrombosis (MAT), which includes decreased red blood cell count, decreased platelet count, and blood clot formation.

Your doctor will check if you have any of these side effects during yourtreatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of thecontainer, blister pack or packagingafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dasatinib Stada

• The active ingredient is dasatinib. Each film-coated tablet contains 50 mg or 70 mg of dasatinib..
• The other components are:

Core tablet:lactose monohydrate (200); microcrystalline cellulose (101 and 102); croscarmellose sodium; hydroxypropyl cellulose (MW 80,000); magnesium stearate.

Film coating:lactose monohydrate; hypromellose (15 mPas); titanium dioxide (E171); triacetin.

(See section 2 "Dasatinib Stada contains lactose and sodium”).

Appearance of the product and contents of thepackage

Dasatinib Stada 50 mg: film-coated tablet, white to off-white, biconvex, oval, approximately 11.0 mm in length and approximately 6.0 mm in width, with "D7SB" engraved on one face and "50" on the other.

Dasatinib Stada 70 mg: film-coated tablet, white to off-white, biconvex, round, with a diameter of approximately 9.1 mm, with "D7SB" engraved on one face and "70" on the other.

Dasatinib Stada 50 mg is available in packages containing 56 or 60 film-coated tablets in blisters, or in packages containing 56 x 1 or 60 x 1 film-coated tablets in unit-dose blisters. It is also available in bottles with 60 film-coated tablets.

Dasatinib Stada 70 mg is available in packages containing 56 or 60 film-coated tablets in blisters, or in packages containing 56 x 1 or 60 x 1 film-coated tablets in unit-dose blisters. It is also available in bottles with 60 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Responsible manufacturer

Synthon Hispania, S.L.

Castelló, 1

08830 Sant Boi de Llobregat

Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyDasatinib Heumann 50 mg Filmtabletten

Dasatinib Heumann 70 mg Filmtabletten

SpainDasatinib Stada 50 mg film-coated tablets

Dasatinib Stada 70 mg film-coated tablets

EstoniaDasatinib Norameda

FinlandDasatinib Avansor 50 mg tabletti, kalvopäällysteinen / tablett, filmdragerad

GreeceASATINIB/FARAN

HungaryDasatinib Onkogen 50 mg filmtabletta

Dasatinib Onkogen 70 mg filmtabletta

LithuaniaDasatinib Norameda 50 mg plevele dengtos tabletes

Dasatinib Norameda 70 mg apvalkotas tabletes

NetherlandsDasatinib Synthon 50 mg, filmomhulde tabletten

Dasatinib Synthon 70 mg, filmomhulde tabletten

SwedenDasatinib Avansor 50 mg tablett, filmdragerad

Last review date of this leaflet:November 2023.

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/