DASATINIB TEVA 100 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the user

Dasatinib Teva 20 mg film-coated tablets EFG

Dasatinib Teva 50 mg film-coated tablets EFG

Dasatinib Teva 70 mg film-coated tablets EFG

Dasatinib Teva 100 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Dasatinib Teva and what is it used for
2. What you need to know before taking Dasatinib Teva
3. How to take Dasatinib Teva
4. Possible side effects
5. Storage of Dasatinib Teva
6. Contents of the pack and further information

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

Dasatinib Teva contains the active substance dasatinib. This medication 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 out of control. Dasatinib Teva inhibits the growth of these leukemic cells.

Dasatinib Teva is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults, adolescents, and children at least 1 year of age, 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 Teva inhibits the growth of these leukemic cells.

If you have any questions about how Dasatinib Teva works or why it has been prescribed for you, consult your doctor.

2. What you need to know before taking Dasatinib Teva

Do not take dasatinib

• if you are allergicto dasatinib or any of the other components of this medication (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 take dasatinib

• if you are taking medications to make your blood more fluidor prevent blood clots (see "Taking dasatinib with other medications")
• if you have or have had any liver or heart problems
• if you start to have difficulty breathing, chest pain, or coughwhile taking dasatinib: this may be a sign of fluid retention 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 Teva, contact your doctor. This may be a sign of damage to the blood vessels known as thrombotic microangiopathy (TMA).

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

Children and adolescents

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

Taking Dasatinib Teva with other medications

Tell your doctor or pharmacistif you are taking, have recently taken, or may need to take any other medication.

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

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

• ketoconazole, itraconazole - antifungal medications
• erythromycin, clarithromycin, telithromycin - antibiotics
• ritonavir - an antiviral medication
• phenytoin, carbamazepine, phenobarbital - treatments for epilepsy
• rifampicin - a treatment for tuberculosis
• famotidine, omeprazole - medications that block stomach acid secretion
• St. John's Wort - a herbal medication that can be purchased without a prescription for the treatment of depressionand other diseases (also known as Hypericum perforatum)

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

Tell your doctorif you are taking medications to make your blood more fluidor prevent blood clots.

Taking Dasatinib Teva with food and drinks

Do not take dasatinib with grapefruit or grapefruit juice.

Pregnancy and breast-feeding

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 treatment with dasatinib.

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

Driving and using machines

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

Dasatinib Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Dasatinib Teva contains sodium

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

3. How to take Dasatinib Teva

Dasatinib will only be prescribed by a doctor with experience in treating leukemia. Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again. Dasatinib is prescribed for adults and children at least 1 year of age.

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

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:

a Dasatinib tablets are not recommended in patients who weigh less than 10 kg; the powder for oral suspension should be used in these patients.

There is no recommended dose 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 temporarily interrupt treatment. To take higher or lower doses, you may need to take combinations of tablets of different concentrations.

How to take Dasatinib Teva

Take the tablets at the same time every 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 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 wear gloves when handling dasatinib.

How long to take Dasatinib Teva

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

If you take more Dasatinib Teva than you should

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, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the leaflet and the medication packaging to the healthcare professional.

If you forget to take Dasatinib Teva

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 about the use of this medication, 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:

unexpected bleeding or bruisingwithout injuryinfection symptoms, such as fever, intense chills

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: 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 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, gastroesophageal reflux, mouth ulcers, weight loss, weight gain, gastritis
• Skin, hair, eyes, general: tingling sensation on 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 hands and feet, chills, muscle and joint stiffness, muscle spasms
• Laboratory tests: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, 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 (pericarditis), irregular heartbeat, chest pain due to reduced blood flow 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: pancreatitis, peptic ulcer, inflammation of the digestive tract, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, 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, and well-defined spots with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, visual disturbances, 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, changes in menstruation, general weakness and discomfort, low thyroid function, loss of balance while walking, osteonecrosis (a disease where blood flow 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
• Laboratory tests: abnormal blood test results and possible kidney failure caused by tumor waste products during healing (tumor lysis syndrome), low albumin levels in the blood, low lymphocyte levels in the blood, high cholesterol levels in the blood, swollen lymph nodes, 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), elevated 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 (chylothorax)

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Heart and lungs: dilation of the right ventricle of the heart, heart muscle inflammation, set of symptoms produced by blockage of blood flow to the heart muscle (acute coronary syndrome), heart attack (interruption of blood flow 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: seizures, 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 vessel inflammation, skin fibrosis
• Brain: stroke, temporary episode of neurological insufficiency caused by loss of blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reactions
• Connective tissue and musculoskeletal system: 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 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, skin blisters, 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 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 Teva

Keep this medicine out of sight and reach of children.

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

Blister: Store in the original package to protect from moisture. This medicine does not require any special storage temperature.

Bottle: Store in the original package to protect from moisture. Keep the bottle tightly closed. This medicine does not require any special storage temperature.

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

6. Package Contents and Additional Information

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 ingredients are:
• Core of the tablet: lactose monohydrate (see section 2 "Dasatinib Teva contains lactose"), microcrystalline cellulose (E460(i)), hypromellose (E463), croscarmellose sodium, magnesium stearate
• Film coating: hypromellose, titanium dioxide (E171), triacetin (E1518)

Appearance of the Product and Package Contents

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

Dasatinib Teva 50 mg: film-coated tablet, oval, white to off-white with beveled edges and "50" engraved on one side of the tablet, approximately 10.8 x 5.8 mm.

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

Dasatinib Teva 100 mg: film-coated tablet, oval, white to off-white with beveled edges and "100" engraved on one side of the tablet, approximately 14.8 x 7.2 mm.

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 single-dose perforated blisters. They are also available in bottles with child-resistant closures and silica gel desiccant containing 60 film-coated tablets. Each box contains one bottle.

Dasatinib Teva 100 mg film-coated tablets are available in packages containing 30, 60, and 120 film-coated tablets in blisters or packages containing 30, 60, and 120 film-coated tablets in single-dose perforated blisters. They are also available in bottles with child-resistant closures and silica gel desiccant containing 30 film-coated tablets. Each box contains one bottle.

Not all 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

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

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

Germany Dasatinib-ratiopharm 20 mg, 50 mg, 70 mg, 80 mg, 100 mg film-coated tablets

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

Norway Dasatinib Teva Pharma B.V.

Date of the last revision of this leaflet:May 2022

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/)