Dasatinib Sandoz

Package Leaflet: Information for the Patient

Dasatinib Sandoz, 100 mg, Film-Coated Tablets

Dasatinib

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

Table of Contents of the 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 pack 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 acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph+) and lymphoblastic blast crisis of CML in adults, adolescents, and children aged 1 year and above, who have not responded to previous treatment. 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 medicines to thin your blood or prevent blood clots (see "Dasatinib Sandoz and other medicines");
• 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 in the lungs or around the heart (which may be more common in people aged 65 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, tiredness, and confusion. Contact your doctor, as these may be signs 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 medicines

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

Medicines that must not be taken with Dasatinib Sandoz:

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

Do not takemedicines 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 medicinesor medicines 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 pregnancyunless it is absolutely necessary. Your doctor will discuss with you the possible risks of 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 with experience in treating leukemia. Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. This medicine is for adults and children aged 1 year and above.

Recommended starting dose for adult patients with chronic phase CML is 100 mg once daily.

Recommended starting dose for adult patients with accelerated phase CML, blast crisis CML, or Ph+ ALL is 140 mg once daily.

Dosing for children with CML or Ph+ ALL is based on body surface area.

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 for you based on your body weight, side effects, and response to treatment. The starting dose of Dasatinib Sandoz is calculated 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. Depending on your response to treatment, your doctor may adjust the dose, or even interrupt treatment for a short time. To take higher or lower doses, it may be necessary to use a combination of tablets of different strengths.

Tablets may be available in calendar packs. These are blister packs 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. Tablets should be swallowed whole, without

crushing, breaking, or chewing.Do not take a crushed tablet. If a tablet is crushed, broken, chewed, or crushed, it cannot be guaranteed 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 Dasatinib Sandoz tablets 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

Dasatinib Sandoz should be taken every day until your doctor tells you to stop. Make sure you take the medicine for as long as your doctor has prescribed.

What to do if you take more Dasatinib Sandoz than you should

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

What to do if you miss a dose of Dasatinib Sandoz

Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time. If you have any further questions on the use of 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, stool, 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 up to 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 swelling of the abdomen, colitis, constipation, heartburn, mouth ulcers, 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 (bruises), loss of appetite, drowsiness, generalized swelling
• Pain:joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness
• Test results:fluid around the heart, fluid in the lungs, heart rhythm disturbances, neutropenic fever, gastrointestinal bleeding, high uric acid levels in the blood

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

• Heart and lungs:heart attack (including cases that were fatal), inflammation of the sac (fibrous sac) around the heart, irregular heart rhythm, chest pain due to lack of blood flow to the heart (angina pectoris), low blood pressure, narrowing of the airways that can cause difficulty breathing, asthma, increased blood pressure in the arteries (blood vessels) in the lungs
• Digestive disorders:pancreatitis, stomach ulcer, 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, pus-filled bumps, hearing loss, sensitivity to light, blurred vision, 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 disease in which there is a reduced blood supply to the bone, leading to bone loss and death)
• 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 the 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 up to 1 in 1,000 people)

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

fluid in the lungs or around the heart

• Digestive disorders:malabsorption of nutrients from the gut, such as protein, bowel obstruction, anal fistula, 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, overactive thyroid gland, thyroid inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, blood vessel inflammation in the skin, 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 closure of the growth plates in bones (epiphyseal growth plates), which can affect bone growth

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

• pneumonia
• stomach or intestinal bleeding, which can be fatal
• reactivation of viral hepatitis B in patients who have had it before
• a reaction that includes fever, blistering of the skin, and ulcers of the mucous membranes
• 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 any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 which is stated on the bottle, blister, and carton after "EXP". The expiry date refers to the last day of that 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 pack and other information

What Dasatinib Sandoz contains

• The active substance is dasatinib. Each film-coated tablet contains 100 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 pack

White or almost white, biconvex, oval film-coated tablets with dimensions 14.8 mm x 7.2 mm, with "100" engraved on one side and smooth on the other. The film-coated tablets are packaged in a single-dose blister pack with aluminum/OPA/aluminum/PVC foil and placed in a carton box. Pack sizes: Carton box containing 30 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 about this medicine and its names in the European Economic Area member states, 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 leaflet:06/2023 Company logo