Dasatinib Sandoz

Package Leaflet: Information for the Patient

Dasatinib Sandoz, 50 mg, Film-Coated Tablets

Dasatinib

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dasatinib Sandoz and What is it Used For
• 2. Important Information Before Taking Dasatinib Sandoz
• 3. How to Take Dasatinib Sandoz
• 4. Possible Side Effects
• 5. How to Store Dasatinib Sandoz
• 6. Contents of the Package and Other Information

1. What is Dasatinib Sandoz and What is it Used For

Dasatinib Sandoz contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children aged 1 year and above. Leukemia is a cancer of white blood cells - cells in the blood that normally help the body fight infection. In people with chronic myeloid leukemia, the number of white blood cells increases in an uncontrolled way. Dasatinib Sandoz works by inhibiting the growth of these leukemia cells. Dasatinib Sandoz is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and lymphoid blast crisis CML in adults, adolescents, and children aged 1 year and above, who have previously been treated with other medications that have not been effective. In people with acute lymphoblastic leukemia, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Sandoz works by inhibiting the growth of these leukemia cells. If you have any questions about how Dasatinib Sandoz works or why it has been prescribed for you, ask your doctor.

2. Important Information Before Taking Dasatinib Sandoz

When Not to Take Dasatinib Sandoz

• if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).

If You Think You May be Allergic, Consult Your Doctor.

Warnings and Precautions

Before taking (or while taking) Dasatinib Sandoz, discuss with your doctor or pharmacist if:

• you are taking medications to thin your blood or prevent blood clots (see "Dasatinib Sandoz and Other Medications");
• you have liver or heart problems, or have had them in the past;
• you experience difficulty breathing, chest pain, or cough while taking dasatinib;

chest pain or cough: these may be symptoms of fluid build-up in the lungs or chest cavity (which may be more common in people aged 65 years or older), or symptoms caused by changes in the blood vessels that supply blood to the lungs

• you have ever had or may currently have viral hepatitis B (dasatinib may cause reactivation of viral hepatitis B, which in some cases can be fatal). Before starting treatment, your doctor will carefully check if you have any symptoms of this infection.
• while taking Dasatinib Sandoz, you experience bruising, bleeding, fever, fatigue, and confusion. Contact your doctor, as these may be symptoms of blood vessel damage, known as thrombotic microangiopathy.

Your doctor will regularly check your condition to assess whether dasatinib is having the desired effect. While taking Dasatinib Sandoz, you will also have regular blood tests.

Children and Adolescents

This medicine must not be given to children under 1 year of age. Experience with dasatinib in this age group is limited. In children treated with dasatinib, bone growth and development should be carefully monitored.

Dasatinib Sandoz and Other Medications

Tell Your Doctorabout all medications you are currently taking or have recently taken, as well as any medications you plan to take. Dasatinib is mainly broken down in the liver. Some medications taken at the same time may interfere with its effects.

The Following Medications Must Not be Taken with Dasatinib Sandoz:

• ketokonazole, itraconazole - antifungal medications
• erythromycin, clarithromycin, telithromycin - antibiotics
• ritonavir - antiviral medication
• phenytoin, carbamazepine, phenobarbital - medications used to treat epilepsy
• rifampicin - medication used to treat tuberculosis
• famotidine, omeprazole - medications that reduce stomach acid production
• St. John's Wort ( Hypericum perforatum) - a herbal medicine available without prescription, used to treat depressionand other conditions.

Do Not Takemedications that reduce stomach acid (such as those containing aluminum or magnesium hydroxide) within 2 hours before or 2 hours after takingDasatinib Sandoz.Tell Your Doctorif you are taking blood-thinning medications or medications to prevent blood clots.

Dasatinib Sandoz with Food and Drink

Do not take Dasatinib Sandoz with grapefruit or grapefruit juice.

Pregnancy and Breastfeeding If You are Pregnant or Think You May be Pregnant, Tell Your Doctor Immediately.

Dasatinib Sandoz Must Not be Taken During Pregnancy, unless it is absolutely necessary. Your doctor will discuss the possible risks associated with taking dasatinib during pregnancy. Both men and women taking Dasatinib Sandoz are advised to use effective contraception during treatment. If You are Breastfeeding, Tell Your Doctor.Do not breastfeed while taking Dasatinib Sandoz.

Driving and Using Machines

If you experience side effects such as dizziness and blurred vision, be careful when driving or operating machinery.

Dasatinib Sandoz Contains Lactose and Sodium

If you have been told that you have an intolerance to some sugars, inform your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free".

3. How to Take Dasatinib Sandoz

Dasatinib Sandoz is prescribed only by a doctor experienced in treating leukemia. This medicine should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist. The medicine is for use in adults and children aged 1 year and above.

Recommended Initial Dose for Adult Patients with Chronic Phase CML is 100 mg Once Daily.

Recommended Initial Dose for Adult Patients with Advanced Phase CML or Ph+ ALL is 140 mg Once Daily.

Dosing for Children with CML or Ph+ ALL is Based on Body Weight.

The medicine is taken orally once daily. It is not recommended to take Dasatinib Sandoz tablets in patients with a body weight below 10 kg. For patients with a body weight below 10 kg and patients who cannot swallow tablets, a powder for oral suspension may be available. When changing the formulation (i.e., tablets and powder for oral suspension), the dose may need to be adjusted, so do not change one formulation to another. Your doctor will determine the appropriate formulation and dose based on your body weight, side effects, and response to treatment. The initial dose of Dasatinib Sandoz is based on body weight as follows: Do not give tablets to patients with a body weight below 10 kg; for these patients, a powder for oral suspension may be available. No dosing recommendations are available for children under 1 year of age.

Tablets May be Available in Calendar Packs. These are blisters with the days of the week marked. Arrows indicate the next tablet to be taken according to the prescribed treatment schedule.

How to Take Dasatinib Sandoz Tablets Should be Taken Once Daily at the Same Time.

Swallow the Tablets Whole, without crushing, breaking, or chewing. Do not take a crushed tablet. If a tablet is crushed, broken, chewed, or crushed, it is not certain that the correct dose of the medicine has been taken. Dasatinib Sandoz can be taken with or without food.

Special Instructions for Handling Dasatinib Sandoz

Breaking a Dasatinib Sandoz tablet is unlikely, but if it happens, people other than the patient should use disposable gloves when handling the tablets.

How Long to Take Dasatinib Sandoz

Take Dasatinib Sandoz once daily until your doctor tells you to stop. Make sure you take the medicine for as long as your doctor has prescribed.

Taking More Than the Prescribed Dose of Dasatinib Sandoz

If you accidentally take too many tablets, contact your doctor immediately. Medical attention may be necessary.

Missing a Dose of Dasatinib Sandoz

Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms That May Indicate a Serious Side Effect:

• chest pain, difficulty breathing, cough, and fainting
• unexpected bleeding or bruisingwithout previous injury
• blood in vomit, stools, or urine, black stools
• infection symptoms, such as fever, severe chills
• fever, mouth or throat pain, blistering or peeling of skin and (or) mucous membranes If you notice any of these symptoms, contact your doctor immediately.

Very Common Side Effects (may affect more than 1 in 10 people)

• Infections(including bacterial, viral, and fungal infections)
• Heart and lungs: shortness of breath
• Digestive disorders:diarrhea, nausea, or vomiting
• Skin, hair, eyes, general disorders:skin rash, fever, swelling of the face, hands, and feet, headache, feeling tired or weak, bleeding
• Pain:muscle pain (during or after treatment), abdominal pain
• Test results:low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs

Common Side Effects (may affect less than 1 in 10 people)

• Infections: pneumonia, viral infection (including cytomegalovirus - CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases that were fatal)

severe infection of the blood or tissues, which can be life-threatening

• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakening of the heart muscle, high blood pressure in the lungs, cough
• Digestive disorders:loss of appetite, taste disorders, bloating or abdominal distension, colitis, constipation, heartburn, mouth sores, weight gain, weight loss, stomach inflammation
• Skin, hair, eyes, general disorders:tingling of the skin, itching, dry skin, acne, skin inflammation, ringing in the ears, hair loss, excessive sweating, vision disturbances (including double vision and vision disturbances), dry eyes, bruising, depression, insomnia, flushing, dizziness, injuries (bruising), anorexia, somnolence, generalized swelling
• Pain:joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness, muscle spasms
• Test results:fluid around the heart, fluid in the lungs, irregular heart rhythm, febrile neutropenia, gastrointestinal bleeding, high uric acid levels in the blood

Uncommon Side Effects (may affect less than 1 in 100 people)

• Heart and lungs:heart attack (including cases that were fatal), inflammation of the sac (fibrous bag) surrounding the heart, irregular heart rhythm, chest pain due to lack of blood flow to the heart (angina), low blood pressure, narrowing of the airways, which can cause difficulty breathing, asthma, increased blood pressure in the arteries (blood vessels) in the lungs
• Digestive disorders:pancreatitis, stomach ulcers, esophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux disease (a condition in which stomach acid and stomach contents back up into the esophagus)
• Skin, hair, eyes, general disorders:allergic reaction, including hives, itching, swelling, and difficulty breathing, anxiety, confusion, mood changes, decreased libido, fainting, tremors, eye inflammation causing redness or pain, skin disease characterized by sensitive, red, lumps, sudden appearance of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, vision disturbances, increased tearing, skin discoloration, inflammation of the fatty tissue under the skin, skin ulcers, blistering of the skin, nail disorders, hair disorders, hand-foot syndrome, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, hypothyroidism, balance disturbances while walking, bone death (a condition in which there is reduced blood flow to the bone, leading to bone tissue loss and death), joint inflammation, skin swelling at any site
• Pain:vein inflammation, which can cause redness, tenderness, and swelling, tendon inflammation
• Brain:memory loss
• Test results:tumor lysis syndrome (a condition caused by the breakdown of cancer cells), low albumin levels in the blood, low lymphocyte count (a type of white blood cell) in the blood, high cholesterol levels in the blood, lymph node swelling, brain bleeding, irregular heart rhythm, heart muscle enlargement, liver inflammation, protein in the urine, increased creatine kinase activity (an enzyme found mainly in the heart, brain, and skeletal muscle), increased troponin levels (a protein found mainly in heart muscle and skeletal muscle), increased gamma-glutamyltransferase activity (an enzyme found mainly in the liver), milky fluid around the lungs (chylous effusion)

Rare Side Effects (may affect less than 1 in 1000 people)

• Heart and lungs:enlargement of the right heart chamber, heart muscle inflammation, acute coronary syndrome (a condition caused by blockage of blood flow to the heart), cardiac arrest (stoppage of heart function), coronary artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs

fluid build-up in the lungs or chest cavity, which can cause difficulty breathing

• Digestive disorders:malabsorption of nutrients from the gut, such as protein, intestinal obstruction, anal fistula (an abnormal passage between the anus and the skin), kidney dysfunction, diabetes
• Skin, hair, eyes, general disorders:seizures, optic nerve inflammation, which can cause total or partial loss of vision, purple spots on the skin, excessive thyroid activity, thyroid inflammation, ataxia (a condition characterized by lack of muscle coordination), difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• Brain:stroke, transient neurological disturbances due to lack of blood flow, facial nerve paralysis, dementia
• Immune system:severe allergic reaction
• Musculoskeletal and Connective Tissue Disorders:delayed bone growth or growth retardation

Other reported side effects include ( frequency not known - cannot be estimated from available data
based on available data):

• pneumonia
• stomach or intestinal bleeding, which can be life-threatening
• reactivation of viral hepatitis B in patients who have had the infection in the past
• a reaction characterized by fever, blistering of the skin, and mouth sores
• kidney disease with symptoms including swelling and abnormal test results, such as protein in the urine and low protein levels in the blood
• blood vessel damage known as thrombotic microangiopathy, including low red blood cell count, low platelet count, and blood clots.

Your doctor will monitor you for some of these side effects.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Dasatinib Sandoz

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the bottle, blister, and carton after "EXP". The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Dasatinib Sandoz Contains

• The active substance is dasatinib. Each film-coated tablet contains 50 mg of dasatinib.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E 171), talc, glycerol monostearate, sodium lauryl sulfate.

What Dasatinib Sandoz Looks Like and Contents of the Package

White or almost white, biconvex, oval film-coated tablets with dimensions 10.9 mm x 5.8 mm ± 5%, with "50" engraved on one side and smooth on the other side. The film-coated tablets are packaged in a single-dose blister of aluminum/OPA/aluminum/PVC and placed in a carton. Pack sizes: The carton contains 60 x 1 film-coated tablets in single-dose blisters.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate
3056 Limassol, Cyprus

For More Information on This Medicinal Product, Please Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of Last Revision of the Package Leaflet: 06/2023

Company Logo