Package Leaflet: Information for the User

Dasatinib Viatris 20mg Film-Coated Tablets

Dasatinib Viatris 50mg Film-Coated Tablets

Dasatinib Viatris 70mg Film-Coated Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Dasatinib Viatris

3.How to take Dasatinib Viatris

4.Possible side effects

5.Storage of Dasatinib Viatris

6.Contents of the pack and additional information

This medicine contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children of at least 1 year. 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. This medicine inhibits the growth of these leukemia cells.

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

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

Do not take Dasatinib Viatris

• If you are allergic to dasatinib or any of the other components of this medication (listed in section6).

Consult your doctor if you think you may be allergic.

Warnings and precautions

Consult your doctor or pharmacist before starting to takethis medication

• If you are taking medications to thin the blood or prevent clots (see “Other medications and Dasatinib Viatris”).
• If you have or have had any liver or heart problems.
• If you start to have difficulty breathing, chest pain, or cough while takingthis medication: this may be a sign of fluid retention in the lungs or chest (which may be more common in patients aged 65years or older) or due to changes in the blood vessels that supply blood to the lungs.
• If you have ever had or could have hepatitis B virus infection at this time. This is becausethis medicationcould 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 takingthis medication, contact your doctor. This may be a sign of blood vessel damage known as microangiopathic thrombocytopenic purpura (MAT).

Your doctor will monitor your condition periodically to check ifthis medicationhas the desired effect. You will also have blood tests periodically while receiving this medication.

Children and adolescents

Do not administer this medication to children under one year of age. Experience with the use ofthis medicationin this age group is limited. In children takingthis medication, closely monitor growth and bone development.

Other medications and Dasatinib Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication is primarily metabolized by the liver. Some medications may interfere with the effect ofthis medicationwhen taken together.

The following medications should not be used during treatment with dasatinib:

• Ketoconazole, itraconazole– antifungal medications.
• Erythromycin, clarithromycin, telithromycin– antibiotics.
• Ritonavir– an antiviral medication.
• Phenytoin, carbamazepine, phenobarbital– epilepsy treatments.
• Rifampicin– a tuberculosis treatment.
• Famotidine, omeprazole– medications that block stomach acid secretion.
• St. John's Wort– a plant-based medication obtained without a prescription for the treatment of depression and other diseases (also known asHypericum perforatum).

Do not take medications thatneutralizestomach acid (antacids such as aluminum hydroxide/magnesium hydroxide) in the 2hours before or 2hours after takingthis medication.

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

Taking Dasatinib Viatris with food and drinks

Do not take this medication with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

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

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

If you are breastfeeding, inform your doctor. You should stop breastfeeding while takingthis medication.

Driving and operating machinery

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

Dasatinib Viatris contains lactose and sodium

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

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

This medication will only be prescribed by a doctor with experience in leukemia treatment. Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, ask your doctor or pharmacist. This medication is prescribed for adults and children at least 1 year old.old.

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

The initial recommended dose for adult patients with CML in accelerated phase or in blast crisis or Ph+ ALL is 140mg once a day.

Dosing schedule in children with CML in chronic phase or Ph+ ALL based on body weight. Dasatinib is administered orally once a day, both in tablets and in oral powder for suspension. Dasatinib tablets are not recommended for patients weighing less than 10kg. The oral powder for suspension should be used in patients weighing less than 10kg 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 initial dose ofthis medicationis calculated based on body weight as shown below:

aNo dasatinib tablets are recommended for patients weighing less than 10kg, the oral powder for suspension should be used in these patients.

No dose recommendations are available forthis medicationin children under 1year old.

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 Viatris

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 ensured that you will receive the correct dose if you crush, cut, chew, or disperse the tablets. Dasatinib tablets can be taken with or without food.

Special handling instructions for dasatinib

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

How long to take this medication

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

If you take more Dasatinib Viatris 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.

If you forgot to take Dasatinib Viatris

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

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 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 experience any of the above.

Side effectsvery common(may affect more than 1 in 10people)

• 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.

Side effectscommon(may affect up to 1 in 10people)

• 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: skin prickling, itching, dry skin, acne, skin inflammation, persistent ear ringing, hair loss, excessive sweating, visual disturbances (including blurred vision and distorted vision), dry eyes, petechiae, depression, insomnia, hot flashes, dizziness, bruises, 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, heart arrhythmias, febrile neutropenia, gastrointestinal bleeding, elevated blood uric acid levels.

Side effectsuncommon(may affect up to 1 in 100people)

• Heart and lungs: heart attack (including fatal outcomes), pericarditis (inflammation of the membrane surrounding the heart), 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) leading to the lungs.
• Digestive problems: pancreatitis, peptic ulcer, intestinal inflammation, abdominal swelling, anal skin tear, difficulty swallowing, gallbladder inflammation, bile duct blockage, gastroesophageal reflux (acid and other stomach contents return to the throat).

-Skin, hair, eyes, general: allergic reactions including sensitivity, red skin bumps (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 tearing, skin color changes, subcutaneous tissue inflammation, skin ulcers, skin blisters, nail changes, hair changes, hand and foot changes, kidney failure, urinary frequency, increased breast size 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 waste products in the healing process (tumor lysis syndrome), low albumin levels in blood, low lymphocyte levels in blood, elevated 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), chylous pleurisy (fluid with a milky appearance around the lungs).

Side effectsrare(may affect up to 1 in 1,000people)

• Heart and lungs: right ventricular dilation, heart muscle inflammation, 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), 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 system, intestinal obstruction, anal fistula (abnormal opening of the anus to the skin surrounding the anus), renal insufficiency, diabetes.
• Skin, hair, eyes, general: convulsions, optic nerve inflammation that can cause complete or partial vision loss, blue or purple skin patches, abnormally elevated thyroid function, thyroid gland inflammation, ataxia (associated with muscle coordination loss), difficulty walking, spontaneous abortion, skin inflammation of blood vessels, cutaneous fibrosis.
• Brain: cerebral hemorrhage, transient neurological insufficiency caused by reduced blood flow, facial nerve paralysis, dementia.
• Immune system: severe allergic reactions.
• Connective tissue and musculoskeletal: delayed fusion of rounded ends forming joints (epiphysis); slow or delayed growth.

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

• Pulmonary inflammation.
• Bleeding in the stomach or intestines that can cause death.
• Recurrence (reactivation) of hepatitis B virus infection if you 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 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 the 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 packaging after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of Dasatinib Viatris

• The active ingredient is dasatinib. Each film-coated tablet contains 20mg, 50mg or 70mg of dasatinib.
• The other components are:

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

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

(see section2 “Dasatinib Viatris contains lactose and sodium”)

Appearance of the product and contents of the pack

Dasatinib Viatris 20mg: the film-coated tablets (tablets) are white to off-white, biconvex, round, with a diameter of approximately 5.6mm with “D7SB” engraved on one face and “20” on the other.

Dasatinib Viatris 50mg: the film-coated tablets (tablets) are white to off-white, biconvex, oval, with a length of approximately 11.0mm and a width of approximately 6.0mm, with “D7SB” engraved on one face and “50” on the other.

Dasatinib Viatris 70mg: the film-coated tablets (tablets) are white to off-white, biconvex, round, with a diameter of approximately 9.1mm with “D7SB” engraved on one face and “70” on the other.

Dasatinib Viatris 20mg, 50mg and 70mgfilm-coated tablets are available in packs containing 56 or 60film-coated tablets in blisters or containing 56 x 1 or 60× 1film-coated tablets in single-dose blisters. They are also available in packs containing 60film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Synthon Hispania S.L.

Castelló, 1 - Polígono Las Salinas

08830 - Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the member states of the European Economic Area with the following names:

Last review date of this leaflet:July 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/