Label:information for the user

Dasatinib Teva 20 mg film-coated tablets

Dasatinib Teva 50 mg film-coated tablets

Dasatinib Teva 70 mg film-coated tablets

Dasatinib Teva 100 mg film-coated tablets

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctoror pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,evenif they are not listed in this label. See section 4.

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

2.What you need to knowbeforestarting totake Dasatinib Teva

3.How to take Dasatinib Teva

4.Possible side effects

5.Storage of Dasatinib Teva

6.Contents of the pack and additional information

Dasatinib Teva 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 Teva inhibits the growth of these leukemia cells.

Dasatinib Teva 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 Teva inhibits the growth of these leukemia cells.

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

Do not take dasatinib

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

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to takedasatinib

• if you are takingblood thinnersor medications to prevent blood clots (see “Taking dasatinib with other medicines”)
• if you have or have had any liver or heart problems
• if you start toexperience difficulty breathing, chest pain, or coughingwhile taking dasatinib: this may be a sign of fluid retention in the lungs or chest (which may be more common in patients aged 65 or older) or due to changes in the blood vessels that supply blood to the lungs
• if you have ever had or could have a current infection with the hepatitis B virus. This is because dasatinib could make hepatitis B become active again, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.
• if you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Teva, contact your doctor. This may be a sign of a condition known as microangiopathic thrombotic anemia (MAT).

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

Children and adolescents

Do not administer this medicine to children under 1 year of age. The experience with the use of dasatinib in this age group is limited. In children taking dasatinib, close monitoring of growth and bone development is required.

Taking Dasatinib Teva with other medicines

Inform your doctor or pharmacistif you aretaking, havetakenrecentlyor may need to take any other medicine.

Dasatinib is primarily metabolized by the liver. Some medicines may interfere with the effect of dasatinib when taken together.

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

• ketoconazole, itraconazole –antifungal medicines
• erythromycin, clarithromycin, telithromycin –antibiotics
• ritonavir – anantiviral medicine
• phenytoin, carbamazepine, phenobarbital – treatments forepilepsy
• rifampicin – a treatment fortuberculosis
• famotidine, omeprazole – medicines thatblock stomach acid secretion
• St. John's Wort – a plant-based medicine that is purchased over-the-counter for the treatment ofdepressionand other diseases (also known asHypericum perforatum)

Do not takemedicines that neutralize stomach acid (antacidssuch as aluminum hydroxide/magnesium hydroxide) in the2 hours before or 2 hours after taking dasatinib

Inform your doctorif you are takingblood thinnersor medications to prevent blood clots.

Taking Dasatinib Teva with food and drinks

Do not takedasatinib with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

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

It is recommended that both men and women use effective contraceptive methods during dasatinib treatment.

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

Driving and operating machinery

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

Dasatinib Teva contains lactose

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

Dasatinib Teva contains sodium

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

Dasatinib will only be prescribed by an experienced doctor in the treatment of leukemia. Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Dasatinib is prescribed for adults and children at least 1 year old.

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

The recommended initial dosefor adult patients with CML in the accelerated phase or in blast crisis or LLA Ph+ is 140 mg once a day.

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

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

aNo se recomienda los comprimidos en pacientes que pesen menos de 10 kg; se debe usar el polvo para suspensión oral en estos pacientes.

No hay recomendación de dosis para dasatinib en niños de menos de 1 año de edad.

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

How to takeDasatinib Teva

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. The tablets can be taken with or without food.

Special handling instructions for Dasatinib Teva

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

How long to take Dasatinib Teva

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 Teva than you should

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

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. It is recommended to bring the package insert and the medication packaging to the healthcare professional.

If you forgot to takeDasatinib Teva

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following may be signs of serious side effects:

• If you have chest pain, difficulty breathing, coughing, and fainting
• If you have an unexpected bleeding or bruising without injury
• If you observe blood in vomit, stools, or urine or have black stools
• If you develop symptoms of infection, such as fever, intense chills
• If you have fever, mouth or throat pain, itching, or skin and mucous membrane peeling

Contact your doctor immediatelyif you notice any of the above.

Very common side 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: skin 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 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 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, gastroesophageal reflux, mouth 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, petechiae, depression, insomnia, hot flashes, dizziness, bruises (ecchymoses), anorexia, somnolence, generalized edema
• Pain: joint pain, muscle weakness, chest pain, foot and hand pain, chills, muscle stiffness and joint stiffness, muscle spasms
• Laboratory tests: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, gastrointestinal bleeding, elevated blood uric acid levels

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

• Heart and lungs:heart attack (including fatal outcomes), pericarditis, irregular heartbeat, angina due to reduced blood flow to the heart, low blood pressure, narrowing of the airways that could cause breathing difficulties, asthma, high blood pressure in the arteries that supply the lungs
• Digestive problems:pancreatitis, peptic ulcer, intestinal inflammation, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux
• 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 can cause redness or pain, skin disease characterized by sensitivity, redness, well-defined patches with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, visual disturbances, increased eye bleeds, skin color changes, subcutaneous fat inflammation, skin ulcers, skin blisters, nail changes, hair changes, hand and foot changes, kidney failure, urinary frequency, gynecomastia in men, menstrual changes, general weakness and discomfort, low thyroid function, balance problems while walking, osteonecrosis (a disease where blood flow to the bones is reduced, causing bone loss and death), arthritis, skin swelling in any part of the body
• Pain: vein inflammation that can cause redness, sensitivity, and swelling, tendon inflammation
• Brain: memory loss
• Laboratory tests: abnormal blood test results and possibly renal insufficiency caused by tumor breakdown 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), increased gamma-glutamyl transferase (an enzyme mainly found in the liver), chylous pleurisy (fluid with a milky appearance around the lungs)

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

• Heart and lungs:right ventricular dilation, myocarditis, acute coronary syndrome (a group of symptoms produced by the blockage of blood flow to the heart muscle), heart attack (interruption of blood flow to the heart) coronary artery disease (of the heart), pericarditis, blood clots, blood clots in the lungs
• Digestive problems:loss of vital nutrients such as protein from the digestive system, intestinal obstruction, anal fistula (abnormal opening of the anus to the skin surrounding the anus), renal insufficiency, diabetes
• Skin, hair, eyes, general:seizure, optic nerve inflammation that can cause complete or partial vision loss, blue or purple patches on the skin, abnormally elevated thyroid function, thyroid gland inflammation, ataxia (associated with muscle coordination loss), difficulty walking, spontaneous abortion, inflammation of the skin of the blood vessels, cutaneous fibrosis
• Brain:stroke, transient ischemic attack (a temporary lack of blood flow to the brain), facial nerve paralysis, dementia
• Immune system:severe allergic reactions
• Connective tissue and musculoskeletal:delayed fusion of rounded ends that form joints (epiphysis); slow or delayed growth

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

• Pneumonitis
• Bleeding in the stomach or intestines 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, skin blisters, and mucous membrane ulcers
• Renal disorders with symptoms such as edema and abnormal laboratory test results such as protein in urine and low protein levels in blood
• Damage to blood vessels 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 your treatment.

Reporting 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label of the bottle, blister pack or caseafter CAD. The expiration date is the last day of the month indicated.

Blister pack: Store in the original packaging to protect from moisture. This medication does not require any special storage temperature.

Bottle: Store in the original packaging to protect from moisture. Keep the bottle perfectly closed. This medication does not require any special storage temperature.

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and

medicines that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthecontainers and themedicines that you no longerneed. By doing so, you will help protect the environment.

Composition of Dasatinib Teva

• The active ingredient is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, or 100 mg of dasatinib (as monohydrate).
• The other components are:
• Core tablet: lactose monohydrate (see section 2 “Dasatinib Teva contains lactose”), microcrystalline cellulose (E460(i)), hydroxypropylcellulose (E463), croscarmellose sodium, magnesium stearate
• Film coating: hypromellose, titanium dioxide (E171), triacetin (E1518)

Appearance of the product and contents of the package

Dasatinib Teva 20 mg: round, white to off-white film-coated tablet with beveled edges and “20” engraved on one face of the tablet, approximately 5.6 mm in diameter.

Dasatinib Teva 50 mg: oval-shaped, white to off-white film-coated tablet with beveled edges and “50” engraved on one face of the tablet, approximately 10.8 x 5.8 mm in size.

Dasatinib Teva 70 mg: round, white to off-white film-coated tablet with beveled edges and “70” engraved on one face of the tablet, approximately 8.8 mm in diameter.

Dasatinib Teva 100 mg: oval-shaped, white to off-white film-coated tablet with beveled edges and “100” engraved on one face of the tablet, approximately 14.8 x 7.2 mm in size.

Dasatinib Teva 20 mg, 50 mg, and 70 mg film-coated tablets are available in packages containing 30 and 60 film-coated tablets in blisters or packages containing 56 and 60 film-coated tablets in perforated unit-dose blisters. They are also available in bottles with child-resistant closures and silica gel desiccants containing 60 film-coated tablets. Each carton contains one bottle.

Dasatinib Teva 100 mg film-coated tablets are available in packages containing 30 film-coated tablets in blisters or packages containing 30 film-coated tablets in perforated unit-dose blisters. They are also available in bottles with child-resistant closures and silica gel desiccants containing 30 film-coated tablets. Each carton contains one bottle.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

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

GermanyDasatinib-ratiopharm 20 mg, 50 mg, 70 mg, 80 mg, 100 mg Filmtabletten

SpainDasatinib Teva 20 mg, 50 mg, 70 mg, and 100 mg film-coated tablets EFG

NorwayDasatinib Teva Pharma B.V.

Last revision date of thissummary of product characteristics:May 2022

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