DASATINIB STADA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Dasatinib Stada 50 mg film-coated tablets EFG

Dasatinib Stada 70 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• 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 signs of illness 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 thepackage leaflet

1. What is Dasatinib Stada and what is it used for
2. What you need to know before you take Dasatinib Stada
3. How to take Dasatinib Stada
4. Possible side effects
5. Storage of Dasatinib Stada
6. Contents of the pack 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 leukaemia (CML) in adults, adolescents, and children aged 1 year and above. Leukaemia 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 start to multiply out of control. Dasatinib inhibits the growth of these leukaemic cells.

Dasatinib is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) in adults, adolescents, and children aged 1 year and above, and lymphoid blast crisis CML in adults who have not benefited 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 leukaemic cells.

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

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

Do not take Dasatinib Stada

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

If you think you may beallergic, consult yourdoctor.

Warnings andprecautions

Consult your doctor or pharmacist before starting dasatinib.

if you are takingmedicines to make your blood more fluidor prevent blood clots (see Use of dasatinib with other medicines)

if you have or have had any liver or heart problems

if you start to havedifficulty breathing, chest pain or coughwhile taking dasatinib: this may be a sign of fluid build-up in the lungs or chest (which may be more frequent in patients 65 years or older) or due to 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 could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will carefully 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 thrombotic microangiopathy (TMA).

Your doctor will regularly check your condition to see if dasatinib is having the desired effect. You will also have regular blood tests while taking dasatinib.

Children andadolescents

Do not give this medicine to children under 1 year of age. Experience with the use of dasatinib in this age group is limited. In children taking dasatinib, growth and bone development should be closely monitored.

Other medicines and Dasatinib Stada

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

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

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

ketoconazole, itraconazole - medicines for fungi

erythromycin, clarithromycin, telithromycin - antibiotics

ritonavir - an antiviral medicine

phenytoin, carbamazepine, phenobarbital - treatments for epilepsy

rifampicin - a treatment for tuberculosis

famotidine, omeprazole - medicines that block stomach acid secretion

St. John's Wort - a herbal medicine that can be bought without a prescription for the treatment of depression and other diseases (also known asHypericum perforatum)

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

Tell your doctor if you are taking medicines to make your blood more fluid or prevent blood clots.

Taking Dasatinib Stada with food anddrinks

Do not take dasatinib with grapefruit or grapefruit juice

Pregnancy andbreast-feeding

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

Both men and women are advised to use effective contraceptive methods during treatment with dasatinib.

If you are breast-feeding, tell your doctor. You should interrupt breast-feeding while taking dasatinib.

Driving and usingmachines

Be careful when driving or using 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 an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Dasatinib Stada

Dasatinib will only be prescribed by a doctor with experience in the treatment of leukaemia. Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again. Dasatinib is prescribed for adults and children aged 1 year and above.

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 blast crisis or Ph+ ALL is 140 mg once a day.

Dosing regimen in children with CML in the chronic phase or Ph+ ALL based on body weight: dasatinib is administered orally once a day, either as tablets or as powder for oral suspension. Dasatinib tablets are not recommended in patients weighing less than 10 kg. The powder for oral suspension should be used in patients weighing less than 10 kg and in patients who cannot swallow tablets. A dose change may be required when changing between formulations (i.e., tablets and powder for oral suspension), so do not change from one formulation to another.

Your doctor will decide on the correct formulation and dose based on your weight, side effects, and response to treatment. In children, the initial dose of dasatinib is calculated based on body weight as shown below:

aDasatinib tablets are not recommended in patients weighing less than 10 kg; the powder for oral suspension should be used in these patients.

There is no dosage recommendation for dasatinib in children under 1 year of age.

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

How to take Dasatinib Stada

Take the tablets at the same time each day.Swallow the tablets whole. Do not crush, cut, or chew them. Do not take the tablets dissolved. You cannot be sure you are getting the correct dose if you crush, cut, chew, or dissolve the tablets. Dasatinib tablets can be taken with or without food.

Special handling instructions for Dasatinib Stada

It is unlikely that dasatinib tablets will break, but if they do, people other than the patient should wear gloves when handling dasatinib.

How long to take Dasatinib Stada

Take dasatinib every day until your doctor tells you to stop. Make sure you take dasatinib for the duration prescribed by your doctor.

If you take more Dasatinib Stada than youshould

If you accidentally take too many tablets, consult your doctor immediately. You may need medical attention.

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

If you forget to take Dasatinib Stada

Do not take a double dose to make up for forgotten doses. Take the next scheduled dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following may be signs of serious adverse effects:

? If you have chest pain, difficulty breathing, coughing, and fainting

? If you have unexpected bleeding or bruisingwithout injury

? If you notice blood in your vomit, stools, or urine, or have black stools

? If you develop infection symptoms, such as fever, intense chills

? If you have fever, pain in the mouth or throat, itching, or skin peeling and/or mucous membranes

Contact your doctor immediatelyif you notice any of the above.

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

? Infections (caused by bacteria, viruses, and fungi)

? Heart and lungs: difficulty breathing

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

? Skin, hair, eyes, general: rash, fever, swelling in the face, hands, and feet, headache, fatigue or weakness, bleeding

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

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

Common adverse 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 fatal outcomes)

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

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

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

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

? Laboratory tests: fluid around the heart, fluid in the lungs, heart arrhythmias, febrile neutropenia, deficiency in all blood cells, gastrointestinal bleeding, high uric acid levels in the blood

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

? Heart and lungs: heart attack (including fatal outcome), inflammation of the membrane surrounding the heart (fibrous sac), irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of the airways that could cause breathing difficulties, asthma, high blood pressure in the arteries (blood vessels) that go to the lungs

? Digestive problems: pancreas inflammation, peptic ulcer, digestive tract inflammation, abdominal swelling, anal canal skin tear, difficulty swallowing, gallbladder inflammation, bile duct blockage, gastroesophageal reflux (stomach acid and other contents return to the throat)

? Skin, hair, eyes, general: allergic reactions including sensitivity, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, low sex drive, fainting, tremors, eye inflammation that can cause redness or pain, skin disease characterized by sensitivity, redness, well-defined spots with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, visual disturbance, increased eye tearing, skin color changes, inflammation of the fatty tissue under the skin, skin ulcers, skin blisters, nail changes, hair changes, changes in hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual changes, general weakness and malaise, low thyroid function, loss of balance while walking, osteonecrosis (a disease where blood supply to the bones is reduced, which can cause bone loss and death), arthritis, skin swelling anywhere on the body

? Pain: inflammation of the veins that can cause redness, sensitivity, and swelling, tendon inflammation

? Brain: memory loss

? Diagnostic tests: abnormal blood test results and possibly kidney failure caused by tumor waste products in the process of healing (tumor lysis syndrome), low albumin levels in the blood, low lymphocyte levels (a type of white blood cell) in the blood, high cholesterol levels in the blood, lymph node swelling, cerebral bleeding, irregular heart activity, enlarged heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin (an enzyme found mainly in the heart and skeletal muscle), increased gamma-glutamyl transferase (an enzyme found mainly in the liver), milky fluid around the lungs (chylotorax)

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

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

? Digestive problems: loss of vital nutrients such as proteins from the digestive system, intestinal obstruction, anal fistula (abnormal opening of the anus to the surrounding skin), kidney failure, diabetes

? Skin, hair, eyes, general: convulsions, inflammation of the optic nerve that can cause complete or partial vision loss, bluish-purple spots on the skin, abnormally high thyroid function, thyroid gland inflammation, ataxia (associated with loss of muscle coordination), difficulty walking, spontaneous abortion, skin blood vessel inflammation, skin fibrosis

? Brain: stroke, temporary episode of neurological failure caused by loss of blood flow, facial nerve paralysis, dementia

? Immune system: severe allergic reactions

? Connective tissue and musculoskeletal disorders: delayed fusion of the rounded ends that form joints (epiphysis); slow or delayed growth

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

? Lung inflammation

? Bleeding in the stomach or intestine that can cause death

? 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 ulcers

? Kidney disorders with symptoms such as edema 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), which includes decreased red blood cell count, decreased platelet count, and blood clot formation

Your doctor will check if you have any of these effects during your treatment.

Reporting of adverse effects

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

5. Storage of Dasatinib Stada

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

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

This medicine does not require special storage conditions.

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Dasatinib Stada

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

Core of the tablet:lactose monohydrate (200); microcrystalline cellulose (101 and 102); sodium croscarmellose; hydroxypropylcellulose (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 package contents

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

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

Dasatinib Stada 50 mg is available in packages containing 56 or 60 tablets in blister packs, or in packages containing 56 x 1 or 60 x 1 tablets in single-dose blister packs. It is also available in bottles with 60 tablets.

Dasatinib Stada 70 mg is available in packages containing 56 or 60 tablets in blister packs, or in packages containing 56 x 1 or 60 x 1 tablets in single-dose blister packs. It is also available in bottles with 60 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Synthon Hispania, S.L.

C/Castelló, 1

08830 Sant Boi de Llobregat

Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

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

Germany Dasatinib Heumann 50 mg Filmtabletten

Dasatinib Heumann 70 mg Filmtabletten

Spain Dasatinib Stada 50 mg film-coated tablets EFG

Dasatinib Stada 70 mg film-coated tablets EFG

Estonia Dasatinib Norameda

Finland Dasatinib Avansor 50 mg tablet, film-coated / tablet, film-coated

Greece ASATINIB/FARAN

Hungary Dasatinib Onkogen 50 mg film-coated tablet

Dasatinib Onkogen 70 mg film-coated tablet

Latvia Dasatinib Norameda 50 mg film-coated tablets

Dasatinib Norameda 70 mg film-coated tablets

Lithuania Dasatinib Norameda 50 mg film-coated tablets

Dasatinib Norameda 50 mg film-coated tablets

Netherlands Dasatinib Synthon 50 mg, film-coated tablets

Dasatinib Synthon 70 mg, film-coated tablets

Sweden Dasatinib Avansor 50 mg tablet, film-coated

Date of the last revision of this leaflet:November 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/